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Sunday, 16 September 2012

Econac Injection BP 75mg / 3ml

1. Name Of The Medicinal Product

Econac injection 75 mg / 3 ml

2. Qualitative And Quantitative Composition

One ampoule contains 75 mg diclofenac sodium in 3 ml injectable solution

3. Pharmaceutical Form

Solution for Injections

4. Clinical Particulars

4.1 Therapeutic Indications

Diclofenac ampoules are indicated in

- acute forms of pain, including renal colic

- exacerbations of osteo- and rheumatoid arthritis

- acute back pain

- acute gout

- acute trauma and fractures

- post-operative pain

4.2 Posology And Method Of Administration

Adults:

One ampoule once (or in severe cases twice) daily intramuscularly by deep intragluteal injection into the upper outer quadrant. If two injections daily are required it is advised that the alternate buttock be used for the second injection. Econac injection 75 mg / 3 ml should not be given for more than 2 days; if necessary, treatment can be continued with tablets or suppositories.

Econac injection 75 mg / 3 ml should not be administered by intravenous injection.

Renal colic: One 75 mg ampoule intramuscularly.

A further ampoule may be administered after 30 minutes if necessary.

The recommended maximum daily dose of 150 mg in any combination of the three formulations of Econac should not be exceeded.

Elderly:

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dosage be used and for the shortest possible duration The patient should be monitored regularly for Gl bleeding during NSAID therapy.

Children (aged 1 - 12 years):

Econac injection 75 mg/3 ml is not suitable for children.

Advice:

The solution should be injected slowly and securely intramuscularly after a control aspiration. A depot into the vicinity of nerves should be avoided. If more severe pain or malaise occurs during the injection, the procedure should be discontinued.

Diclofenac ampoules are friable ampoules with a break under a blue point. The coloured rings at the neck of the ampoules are of significance to the company as they are necessary for identification of ampoules before labelling.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms(see section 4.4).

4.3 Contraindications

Hypersensitivity to diclofenac or any of the excipients mannitol, propylene glycol, benzyl alcohol, sodium metabisulphite, sodium hydroxide.

- Active or history of recurrent peptic ulcer /haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

- History of gastro-intestinal bleeding or perforation, related to previous NSAIDs therapy

- Previous sensitivity to diclofenac

- NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e g attacks of asthma, urticaria , angioedema or acute rhinitis) in response to ibuprofen, aspirin or other non-steroidal anti- inflammatory drugs.

- Severe heart failure, hepatic failure and renal failure (see section 4.4).

- During the last trimester of pregnancy (see section 4 6)

4.4 Special Warnings And Precautions For Use

Warnings:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

The use of Econac injection with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2)

Cardiovascular, Renal and Hepatic impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics or recovering from major surgery and the elderly. Renal function should be monitored in these patients (see also section 4.3). The lowest effective dose should be used. Effects on renal function are usually reversible on withdrawal of Econac injection 75 mg/3 ml.

Gastro-intestinal: Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history suggestive of gastro-intestinal ulceration, with ulcerative colitis or with Crohn's disease, bleeding diathesis or haematological abnormalities.

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Gastro-intestinal bleeding or ulcerative/perforation, haematemesis and melaena have in general more serious consequences in the elderly. They can occur at any time during treatment with or without warning symptoms or a previous history. In the rare instances where gastro-intestinal bleeding or ulceration occurs in patients receiving Econac injection 75 mg/3 ml the drug should be withdrawn.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e g misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, Anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents; such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Econac injection, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

Hepatic: Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).

Dermatological

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Econac injection should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Hypersensitivity reactions: As with other nonsteroidal anti-inflammatory drugs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.

Precautions:

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Respiratory disorders:

Caution is required if administered to patients suffering from, or with a previous history of bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients

Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Econac injection 75mg/3 ml should be discontinued. Hepatitis may occur without prodromal symptoms. Use of Econac injection 75 mg/3 ml in patients with hepatic porphyria may trigger an attack.

Haematological: Econac injection 75mg/3 ml may reversibly inhibit platelet aggregation (see anticoagulants in 'drug interactions').

Long-term treatment: All patients who are receiving non-steroidal anti-inflammatory agents should be monitored as a precautionary measure e.g. renal function, hepatic function (elevation of liver enzymes may occur) and blood counts. This is particularly important in the elderly.

Impaired female fertility

The use of Econac injection may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Econac injection should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drug interactions: digoxin: Econac injection 75 mg/3 ml may increase plasma concentrations of digoxin.

Lithium: Decreased elimination of lithium

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants such as warfarin (see section 4.4). Although clinical investigations do not appear to indicate that Econac injection 75 mg/3 ml has an influence on the effect of anticoagulants, there are isolated reports of an increased risk of haemorrhage with the combined use of diclofenac and anticoagulant therapy. Therefore, to be certain that no change in anticoagulant dosage is required, close monitoring of such patients is required. As with other non-steroidal anti-inflammatory agents, diclofenac in high dose can reversibly inhibit platelet aggregation.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4)

Antidiabetic agents: Clinical studies have shown that Econac injection 75 mg/3 ml can be given together with oral antidiabetic agents without influencing their clinical effect. However there have been isolated reports of hypoglycaemic and hyperglycaemic effects which have required adjustment to the dosage of hypoglycaemic agents.

Cyclosporin: Increased risk of nephrotoxicity. Cases of nephrotoxicity have been reported in patients receiving concomitant cyclosporin and NSAIDS, including Econac injection 75 mg/3 ml. This might be mediated through combined renal antiprostaglandin effects of both the NSAID and cyclosporin.

Methotrexate: Decreased elimination of methotrexate. Cases of serious toxicity have been reported when methotrexate and NSAIDS are given within 24 hours of each other. This interaction is mediated through accumulation of methotrexate resulting from impairment of renal excretion in the presence of the NSAID.

Quinolone antimicrobials: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Convulsions may occur due to an interaction between quinolones and NSAIDS. This may occur in patients with or without a previous history of epilepsy or convulsions. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients who are already receiving an NSAID.

Other analgesics including cyclooxygenase—2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4. 4)

Other NSAIDS and steroids: Co-administration of Econac injection 75 mg/3 ml with other systemic NSAIDS and steroids may increase the frequency of unwanted effects. Concomitant therapy with aspirin lowers the plasma levels of each, although no clinical significance is known.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see sec 4.4)

Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Various NSAIDS are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, hence serum potassium should be monitored

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels

Anti-hypertensives: Reduced anti-hypertensive effect

Tacrolimus: Possible increased risk of nephrotoxicity when NSAlDs are given with tacrolimus

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine

4.6 Pregnancy And Lactation

Pregnancy:

Econac injection 75 mg/3 ml should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern Use of prostaglandin synthetase inhibitors may result in premature closure of the ductus arteriosus or uterine inertia, such drugs are therefore not recommended during the last trimester of pregnancy. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 43) NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.

Lactation:

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

See section 4.4 Special warnings and precautions for use, regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea (approximately 6 - 14 % of patients), flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (See section 4.4) have been reported following administration. Also minor gastrointestinal blood loss which in exceptional cases may cause anaemia. Occasionally intestinal cramps, anorexia as well as or intestinal ulcer may occur, possibly with haemorrhagic diarrhoea. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely. In isolated cases, glossitis, oesophageal lesions may occur.

Other adverse reactions reported less commonly include:

Neurological and special senses:

Visual disturbances (diplopia or blurred vision), optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing auto immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (See section 4.4) depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Central nervous disturbances, e.g. excitation, irritability, insomnia, and giddiness may occasionally be expected. In individual cases disturbances of sensibility have been observed, impairment of taste, or reversible defective hearing, impaired memory, cramps, anxiety, nightmares, trembling or psychotic reactions.

Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare) Photosensitivity. Occasionally hypersensitivity reactions, i.e. skin eruptions and itching have been observed, seldom urticaria or alopecia, rash with bullous eruptions, eczema, erythema, purpura, including allergic purpura occurred in individual cases.

Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Individual cases of acute renal insufficiency (proteinuria, hematuria) or necrosis of renal papillae have been reported.

Hepatic: abnormal liver function, hepatitis and jaundice.

Occasionally elevation of serum aminotransferase enzymes (ALT, AST).

Pancreas:

Individual cases of pancreatitis have been reported.

Haematological: thrombocytopenia, neutropenia, agranulocytosis, hemolytic and aplastic anemia. During long-term therapy haematological parameters should be monitored regularly. Intramuscular diclofenac is not recommended for long term use.

Other Organs:

Peripheral oedema rarely occurred especially in patients with hypertension.

Rarely hypersensitivity reactions may occur with symptoms of facial oedema, swelling of the tongue or larynx with restriction of the respiratory tract, dyspnoea and asthma attacks, tachycardia, hypotension including hypotensive shock. If any of these symptoms occur, rapid medical assistance is necessary. Individual cases of palpitations and chest pain or hypertension have been reported.

Rarely injection site disorders e.g. local pain and indurations; in isolated cases: abscesses and local necrosis.

Cardiovascular and Cerebrovascular:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

4.9 Overdose

a) Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

b) Therapeutic measure

Patients should be treated symptomatically as required.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose,

Good urine output should be ensured.

Renal and liver function should be closely monitored

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with Intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDS due to their high rate of protein binding and extensive metabolism.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Econac injection 75 mg/3 ml is a non-steroidal agent with marked analgesic/anti-inflammatory properties. It is an inhibitor of prostaglandin synthetase, (cyclo-oxygenase). Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is absorbed after all forms of administration. The plasma concentrations of the agent is linearly proportional to the administered dose.

After intramuscular injection of 75 mg diclofenac a plasma maximum of 2,5 µg/ml (8µmol/l) will be achieved after approximately 20 minutes. The area under the plasma concentration curve (AUC) after i.m. injection is approximately the double of that after oral or rectal administration of the same dose, because approximately half of the active substance is metabolized (first pass effect) in the first passage in the liver.

Distribution

Diclofenac is 99.7 % bound to serum proteins mainly albumin (99.4 %).

Diclofenac passes into the synovial fluid. Here maximum concentrations are measured 2 - 4 hours after maximal plasma values have been reached. The elimination half-life of the synovial fluid is 3 - 6 hours. Therefore the concentrations of the active substance are higher 4 - 6 hours after administration than in the plasma and remain at this level for up to 12 hours after administration.

Metabolism

The metabolism of diclofenac occurs quickly and almost completely. The metabolites are known. The biotransformation occurs for a small part by glucuronidation of the unchanged molecule, by mainly a simple or multiple hydroxylation which leads to a formation of several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5'-hydroxy-, 4',5'-dihydroxy- and 3'-hydroxy-4'-methoxydiclofenac), which are then extensively conjugated to glucuronic acid.

Elimination

The elimination of the active substance out of the plasma occurs with a systemic clearance of 263 + 56 ml/min.

The terminal half-life is 1 - 2 hours.

Less than 1 % of the active substance is renally eliminated in its unchanged form. 60 % of the administered amount are renally eliminated as metabolites, the rest is eliminated with the feces.

The pharmacokinetics of diclofenac also remain unchanged after repeated administration.

No cumulation is to be expected, if the recommended dosage is observed. No relevant differences of absorption, metabolism and elimination caused by the age of the patients have been observed.

In patients with impaired renal function, no accumulation of diclofenac has been reported.

Elimination rates in renally impaired patients are comparable to those in other patients. The steady state concentrations of the total metabolites in patients with severe renal impairment are four times higher than in subjects with normal renal function, but exert no additional pharmacological effects.

Bioavailability

Bioavailability studies are not necessary because it is an injection solution.

5.3 Preclinical Safety Data

Acute Toxicity

The study of acute toxicity in various animal models did not reveal any special sensitivity.

Chronic Toxicity

The chronic toxicity was examined in rats, dogs and monkeys. Ulceration in the gastrointestinal tract was observed and produced complications, i.e. peritonitis, anemia and leucocytosis.

Mutagenic and Cancerogenic Potential

A mutagenic effect of diclofenac seems to be excluded by the results of in-vitro and in-vivo tests. Studies on carcinogenicity in rats did not show any evidence of tumour-developing activities.

Reproduction Toxicology

The embryotoxic potential of diclofenac was studied in 3 animal models (rat, mouse and rabbit). Fetal death and retardation of growth resulted in doses in the toxic range. Malformations have not been observed. The gestation period and duration of parturition were prolonged by diclofenac. The effect on fertility was not examined. Doses below the maternal-toxic range did not reveal any influence on the postnatal development of the descendants.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Mannitol, propylene glycol, benzyl alcohol, sodium metabisulphite, sodium hydroxide, water for injections

6.2 Incompatibilities

Diclofenac ampoules for intramuscular use should not be mixed with other solutions for injections.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original outer carton.

6.5 Nature And Contents Of Container

3 ml Type I glass ampoules.

10 ampoules per carton.

6.6 Special Precautions For Disposal And Other Handling

See 4.2.

Administrative Data

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals (Europe) Ltd.

NLA TOWER

12-16 ADDISCOMBE ROAD

CROYDON

SURREY

CR0 0XT

8. Marketing Authorisation Number(S)

PL 10972/0070

9. Date Of First Authorisation/Renewal Of The Authorisation

05/03/2009

10. Date Of Revision Of The Text

18/05/2010

Tuesday, 11 September 2012

lubiprostone

Generic Name: lubiprostone (loo bee PROS tone)

Brand Names: Amitiza

What is lubiprostone?

Lubiprostone increases the secretion of fluid in your intestines to help make it easier to pass stools (bowel movements).

Lubiprostone is used to treat chronic constipation in adults. It is also used to treat irritable bowel syndrome in women with constipation as the main symptom.

Lubiprostone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about lubiprostone?

Do not take lubiprostone if you have severe diarrhea. Call your doctor for instructions.

Before using this medication, tell your doctor if you have a history of hernia, gallstones, Crohn's disease, Hirschsprung's disease, impacted bowel movement, diverticulitis, polyps, or any other cause for obstruction in your gastrointestinal (digestive) system.

You may have tightness in your chest or feel short of breath within 1 hour after taking lubiprostone. This side effect should go away within 3 hours, but it may occur again when you take your next dose. Talk with your doctor if this side effect becomes bothersome.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What should I discuss with my health care provider before taking lubiprostone?

You should not use this medication if you have blockage in your digestive tract, or if you have severe diarrhea.

If you have any of these conditions, you may not be able to use lubiprostone or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C: This medication may be harmful to an unborn baby. Do not use lubiprostone without telling your doctor if you are pregnant. You may be asked to have a pregnancy test before you start taking lubiprostone. Tell your doctor if you become pregnant during treatment. It is not known if lubiprostone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Lubiprostone should not be given to a child.

How should I take lubiprostone?

Take lubiprostone exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Take lubiprostone with food. Drink a full glass of water when you take this medication.

Do not take lubiprostone if you have severe diarrhea. Call your doctor for instructions. Store lubiprostone at room temperature away from moisture and heat.

See also: Lubiprostone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include vomiting, diarrhea, stomach pain, dizziness, hot flashes, trouble breathing, pale skin, headache, or fainting.

What should I avoid while taking lubiprostone?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using lubiprostone.

Lubiprostone side effects

Stop using lubiprostone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe vomiting or diarrhea.

Less serious side effects are more likely to occur. Continue using lubiprostone and talk with your doctor if you have any of these less serious side effects:

nausea, vomiting, mild diarrhea, loss of appetite;

stomach pain, bloating, gas,

sore throat, cough;

headache, dizziness;

swelling in your hands, ankles, or feet;

joint or muscle pain; or

anxiety, cold sweats.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Lubiprostone Dosing Information

Usual Adult Dose for Constipation -- Chronic:

Chronic idiopathic constipation: 24 mcg orally twice a day with food and water

Usual Adult Dose for Irritable Bowel Syndrome:

Irritable bowel syndrome with constipation in women: 8 mcg orally twice a day with food and water

What other drugs will affect lubiprostone?

There may be other drugs that can affect lubiprostone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More lubiprostone resources

Lubiprostone Side Effects (in more detail)
Lubiprostone Dosage
Lubiprostone Use in Pregnancy & Breastfeeding
Lubiprostone Support Group
59 Reviews for Lubiprostone - Add your own review/rating

lubiprostone Advanced Consumer (Micromedex) - Includes Dosage Information

Lubiprostone Professional Patient Advice (Wolters Kluwer)

Lubiprostone MedFacts Consumer Leaflet (Wolters Kluwer)

Lubiprostone Monograph (AHFS DI)

Amitiza Prescribing Information (FDA)

Amitiza Consumer Overview

Compare lubiprostone with other medications

Constipation, Chronic
Constipation, Drug Induced
Irritable Bowel Syndrome

Where can I get more information?

Your pharmacist can provide more information about lubiprostone.

See also: lubiprostone side effects (in more detail)

Sunday, 9 September 2012

Minerals/Iron

Pronunciation: muhl-tee-VYE-ta-mins/MIN-er-als/EYE-urn
Generic Name: Minerals/Iron
Brand Name: Centrum Liquid

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call a doctor or poison control center right away.

Minerals/Iron is used for:

Treating or preventing low levels of vitamins, iron, and minerals in the body. It may also be used for other conditions as determined by your doctor.

Minerals/Iron is a vitamin, iron, and mineral supplement. It works by providing extra vitamins and minerals to the body when you do not get enough from your diet.

Do NOT use Minerals/Iron if:

you are allergic to any ingredient in Minerals/Iron

you have hemochromatosis (a disorder of iron metabolism)

Contact your doctor or health care provider right away if this applies to you.

Before using Minerals/Iron:

Some medical conditions may interact with Minerals/Iron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have bowel problems (eg, colitis, Crohn disease, diverticulitis), certain blood disorders (eg, hemolytic anemia, porphyria cutanea tarda, thalassemia), or a peptic ulcer

if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Minerals/Iron. Tell your health care provider if you are taking any other medicines, especially any of the following:

Acitretin because some of these products contain vitamin A, which may increase the risk of acitretin's side effects. If you are taking acitretin, ask your pharmacist if your product contains vitamin A

Anticoagulants (eg, warfarin) because the risk of its side effects may be increased by Minerals/Iron

Levodopa, mycophenolate, penicillamine, or thyroid because their effectiveness may be decreased by Minerals/Iron

This may not be a complete list of all interactions that may occur. Ask your health care provider if Minerals/Iron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Minerals/Iron:

Use Minerals/Iron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Minerals/Iron by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Take Minerals/Iron with a full glass of water (8 oz/240 mL).

Do not take an antacid within 1 hour before or 2 hours after you take Minerals/Iron.

Avoid taking Minerals/Iron with dairy products; they may interfere with the absorption of the iron in Minerals/Iron.

Many medicines (eg, used for infection, high blood pressure, low blood platelet levels, osteoporosis, thyroid problems) should not be taken at the same time as Minerals/Iron; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Minerals/Iron should be separated from your dose of any of your other medicines.

If you miss a dose of Minerals/Iron, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Minerals/Iron.

Important safety information:

Do not take large doses of vitamins while you use Minerals/Iron unless your doctor tells you to.

Minerals/Iron may discolor the stools. This is normal and not a cause for concern.

Minerals/Iron has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Minerals/Iron while you are pregnant. It is not known if Minerals/Iron is found in breast milk. If you are or will be breast-feeding while you use Minerals/Iron, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Minerals/Iron:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit; persistent nausea, vomiting, or diarrhea; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; blood in the vomit; diarrhea; headache; nausea; vomiting.

Proper storage of Minerals/Iron:

Store Minerals/Iron at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Minerals/Iron out of the reach of children and away from pets.

General information:

If you have any questions about Minerals/Iron, please talk with your doctor, pharmacist, or other health care provider.

Minerals/Iron is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Minerals/Iron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Micardis

Dosage Form: tablet
FULL PRESCRIBING INFORMATION

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Micardis as soon as possible [see Warnings and Precautions (5.1)].

Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

Hypertension

Micardis is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)].

Cardiovascular Risk Reduction

Micardis is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.

High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage [see Clinical Studies (14.2)]. Micardis can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy) [see Clinical Studies (14.2)].

Studies of telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.

Use of telmisartan with an ACE inhibitor is not recommended [see Warnings and Precautions (5.6)].

2 DOSAGE AND ADMINISTRATION

Hypertension

Dosage must be individualized. The usual starting dose of Micardis tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg [see Clinical Studies (14.1)].

Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Micardis is required, a diuretic may be added.

No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.

Micardis tablets may be administered with other antihypertensive agents.

Micardis tablets may be administered with or without food.

Cardiovascular Risk Reduction

The recommended dose of Micardis tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the risk of cardiovascular morbidity and mortality.

When initiating Micardis therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.

3 DOSAGE FORMS AND STRENGTHS

20 mg, white or off-white, round, uncoated tablets imprinted with BI logo on one side and 50 H on the other side

40 mg, white or off-white, oblong, uncoated tablets imprinted with BI logo on one side and 51 H on the other side

80 mg, white or off-white, oblong, uncoated tablets imprinted with BI logo on one side and 52 H on the other side

4 CONTRAINDICATIONS

Micardis is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

Fetal Toxicity

Pregnancy Category D

Hypotension

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with Micardis. Either correct this condition prior to administration of Micardis, or start treatment under close medical supervision with a reduced dose.

If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Hyperkalemia

Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.

Impaired Hepatic Function

As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate telmisartan at low doses and titrate slowly in these patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results have been reported with Micardis [see Clinical Pharmacology (12.3)].

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. There has been no long term use of Micardis in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen with ACE inhibitors.

Dual Blockade of the Renin-Angiotensin-Aldosterone System

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function (including acute renal failure) have been reported. Dual blockade of the renin-angiotensin-aldosterone system (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should include close monitoring of renal function.

The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan only, ramipril only, or the combination, and followed them for a median of 56 months. Patients receiving the combination of Micardis and ramipril did not obtain any additional benefit compared to monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with groups receiving telmisartan alone or ramipril alone. Concomitant use of Micardis and ramipril is not recommended.

6 ADVERSE REACTIONS

The following adverse reaction is described elsewhere in labeling:

Renal dysfunction upon use with ramipril [see Warnings and Precautions (5.6)]

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

Micardis has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of Micardis (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with Micardis and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with Micardis and at a Greater Rate Than Patients Treated with Placebo

	Telmisartan n=1455 %	Placebo n=380 %
Upper respiratory tract infection	7	6
Back pain	3	1
Sinusitis	3	2
Diarrhea	3	2
Pharyngitis	1	0

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with Micardis tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.

The incidence of cough occurring with telmisartan in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with Micardis monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Micardis tablets:

Autonomic Nervous System: impotence, increased sweating, flushing; Body as a Whole: allergy, fever, leg pain, malaise; Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG; CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia; Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders; Metabolic: gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal: arthritis, arthralgia, leg cramps; Psychiatric: anxiety, depression, nervousness; Resistance Mechanism: infection, fungal infection, abscess, otitis media; Respiratory: asthma, bronchitis, rhinitis, dyspnea, epistaxis; Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis; Vascular: cerebrovascular disorder; and Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Micardis tablets.

Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% telmisartan patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients compared with 0.3% placebo patients. One telmisartan-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of telmisartan in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of telmisartan for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on telmisartan and 7.6% on placebo. The only serious adverse events at least 1% more common on telmisartan than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Micardis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Micardis.

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including Micardis.

7 DRUG INTERACTIONS

Digoxin: When Micardis was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan for the purpose of keeping the digoxin level within the therapeutic range.

Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Micardis. Therefore, monitor serum lithium levels during concomitant use.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

Ramipril and Ramiprilat: Co-administration of telmisartan 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3- and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4- and 1.5-fold, respectively. In contrast, Cmax and AUC of telmisartan decrease by 31% and 16%, respectively. When co-administering telmisartan and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of telmisartan. Concomitant use of Micardis and ramipril is not recommended.

Other Drugs: Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmisartan is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

8 USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category D. [See Warnings and Precautions (5.1)].

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Micardis as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Micardis, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Micardis for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)].

Nursing Mothers

It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Neonates with a history of in utero exposure to Micardis:

If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology (12.3)] .

Geriatric Use

Of the total number of patients receiving Micardis in hypertension clinical studies, 551 (19%) were 65 to 74 years of age and 130 (4%) were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Of the total number of patients receiving Micardis in the cardiovascular risk reduction study (ONTARGET), the percentage of patients ≥65 to <75 years of age was 42%; 15% of patients were ≥75 years old. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Insufficiency

Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency [see Warnings and Precautions (5.4)].

10 OVERDOSAGE

Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with Micardis tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

11 DESCRIPTION

Micardis is a non-peptide angiotensin II receptor (type AT1) antagonist.

Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:

Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.

Micardis is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate. Micardis tablets are hygroscopic and require protection from moisture.

12 CLINICAL PHARMACOLOGY

Mechanism of Action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.

Pharmacodynamics

In normal volunteers, a dose of telmisartan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours.

Plasma concentration of angiotensin II and plasma renin activity (PRA) increased in a dose-dependent manner after single administration of telmisartan to healthy subjects and repeated administration to hypertensive patients. The once-daily administration of up to 80 mg telmisartan to healthy subjects did not influence plasma aldosterone concentrations. In multiple dose studies with hypertensive patients, there were no clinically significant changes in electrolytes (serum potassium or sodium), or in metabolic function (including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric acid).

In 30 hypertensive patients with normal renal function treated for 8 weeks with telmisartan 80 mg or telmisartan 80 mg in combination with hydrochlorothiazide 12.5 mg, there were no clinically significant changes from baseline in renal blood flow, glomerular filtration rate, filtration fraction, renovascular resistance, or creatinine clearance.

Pharmacokinetics

Following oral administration, peak concentrations (Cmax) of telmisartan are reached in 0.5 to 1 hour after dosing. Food slightly reduces the bioavailability of telmisartan, with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of telmisartan is dose dependent. At 40 and 160 mg the bioavailability was 42% and 58%, respectively. The pharmacokinetics of orally administered telmisartan are nonlinear over the dose range 20 to 160 mg, with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses. Telmisartan shows bi-exponential decay kinetics with a terminal elimination half life of approximately 24 hours. Trough plasma concentrations of telmisartan with once daily dosing are about 10% to 25% of peak plasma concentrations. Telmisartan has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing.

Distribution

Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and α1 - acid glycoprotein. Plasma protein binding is constant over the concentration range achieved with recommended doses. The volume of distribution for telmisartan is approximately 500 liters indicating additional tissue binding.

Metabolism and Elimination

Following either intravenous or oral administration of 14C-labeled telmisartan, most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively).

Telmisartan is metabolized by conjugation to form a pharmacologically inactive acyl glucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma and urine. After a single dose, the glucuronide represents approximately 11% of the measured radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.

Total plasma clearance of telmisartan is >800 mL/min. Terminal half-life and total clearance appear to be independent of dose.

Specific Populations

Renal Insufficiency

No dosage adjustment is necessary in patients with decreased renal function. Telmisartan is not removed from blood by hemofiltration [see Warnings and Precautions (5.5) and Dosage and Administration (2.1)].

Hepatic Insufficiency

In patients with hepatic insufficiency, plasma concentrations of telmisartan are increased, and absolute bioavailability approaches 100% [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

Gender

Plasma concentrations of telmisartan are generally 2 to 3 times higher in females than in males. In clinical trials, however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women. No dosage adjustment is necessary.

Geriatric Patients

The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years [see Dosage and Administration (2.1)].

Pediatric Patients

Telmisartan pharmacokinetics have not been investigated in patients <18 years of age.

13 NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of carcinogenicity when telmisartan was administered in the diet to mice and rats for up to 2 years. The highest doses administered to mice (1000 mg/kg/day) and rats (100 mg/kg/day) are, on a mg/m2 basis, about 59 and 13 times, respectively, the maximum recommended human dose (MRHD) of telmisartan. These same doses have been shown to provide average systemic exposures to telmisartan >100 times and >25 times, respectively, the systemic exposure in humans receiving the MRHD (80 mg/day).

Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level. These assays included bacterial mutagenicity tests with Salmonella and E. coli (Ames), a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse micronucleus test.

No drug-related effects on the reproductive performance of male and female rats were noted at 100 mg/kg/day (the highest dose administered), about 13 times, on a mg/m2 basis, the MRHD of telmisartan. This dose in the rat resulted in an average systemic exposure (telmisartan AUC as determined on day 6 of pregnancy) at least 50 times the average systemic exposure in humans at the MRHD (80 mg/day).

Developmental Toxicity

There is no clinical experience with the use of Micardis tablets in pregnant women. No teratogenic effects were observed when telmisartan was administered to pregnant rats at oral doses of up to 50 mg/kg/day and to pregnant rabbits at oral doses up to 45 mg/kg/day. In rabbits, embryolethality associated with maternal toxicity (reduced body weight gain and food consumption) was observed at 45 mg/kg/day [about 12 times the maximum recommended human dose (MRHD) of 80 mg on a mg/m2 basis]. In rats, maternally toxic (reduction in body weight gain and food consumption) telmisartan doses of 15 mg/kg/day (about 1.9 times the MRHD on a mg/m2 basis), administered during late gestation and lactation, were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain. Telmisartan has been shown to be present in rat fetuses during late gestation and in rat milk. The no observed effect doses for developmental toxicity in rats and rabbits, 5 and 15 mg/kg/day, respectively, are about 0.64 and 3.7 times, on a mg/m2 basis, the maximum recommended human dose of telmisartan (80 mg/day).

14 CLINICAL STUDIES

Hypertension

The antihypertensive effects of Micardis have been demonstrated in six principal placebo-controlled clinical trials, studying a range of 20 to 160 mg; one of these examined the antihypertensive effects of telmisartan and hydrochlorothiazide in combination. The studies involved a total of 1773 patients with mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1031 of whom were treated with telmisartan. Following once daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure.

Upon initiation of antihypertensive treatment with telmisartan, blood pressure was reduced after the first dose, with a maximal reduction by about 4 weeks. With cessation of treatment with Micardis tablets, blood pressure gradually returned to baseline values over a period of several days to one week. During long term studies (without placebo control) the effect of telmisartan appeared to be maintained for up to at least one year. The antihypertensive effect of telmisartan is not influenced by patient age, gender, weight, or body mass index. Blood pressure response in black patients (usually a low-renin population) is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II antagonists and ACE inhibitors.

In a controlled study, the addition of telmisartan to hydrochlorothiazide produced an additional dose-related reduction in blood pressure that was similar in magnitude to the reduction achieved with telmisartan monotherapy. Hydrochlorothiazide also had an added blood pressure effect when added to telmisartan.

The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. At doses of 20, 40, and 80 mg, the antihypertensive effect of once daily administration of telmisartan is maintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40 to 80 mg doses of telmisartan was 70 to 100% for both systolic and diastolic blood pressure. The incidence of symptomatic orthostasis after the first dose in all controlled trials was low (0.04%).

There were no changes in the heart rate of patients treated with telmisartan in controlled trials.

Cardiovascular Risk Reduction

Support for use to reduce the risk of cardiovascular events was obtained in a pair of studies. Both enrolled subjects age ≥55 years, at high cardiovascular risk as evidenced by coronary artery disease (75%), diabetes mellitus (27%) accompanied with end-organ damage (e.g., retinopathy, left ventricular hypertrophy, and, in ONTARGET only, macro- or microalbuminuria), stroke (16%), peripheral vascular disease (13%), or transient ischemic attack (4%). Patients without a history of intolerance to ACE inhibitors entered ONTARGET, and those with such a history, usually cough (90%), entered TRANSCEND, but patients with >1+ proteinuria on dipstick were excluded from TRANSCEND. For both ONTARGET and TRANSCEND trials, the primary 4-component composite endpoint was death from cardiovascular causes, myocardial infarction, stroke, and hospitalization for heart failure. The secondary 3-component composite endpoint was death from cardiovascular causes, myocardial infarction, and stroke.

ONTARGET was a randomized, active-controlled, multinational, double-blind study in 25,620 patients who were randomized to telmisartan 80 mg, ramipril 10 mg, or their combination. The population studied was 73% male, 74% Caucasian, 14% Asian, and 57% were 65 years of age or older. Baseline therapy included acetylsalicylic acid (76%), lipid lowering agents (64%), beta-blockers (57%), calcium channel blockers (34%), nitrates (29%), and diuretics (28%). The mean duration of follow up was about 4 years and 6 months. During the study, 22.0% (n=1878) of telmisartan patients discontinued the active treatment, compared to 24.4% (n=2095) of ramipril patients and 25.3% (n=2152) of telmisartan/ramipril patients.

TRANSCEND randomized patients to telmisartan 80 mg (n=2954) or placebo (n=2972). The mean duration of follow up was 4 years and 8 months. The population studied was 57% male, 62% Caucasian, 21% Asian, and 60% were 65 years of age or older. Baseline therapy included acetylsalicylic acid (75%), lipid lowering agents (58%), beta-blockers (58%), calcium channel blockers (41%), nitrates (34%) and diuretics (33%). During the study, 17.7% (n=523) of telmisartan patients discontinued the active treatment, compared to 19.4% (n=576) of placebo patients.

The results for the TRANSCEND trial are summarized in Table 2, and the results for ONTARGET are summarized in Table 3, below:

Table 2 Incidence of the Primary and Secondary Outcomes from TRANSCEND
	Telmisartan vs. Placebo (n=2954) (n=2972)
The primary endpoint was defined as the time to first event. In case of multiple simultaneous events, all individual events were considered; the sum of patients with individual outcomes may exceed the number of patients with composite (primary or secondary) outcomes. *For individual components of the primary composite endpoints, all events, regardless whether or not they were the first event, were considered. Therefore, they are more than the first events considered for the primary or secondary composite endpoint.
	No. of Events Telmisartan / Placebo	Hazard Ratio 95% CI	p-value
*Composite of CV death, myocardial infarction, stroke, or hospitalization for heart failure	465 (15.7%) / 504 (17.0%)	0.92 (0.81 – 1.05)	0.2129
*Composite of CV death, myocardial infarction, or stroke	384 (13.0%) / 440 (14.8%)	0.87 (0.76 – 1.00)	0.0483
Individual components of the primary composite endpoint	No. of Events Telmisartan / Placebo	Hazard Ratio 95% CI	p-value
**All non-fatal MI	114 (3.9%) / 145 (4.9%)	0.79 (0.62 – 1.01)	0.0574
**All non-fatal strokes	112 (3.8%) / 136 (4.6%)	0.83 (0.64 – 1.06)	0.1365

Table 3 Incidence of the Primary and Secondary Outcomes from ONTARGET
	Telmisartan vs. Ramipril (n=8542) (n=8576)
	No. of Events Telmisartan / Ramipril	Hazard Ratio 97.5% CI
Composite of CV death, myocardial infarction, stroke, or hospitalization for heart failure	1423 (16.7%) / 1412 (16.5%)	1.01 (0.93 – 1.10)
Composite of CV death, myocardial infarction, or stroke	1190 (13.9%) / 1210 (14.1%)	0.99 (0.90 – 1.08)

Although the event rates in ONTARGET were similar on telmisartan and ramipril, the results did not unequivocally rule out that Micardis may not preserve a meaningful fraction of the effect of ramipril in reducing cardiovascular events. However, the results of both ONTARGET and TRANSCEND do adequately support Micardis being more effective than placebo would be in this setting, particularly for the end point of time to cardiovascular death, myocardial infarction, or stroke.

In ONTARGET, there was no evidence that combining ramipril and Micardis reduced the risk of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure greater than ramipril alone; instead, patients who received the combination of ramipril and telmisartan in ONTARGET experienced an increased incidence of clinically important renal dysfunction (e.g., acute renal failure) compared to patients receiving Micardis or ramipril alone.

Multiple sub-group analyses did not demonstrate any differences in the 4-component composite primary endpoint based on age, gender, or ethnicity for either ONTARGET or TRANSCEND trial.

16 HOW SUPPLIED/STORAGE AND HANDLING

Micardis is available as white or off-white, uncoated tablets containing telmisartan 20 mg, 40 mg, or 80 mg. Tablets are marked with the BOEHRINGER INGELHEIM logo on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows:

Micardis tablets 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0039-37).

Micardis tablets 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0040-37).

Micardis tablets 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0041-37).

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling

Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to Micardis during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1)].

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

OT1200SA252012

090340194/12

IT12004O

10005385/9

Patient Information

Micardis® (my-CAR-dis)

(telmisartan)

Tablets

Read this Patient Information before you start taking Micardis tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Micardis tablets?

Micardis can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Micardis, tell your doctor right away.

What is Micardis?

Micardis is a prescription medicine used:

to treat high blood pressure (hypertension)

in certain high risk people aged 55 years and older to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death

It is not known if Micardis is safe and effective in children.

Who should not take Micardis?

You should not take Micardis tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet.

What should I tell my doctor before taking Micardis tablets?

Before you take Micardis tablets, tell your doctor if you:

have liver problems

have kidney problems

have heart problems

have any other medical conditions

are pregnant or are planning to become pregnant. See "What is the most important information I should know about Micardis tablets?"

are breast-feeding or plan to breast-feed. It is not known if Micardis passes into your breast milk. You and your doctor should decide if you will take Micardis tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Micardis tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Micardis may affect the way other medicines work, and other medicines may affect how Micardis works. Especially tell your doctor if you take:

digoxin (Lanoxin®, Lanoxicaps®)

lithium (Eskalith®, Lithobid®)

medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors

ramipril (Altace®) or other medicines used to treat your high blood pressure or heart problem

water pills (diuretic)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take Micardis tablets?

Take Micardis tablets exactly as your doctor tells you to take it.

Your doctor will tell you how much Micardis to take and when to take it.

Do not change your dose unless your doctor tells you to.

Take Micardis one time each day at the same time.

Take Micardis tablets with or without food.

If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.

If you take too much Micardis, call your doctor, or go to the nearest hospital emergency room right away.

Read the "How to Open the Blister" at the end of this leaflet before you use Micardis. Talk with your doctor if you do not understand the instructions.

What are the possible side effects of Micardis tablets?

Micardis tablets may cause serious side effects, including:

Injury or death to your unborn baby. See "What is the most important information I should know about Micardis tablets?"

Low blood pressure (hypotension) is most likely to happen if you also:
- take water pills (diuretics)
- are on a low-salt diet
- get dialysis treatments
- have heart problems
- get sick with vomiting or diarrhea

: If you feel faint or dizzy, lie down and call your doctor right away.

Kidney problems, which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of Micardis tablets. Call your doc

Thursday, 6 September 2012

Ulipristal

Pronunciation: UE-li-PRIS-tal
Generic Name: Ulipristal
Brand Name: ella

Ulipristal is used for:

Preventing pregnancy after unprotected sexual intercourse or known or suspected birth control failure.

Ulipristal is a progesterone agonist/antagonist. Exactly how it works is not known. It may prevent pregnancy by stopping or delaying ovulation or altering the lining of the uterus to prevent implantation should fertilization occur.

Do NOT use Ulipristal if:

you are allergic to any ingredient in Ulipristal

you are or suspect that you are pregnant

you have already taken Ulipristal during your current menstrual cycle

you have been through menopause

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ulipristal:

Some medical conditions may interact with Ulipristal. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are planning to become pregnant or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of ectopic pregnancy (pregnancy outside of uterus), or you have not had your first menstrual period

if you are overweight

Some MEDICINES MAY INTERACT with Ulipristal. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, itraconazole, ketoconazole) because they may increase the risk of Ulipristal's side effects

Barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, efavirenz, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, primidone, rifamycins (eg, rifabutin, rifampin, rifapentine), St. John's wort, or topiramate because they may decrease Ulipristal's effectiveness

Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Ulipristal

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ulipristal may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ulipristal:

Use Ulipristal as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Ulipristal. Talk to your pharmacist if you have questions about this information.

Take Ulipristal by mouth with or without food.

Keep Ulipristal in its original packaging until you are ready to take it. Do not take it if the package is torn or broken.

Take Ulipristal as soon as possible after known or suspected birth control failure or after you have unprotected sexual intercourse. The dose must be taken within 120 hours (5 days), or as directed by your doctor.

Ulipristal can be used any time during the menstrual cycle.

If vomiting occurs within 3 hours after taking Ulipristal, talk with your health care provider to discuss whether to repeat that dose.

If you are unsure about your general health or pregnancy status, a follow-up physical or pelvic exam may be needed after taking Ulipristal.

If you miss a dose of Ulipristal, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ulipristal.

Important safety information:

Ulipristal may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ulipristal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Ulipristal is an emergency contraceptive. It should not be used for routine birth control. Ulipristal may reduce the effectiveness of hormonal contraceptives (eg, birth control pills). If you have sexual intercourse after you take Ulipristal but before you have your next menstrual period, be sure to use an effective form of contraception, such as a diaphragm or condom.

You should not take Ulipristal more than once within the same menstrual cycle; safety and effectiveness with repeated use within the same menstrual cycle have not been confirmed. Contact your doctor if you have questions about this information.

Seek immediate medical attention if you experience severe lower stomach pain about 3-5 weeks after you take Ulipristal. This may be a symptom of an ectopic pregnancy (pregnancy outside of the uterus).

Ulipristal may affect your normal menstrual cycle. Contact your doctor if your menstrual period is delayed for longer than 7 days after you expected it to occur.

Ulipristal does not protect against HIV infection and other sexually transmitted diseases.

Before you take Ulipristal, a pregnancy test may be performed. It is important to determine that you are not pregnant before you take Ulipristal. Discuss any questions or concerns with your doctor.

Ulipristal should not be used in CHILDREN younger than 18 years old who have not started having a menstrual cycle; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Ulipristal will not end an existing pregnancy. Do not use Ulipristal if you are pregnant. If you find out you are pregnant after taking Ulipristal, contact your doctor. You will need to discuss the risks of using Ulipristal while you are pregnant. It is not known if Ulipristal is found in breast milk. Do not breast-feed while taking Ulipristal.

Possible side effects of Ulipristal:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; changes in menstrual flow or duration; dizziness; headache; nausea; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); lower stomach pain; missed menstrual period; pain during menstrual period; spotting instead of your usual period.

See also: Ulipristal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ulipristal:

Store Ulipristal between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ulipristal out of the reach of children and away from pets.

General information:

If you have any questions about Ulipristal, please talk with your doctor, pharmacist, or other health care provider.

Ulipristal is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ulipristal. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Ulipristal resources

Ulipristal Side Effects (in more detail)
Ulipristal Dosage
Ulipristal Use in Pregnancy & Breastfeeding
Ulipristal Drug Interactions
Ulipristal Support Group
1 Review for Ulipristal - Add your own review/rating

ulipristal Advanced Consumer (Micromedex) - Includes Dosage Information

Ella Prescribing Information (FDA)

ella Monograph (AHFS DI)

ella Consumer Overview

Compare Ulipristal with other medications

Birth Control
Emergency Contraception
Uterine Fibroids

Monday, 3 September 2012

Complete Sinus Relief

Pronunciation: ah-seet-ah-MIN-oh-fen/dex-brome-fen-IR-a-meen/soo-doe-e-FED-rin
Generic Name: Acetaminophen/Dexbrompheniramine/Pseudoephedrine
Brand Name: Examples include Complete Sinus Relief and Sinadrin Plus

Complete Sinus Relief is used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Complete Sinus Relief is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages.

Do NOT use Complete Sinus Relief if:

you are allergic to any ingredient in Complete Sinus Relief

you are taking sodium oxybate (GHB) or you have taken furazolidone a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Complete Sinus Relief:

Some medical conditions may interact with Complete Sinus Relief. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of asthma; lung problems (eg, emphysema); heart problems; diabetes; difficulty urinating; an enlarged prostate or other prostate problems; glaucoma; high blood pressure; an overactive thyroid; liver problems (eg, hepatitis) or severe kidney problems; adrenal gland problems (eg, pheochromocytoma); sleep apnea; trouble sleeping; stomach problems; ulcers; seizures; blood vessel problems; stroke; or a blockage of your stomach, intestines, or bladder

if you drink more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Complete Sinus Relief. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), furazolidone, indomethacin, isoniazid, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Complete Sinus Relief may be increased

Anticoagulants (eg, warfarin), bromocriptine, digoxin, droxidopa, or hydantoins (eg, phenytoin) because the risk of side effects may be increased by Complete Sinus Relief

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Complete Sinus Relief may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Complete Sinus Relief:

Use Complete Sinus Relief as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Complete Sinus Relief may be taken with food if it upsets your stomach.

If you miss a dose of Complete Sinus Relief and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Complete Sinus Relief.

Important safety information:

Complete Sinus Relief may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Complete Sinus Relief. Using Complete Sinus Relief alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Complete Sinus Relief will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Do not exceed the recommended dose of Complete Sinus Relief. Doing so will not improve your condition faster and may increase your risk for side effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Complete Sinus Relief contains acetaminophen, dexbrompheniramine, and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen, dexbrompheniramine, or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Do not take diet or appetite control medicines while you are taking Complete Sinus Relief without checking with your doctor.

If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Complete Sinus Relief or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Complete Sinus Relief may increase your risk for liver damage.

If you are scheduled for allergy skin testing, do not take Complete Sinus Relief for several days before the test because it may decrease your response to the skin tests.

If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Complete Sinus Relief.

Use Complete Sinus Relief with caution in the ELDERLY because they may be more sensitive to its effects.

Use Complete Sinus Relief with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is unknown if Complete Sinus Relief can cause harm to the fetus. If you become pregnant while taking Complete Sinus Relief, discuss with your doctor the benefits and risks of using Complete Sinus Relief during pregnancy. Some of the ingredients in Complete Sinus Relief are excreted in breast milk. If you are or will be breast-feeding while you are using Complete Sinus Relief, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Complete Sinus Relief:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine or pale stools; difficulty urinating; excessive sweating; frequent urination; hallucinations; pounding in the chest; rapid pulse; severe nervousness; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

See also: Complete Sinus Relief side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of Complete Sinus Relief:

Store Complete Sinus Relief at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Complete Sinus Relief out of the reach of children and away from pets.

General information:

If you have any questions about Complete Sinus Relief, please talk with your doctor, pharmacist, or other health care provider.

Complete Sinus Relief is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Complete Sinus Relief. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Complete Sinus Relief resources

Complete Sinus Relief Side Effects (in more detail)
Complete Sinus Relief Use in Pregnancy & Breastfeeding
Complete Sinus Relief Drug Interactions
Complete Sinus Relief Support Group
0 Reviews for Complete Sinus Relief - Add your own review/rating

Compare Complete Sinus Relief with other medications

Cold Symptoms
Hay Fever
Sinus Symptoms

Sunday, 2 September 2012

Excel Salve

Dosage Form: FOR ANIMAL USE ONLY

Excel Medicated Antiseptic Creme

With antiseptic to relieve minor cuts, flea bites, and skin irritations

with aloe vera to soothe skin

For dogs and cats

Directions

Clean area thoroughly. Apply as needed to sore areas, abrasions, lesions and other minor skin irritations. Consult a veteranarian if condition persists. May be covered or bandaged after application.

Active Ingredient

1.0% Chlorhexidine Diacetate.

Ingredients

Petrolatum, Boric Acid, Propylene Glycol, Sucrose Octa Acetate, Fragrance, Vitamin A Palmitate, dl-Alpha tocopheryl Acetate(source of Vitamin E), Vitamin D3.

Caution

Consult your veterinarian in cases of deep or puncture wounds, serious burns, or if redness and irritation persists or increases.

KEEP THIS AND OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN AND PETS. USE ONLY AS DIRECTED.

Excel

Medicated Antiseptic Creme

Helps Heal Minor Cuts, Flea Bites and Skin Irritations

With Aloe Vera

Non-Stinging

Net WT. 0.85ml(24g)

EXCEL
chlorhexidine salve

Product Information
Product Type	OTC ANIMAL DRUG	NDC Product Code (Source)	24730-748
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE (CHLORHEXIDINE)	CHLORHEXIDINE	4.16 g in 24 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM
BORIC ACID
PROPYLENE GLYCOL
VITAMIN A PALMITATE
CORN OIL
ALPHA-TOCOPHEROL ACETATE

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL (Antiseptic Fragrance)	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	24730-748-09	24 g In 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2000

Labeler - United Pet Group (931135730)

Establishment
Name	Address	ID/FEI	Operations
JUNGLE LABORATORIES CORPORATION		032615270	manufacture

Revised: 01/2010United Pet Group