promethazine

proe-METH-a-zeen

Oral route(Syrup)

Promethazine hydrochloride plain oral solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Exercise caution when administering to pediatric patients 2 years of age and older and use at the lowest effective dose. Avoid concomitant use of other drugs with respiratory depressant effects .

Oral route(Tablet)

Promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Exercise caution when administering to pediatric patients 2 years of age and older and use at the lowest effective dose. Avoid concomitant use of other drugs with respiratory depressant effects .

Commonly used brand name(s)

In the U.S.

• Phenergan


• Promacot

Available Dosage Forms:

• Syrup


• Tablet


• Elixir

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antihistamine

Chemical Class: Aliphatic

Uses For promethazine

Promethazine is used to relieve or prevent the symptoms of hay fever, allergic conjunctivitis (inflammation of the eye), and other types of allergy or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes (air passages of the lungs) and make breathing difficult .

Promethazine is also used to prevent and control motion sickness, nausea, vomiting, and dizziness. In addition, it may be used to help people go to sleep and control their pain or anxiety before or after surgery or other procedures .

Promethazine may also be used for other conditions as determined by your doctor .

promethazine is only available with your doctor's prescription .

Before Using promethazine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For promethazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to promethazine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of promethazine in the pediatric population. Safety and efficacy have not been established in children below 2 years of age. Caution should be used when promethazine is given to children 2 years of age and older .

Geriatric

Insufficient information is available on the relationship of age to the effects of promethazine in geriatric patients. However, elderly patients may be more sensitive to the side effects of promethazine (such as confusion and severe drowsiness) than in younger adults, and are more likely to have age-related heart or blood vessel disease, liver problems, and kidney disease, which may require adjustment of dosage in patients receiving promethazine .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking promethazine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using promethazine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Dronedarone


• Grepafloxacin


• Mesoridazine


• Metoclopramide


• Pimozide


• Sparfloxacin


• Thioridazine

Using promethazine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Fentanyl


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Hydromorphone


• Ibutilide


• Iloperidone


• Imipramine


• Isradipine


• Lapatinib


• Levofloxacin


• Levorphanol


• Lithium


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Metrizamide


• Morphine


• Morphine Sulfate Liposome


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Oxycodone


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Posaconazole


• Procainamide


• Procarbazine


• Prochlorperazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tapentadol


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Tramadol


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone


• Zolpidem

Using promethazine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Belladonna


• Belladonna Alkaloids


• Betel Nut


• Evening Primrose


• Meperidine


• Midodrine


• Phenylalanine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of promethazine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease or injury or


• Breathing or lung problems (e.g., asthma) or


• Comatose state (unconscious) or


• Reye's syndrome or


• Sleep apnea, history of—Promethazine should NOT be used in patients with any of these conditions .

• Bone marrow disease or


• Enlarged prostate or


• Glaucoma or


• Heart or blood vessel disease or


• Intestinal tract obstruction or


• Jaundice or


• Liver disease or


• Neuroleptic malignant syndrome, or history of, or


• Stomach ulcer or


• Urinary tract blockage or difficult urination—Use with caution. promethazine may make these conditions worse .

• Seizure disorders—promethazine may increase the chance of seizures especially in patients who are also using narcotic or anesthetic medicines .

Proper Use of promethazine

promethazine can be taken with food or a glass of water or milk to lessen stomach irritation if necessary.

Dosing

The dose of promethazine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of promethazine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For allergy symptoms:
    
    • Adults and teenagers—12.5 milligrams (mg) before meals and at bedtime; or 25 mg at bedtime as needed.
    
    
    • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 6.25 to 12.5 mg three times a day; or 25 mg at bedtime as needed.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For prevention of motion sickness:
    
    • Adults and teenagers—25 mg twice daily; this initial dose should be taken one-half to one hour before traveling. The dose may be repeated eight to twelve hours later if needed. On other days of travel, 25 mg may be taken on arising and again before the evening meal.
    
    
    • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 12.5 to 25 mg one-half to one hour before traveling. The dose may be repeated eight to twelve hours later if needed.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For nausea and vomiting:
    
    • Adults and teenagers—25 mg for the first dose, then 12.5 to 25 mg every four to six hours if needed.
    
    
    • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 0.5 mg per pound of body weight (1.1 mg per kg) or 12.5 to 25 mg every four to six hours as needed.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For sedation:
    
    • Adults and teenagers—25 to 50 mg.
    
    
    • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 12.5 to 25 mg.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For control of pain or anxiety before or after surgery:
    
    • Adults and teenagers—50 mg the night before surgery; 25 to 50 mg after surgery.
    
    
    • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 0.5 mg per pound of body weight (1.1 mg per kg) or 12.5 to 25 mg the night before surgery or after the surgery.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

If you miss a dose of promethazine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep outdated medicine or medicine no longer needed.

Keep out of the reach of children.

Precautions While Using promethazine

It is very important that your doctor check your progress at regular visits to make sure promethazine is working properly. Blood tests may be needed to check for unwanted effects .

promethazine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor .

promethazine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to promethazine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

promethazine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, antidepressants, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking promethazine.

Check with your doctor right away if you have symptoms of pale or blue lips, fingernails, or skin; difficult or troubled breathing; irregular, fast, slow, or shallow breathing; or shortness of breath. These could be signs of a condition called respiratory depression .

Check with your doctor right away and stop taking your medicine (if directed by your doctor) if you have muscle stiffness, fever, difficult or fast breathing, seizures, fast heartbeat, increased sweating, loss of bladder control, unusually pale skin, or tiredness or weakness. These may be symptoms of a serious condition called neuroleptic malignant syndrome (NMS) .

Before you have any medical tests, tell the medical doctor in charge that you are taking promethazine. The results of some tests may be affected by promethazine .

promethazine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections .

promethazine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

promethazine controls nausea and vomiting. For this reason, it may cover up some of the signs of overdose caused by other medicines or the symptoms of encephalopathy or Reye's syndrome. This will make it difficult for your doctor to diagnose these conditions. Make sure your doctor knows that you are taking promethazine .

promethazine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking promethazine and get emergency help immediately if any of the following effects occur:

Rare - Symptoms of neuroleptic malignant syndrome; two or more occur together; most of these effects do not require emergency medical attention if they occur alone

• Convulsions (seizures)


• difficult or unusually fast breathing


• fast heartbeat or irregular pulse


• high fever


• high or low (irregular) blood pressure


• increased sweating


• loss of bladder control


• severe muscle stiffness


• unusually pale skin


• unusual tiredness or weakness

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain


• black, tarry stools


• bleeding gums


• blood in urine or stools


• bloody nose


• blurred vision


• chest pain or discomfort


• chills


• clay-colored stools


• confusion as to time, place, or person


• cough or hoarseness


• dark urine


• decreased awareness or responsiveness


• difficulty or troubled breathing


• double vision


• fast, pounding, or irregular heartbeat or pulse


• fever with or without chills


• fixed position of eye


• headache


• heavier menstrual periods


• high fever


• holding false beliefs that cannot be changed by fact


• hyperexcitability


• increased or decreased blood pressure


• increased sweating


• irregular, fast or slow, or shallow breathing


• itching


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lightheadedness, dizziness, or fainting


• loss of appetite


• loss of bladder control


• lower back or side pain


• mimicry of speech or movements


• mutism


• nasal stuffiness


• nausea


• negativism


• nightmares


• noisy breathing


• not breathing


• painful or difficult urination


• pale or blue lips, fingernails, or skin


• peculiar postures or movements, mannerisms or grimacing


• pinpoint red spots on skin


• seeing double


• seeing, hearing, or feeling things that are not there


• seizures


• severe muscle stiffness


• severe sleepiness


• shortness of breath


• skin rash


• slow or irregular heartbeat


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• sticking out of tongue


• swollen glands


• tightness in chest


• tremors


• uncontrolled twisting movements of neck


• unpleasant breath odor


• unusual bleeding or bruising


• unusual excitement, nervousness, or restlessness


• unusual tiredness or weakness


• vomiting of blood


• wheezing


• yellow eyes or skin

Symptoms of overdose

• Discouragement


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• dry mouth


• excessive muscle tone


• feeling of warmth


• feeling sad or empty


• irritability


• lack of appetite


• loss of interest or pleasure


• muscle tension or tightness


• overactive reflexes


• pupils of eyes large and not moving or responding to light


• redness of the face, neck, arms and occasionally, upper chest


• shakiness and unsteady walk


• sudden death


• trouble concentrating


• trouble sleeping


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual paleness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• blistering, crusting, irritation, itching, or reddening of skin


• continuing ringing or buzzing or other unexplained noise in ears


• cracked, dry, scaly skin


• dizziness


• drowsiness


• excitation


• false or unusual sense of well-being


• hearing loss


• hives or welts


• increased sensitivity of skin to sunlight


• lack of coordination


• loss of strength or energy


• muscle pain or weakness


• redness or other discoloration of skin


• relaxed and calm


• sunburn


• swelling


• unable to sleep


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: promethazine side effects (in more detail)

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More promethazine resources

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

• Promethazine MedFacts Consumer Leaflet (Wolters Kluwer)


• Promethazine Prescribing Information (FDA)


• Phenadoz Prescribing Information (FDA)


• Phenergan Consumer Overview


• Phenergan Prescribing Information (FDA)


• Promethazine Hydrochloride Monograph (AHFS DI)


• Promethegan Prescribing Information (FDA)

Compare promethazine with other medications

• Allergic Reactions
• Anaphylaxis
• Hay Fever
• Light Sedation
• Motion Sickness
• Nausea/Vomiting
• Opiate Adjunct
• Sedation
• Urticaria
• Vertigo

Tracleer

Generic Name: bosentan (boe SEN tan)

Brand Names: Tracleer

What is Tracleer (bosentan)?

Bosentan prevents thickening of the blood vessels, especially those in the lungs and heart. Bosentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

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

What is the most important information I should know about Tracleer (bosentan)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Do not use this medication if you are allergic to bosentan, or if you are also taking cyclosporine (Sandimmune, Neoral, Gengraf), glyburide (Micronase, DiaBeta, Glynase Pres Tab), or HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir). Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What should I discuss with my healthcare provider before taking Tracleer (bosentan)?

Do not use this medication if you are allergic to bosentan, or if you:

• 
  

  are also taking HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir);

  
  


• 
  

  are also taking using glyburide (Micronase, DiaBeta, Glynase Pres Tab);

  
  


• 
  

  are pregnant or might become pregnant during treatment; or

  
  


• 
  

  are also using cyclosporine (Sandimmune, Neoral, Gengraf).

  
  

Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. FDA pregnancy category X. This medication can cause birth defects. Do not use bosentan if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tracleer (bosentan)?

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

Take each dose with a full glass (8 ounces) of water.

Bosentan can be taken with or without food.

Bosentan is usually taken twice a day, morning and evening.

Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store bosentan at room temperature away from moisture and heat.

See also: Tracleer 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 can cause headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).

What should I avoid while using Tracleer (bosentan)?

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

Tracleer (bosentan) 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 any of these serious side effects:

• 
  

  nausea, stomach pain, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  flushing;

  
  


• 
  

  swelling of the feet, ankles, or legs;

  
  


• 
  

  dizziness;

  
  


• 
  

  upset stomach;

  
  


• 
  

  fatigue; or

  
  


• 
  

  itching.

  
  

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 Tracleer (bosentan)?

Do not take bosentan without first talking to your doctor if you are taking any of the following medicines:

• 
  

  amiodarone (Cordarone, Pacerone);

  
  


• 
  

  diltiazem (Tiazac, Cartia, Cardizem);

  
  


• 
  

  erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  an antifungal medication such as ketoconazole (Nizoral), fluconazole (Diflucan), or itraconazole (Sporanox);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  a cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).

  
  

This list is not complete and there may be other drugs not listed that can affect bosentan. 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 Tracleer resources

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

• Tracleer Prescribing Information (FDA)


• Tracleer MedFacts Consumer Leaflet (Wolters Kluwer)


• Tracleer Monograph (AHFS DI)


• Tracleer Advanced Consumer (Micromedex) - Includes Dosage Information


• Bosentan Professional Patient Advice (Wolters Kluwer)

Compare Tracleer with other medications

• Pulmonary Arterial Hypertension

Where can I get more information?

• Your doctor or pharmacist can provide more information about bosentan.

See also: Tracleer side effects (in more detail)

Extuss LA

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 Extuss LA (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 Extuss LA (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 Extuss LA (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 Extuss LA (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 Extuss LA (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.

Extuss LA (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 Extuss LA (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 Extuss LA resources

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

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


• Bidex-A Extended-Release Tablets 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 Extuss LA with other medications

• Cough
• Expectoration

Where can I get more information?

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

See also: Extuss LA side effects (in more detail)

Starlix 60mg, 120mg, 180mg film coated tablets

Starlix 60 mg film-coated tablets

Starlix 120 mg film-coated tablet

Starlix 180 mg film-coated tablets

Nateglinide

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Starlix is and what it is used for


• 2. Before you take Starlix


• 3. How to take Starlix


• 4. Possible side effects


• 5. How to store Starlix


• 6. Further information

What Starlix Is And What It Is Used For

Starlix is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics).

It is used by people with type 2 diabetes. (This kind of diabetes is also called non-insulin-dependent diabetes mellitus.)

Insulin is a substance produced by a body organ called the pancreas. It helps to decrease blood sugar levels, especially after meals. In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly. This helps to keep the blood sugar controlled after meals.

Your doctor will prescribe Starlix together with another oral anti-diabetic containing metformin.

Starlix tablets start to act quickly after you take them and are eliminated from the body rapidly.

Before You Take Starlix

Follow all instructions given to you by your doctor and pharmacist carefully, even if they are different from what is in this leaflet.

Do not take Starlix

• if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Starlix.


• if you have type 1 diabetes (i.e. your body does not produce any insulin).


• if you know that you have a severe liver problem.


• if you are pregnant or planning to become pregnant.


• if you are breast-feeding.

Talk to your doctor if you have any further questions or you think that any of these may apply to you.

Take special care with Starlix

People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia). Medicines, including Starlix, may also produce symptoms of low blood sugar.

If you get any of these symptoms – feeling dizzy, light-headed, hungry, shaky or any of the other signs in section 4, “Possible side effects” – eat or drink something containing sugar.

Some people are more likely to get symptoms of low blood sugar than others. Take care

• if you are over 65 years of age.


• if you are undernourished.


• if you have another medical condition that may cause low blood sugar (e.g. an under-active pituitary or adrenal gland).

If any of these apply to you, monitor your blood sugar levels more carefully.

Talk to your doctor

• if you know that you have a liver problem.


• if you have a severe kidney problem.


• if you have problems of drug metabolism.


• if you are due to have an operation.


• if you have suffered a fever, an accident or an infection.

Your treatment may need to be adjusted.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The amount of Starlix that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.

It is especially important that you tell your doctor or pharmacist if you are taking:

• Beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high blood pressure and certain heart conditions).


• Diuretics (used in the treatment of high blood pressure).


• Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).


• Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout).

Your doctor may adjust the dose of these medicines.

Food, drink and exercise

Take Starlix before meals (see section 3, “How to take Starlix”). Its effect may be delayed if it is taken during or after meals.

Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise your doctor has recommended for you.

Watch carefully for signs of low blood sugar, especially

• if you have exercised more strenuously than usual.


• if you have drunk alcohol.

Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Starlix. If you do get symptoms of low blood sugar, eat or drink something containing sugar and talk to your doctor.

Starlix and older people

Starlix can be used by people over 65 years of age. Take special care to avoid low blood sugar.

Starlix and children and adolescents

Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.

Pregnancy and breast-feeding

Do not take Starlix if you are pregnant or planning to become pregnant. See your doctor as soon as possible if you become pregnant during treatment.

Do not breast-feed during treatment with Starlix.

Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.

Driving and using machines

You are advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

Important information about some of the ingredients of Starlix

Starlix tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Take Starlix

Always take Starlix exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

When to take Starlix

Take Starlix before the three main meals, usually:

• 1 dose before breakfast


• 1 dose before lunch


• 1 dose before dinner

It is best to take it right before a main meal but you can take it up to 30 minutes before.

Do not take it if you are not going to eat a main meal. If you miss a meal, skip that dose of Starlix and wait until your next meal.

How much to take

Take Starlix as your doctor told you to. Your doctor will determine the dosage you require.

The usual dose of Starlix to start with is 60 mg before the three main meals. In some cases your doctor may prescribe higher doses. The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.

Swallow the tablets whole with a glass of water before the meal.

How long to take Starlix

Take Starlix daily until your doctor tells you to stop.

If you take more Starlix than you should

If you have accidentally taken too many tablets, talk to a doctor straight away. If you experience symptoms of low blood sugar – if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, “Possible side effects” – eat or drink something containing sugar.

If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help – or make sure that someone else does this for you.

If you forget to take Starlix

If you forget to take a tablet simply take the next one before your next meal. Do not take a double dose of Starlix to make up for the one that you missed.

Possible Side Effects

Like all medicines, Starlix can cause side effects, although not everybody gets them. The side effects caused by Starlix are usually mild to moderate.

The most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually mild. These include

• sweating,


• dizziness,


• shaking,


• weakness,


• hunger,


• feeling your heart beating fast,


• tiredness,


• feeling sick (nausea).

They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking. If you do get symptoms of low blood sugar, eat or drink something containing sugar.

Abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported.

Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such as rash and itching.

A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, fever and/or diarrhoea.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Starlix

Keep out of the reach and sight of children.

Store in the original package.

Do not use Starlix after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use any Starlix pack that is damaged or shows signs of tampering.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Starlix contains

• The active substance is nateglinide.


• The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.


• The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).

What Starlix looks like and contents of the pack

Starlix 60 mg film-coated tablets are pink, round tablets with “STARLIX” marked on one side and “60” on the other.

Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.

Starlix 180 mg film-coated tablets are red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other.

Each blister pack contains 12, 24, 30, 60, 84, 120 or 360 tablets. Not all pack sizes or tablet strengths may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito, 131

I-80058 Torre Annunziata - Napoli

Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel:+44 1276 698370

This leaflet was last approved in: 05/11/2007

Paromomycin

Dosage Form: capsules
Paromomycin Sulfate Capsules, USP

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules, USP, and other antibacterial drugs, Paromomycin Sulfate Capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomycesriomosus var. Paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated chemically as 0-2, 6-Diamino-2, 6 - dideoxy - β - L - idopyranosyl - (1→3) - 0 - β - D - ribofuranosyl - (1→5) - 0 - [2 - amino - 2 - deoxy - α - D - glucopyranosyl - (1→4)] - 2 - deoxystreptamine sulfate (salt). The molecular formula is C23H45N5O14•xH2SO4, with a molecular weight of 615.64 (base). Its structural formula is:

Each capsule, for oral administration, contains Paromomycin sulfate equivalent to 250mg Paromomycin. Each capsule also contains the following inactive ingredients: FD&C Blue # 1, D&C Red # 28, FD&C Red # 40, gelatin and titanium dioxide.

The imprinting ink for the 250 mg capsule contains D&C yellow #10, FD&C blue # 1, FD&C blue # 2, FD&C red # 40, iron oxide black, pharmaceutical shellac glaze, and propylene glycol.

CLINICAL PHARMACOLOGY

The in-vitro and in-vivo antibacterial action of Paromomycin closely parallels that of neomycin. It is poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool.

INDICATIONS AND USAGE

Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS

Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

PRECAUTIONS

Prescribing Paromomycin Sulfate Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient is essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken. The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption.

Information for Patients

Patients should be counseled that antibacterial drugs including Paromomycin Sulfate Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Paromomycin Sulfate Capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Paromomycin Sulfate Capsules or other antibacterial drugs in the future.

PEDIATRIC USE

See DOSAGE AND ADMINISTRATION section.

Adverse Reactions

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily.

DOSAGE AND ADMINISTRATION

Intestinal amebiasis: Adults and Pediatric Patients: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days.

Management of hepatic coma: Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days.

HOW SUPPLIED

Paromomycin Sulfate Capsules, USP each contain Paromomycin sulfate equivalent to 250 mg Paromomycin, are supplied as follows:

NDC 23155-038-01: Bottles of 100

The capsule is Dark Blue Opaque / White Opaque, imprinted with “HP 38” in black ink on the cap and on the body.

STORAGE

Store at 20°-25°C (68°-77°F)

[See USP controlled Room Temperature]

Protect from moisture.

Preserve in tight containers as defined in the USP.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Heritage Pharmaceuticals Inc.

Edison, NJ 08837

1.866.901.DRUG (3784)

Heritage®

Iss. 09/09

BOTTLE LABEL – PRINCIPAL DISPLAY PANEL

NDC 23155-038-01

Paromomycin Sulfate

Capsules USP

250 mg

100 Capsules              Rx only

Heritage

Paromomycin SULFATE  Paromomycin sulfate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 23155-038 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Paromomycin sulfate (Paromomycin) Paromomycin sulfate 250 mg

Inactive Ingredients Ingredient Name Strength FD&C Blue No. 1   D&C Red No. 28   FD&C Red No. 40   gelatin   titanium dioxide   D&C yellow No. 10   FD&C blue No. 2   ferrosoferric oxide   shellac   propylene glycol

Product Characteristics Color BLUE (Dark Blue Opaque) , WHITE (White Opaque) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code HP;38;HP;38 Contains

Packaging # NDC Package Description Multilevel Packaging 1 23155-038-01 100 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065173	10/22/2009

Labeler - Heritage Pharmaceuticals Inc (780779901)

Revised: 09/2009Heritage Pharmaceuticals Inc

More Paromomycin resources

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

• Paromomycin MedFacts Consumer Leaflet (Wolters Kluwer)


• paromomycin Advanced Consumer (Micromedex) - Includes Dosage Information


• paromomycin Concise Consumer Information (Cerner Multum)


• Humatin Concise Consumer Information (Cerner Multum)


• Paromomycin Sulfate Monograph (AHFS DI)

Compare Paromomycin with other medications

• Amebiasis
• Cryptosporidiosis
• Dientamoeba fragilis
• Dog Tapeworm
• Fish Tapeworm Infection
• Giardiasis
• Hepatic Coma
• Hymenolepis nana, Dwarf Tapeworm
• Taenia saginata, beef tapeworm
• Taenia solium, pork tapeworm

Menveo Group A, C, W135 and Y conjugate vaccine

1. Name Of The Medicinal Product

Menveo powder and solution for solution for injection

Meningococcal Group A, C, W135 and Y conjugate vaccine

2. Qualitative And Quantitative Composition

One dose (0.5 ml of the reconstituted vaccine) contains:

(Originally contained in the powder)
• Meningococcal group A oligosaccharide	10 micrograms
Conjugated to Corynebacterium diphtheriae CRM197 protein	16.7 to 33.3 micrograms
(Originally contained in the solution)
• Meningococcal group C oligosaccharide	5 micrograms
Conjugated to Corynebacterium diphtheriae CRM197 protein	7.1 to 12.5 micrograms
• Meningococcal group W135 oligosaccharide	5 micrograms
Conjugated to Corynebacterium diphtheriae CRM197 protein	3.3 to 8.3 micrograms
• Meningococcal group Y oligosaccharide	5 micrograms
Conjugated to Corynebacterium diphtheriae CRM197 protein	5.6 to 10.0 micrograms

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solution for solution for injection (powder and solution for injection).

The powder is a white to off- white cake.

The solution is a colourless clear solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Menveo is indicated for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.

The use of this vaccine should be in accordance with official recommendations.

4.2 Posology And Method Of Administration

Posology

Adults

Menveo should be administered as a single 0.5 ml injection.

Paediatric population

Menveo is indicated from the age of 11 years and above and should be administered as a single 0.5 ml injection.

Elderly

There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years.

The need for, and timing of, a booster dose of Menveo has not yet been determined.

Method of administration

Menveo is given as an intramuscular injection, preferably into the deltoid muscle.

It must not be administered intravascularly, subcutaneously or intradermally.

Separate injection sites must be used if more than one vaccine is being administered at the same time.

For instructions on preparation and reconstitution of the product, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients, including diphtheria toxoid (CRM₁₉₇), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4).

As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection is not a contraindication.

4.4 Special Warnings And Precautions For Use

Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine.

Menveo should under no circumstances be administered intravascularly.

Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine.

As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).

There are no data on the applicability of the vaccine for post-exposure prophylaxis.

In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response. While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W135 and Y conjugate vaccines.

Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma. The risk-benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.

The tip cap of the syringe contains 10% Dry Natural Rubber. Although the risk for developing allergic latex reactions is very small, healthcare professionals are encouraged to consider the benefit risk prior to administering this vaccine to patients with known history of hypersensitivity to latex.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, Adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines.

There was no evidence of an increased rate of reactogenicity or change in the safety profile of the vaccines in either study. Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine components were not negatively affected by co-administration.

The administration of Menveo one month after Tdap resulted in statistically significantly lower group W135 seroresponses. Since there was no direct impact on the seroprotection rate, the clinical consequences are presently unknown.

There was evidence of some suppression of antibody response to two of the three pertussis antigens. The clinical relevance of this observation is unknown. After vaccination, over 97% of subjects had detectable pertussis titers to all three pertussis antigens.

Concomitant administration of Menveo and other vaccines than those listed above has not been studied. It is advised that Menveo should not be administered at the same time as other vaccines in particular live vaccines, unless absolutely necessary. Concomitant vaccines should always be administered at separate injection sites and preferably contralateral. It should be checked if the adverse reactions may be intensified by any co-administration.

If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.

4.6 Pregnancy And Lactation

Insufficient clinical data on exposed pregnancies are available.

In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined.

Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant. Therefore, Menveo may be used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been very rarely reported following vaccination. This may temporarily affect the ability to drive or use machines.

4.8 Undesirable Effects

The safety of Menveo was evaluated in five randomized controlled clinical trials including 6,185 participants (from 11-65 years) who received Menveo. Among Menveo recipients, 61%, 17%, 22% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively. The two primary safety studies were randomized, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.

The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups. The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipients subjects aged 11-55.

The most common local and systemic adverse reactions observed in clinical trials were pain at the injection site and headache.

Adverse reactions reported in three pivotal and two supportive clinical trials are listed here below per system organ class. The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Frequencies are defined as follows:

Very common: (

Common: (

Uncommon: (

Rare: (

Very rare: (<1/10,000)

Not known (cannot be estimated from the available data)

Nervous system disorders:

Very common: headache

Uncommon: dizziness

Gastrointestinal disorders:

Very common: nausea

Skin and subcutaneous tissue disorders:

Common: rash

General disorders and administration site conditions:

Very common: injection site pain, injection site erythema (

Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever

In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.

4.9 Overdose

No case of overdose has been reported.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH08.

Immunogenicity

The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-capsular antibodies with bactericidal activity. Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA). The hSBA was the original correlate of protection against meningococcal disease.

Immunogenicity was evaluated in randomized, multicenter, active controlled clinical trials that enrolled adolescents (11-18 years of age) adults (19-55 years of age) and older adults (56-65 years of age).

In the pivotal study (V59P13), participants received either a dose of Menveo (N = 2649) or quadrivalent, diphtheria toxoid conjugated, meningococcal vaccine as comparator (ACWY-D) (N = 875). Sera were obtained both before vaccination and 28 days after vaccination.

In another study (V59P6) conducted in 524 adolescents, the immunogenicity of Menveo was compared to that of ACWY-PS.

Immunogenicity in adolescents

In the 11-18 year old population of the pivotal study, V59P13, the immunogenicity of a single dose of Menveo one month post vaccination is compared with the quadrivalent, ACWY-Diphtheria toxoid protein conjugate vaccine (ACWY-D). Immunogenicity results at one month after Menveo are summarized below in Table 1.

In the subset of subjects aged 11-18 years who were seronegative at baseline (hSBA < 1:4), the proportion of subjects who achieved a titer

Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years

Serogroup	N	GMT (95% CI)	hSBA > 1:8 (95% CI)
A	1075	29 (24 , 35)	75% (73 , 78)
C	1396	50 (39, 65)	85% (83, 87)
W135	1024	87 (74, 102)	96% (95, 97)
Y	1036	51 (42, 61)	88% (85, 90)

The persistence of immune responses for Menveo at 21 months post vaccination among subjects aged 11-18 years at the time of vaccination is shown in Table 2.

Table 2: Persistence of immune responses approximately 21 months after vaccination with Menveo (subjects were aged 11-18 years at vaccination)

Serogroup	GMT (95% CI)	hSBA (95% CI)
A	5.29 (4.63, 6.05)	36% (30, 42)
C	10 (9.02, 12)	62% (56, 68)
W135	18 (15, 20)	84% (79, 88)
Y	12 (10, 14)	67% (61, 72)

In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomized to receive either Menveo or quadrivalent meningococcal polysaccharide vaccine (ACWY-PS). Menveo was shown to be non-inferior to ACWY-PS vaccine for all four serogroups (A, C, W and Y) based on seroresponse, proportions achieving hSBA titres

Table 3: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination

Serogroup	hSBA (95% CI)	hSBA GMTs (95% CI)
Menveo	ACWY-PS	Menveo	ACWY-PS
A	N=140	N=149	N=140	N=149
	81% (74, 87)	41% (33, 49)	33 (25, 44)	7.31 (5.64, 9.47)
C	N=140	N=147	N=140	N=147
	84% (77, 90)	61% (53, 69)	59 (39, 89)	28 (19, 41)
W	N=138	N=141	N=138	N=141
	91% (84, 95)	84% (77, 89)	48 (37, 62)	28 (22, 36)
Y	N=139	N=147	N=139	N=147
	95% (90, 98)	82% (75, 88)	92 (68, 124)	35 (27, 47)

At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA titers

Immunogenicity in adults

In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years. Results are presented in Table 4. In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a titer

Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years

Serogroup	N	GMT (95% CI)	hSBA (95% CI)
A	963	31 (27, 36)	69% (66, 72)
C	902	50 (43, 59)	80% (77, 83)
W135	484	111 (93, 132)	94% (91, 96)
Y	503	44 (37, 52)	79% (76, 83)

Immunogenicity in older adults

The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17. The proportion of subjects with hSBA titers

Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adults aged 56-65 years, measured at one month post vaccination .

Serogroup	Menveo hSBA (95% CI)	ACWY-PS hSBA (95% CI)
A	N=83	N=41
87% (78, 93)	63% (47, 78)
C	N=84	N=41
90% (82, 96)	83% (68, 93)
W	N=82	N=39
94% (86, 98)	95% (83, 99)
Y	N=84	N=41
88% (79, 94)	68% (52, 82)

The European Medicines Agency has deferred the obligation to submit the results of studies with Menveo in one or more subsets of the paediatric population in meningococcal meningitis. See 4.2 for information on paediatric use.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and reproductive and developmental toxicity studies.

In laboratory animals, no adverse reactions were seen in vaccinated maternal rabbits or in their offspring through postnatal day 29.

No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Powder

Sucrose

Potassium dihydrogen phosphate

Solution

Sodium dihydrogen phosphate monohydrate

Disodium phosphate dihydrate

Sodium chloride

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

3 years.

After reconstitution, the product should be used immediately. However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the vial and the syringe in the outer carton in order to protect from light.

For storage conditions of the reconstituted product, see section 6.3.

6.5 Nature And Contents Of Container

Powder in vial (type I glass) with a stopper (halobutyl rubber) and solution in pre-filled syringe (type I glass) with a tip cap (type I elastomeric closure with 10% of latex or type II elastomeric closure latex free).

Each pack contains a single dose of one vial and one pre-filled syringe.

6.6 Special Precautions For Disposal And Other Handling

Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in pre-filled syringe).

The components of the vaccine should be visually inspected before and after reconstitution.

Remove the tip cap from the syringe and attach a suitable needle for the withdrawal (21G, 1 1/2''). Use the whole contents of the syringe (0.6 ml) to reconstitute the powder.

Invert and shake the vial vigorously and then withdraw 0.5 ml of reconstituted product. Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.

Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible foreign particles. In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.

Prior to injection, change the needle for one suitable for the administration (25G, 1''). Ensure that no air bubbles are present in the syringe before injecting the vaccine.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina 1

53100 Siena, Italy

8. Marketing Authorisation Number(S)

EU/1/10/614/001

9. Date Of First Authorisation/Renewal Of The Authorisation

15 March 2010

10. Date Of Revision Of The Text

July 2011

Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu