Tuesday 31 July 2012

In vivo diagnostic biologicals


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

See also

Medical conditions associated with in vivo diagnostic biologicals:

  • Diagnosis and Investigation
  • Dietary Supplementation
  • Thyroid Cancer

Drug List:

Sunday 29 July 2012

Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup


Pronunciation: SOO-doe-e-FED-rin/KLOR-fen-IR-a-meen/KLOE-fe-DYE-a-nol
Generic Name: Pseudoephedrine/Chlorpheniramine/Chlophedianol
Brand Name: DryMax AF


Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, hay fever, and other upper respiratory allergies. It may also be used for other conditions as determined by your doctor.


Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.


Do NOT use Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup if:


  • you are allergic to any ingredient in Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup

  • you have severe or uncontrolled 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

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

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



Before using Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup:


Some medical conditions may interact with Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup. 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 history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, stroke, glaucoma or increased pressure in the eye, seizures, mental or mood problems (eg, depression), thyroid problems, or trouble sleeping

  • if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea); chronic cough; or if your cough occurs with large amounts of mucus

  • if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowels ; an enlarged prostate or other prostate problems; kidney problems; or trouble urinating

  • if you take medicine for high blood pressure or depression

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


  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup's side effects

  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup 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 Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup:


Use Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Take Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup with a full glass of water (8 oz/240 mL).

  • If you miss a dose of Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup 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 Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup.



Important safety information:


  • Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol while you are using Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do not take diet or appetite control medicines while you take Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup without checking with your doctor.

  • Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not use Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • Do NOT take more than the recommended dose or use for longer than recommended without checking with your doctor.

  • If new symptoms occur, or if cough or nasal congestion persists for more than 1 week, goes away and returns, or occurs along with a fever, rash, or persistent headache, check with your doctor. A persistent cough may be a sign of a serious condition.

  • Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup for a few days before the tests.

  • Tell your doctor or dentist that you take Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup before you receive any medical or dental care, emergency care, or surgery.

  • Use Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.

  • Caution is advised when using Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup in CHILDREN; they may be more sensitive to its effects, especially excitability.

  • Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup while you are pregnant. Some ingredients of Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup are found in breast milk. Do not breast-feed while taking Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup.


Possible side effects of Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup:


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:



Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; trouble sleeping; upset stomach; vomiting; weakness.



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); difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; flushing or redness of the face; hallucinations; loss of coordination; mental or mood changes (eg depression, nervousness); numbness or tingling; seizures; severe dryness of mouth, nose, or throat; severe or persistent dizziness, drowsiness, light-headedness, or headache; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).



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 blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; trouble breathing; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup:

Store Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup 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 Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup out of the reach of children and away from pets.


General information:


  • If you have any questions about Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup, please talk with your doctor, pharmacist, or other health care provider.

  • Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup 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 Pseudoephedrine/Chlorpheniramine/Chlophedianol Syrup. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

Thursday 26 July 2012

Sepracor Inc. (renamed Sunovion Pharmaceuticals Inc)


Address


Sepracor Inc. (renamed Sunovion Pharmaceuticals Inc),
84 Waterford Drive

Marlborough, MA 01752

Contact Details

Phone: 508-481-6700
Website: http://www.sunovion.com/
Careers: http://www.sunovion.com/careers...

Monday 23 July 2012

K-Tab



potassium chloride

Dosage Form: tablet, film coated, extended release
K-Tab®

(potassium chloride extended-release tablets, USP)

K-Tab Description


K-Tab (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 750 mg of potassium chloride, USP, equivalent to 10 mEq of potassium in a film-coated (not enteric-coated), wax matrix tablet. This formulation is intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool.


K-Tab tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.



Inactive Ingredients


Castor oil, cellulosic polymers, colloidal silicon dioxide, D&C Yellow No. 10, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin and vitamin E.



K-Tab - Clinical Pharmacology


Potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle, and the maintenance of normal renal function.


The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.


Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.


Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.


If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may restore normal potassium levels.


In rare circumstances, (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.



Indications and Usage for K-Tab


BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.


  1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.

  2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern, and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases and if dose adjustment of the diuretic is ineffective or unwarranted supplementation with potassium salts may be indicated.



Contraindications


Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic, e.g., spironolactone, triamterene, or amiloride (see OVERDOSAGE ).


K-Tab tablets are contraindicated in patients with known hypersensitivity to any ingredient in this product.


Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation.


All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological, e.g., diabetic gastroparesis, or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.



Warnings



Hyperkalemia (see OVERDOSAGE)


In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium intravenously, but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and can be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.



Interaction with Potassium-Sparing Diuretics


Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic, e.g., spironolactone, triamterene, or amiloride, since the simultaneous administration of these agents can produce severe hyperkalemia.



Interaction with Angiotensin Converting Enzyme Inhibitors


Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.



Gastrointestinal Lesions


Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained-release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. K-Tab tablets consist of a wax matrix formulated to provide a controlled rate of release potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall.


Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after one week of solid oral potassium chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice, i.e., 96 mEq per day in divided doses of potassium chloride administered, to fasted patients in the presence of an anticholinergic drug to delay gastric emptying. The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (hemoccult testing). The relevance of these findings to the usual conditions, i.e., nonfasting, no anticholinergic agent, and smaller doses, under which controlled-release potassium chloride products are used is uncertain. Epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. K-Tab tablets should be discontinued immediately and the possibility of ulceration, obstruction or perforation considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.



Metabolic Acidosis


Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.



Precautions



General


The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium, while acute acidosis per se can increase the serum potassium concentration to within the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.



Information for Patients


Physicians should consider reminding the patient of the following:


To take each dose with meals and with a full glass of water or other liquid.


To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.


To check with the physician if there is trouble swallowing tablets or if the tablets seem to stick in the throat.


To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.


To take each dose without crushing, chewing or sucking the tablets.



Laboratory Tests


When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.



Drug Interactions


Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see WARNINGS).



Carcinogenesis, Mutagenesis, Impairment of Fertility


Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.



Pregnancy Category C


Animal reproduction studies have not been conducted with K-Tab tablets. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.



Nursing Mothers


The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.



Pediatric Use


Safety and effectiveness in children have not been established.



Geriatric Use


Clinical Studies of K-Tab tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.



Adverse Reactions


One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS , and OVERDOSAGE). There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS).


The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals, or reducing the amount taken at one time.


Skin rash has been reported rarely.



Overdosage


The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if intravenous administration is too rapid, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).


Treatment measures for hyperkalemia include the following:


  1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties;

  2. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL;

  3. Correction of acidosis, if present, with intravenous sodium bicarbonate;

  4. Use of exchange resins, hemodialysis, or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, lowering the serum potassium concentration too rapidly can produce digitalis toxicity.


The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.



K-Tab Dosage and Administration


The usual dietary potassium intake by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.


Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.


K-Tab tablets provide 10 mEq of potassium chloride.


K-Tab tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).


NOTE:K-Tab tablets are to be swallowed whole without crushing, chewing or sucking the tablets.



How is K-Tab Supplied


K-Tab (potassium chloride extended-release tablets, USP) contains 750 mg of potassium chloride (equivalent to 10 mEq). K-Tab tablets are provided as yellow, ovaloid, extended-release Filmtab® tablets in bottles of 100 (NDC 0074-7804-13), 1000 (NDC 0074-7804-19) and 5000 (NDC 0074-7804-59) and in ABBO-PAC® unit dose packages of 100 (NDC 0074-7804-11).



Recommended Storage


Store below 86°F (30°C).



Filmtab - Film-sealed tablet, Abbott


Manufactured by:

Abbott Pharmaceuticals PR Ltd.

Barceloneta, PR 00617

For:

Abbott Laboratories

North Chicago, IL 60064



NDC 0074–7804–13


100 Filmtab® Tablets


K-Tab® Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg)


Rx only Abbott




NDC 0074–7804–19


1000 Filmtab® Tablets


K-Tab® Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg)


Rx only Abbott










K-Tab 
potassium chloride  tablet, film coated, extended release










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0074-7804
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CHLORIDE (POTASSIUM)POTASSIUM CHLORIDE750 mg




















Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
PARAFFIN 
TITANIUM DIOXIDE 
VANILLIN 
ALPHA-TOCOPHEROL 


















Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize15mm
FlavorImprint CodeKTAB;a
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10074-7804-13100 TABLET In 1 BOTTLENone
20074-7804-191000 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01827906/09/1980


Labeler - Abbott Laboratories (001307602)
Revised: 08/2011Abbott Laboratories

More K-Tab resources


  • K-Tab Side Effects (in more detail)
  • K-Tab Dosage
  • K-Tab Use in Pregnancy & Breastfeeding
  • Drug Images
  • K-Tab Drug Interactions
  • K-Tab Support Group
  • 0 Reviews for K-Tab - Add your own review/rating


  • K-Tab Advanced Consumer (Micromedex) - Includes Dosage Information

  • Klor-Con Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Klor-Con M10 Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Klor-con Consumer Overview

  • Klor-con Powder MedFacts Consumer Leaflet (Wolters Kluwer)

  • Micro-K Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rum-K Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare K-Tab with other medications


  • Hypokalemia
  • Prevention of Hypokalemia

Sunday 22 July 2012

Josezon




Josezon may be available in the countries listed below.


Ingredient matches for Josezon



Pentazocine

Pentazocine is reported as an ingredient of Josezon in the following countries:


  • Ethiopia

International Drug Name Search

Friday 20 July 2012

Zenpep


Generic Name: pancrelipase (oral) (pan kre LYE pace)

Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep


What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.


Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.


Pancrelipase may also be used following surgical removal of the pancreas.


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


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


You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.


Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.


Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.


What should I discuss with my healthcare provider before taking pancrelipase?


You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:


  • kidney disease;


  • gout;




  • a history of blockage in your intestines;




  • a sudden onset of pancreatitis; or




  • worsening of chronic pancreatic disease.




This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase 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.

How should I take pancrelipase?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.


Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.


Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.


What should I avoid while taking pancrelipase?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Pancrelipase side effects


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 or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:



  • nausea or vomiting;




  • mild stomach pain or upset;




  • diarrhea or constipation;




  • bloating or gas.




  • greasy stools;




  • rectal irritation;




  • headache, dizziness;




  • cough; or




  • weight loss.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect pancrelipase?


There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Zenpep resources


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


  • Zenpep Prescribing Information (FDA)

  • Zenpep Advanced Consumer (Micromedex) - Includes Dosage Information

  • Zenpep MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zenpep Consumer Overview

  • Pancrelipase Professional Patient Advice (Wolters Kluwer)

  • Pancrelipase Prescribing Information (FDA)

  • Pancrelipase Monograph (AHFS DI)

  • Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer)

  • Creon Consumer Overview

  • Creon Prescribing Information (FDA)

  • Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dygase MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pancreaze Consumer Overview

  • Pancreaze Prescribing Information (FDA)



Compare Zenpep with other medications


  • Chronic Pancreatitis
  • Cystic Fibrosis
  • Pancreatic Exocrine Dysfunction


Where can I get more information?


  • Your pharmacist can provide more information about pancrelipase.

See also: Zenpep side effects (in more detail)


Codeine Phosphate Solution



Pronunciation: KOE-deen FOS-fate
Generic Name: Codeine Phosphate
Brand Name: Generic only. No brands available.


Codeine Phosphate Solution is used for:

Treating mild to moderate pain.


Codeine Phosphate Solution is a narcotic analgesic. It works in certain areas of the brain and nervous system to decrease pain.


Do NOT use Codeine Phosphate Solution if:


  • you are allergic to any ingredient in Codeine Phosphate Solution or to any codeine- or morphine-related medicine (eg, oxycodone)

  • you are taking sodium oxybate (GHB)

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



Before using Codeine Phosphate Solution:


Some medical conditions may interact with Codeine Phosphate Solution. 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 or recently have had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures

  • if you have a history of heart problems, stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), gallbladder problems (eg, gallstones), an enlarged prostate gland or other prostate problems, a blockage of your bladder or bowel, recent abdominal surgery, kidney or liver problems, adrenal gland problems (eg, Addison disease), or an underactive thyroid

  • if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

  • if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

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


  • HIV protease inhibitors (eg, ritonavir), monoamine oxidase (MAO) inhibitors (eg, phenelzine), other narcotic pain medicines, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Codeine Phosphate Solution may be increased

  • Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, and seizures may be increased

  • Naltrexone or quinidine because effectiveness of Codeine Phosphate Solution may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Codeine Phosphate Solution 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 Codeine Phosphate Solution:


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


  • Codeine Phosphate Solution is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Codeine Phosphate Solution at home, carefully follow the injection procedures taught to you by your health care provider.

  • If Codeine Phosphate Solution contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

  • If you miss a dose of Codeine Phosphate Solution, 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 Codeine Phosphate Solution.



Important safety information:


  • Codeine Phosphate Solution 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 Codeine Phosphate Solution. Using Codeine Phosphate Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Codeine Phosphate Solution. Codeine Phosphate Solution will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

  • Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Codeine Phosphate Solution.

  • Use Codeine Phosphate Solution with caution in the ELDERLY because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: It is unknown if Codeine Phosphate Solution can cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Codeine Phosphate Solution during pregnancy. Codeine Phosphate Solution is excreted in breast milk. Do not breast-feed while taking Codeine Phosphate Solution.

When used for long periods of time or at high doses, Codeine Phosphate Solution may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Codeine Phosphate Solution stops working well. Do not take more than prescribed.


When used for long periods of time or at high doses, some people develop a need to continue taking Codeine Phosphate Solution. This is known as DEPENDENCE or addiction.


If you suddenly stop taking Codeine Phosphate Solution, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.



Possible side effects of Codeine Phosphate Solution:


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; dizziness; drowsiness; flushing; lightheadedness; nausea; sweating; tiredness; vomiting.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast heartbeat; fainting; mental or mood changes; seizures; severe drowsiness or dizziness; slow or shallow breathing; trouble urinating.



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.


See also: Codeine Phosphate 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 cold and clammy skin; coma; confusion; dizziness; excitability; fever; garbled speech; hallucinations; loss of consciousness; mood or mental changes; nausea; rapid breathing; restlessness; ringing in the ears or trouble hearing; seizures; skin rash; slow or shallow breathing; sluggishness; small pupils; sweating; thirst; unusual sleepiness; vision changes; vomiting.


Proper storage of Codeine Phosphate Solution:

Codeine Phosphate Solution is usually handled and stored by a health care provider. If you are using Codeine Phosphate Solution at home, store Codeine Phosphate Solution as directed by your pharmacist or health care provider.


General information:


  • If you have any questions about Codeine Phosphate Solution, please talk with your doctor, pharmacist, or other health care provider.

  • Codeine Phosphate Solution 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 Codeine Phosphate Solution. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Codeine Phosphate resources


  • Codeine Phosphate Side Effects (in more detail)
  • Codeine Phosphate Use in Pregnancy & Breastfeeding
  • Drug Images
  • Codeine Phosphate Drug Interactions
  • Codeine Phosphate Support Group
  • 19 Reviews for Codeine Phosphate - Add your own review/rating


Compare Codeine Phosphate with other medications


  • Cough
  • Diarrhea
  • Pain

Thursday 12 July 2012

Metoprolol Succinate Extended-Release Tablets



Pronunciation: MET-oh-PROE-lol SUX-i-nate
Generic Name: Metoprolol Succinate
Brand Name: Toprol XL

Do not suddenly stop taking Metoprolol Succinate Extended-Release Tablets. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Metoprolol Succinate Extended-Release Tablets. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Metoprolol Succinate Extended-Release Tablets for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Metoprolol Succinate Extended-Release Tablets again.


Tell your doctor or dentist that you take Metoprolol Succinate Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


Tell your doctor if you have a history of diabetes or if you take medicine to lower your blood sugar (eg, glyburide, insulin). Metoprolol Succinate Extended-Release Tablets may hide signs of low blood sugar, such as fast heartbeat. Be sure to watch for other signs of low blood sugar (eg, anxiety, chills, dizziness, drowsiness, fainting, headache, tremor, unusual sweating, vision changes, weakness). Tell your doctor right away if these effects occur.


Metoprolol Succinate Extended-Release Tablets should not usually be used by patients who have a history of certain lung or breathing problems (eg, asthma) or who have a certain type of adrenal gland tumor (pheochromocytoma). It may worsen these conditions. Tell your doctor if you have a history of breathing problems or adrenal gland tumors. If you have these conditions and must take Metoprolol Succinate Extended-Release Tablets, your doctor may need to adjust your dose or prescribe additional medicine to reduce the risk of side effects. Check with your doctor for more information.


Tell your doctor if you have a history of overactive thyroid. Metoprolol Succinate Extended-Release Tablets may hide symptoms of overactive thyroid (eg, fast heartbeat). Do not suddenly stop taking Metoprolol Succinate Extended-Release Tablets; suddenly stopping Metoprolol Succinate Extended-Release Tablets could worsen your condition. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. Check with your doctor for more information.





Metoprolol Succinate Extended-Release Tablets are used for:

Treating high blood pressure, alone or with other medicines; long-term treatment of chest pain; and treating certain types of heart failure. It may also be used for other conditions as determined by your doctor.


Metoprolol Succinate Extended-Release Tablets are a beta-adrenergic blocking agent (beta-blocker). It works by reducing the amount of work the heart has to do (reduces chest pain) and the amount of blood the heart pumps out (lowers high blood pressure). It is also used to stabilize the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm.


Do NOT use Metoprolol Succinate Extended-Release Tablets if:


  • you are allergic to any ingredient in Metoprolol Succinate Extended-Release Tablets or to another beta-blocker (eg, propranolol)

  • you have a very slow heart rate (eg, bradycardia), certain types of irregular heartbeat (eg, atrioventricular [AV] block, sick sinus syndrome), moderate to severe heart failure, very low systolic blood pressure (less than 100 mm Hg), or severe blood circulation problems

  • you are taking mibefradil

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



Before using Metoprolol Succinate Extended-Release Tablets:


Some medical conditions may interact with Metoprolol Succinate Extended-Release Tablets. 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 an adrenal gland tumor (pheochromocytoma), an overactive thyroid, or are scheduled to have surgery

  • if you have low blood pressure or a history of heart attack, slow or irregular heartbeat, heart failure, or other heart problems; chest pain or angina; blood circulation problems; or liver problems

  • if you have diabetes mellitus, chronic obstructive pulmonary disease (COPD), bronchitis, breathing problems, or a history of asthma

Some MEDICINES MAY INTERACT with Metoprolol Succinate Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Amiodarone, bupropion, cimetidine, digoxin, diltiazem, diphenhydramine, disopyramide, flecainide, certain HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), hydralazine, hydroxychloroquine, ketanserin, mefloquine, mibefradil, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), phenothiazines (eg, thioridazine), propafenone, propylthiouracil, quinazolines (eg, alfuzosin), quinidine, reserpine, certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), terbinafine, or verapamil because serious side effects, such as very slow heart rate, very low blood pressure, fainting, severe dizziness, or lightheadedness when standing, may occur

  • Clonidine because stopping either of these medicines suddenly can lead to a rapid increase in blood pressure

  • Barbiturates (eg, phenobarbital), indomethacin, or phenylpropanolamine because they may decrease Metoprolol Succinate Extended-Release Tablets's effectiveness

  • Bupivacaine, disopyramide, flecainide, hydralazine, ketanserin, or lidocaine because the risk of their side effects may be increased by Metoprolol Succinate Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metoprolol Succinate Extended-Release Tablets 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 Metoprolol Succinate Extended-Release Tablets:


Use Metoprolol Succinate Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Metoprolol Succinate Extended-Release Tablets by mouth either always with food or immediately following a meal, at the same time each day.

  • Swallow Metoprolol Succinate Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Metoprolol Succinate Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.

  • If you miss a dose of Metoprolol Succinate Extended-Release Tablets, take it if you remember the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, check with your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Metoprolol Succinate Extended-Release Tablets.



Important safety information:


  • Metoprolol Succinate Extended-Release Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Metoprolol Succinate Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Metoprolol Succinate Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Do not suddenly stop taking Metoprolol Succinate Extended-Release Tablets without first consulting your doctor. If your doctor decides you should no longer use Metoprolol Succinate Extended-Release Tablets, you will need to stop Metoprolol Succinate Extended-Release Tablets gradually according to your doctor's instructions.

  • If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.

  • Do not take any medicines used to treat colds or congestion without first consulting with your doctor or pharmacist.

  • Diabetes patients - Metoprolol Succinate Extended-Release Tablets may hide signs of low blood sugar, such as rapid heartbeat. Be sure to watch for other signs or low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Tell your doctor or dentist that you take Metoprolol Succinate Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

  • If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Metoprolol Succinate Extended-Release Tablets.

  • Lab tests, including liver function and blood cholesterol levels, may be performed while you use Metoprolol Succinate Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Metoprolol Succinate Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metoprolol Succinate Extended-Release Tablets while you are pregnant. Metoprolol Succinate Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Metoprolol Succinate Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Metoprolol Succinate Extended-Release Tablets:


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; diarrhea; dizziness; dry mouth or eyes; gas; headache; heartburn; lightheadedness; mild drowsiness; muscle aches; nausea; stomach pain; trouble sleeping; unusual tiredness or weakness; 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; unusual hoarseness); blue or unusually cold hands or feet; chest pain; chills, fever, or sore throat; fainting; hallucinations; mood or mental changes (eg, confusion, depression, foggy thinking, short-term memory loss); pounding in the chest; severe dizziness or lightheadedness; shortness of breath; slow or irregular heartbeat; swelling of the arms, hands, and feet; unusual bruising or bleeding; vision changes; wheezing; yellowing of the skin or eyes.



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.


See also: Metoprolol Succinate 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include blue skin discoloration; difficult or slowed breathing; fainting; impaired consciousness; severe dizziness; very slow heart rate; vomiting; weakness.


Proper storage of Metoprolol Succinate Extended-Release Tablets:

Store Metoprolol Succinate Extended-Release Tablets at room temperature, 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 Metoprolol Succinate Extended-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Metoprolol Succinate Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Metoprolol Succinate Extended-Release Tablets are 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 Metoprolol Succinate Extended-Release Tablets. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Metoprolol Succinate resources


  • Metoprolol Succinate Side Effects (in more detail)
  • Metoprolol Succinate Dosage
  • Metoprolol Succinate Use in Pregnancy & Breastfeeding
  • Drug Images
  • Metoprolol Succinate Drug Interactions
  • Metoprolol Succinate Support Group
  • 102 Reviews for Metoprolol Succinate - Add your own review/rating


Compare Metoprolol Succinate with other medications


  • Angina
  • Angina Pectoris Prophylaxis
  • Atrial Fibrillation
  • Benign Essential Tremor
  • Heart Attack
  • Heart Failure
  • High Blood Pressure
  • Left Ventricular Dysfunction
  • Mitral Valve Prolapse
  • Premature Ventricular Depolarizations
  • Supraventricular Tachycardia

Tuesday 10 July 2012

Guaifenex DM


Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E


What is Guaifenex DM (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Guaifenex DM (dextromethorphan and guaifenesin)?


Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Guaifenex DM (dextromethorphan and guaifenesin)?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.


FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Guaifenex DM (dextromethorphan and guaifenesin)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?


Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 your 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 feeling restless or nervous.


What should I avoid while taking Guaifenex DM (dextromethorphan and guaifenesin)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Guaifenex DM (dextromethorphan and guaifenesin) side effects


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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness, anxiety, restless feeling, or nervousness;




  • confusion, hallucinations; or




  • slow, shallow breathing.



Less serious side effects may include:



  • dizziness;




  • headache;




  • skin rash or itching; or




  • nausea, vomiting, or stomach upset.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Guaifenex DM (dextromethorphan and guaifenesin)?


Before taking this medication, tell your doctor if you are using any of the following drugs:



  • celecoxib (Celebrex);




  • cinacalcet (Sensipar);




  • darifenacin (Enablex);




  • imatinib (Gleevec);




  • quinidine (Quinaglute, Quinidex);




  • ranolazine (Ranexa);




  • ritonavir (Norvir);




  • sibutramine (Meridia);




  • terbinafine (Lamisil);




  • medicines to treat high blood pressure; or




  • an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.



This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. 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 Guaifenex DM resources


  • Guaifenex DM Side Effects (in more detail)
  • Guaifenex DM Use in Pregnancy & Breastfeeding
  • Drug Images
  • Guaifenex DM Drug Interactions
  • Guaifenex DM Support Group
  • 0 Reviews for Guaifenex DM - Add your own review/rating


  • Guaifenex DM Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mucinex DM Prescribing Information (FDA)

  • Mucinex DM Maximum Strength Prescribing Information (FDA)

  • Robitussin DM infant drops

  • Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tussin DM Prescribing Information (FDA)



Compare Guaifenex DM with other medications


  • Cough
  • Expectoration


Where can I get more information?


  • Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: Guaifenex DM side effects (in more detail)


Monday 9 July 2012

Irrigandum




Irrigandum may be available in the countries listed below.


Ingredient matches for Irrigandum



Nimodipine

Nimodipine is reported as an ingredient of Irrigandum in the following countries:


  • Peru

International Drug Name Search

Sunday 8 July 2012

Caltrate 600 with D


Generic Name: calcium and vitamin D combination (KAL see um and VYE ta min D)

Brand Names: Calcarb with D, Calcet, Calcio Del Mar, Calcitrate with D, Calcium 600+D, Caltrate 600 with D, Caltrate 600 with D Plus Soy, Caltrate Colon Health, Citracal + D, Citracal 250 mg + D, Citracal Creamy Bites, Citracal Maximum + D, Citracal Petites, Citrus Calcium with Vitamin D, Dical-D, Os-Cal 250 with D, Os-Cal 500 + D, Os-Cal with D, Oysco 500 with D, Oysco D, Oyst-Cal-D, Oyster Shell Calcium with Vitamin D, Oyster-D, Oystercal-D, Posture-D H/P, Risacal-D


What is Caltrate 600 with D (calcium and vitamin D combination)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance.


Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.


Calcium and vitamin D combination is used to prevent or to treat a calcium deficiency.


Calcium and vitamin D combination may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Caltrate 600 with D (calcium and vitamin D combination)?


Before you take calcium and vitamin D combination, tell your doctor if you have kidney disease, past or present kidney stones, heart disease, circulation problems, a parathyroid disorder, or if you are pregnant or breast-feeding.


Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Before taking calcium and vitamin D combination, tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.


What should I tell my healthcare provider before taking Caltrate 600 with D (calcium and vitamin D combination)?


If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take calcium and vitamin D combination, tell your doctor if you have:


  • kidney disease;

  • past or present kidney stones;


  • heart disease;




  • circulation problems; or




  • a parathyroid gland disorder.




Talk to your doctor before taking calcium and vitamin D combination if you are pregnant. Talk to your doctor before taking calcium and vitamin D combination if you are breast-feeding.

How should I take Caltrate 600 with D (calcium and vitamin D combination)?


Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


Take the calcium and vitamin D regular tablet with a full glass of water.

The chewable tablet should be chewed before you swallow it.


Store calcium and vitamin D combination at room temperature away from moisture and heat.

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, wait until then to take the medicine and skip the missed dose. 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 irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, a metallic taste in your mouth, confusion, loss of appetite, constipation, weakness, headache, confusion, or fainting.


What should I avoid while taking Caltrate 600 with D (calcium and vitamin D combination)?


Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Caltrate 600 with D (calcium and vitamin D combination) side effects


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.

Less serious side effects may include:



  • an irregular heartbeat;




  • nausea, vomiting, or decreased appetite;




  • dry mouth;




  • constipation;




  • weakness;




  • headache;




  • a metallic taste;




  • muscle or bone pain; or




  • drowsiness.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Caltrate 600 with D (calcium and vitamin D combination)?


Before taking calcium and vitamin D combination, tell your doctor if you are taking:



  • digoxin (Lanoxin, Lanoxicaps);




  • antacids containing calcium, aluminum, or magnesium;




  • other calcium supplements;




  • calcitriol (Rocaltrol) or other vitamin D supplements; or




  • a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).



This list is not complete and there may be other drugs that can interact with calcium and vitamin D combination. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Caltrate 600 with D resources


  • Caltrate 600 with D Side Effects (in more detail)
  • Caltrate 600 with D Use in Pregnancy & Breastfeeding
  • Caltrate 600 with D Drug Interactions
  • Caltrate 600 with D Support Group
  • 0 Reviews for Caltrate 600 with D - Add your own review/rating


Compare Caltrate 600 with D with other medications


  • Dietary Supplementation
  • Osteoporosis


Where can I get more information?


  • Your pharmacist can provide more information about calcium and vitamin D combination.

See also: Caltrate 600 with D side effects (in more detail)