Tuesday, October 25, 2016

Galantase




Galantase may be available in the countries listed below.


Ingredient matches for Galantase



Tilactase

Tilactase is reported as an ingredient of Galantase in the following countries:


  • Japan

International Drug Name Search

Oflodis




Oflodis may be available in the countries listed below.


Ingredient matches for Oflodis



Ofloxacin

Ofloxacin is reported as an ingredient of Oflodis in the following countries:


  • Tunisia

International Drug Name Search

Dolidon




Dolidon may be available in the countries listed below.


Ingredient matches for Dolidon



Caffeine

Caffeine monohydrate (a derivative of Caffeine) is reported as an ingredient of Dolidon in the following countries:


  • France

Paracetamol

Paracetamol is reported as an ingredient of Dolidon in the following countries:


  • France

International Drug Name Search

Pinavérium EG




Pinavérium EG may be available in the countries listed below.


Ingredient matches for Pinavérium EG



Pinaverium Bromide

Pinaverium Bromide is reported as an ingredient of Pinavérium EG in the following countries:


  • France

International Drug Name Search

Monday, October 24, 2016

Risperidon Pharmachemie




Risperidon Pharmachemie may be available in the countries listed below.


Ingredient matches for Risperidon Pharmachemie



Risperidone

Risperidone is reported as an ingredient of Risperidon Pharmachemie in the following countries:


  • Netherlands

International Drug Name Search

Capréomycine




Capréomycine may be available in the countries listed below.


Ingredient matches for Capréomycine



Capreomycin

Capréomycine (DCF) is known as Capreomycin in the US.

International Drug Name Search

Glossary

DCFDénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

zanamivir


Generic Name: zanamivir (zan AM i vir)

Brand Names: Relenza


What is zanamivir?

Zanamivir is an antiviral medication. It blocks the actions of viruses in your body.


Zanamivir is used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. Zanamivir may also be given to prevent influenza in people who may be exposed but do not yet have symptoms. Zanamivir will not treat the common cold.


Zanamivir may also be used for purposes other than those listed in this medication guide.


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


Do not use a nebulizer or ventilator to give zanamivir. Zanamivir inhalation powder should never be mixed with a liquid.

Zanamivir is used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. Zanamivir may also be given to prevent influenza in people who may be exposed but do not yet have symptoms. Zanamivir will not treat the common cold.


Treatment with zanamivir should start as soon as possible when flu symptoms appear, such as fever, chills, muscle aches, sore throat, and runny or stuffy nose.


Do not use this medication to treat flu symptoms in a child younger than 7 years old. Children as young as 5 may use the medication to prevent flu symptoms. Do not use an inhaled nasal flu vaccine (FluMist) within 2 weeks before or 48 hours after using zanamivir. Zanamivir may interfere with the drug action of FluMist, making the vaccine less effective. Follow your doctor's instructions. Before using zanamivir, tell your doctor if you have asthma, chronic obstructive pulmonary disease (COPD), or any other chronic lung condition. Serious or life-threatening bronchospasm (difficulty breathing) and other effects on the lungs can occur while using zanamivir. Stop using zanamivir and call your doctor at once if you have wheezing or severe breathing problems.

If you have asthma, COPD, or other chronic lung disease, make sure you have a fast-acting inhaled bronchodilator available to treat any serious breathing problems that may occur while using zanamivir. Fast-acting bronchodilators include albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), and pirbuterol (Maxair). Talk with your doctor about which medicine is best for you.


Some people using zanamivir have had rare side effects of confusion, delirium and self-injury. These symptoms have occurred most often in children. It is not known whether zanamivir was the exact cause of these symptoms. However, anyone using zanamivir should be watched closely for signs of confusion or unusual behavior. Call a doctor at once if you or the child using zanamivir has any of these symptoms. Zanamivir should not be used in place of getting a yearly flu shot. The Centers for Disease Control recommends an annual flu shot to help protect you each year from new strains of influenza virus.

What should I discuss with my healthcare provider before using zanamivir?


Zanamivir should not be used in place of getting a yearly flu shot. The Centers for Disease Control recommends an annual flu shot to help protect you each year from new strains of influenza virus.


You should not use this medication if you are allergic to zanamivir or to lactose. Before using zanamivir, tell your doctor if you have asthma, chronic obstructive pulmonary disease (COPD), or any other chronic lung condition. Serious or life-threatening bronchospasm (difficulty breathing) and other effects on the lungs can occur while using zanamivir.

If you have asthma, COPD, or other chronic lung disease, make sure you have a fast-acting inhaled bronchodilator available to treat any serious breathing problems that may occur while using zanamivir. Fast-acting bronchodilators include albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), and pirbuterol (Maxair). Talk with your doctor about which medicine is best for you.


If you are scheduled to use a bronchodilator at the same time as zanamivir, use the inhaler first.


FDA pregnancy category C. It is not known whether zanamivir will harm an unborn baby. However, not receiving this medication to prevent influenza could be harmful to the baby if the mother becomes infected with a disease that zanamivir could prevent. Tell your doctor if you are pregnant. Your doctor will decide whether you should receive zanamivir, especially if you have a high risk of infection with H1N1 influenza (also called "swine" flu). It is not known whether zanamivir 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. Do not use this medication to treat flu symptoms in a child younger than 7 years old. Children as young as 5 may use the medication to prevent flu symptoms.

How should I use zanamivir?


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


Treatment with zanamivir should start as soon as possible when flu symptoms appear, such as fever, chills, muscle aches, sore throat, and runny or stuffy nose.


Zanamivir is packaged in disk-shaped foil packs that contain 4 blisters of medicine. These disks are placed into a device called a DISKHALER that you will use to inhale the medicine. The device opens and loads a blister of zanamivir each time you use the inhaler. The disk device is not to be used with a spacer. Follow the patient instructions provided with the DISKHALER.


Do not use a nebulizer or ventilator to give zanamivir. Zanamivir inhalation powder should never be mixed with a liquid. Do not use any other medicines in the DISKHALER. Always put the cover back on the device when not in use.

To treat flu symptoms: Use 2 inhalations every 12 hours for 5 days. Your doctor may tell you to use two doses on the first day of treatment, spaced at least 2 hours apart. On the following days, the doses should be spaced 12 hours apart. Follow your doctor's instructions.


To prevent flu symptoms: Use 2 inhalations every 24 hours for 10 to 28 days. Follow your doctor's instructions.


If you have a chronic respiratory disease such as asthma or COPD and you are scheduled to use an inhaled bronchodilator at the same time as zanamivir, use the inhaled bronchodilator before using zanamivir.


Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Tell your doctor if your symptoms do not improve, or if they get worse.


Store zanamivir at room temperature away from moisture and heat. Throw away the DISKHALER after your treatment ends.

What happens if I miss a dose?


Use the missed dose as soon as you remember. Skip the missed dose if it is within 2 hours of your next scheduled dose. Do not use extra medicine to make up the missed dose.


Call your doctor if you miss several doses.


What happens if I overdose?


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

What should I avoid while using zanamivir?


Do not use an inhaled nasal flu vaccine (FluMist) within 2 weeks before or 48 hours after using zanamivir. Zanamivir may interfere with the drug action of FluMist, making the vaccine less effective. Follow your doctor's instructions.

Zanamivir 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. Some people using zanamivir have had rare side effects of confusion, delirium and self-injury. These symptoms have occurred most often in children. It is not known whether zanamivir was the exact cause of these symptoms. However, anyone using zanamivir should be watched closely for signs of confusion or unusual behavior. Call a doctor at once if you or the child using zanamivir has any of these symptoms. Stop using zanamivir and call your doctor at once if you have wheezing or severe breathing problems.

Less serious side effects may include:



  • headache;




  • dizziness;




  • nausea, vomiting, or diarrhea;




  • infection of your ear, nose, or throat;




  • stuffy or irritated nose; or




  • cough or respiratory symptoms.



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.


Zanamivir Dosing Information


Usual Adult Dose for Influenza:

10 mg (2 inhalations) inhaled orally twice a day (12 hours apart) for 5 days

If possible, 2 doses should be taken on the first day, provided there are at least 2 hours between the doses.

Usual Adult Dose for Influenza Prophylaxis:

10 mg (2 inhalations) inhaled orally once a day

Duration:
Household setting: 10 days
Community outbreak: 28 days

Usual Pediatric Dose for Influenza:

7 years or older: 10 mg (2 inhalations) inhaled orally twice a day (12 hours apart) for 5 days

If possible, 2 doses should be taken on the first day, provided there are at least 2 hours between the doses.

Usual Pediatric Dose for Influenza Prophylaxis:

5 years or older: 10 mg (2 inhalations) inhaled orally once a day

Duration:
Household setting: 10 days
Community outbreak: 28 days


What other drugs will affect zanamivir?


There may be other drugs that can interact with zanamivir. 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 zanamivir resources


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


  • zanamivir Inhalation, oral/nebulization Advanced Consumer (Micromedex) - Includes Dosage Information

  • Zanamivir Professional Patient Advice (Wolters Kluwer)

  • Zanamivir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zanamivir Monograph (AHFS DI)

  • Relenza Prescribing Information (FDA)

  • Relenza Consumer Overview



Compare zanamivir with other medications


  • Influenza
  • Influenza Prophylaxis
  • Swine Flu


Where can I get more information?


  • Your pharmacist can provide more information about zanamivir.

See also: zanamivir side effects (in more detail)


Adrekar




Adrekar may be available in the countries listed below.


Ingredient matches for Adrekar



Adenosine

Adenosine is reported as an ingredient of Adrekar in the following countries:


  • Germany

International Drug Name Search

Normalip




Normalip may be available in the countries listed below.


Ingredient matches for Normalip



Atorvastatin

Atorvastatin is reported as an ingredient of Normalip in the following countries:


  • Argentina

International Drug Name Search

Friday, October 21, 2016

TNF alfa inhibitors


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 TNF alfa inhibitors:

  • Alzheimer's Disease
  • Ankylosing Spondylitis
  • Behcet's Disease
  • Bullous Pemphigoid
  • Celiac Disease
  • Cogan's Syndrome
  • Crohn's Disease
  • Crohn's Disease, Acute
  • Crohn's Disease, Maintenance
  • Giant Cell Arteritis
  • Histiocytosis
  • Inflammatory Bowel Disease
  • Juvenile Idiopathic Arthritis
  • Juvenile Rheumatoid Arthritis
  • Kawasaki Disease
  • Macrophage Activation Syndrome
  • Neurosarcoidosis
  • Pemphigoid
  • Pemphigus
  • Polychondritis
  • Psoriasis
  • Psoriatic Arthritis
  • Pulmonary Fibrosis
  • Pyoderma Gangrenosum
  • Reiter's Syndrome
  • Rheumatoid Arthritis
  • SAPHO Syndrome
  • Sarcoidosis
  • Sjogren's Syndrome
  • Still's Disease
  • Subcorneal Pustular Dermatosis
  • Toxic Epidermal Necrolysis
  • Ulcerative Colitis
  • Uveitis
  • Wegener's Granulomatosus

Drug List:

Zacare 8% Kit Lotion


Pronunciation: BEN-zoe-il per-OX-ide and SOE-dee-um HYE-al-ure-ON-ate
Generic Name: Benzoyl Peroxide
Brand Name: Examples include Zacare 4% Kit and Zacare 8% Kit


Zacare 8% Kit Lotion is used for:

Treating mild to moderate acne.


Zacare 8% Kit Lotion is a kit. It contains an antibacterial and keratolytic medicine (benzoyl peroxide) along with a skin conditioning medicine (sodium hyaluronate). The benzoyl peroxide works to treat acne by killing certain bacteria on the skin and by causing a mild drying and peeling (keratolytic) effect. The sodium hyaluronate helps treat or prevent very dry or scaly skin.


Do NOT use Zacare 8% Kit Lotion if:


  • you are allergic to any ingredient in Zacare 8% Kit Lotion

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



Before using Zacare 8% Kit Lotion:


Some medical conditions may interact with Zacare 8% Kit Lotion. 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 inflamed or damaged skin at the application site

Some MEDICINES MAY INTERACT with Zacare 8% Kit Lotion. Because little, if any, of Zacare 8% Kit Lotion is absorbed into the blood, the risk of it interacting with another medicine is low.


Ask your health care provider if Zacare 8% Kit Lotion 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 Zacare 8% Kit Lotion:


Use Zacare 8% Kit Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • To use the benzoyl peroxide lotion: Wash the affected area with soap and water or as directed by your doctor. Shake the lotion well before each use. Wet the skin areas to be treated with water. Apply the lotion over the affected area. Gently rub it into a full lather. Rinse well with water then pat the area dry.

  • To use the sodium hyaluronate gel: Apply to the affected areas and rub in well as directed by your doctor.

  • Wash your hands immediately after using Zacare 8% Kit Lotion.

  • If you miss a dose of Zacare 8% Kit Lotion, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zacare 8% Kit Lotion.



Important safety information:


  • Zacare 8% Kit Lotion is for external use only. Avoid getting it in your eyes, on the inside of your nose or mouth, or on your lips. If you get it in any of these areas, rinse right away with cool tap water.

  • Do not apply Zacare 8% Kit Lotion to raw, inflamed, or irritated skin, including sunburns. Do not apply Zacare 8% Kit Lotion to open wounds.

  • Several weeks may pass before you see improvement in your acne. It may take up to 8 to 12 weeks before you notice the full effect of Zacare 8% Kit Lotion. Continue to use Zacare 8% Kit Lotion for the full time recommended by your doctor. If your acne does not improve or if it gets worse, check with your doctor.

  • Talk with your doctor before you use any other medicines, special cleansers, aftershave, or cosmetics on your skin.

  • Zacare 8% Kit Lotion may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Zacare 8% Kit Lotion. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Benzoyl peroxide may cause bleaching. Avoid contact with hair, fabrics, or carpeting.

  • Zacare 8% Kit Lotion should be used with extreme caution in CHILDREN younger than 12 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 Zacare 8% Kit Lotion while you are pregnant. It is not known if Zacare 8% Kit Lotion is found in breast milk. If you are or will be breast-feeding while you use Zacare 8% Kit Lotion, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Zacare 8% Kit Lotion:


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:



Mild burning, dryness, itching, peeling, redness, stinging, or swelling of the treated areas.



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

Severe allergic reactions (rash; hives; itching; dizziness; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent burning, dryness, irritation, itching, peeling, redness, stinging, or swelling of the treated areas; shedding of the skin.



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: Zacare 8% 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 excessive scaling; flushing; redness; swelling.


Proper storage of Zacare 8% Kit Lotion:

Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly closed container, away from fire, flame, heat, and light. Keep Zacare 8% Kit Lotion out of the reach of children and away from pets.


General information:


  • If you have any questions about Zacare 8% Kit Lotion, please talk with your doctor, pharmacist, or other health care provider.

  • Zacare 8% Kit Lotion 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 Zacare 8% Kit Lotion. 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 Zacare 8% Kit resources


  • Zacare 8% Kit Side Effects (in more detail)
  • Zacare 8% Kit Use in Pregnancy & Breastfeeding
  • Zacare 8% Kit Drug Interactions
  • Zacare 8% Kit Support Group
  • 0 Reviews for Zacare 8% - Add your own review/rating


Compare Zacare 8% Kit with other medications


  • Acne

Daunorubicin Hydrochloride




Ingredient matches for Daunorubicin hydrochloride



Daunorubicin

Daunorubicin hydrochloride (BANM, USAN) is known as Daunorubicin in the US.

International Drug Name Search

Glossary

BANMBritish Approved Name (Modified)
USANUnited States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Thursday, October 20, 2016

Prednisolon Sandoz




Prednisolon Sandoz may be available in the countries listed below.


Ingredient matches for Prednisolon Sandoz



Prednisolone

Prednisolone is reported as an ingredient of Prednisolon Sandoz in the following countries:


  • Netherlands

International Drug Name Search

fenofibrate



fen-oh-FYE-brate


Commonly used brand name(s)

In the U.S.


  • Antara

  • Fenoglide

  • Lipofen

  • Lofibra

  • Tricor

  • Triglide

Available Dosage Forms:


  • Tablet

  • Capsule

Therapeutic Class: Antihyperlipidemic


Chemical Class: Fibric Acid


Uses For fenofibrate


Fenofibrate is used together with a proper diet to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation of the pancreas) caused by high levels of triglycerides in the blood.


fenofibrate is available only with your doctor's prescription.


Before Using fenofibrate


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 fenofibrate, the following should be considered:


In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects. Results of large studies using other agents that are similar to fenofibrate seem to suggest that fenofibrate may increase the patient's risk of cancer, pancreatitis (inflammation of the pancreas), gallstones, and problems from gallbladder surgery. Studies with fenofibrate in rats found an increased risk of liver and pancreatic tumors when doses up to 6 times the human dose were given for a long time. Be sure you have discussed this with your doctor before taking fenofibrate.


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to fenofibrate 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 fenofibrate in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenofibrate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving fenofibrate.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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 fenofibrate, 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 fenofibrate 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.


  • Acenocoumarol

  • Anisindione

  • Atorvastatin

  • Cerivastatin

  • Dicumarol

  • Fluvastatin

  • Lovastatin

  • Phenindione

  • Phenprocoumon

  • Pitavastatin

  • Pravastatin

  • Rosuvastatin

  • Simvastatin

  • Warfarin

Using fenofibrate 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.


  • Colchicine

  • Colestipol

  • Cyclosporine

  • Ezetimibe

  • Glimepiride

  • Rosiglitazone

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 fenofibrate. Make sure you tell your doctor if you have any other medical problems, especially:


  • Diabetes or

  • Hypothyroidism (an underactive thyroid)

  • Kidney disease—Use with caution. May cause side effects to become worse.

  • Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or

  • Muscle pain or tenderness, history of or

  • Muscle weakness, history of—Use with caution. May make these conditions worse.

  • Breastfeeding mothers or

  • Gallbladder disease, or history of or

  • Kidney disease, severe or

  • Liver disease (including cirrhosis) or

  • Liver enzymes, persistently elevated—Should not be used with these conditions.

Proper Use of fenofibrate


Use fenofibrate only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.


In addition to fenofibrate, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.


fenofibrate is usually taken once a day. Take the medicine at the same time each day to maintain the medication's effect.


Fenoglide®, Lipofen®, and Lofibra™ should be taken with a meal. Antara™, Tricor®, and Triglide™ can be taken with or without a meal.


Swallow Tricor® tablet whole. Do not break, crush, or chew it.


Dosing


The dose of fenofibrate 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 fenofibrate. 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 (capsules):
    • For high cholesterol:
      • Adults—
        • Antara™: 130 milligrams (mg) once a day with a meal.

        • Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed.

        • Lofibra™: 200 mg once a day with a meal.


      • Children—Use and dose must be determined by your doctor.


    • For high triglycerides or fats:
      • Adults—
        • Antara™: At first, 43 milligrams (mg) once a day with a meal. Your doctor may increase your dose as needed.

        • Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg per day.

        • Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed.


      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For high cholesterol:
      • Adults—
        • Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed.

        • Tricor®: At first, 145 mg once a day. Your doctor may adjust your dose as needed.

        • Triglide®: 160 mg once a day.


      • Children—Use and dose must be determined by your doctor.


    • For high triglycerides or fats:
      • Adults—
        • Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.

        • Tricor®: At first, 48 to 145 mg once a day. Your doctor may increase your dose as needed.

        • Triglide®: At first, 50 to 160 mg once a day. Your doctor may increase your dose as needed.


      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of fenofibrate, 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.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using fenofibrate


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.


Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.


Stop using fenofibrate and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.


Pancreatitis may occur while you are using fenofibrate. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.


fenofibrate may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting.


Serious skin reactions can occur with fenofibrate. Check with your doctor right away if you have any of the following symptoms while using fenofibrate: blistering, peeling, or loosening of the skin; chills; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.


Check with your doctor right away if you have signs of a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts, which may be caused by fenofibrate.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


fenofibrate 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.


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


Less common
  • Chills

  • fever

  • hives

  • itching

  • muscle aches and pains

  • nausea or vomiting

  • skin rash

Rare
  • Bloating or pain of the stomach

  • chronic indigestion

  • cough

  • dark urine

  • general ill feeling

  • loss of appetite

  • muscle cramps, pain, stiffness, swelling, or weakness

  • shortness of breath or troubled breathing

  • sore throat

  • unusual bleeding or bruising

  • unusual tiredness

  • yellow eyes or skin

Incidence not known
  • Bloody urine

  • constipation

  • decreased frequency or amount of urine

  • difficulty with moving

  • fast heartbeat

  • general tiredness and weakness

  • increased blood pressure

  • increased thirst

  • indigestion

  • light-colored stools

  • lower back or side pain

  • muscle cramps or spasms

  • pains in the stomach, side, or abdomen, possibly radiating to the back

  • pale skin

  • swelling of the face, fingers, or lower legs

  • swollen joints

  • troubled breathing

  • troubled breathing with exertion

  • upper right abdominal or stomach pain

  • vomiting

  • weight gain

  • yellow eyes or skin

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:


More common
  • Chest congestion

  • difficulty with breathing

  • runny nose

  • sneezing

  • sore throat

  • stuffy nose

Less common
  • Back pain

  • belching

  • decreased sexual drive

  • diarrhea

  • dizziness

  • eye irritation

  • gas

  • headache

  • increased sensitivity of the skin to sunlight

  • lack or loss of strength

  • nausea

Incidence not known
  • Lack or loss of strength

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: fenofibrate side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More fenofibrate resources


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


  • Fenofibrate Monograph (AHFS DI)

  • Fenofibrate Prescribing Information (FDA)

  • Fenofibrate MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fenofibrate Professional Patient Advice (Wolters Kluwer)

  • Antara Prescribing Information (FDA)

  • Fenoglide Prescribing Information (FDA)

  • Lipofen Prescribing Information (FDA)

  • Lipofen MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lofibra Prescribing Information (FDA)

  • Tricor Consumer Overview

  • Tricor Prescribing Information (FDA)

  • Triglide Prescribing Information (FDA)



Compare fenofibrate with other medications


  • Hyperlipoproteinemia
  • Hyperlipoproteinemia Type IIa, Elevated LDL
  • Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
  • Hyperlipoproteinemia Type IV, Elevated VLDL
  • Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
  • Hypertriglyceridemia

Wednesday, October 19, 2016

Calcium Gluconate Injection BP 10% (hameln)





CALCIUM GLUCONATE INJECTION BP 10%




What you should know about Calcium Gluconate Injection BP



This leaflet contains important information about Calcium Gluconate Injection. Please read this leaflet before you are given this injection. In some circumstances this may not be possible if you are given this injection in an emergency.



If you have any questions or are not sure about anything, ask your doctor or pharmacist for more information.



This leaflet will be kept in a safe place for you should you wish to read it again.






What does Calcium Gluconate Injection contain?



This injection contains the active ingredient calcium gluconate. Each 10 ml ampoule contains 950 mg calcium gluconate in a 10 ml sterile solution for injection.



This injection contains the following inactive ingredients:



  • Calcium D Saccharate USP

  • Sterile Water for Injections EP

The injection is supplied in 10 ml clear glass ampoules. 10 ampoules supplied in each carton.





Product Licence Holder




hameln pharmaceuticals ltd

Gloucester

United Kingdom





Manufacturer




hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany





What is Calcium Gluconate Injection used for?



Calcium is necessary for the normal function of muscles and nerves. It is needed to make the heart work properly and for the blood to clot. Calcium Gluconate Injection is used to replace low levels of calcium in the body, in the treatment of heart attacks and may be used in neonatal tetany.





Before this injection is given to you




Please tell your doctor or nurse before being given this injection if:



  • You are taking digoxin or a diuretic (water tablet)

  • You have hyperparathyroidism (overactivity of the parathyroid gland)

  • You have kidney disease

  • You have heart failure

  • You have excessive levels of vitamin D

  • You have a tumour which has increased your levels of calcium

  • You have excessive levels of calcium in the urine

  • You are pregnant or breastfeeding.

Please tell your doctor or pharmacist if you are taking any other medicines, as these may interfere with this injection.






How is the injection given?



Your nurse or doctor will give you the injection. Calcium Gluconate Injection is given by very slow intravenous injection (into the vein) at a rate of 10 ml per 3 minutes.



Your dose of Calcium Gluconate Injection will be adjusted to restore your calcium blood levels to the normal range. During treatment, your blood calcium levels should be monitored closely.



The usual dosage of Calcium Gluconate Injection is:



Acute Hypocalcaemic tetany:


10-20 ml



Fluoride or lead poisoning:

0.3 ml/kg body weight



Neonatal Tetany:

0.3 ml/kg/body weight



Cardiac Resuscitation:

7-15 ml



Elderly patients may require a reduction in dosage.



Your doctor will decide the correct dosage for you and how and when the injection will be given.



Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if after the injection you feel sick, are sick, are constipated, have stomach pain, suffer muscle weakness, feel thirsty, are passing a lot of urine, feel confused or have bone pain, you should tell the person giving you the injection.





What are the possible unwanted side effects?



If the injection is given too quickly, the following symptoms may occur: feeling sick, being sick, hot flushes, sweating or low blood pressure.



If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.





How should Calcium Gluconate injection be kept?



Your injection will be stored below 25° C.



The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.




Leaflet Revision Date



7th May 2004



43888/22/04






Dyazide




In the US, Dyazide (hydrochlorothiazide/triamterene systemic) is a member of the drug class antihypertensive combinations and is used to treat Edema and High Blood Pressure.

US matches:

  • Dyazide

UK matches:

  • Dyazide Tablets (SPC)

Ingredient matches for Dyazide



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Dyazide in the following countries:


  • Bahrain

  • South Africa

  • United Kingdom

  • United States

Triamterene

Triamterene is reported as an ingredient of Dyazide in the following countries:


  • Bahrain

  • Ireland

  • South Africa

  • United Kingdom

  • United States

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Excedrin Tension Headache Express Gels


Generic Name: acetaminophen and caffeine (a SEET a MIN oh fen and KAF een)

Brand Names: Excedrin Quick Tab Peppermint, Excedrin Quick Tab Spearmint, Excedrin Tension Headache, Excedrin Tension Headache Caplet, Excedrin Tension Headache Express Gels, Excedrin Tension Headache Geltab, Valorin Extra


What is Excedrin Tension Headache Express Gels (acetaminophen and caffeine)?

Acetaminophen is a pain reliever and a fever reducer.


Caffeine is used in this product to increase the pain relieving effects of acetaminophen.


The combination of acetaminophen and caffeine is used to treat pain from conditions such as headache, muscle aches, menstrual cramps, arthritis, backache, toothaches, colds and fevers.


Acetaminophen and caffeine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Excedrin Tension Headache Express Gels (acetaminophen and caffeine)?


Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Excedrin Tension Headache Express Gels (acetaminophen and caffeine)?


Do not take this medication if you are allergic to acetaminophen (Tylenol) or caffeine. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney or liver disease, or a history of alcoholism.


It is not known whether this medicine will harm an unborn baby. Do not take acetaminophen and caffeine without medical advice if you are pregnant. Acetaminophen and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Excedrin Tension Headache Express Gels (acetaminophen and caffeine)?


Use this medication exactly as directed on the label, or as prescribed by your doctor.


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and caffeine pill contains 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.


The orally disintegrating tablet (Excedrin QuickTabs) should be placed directly on the tongue. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.


Call your doctor if your symptoms do not improve, especially if you still have a fever after 3 days of using this medication, or pain after 10 days of use. Stop taking acetaminophen and caffeine and call your doctor at any time if your symptoms get worse.

Acetaminophen may cause false urine glucose test results. Talk to your doctor if you have diabetes and you notice changes in glucose test results while taking acetaminophen and caffeine.


Store at room temperature away from heat and moisture.

What happens if I miss a dose?


Since acetaminophen and caffeine is taken 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. 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 loss of appetite, confusion, nausea, vomiting, diarrhea, sweating, fast or uneven heart rate, seizure (convulsions), pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


What should I avoid while taking Excedrin Tension Headache Express Gels (acetaminophen and caffeine)?


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. They can add to the side effects of the caffeine in the medication.

Excedrin Tension Headache Express Gels (acetaminophen and caffeine) 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 acetaminophen and caffeine and call your doctor at once if you have a serious side effect such as:

  • low fever with nausea, stomach pain, and loss of appetite;




  • dark urine, clay-colored stools; or




  • jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • sleep problems (insomnia); or




  • feeling nervous, irritable, or jittery.



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 Excedrin Tension Headache Express Gels (acetaminophen and caffeine)?


There may be other drugs that can interact with acetaminophen and caffeine. 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 Excedrin Tension Headache Express Gels resources


  • Excedrin Tension Headache Express Gels Side Effects (in more detail)
  • Excedrin Tension Headache Express Gels Use in Pregnancy & Breastfeeding
  • Excedrin Tension Headache Express Gels Drug Interactions
  • Excedrin Tension Headache Express Gels Support Group
  • 2 Reviews for Excedrin Tension Headache Expresss - Add your own review/rating


Compare Excedrin Tension Headache Express Gels with other medications


  • Cold Symptoms
  • Headache
  • Osteoarthritis
  • Pain
  • Period Pain
  • Sinusitis


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen and caffeine.

See also: Excedrin Tension Headache Expresss side effects (in more detail)


Takayasu's Arteritis Medications


Definition of Takayasu's Arteritis: A thrombo-obliterative process of the great vessels stemming from the aortic arch, occurring generally in young women. Radial and carotid pulses are typically obliterated. Skin changes are due to the disturbed circulation. There may be loss of hair and atrophy of the skin and its appendages with underlying muscle atrophy.

Drugs associated with Takayasu's Arteritis

The following drugs and medications are in some way related to, or used in the treatment of Takayasu's Arteritis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Takayasu's Arteritis





Drug List:

Cobalamin H




Cobalamin H may be available in the countries listed below.


Ingredient matches for Cobalamin H



Hydroxocobalamin

Hydroxocobalamin acetate (a derivative of Hydroxocobalamin) is reported as an ingredient of Cobalamin H in the following countries:


  • Japan

International Drug Name Search

Tuesday, October 18, 2016

Pyme Nife




Pyme Nife may be available in the countries listed below.


Ingredient matches for Pyme Nife



Nifedipine

Nifedipine is reported as an ingredient of Pyme Nife in the following countries:


  • Vietnam

International Drug Name Search

Zomig



Generic Name: Zolmitriptan
Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: (S)-4-[[3-[2-(dimethylamino)ethyl]indol-5-yl]methyl]-2-oxazolidinone
Molecular Formula: C16H21N3O2
CAS Number: 139264-17-8

Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptor agonist (“triptan”).1 2 3 4 5 6 7 8 9 10 11 14 15 21 22 23 24 27


Uses for Zomig


Vascular Headaches


Acute treatment of migraine attacks with or without aura.1 27


Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.1 27


Safety and efficacy not established for management of cluster headaches.1 27


Zomig Dosage and Administration


Administration


Administer orally or intranasally.1 27 28


Oral Administration


Administer orally as conventional or orally disintegrating tablets without regard to meals.1


To achieve a dose <2.5 mg, manually break the scored 2.5-mg conventional tablet in half.1 Do not break orally disintegrating tablets.1


Just prior to administration of orally disintegrating tablet, remove tablet from blister package; peel open blister package, place tablet on tongue to dissolve, and swallow with saliva.1


Administration of orally disintegrating tablet with liquid is not necessary.1


Intranasal Administration


Administer intranasally as a single spray into 1 nostril.28


Do not spray contents into eyes.28


To administer, blow nose gently and remove protective cap just before use.28 Hold nasal spray device gently and do not press plunger until tip is placed into nostril.28 Block one nostril by pressing firmly on side of nose and put tip into other nostril as far as feels comfortable.28 Tilt head slightly back and breathe gently through nose while pressing plunger firmly with thumb; a click may be heard.28 Keep head tilted slightly back and remove tip of device from nose; breathe gently through mouth for 5–10 seconds.28 Liquid may be felt in nose or back of throat.28 Consult manufacturer’s patient information for complete directions.28


Single-use spray pump; discard after use.27


Dosage


Due to similarity in systemic exposure, dosage adjustments with oral and intranasal formulations should be similar; doses <5 mg can be achieved only through use of oral formulations.27


Adults


Vascular Headaches

Migraine

Oral

Initially, ≤2.5 mg.1 In clinical studies, single oral doses of 1 (not commercially available in US), 2.5, or 5 mg were effective, but the 2.5- and 5-mg doses were effective in a greater proportion of patients.1 The 5-mg dose appears to offer little additional benefit and is associated with increased risk of adverse effects.1


If headache recurs, dose may be repeated after ≥2 hours.1


Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.1


Intranasal

5 mg (1 spray) as a single dose; individualize selection of dosage and administration route.27


If headache recurs, dose may be repeated after 2 hours.27


Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.27


Prescribing Limits


Adults


Vascular Headaches

Migraine

Oral

Maximum 10 mg in any 24-hour period.1


Safety of treating an average of >3 headaches per 30-day period has not been established.1


Intranasal

Maximum 10 mg in any 24-hour period.27


Safety of treating an average of >4 headaches per 30-day period has not been established.27


Special Populations


Hepatic Impairment


Generally use <2.5 mg as a single oral dose in patients with moderate to severe hepatic impairment; concurrent BP monitoring recommended.1


Recommended doses can be achieved only with oral formulations; use of intranasal formulation not recommended.27


Cautions for Zomig


Contraindications



  • Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).1 27




  • Coronary artery vasospasm (e.g., Prinzmetal variant angina).1 27




  • Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).1 27




  • Cerebrovascular syndromes (e.g., stroke syndromes, TIAs).27




  • Hemiplegic or basilar migraine.1 27




  • Treatment within previous 24 hours with another 5-HT1 receptor agonist or an ergot alkaloid.1 27 (See Specific Drugs under Interactions.)




  • Concurrent or recent (within 2 weeks) treatment with an MAO-A inhibitor.1 27 (See Specific Drugs under Interactions.)




  • Known sensitivity to zolmitriptan or any ingredient in the formulation.1 27



Warnings/Precautions


Warnings


Use only in patients in whom a clear diagnosis of migraine has been established.1 27


Cardiac Effects

Risk of coronary vasospasm, myocardial ischemia and/or infarction, life-threatening cardiac rhythm disturbances, and death with use of 5-HT1 receptor agonists.1 27


Use not recommended in patients with symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other accessory pathway conduction disorders.1 27


Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.1 27


Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician's office, possibly followed by ECG) unless patient previously received the drug.1 27


Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.1 27


Patients with symptoms suggestive of angina after receiving zolmitriptan should be evaluated for the presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.1 27


Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT1 receptor agonists.1 27


Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.1 27


Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT1 receptor agonists.1 27 Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic bowel syndrome, Raynaud's syndrome) occur following administration.1 27


Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT1 receptor agonists in patients with or without history of hypertension.1 27


Increases in mean pulmonary artery pressure observed following administration of a 5-HT1 receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.1 27


Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT1 receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).27 29 Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).27 29


Local Effects

Possible local irritation or soreness after intranasal administration.27 Adverse effects perceived in nasopharynx, occasionally severe, usually resolve within 1 hour.27


No clinically important nasopharyngeal changes observed by examination following repeated use for up to 1 year’s duration.27


General Precautions


Ocular Effects

Possible accumulation of zolmitriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.1 27


Phenylketonuria

Each 2.5- or 5-mg Zomig-ZMT orally disintegrating tablet contains aspartame, which is metabolized in GI tract to provide 2.81 or 5.62 mg of phenylalanine, respectively.1 Conventional tablets do not contain aspartame.1


Specific Populations


Pregnancy

Category C.1 27


Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 27 Caution advised if zolmitriptan is used.1 27


Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.1 27


Geriatric Use

Pharmacokinetic profile similar to that in younger adults.1 27 However, patients >65 years of age were excluded from clinical studies; safety and efficacy not established.1 27


Hepatic Impairment

Substantial elevation of BP observed in some patients with moderate-to-severe hepatic impairment following 10-mg oral dose.1 27 Use with caution in patients with hepatic impairment;1 27 BP monitoring and dosage adjustment recommended.1 27


Common Adverse Effects


Dizziness,1 27 paresthesia,1 27 hyperesthesia,1 27 neck/throat/jaw/chest symptoms (e.g., pain, tightness, pressure, heaviness),1 27 nausea,1 27 somnolence,1 27 warm or cold sensation,1 asthenia,1 27 dry mouth,1 27 dyspepsia1 ; with intranasal therapy, also nasal cavity disorder/discomfort,27 unusual taste.27


Interactions for Zomig


Appears to be metabolized by CYP1A2; active N-desmethyl metabolite appears to be further metabolized by MAO-A.22 23 24 26


Specific Drugs




































Drug



Interaction



Comments



Acetaminophen



Increased time to peak plasma acetaminophen concentrations1 27



Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)



Potentially life-threatening serotonin syndrome27 29


Zolmitriptan pharmacokinetics or effect on BP not altered by fluoxetine pretreatment1 27 30



Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated27 29



Cimetidine



Increased half-life and systemic exposure to zolmitriptan and its active metabolite1 27



Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)



Additive vasospastic effects1 27



Use within 24 hours contraindicated1 27



5-HT1 receptor agonists



Additive vasospastic effects1 27



Use within 24 hours contraindicated1 27



MAO inhibitors



Increased plasma concentrations of zolmitriptan and its active metabolite with concurrent use of MAO-A inhibitors; 1 27 selegiline (selective MAO-B inhibitor) did not affect pharmacokinetics of zolmitriptan or its active metabolite27



Use of oral or intranasal zolmitriptan within 2 weeks of MAO-A inhibitor contraindicated1 27



Metoclopramide



Metoclopramide (single 10-mg dose) did not affect pharmacokinetics of zolmitriptan or its metabolites1 27



Oral contraceptives



Increased plasma zolmitriptan concentrations1 27



Propranolol



Increased plasma zolmitriptan concentrations; peak zolmitriptan concentration may be delayed1 27



Xylometazoline



Topical application of xylometazoline to nasal mucosa 30 minutes prior to intranasal zolmitriptan did not affect zolmitriptan pharmacokinetics27


Zomig Pharmacokinetics


Absorption


Bioavailability


Well absorbed after oral administration, with peak plasma concentrations attained within 1.5 hours (conventional tablets) or 3 hours (orally disintegrating tablets).1 Rapidly absorbed via the nasopharynx after intranasal administration, with peak plasma concentrations attained within 3 hours.27


Mean absolute bioavailability after oral administration is approximately 40%;1 mean bioavailability of nasal solution is 102% compared with oral tablet.27


Mean plasma concentrations after oral administration are increased by up to 1.5-fold in females compared with males.1 27


Food


Food does not substantially affect bioavailability.1 27


Distribution


Plasma Protein Binding


25%.1 27


Elimination


Metabolism


Undergoes hepatic metabolism to form 3 principal metabolites, including N-desmethyl zolmitriptan (5-HT1B/1D potency is 2–6 times that of zolmitriptan).1 22 23 24 27 Formation of N-desmethyl zolmitriptan may depend on CYP1A2; MAO-A appears to mediate metabolism of N-desmethyl zolmitriptan.22 23 24 26


Elimination Route


Excreted in urine (65%) and feces (30%) as unchanged drug and metabolites;1 24 dose recovered in urine as unchanged drug (8%) and indole acetic acid (31%), N-oxide (7%), and N-desmethyl (4%) metabolites.1


Half-life


Approximately 3 hours for zolmitriptan and active N-desmethyl metabolite after oral or intranasal administration.1 13 23 24 27


Special Populations


In patients with severe hepatic impairment, peak plasma concentrations, time to achieve peak plasma concentrations, and AUC are 1.5-, 2-, and 3-fold higher, respectively, than in healthy individuals after oral administration.1 27 Pharmacokinetics of nasal spray not evaluated in patients with hepatic impairment.27


In patients with severe renal impairment (Clcr 5–25 mL/minute), clearance is reduced by 25% after oral administration; no substantial change in clearance in patients with moderate renal impairment (Clcr 26–50 mL/minute).1 Pharmacokinetics of nasal spray not evaluated in patients with renal impairment.27


Stability


Storage


Oral


Conventional and Orally Disintegrating Tablets

20–25°C; protect from light and moisture.1


Intranasal


Solution

20–25°C.27


ActionsActions



  • Binds with high affinity to 5-HT1B and 5-HT1D receptors.1 2 3 4 5 6 7 8 9 10 11 14 15 21 22 23 24 27




  • Structurally and pharmacologically related to other selective 5-HT1B/1D receptor agonists (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan).21 22




  • Precise mechanism of action not established; may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.1 21 22 23 27



Advice to Patients



  • Importance of immediately informing clinician of occurrence of tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck; sudden or severe abdominal pain; shortness of breath or wheezing; heart throbbing; facial swelling (e.g., eyelids, face, lips); tongue, mouth or throat swelling; rash or hives and of not taking zolmitriptan again until evaluated by a clinician.1 27 Importance of informing clinician of any other symptoms not understood by patient.1 27




  • Importance of adhering to prescribed directions for use.1 27 28 Importance of patient reading manufacturer's patient information before initial use and each time prescription is refilled.1 28




  • For patients taking zolmitriptan orally disintegrating tablets, importance of not removing tablet from blister package until just before administering dose;1 importance of peeling blister open and placing tablet on tongue to dissolve and be swallowed with saliva.1




  • Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1 27




  • Importance of informing patients of risk of serotonin syndrome with concurrent use of zolmitriptan and an SSRI or SNRI.27 29 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.27 29




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 27




  • Importance of informing patients of other important precautionary information.1 27 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

































Zolmitriptan

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Nasal



Solution



5 mg/0.1 mL



Zomig Nasal Spray



AstraZeneca



Oral



Tablets, film-coated



2.5 mg



Zomig



AstraZeneca



5 mg



Zomig



AstraZeneca



Tablets, orally disintegrating



2.5 mg



Zomig-ZMT (with aspartame)



AstraZeneca



5 mg



Zomig-ZMT (with aspartame)



AstraZeneca


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Zomig 2.5MG Tablets (ASTRAZENECA): 6/$156 or 18/$441.97


Zomig 5MG Solution (ASTRAZENECA): 6/$216 or 18/$615.99


Zomig 5MG Tablets (ASTRAZENECA): 3/$95.99 or 9/$259.96


Zomig ZMT 2.5MG Dispersible Tablets (ASTRAZENECA): 6/$155.99 or 18/$452.99


Zomig ZMT 5MG Dispersible Tablets (ASTRAZENECA): 3/$85.99 or 9/$230.98



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. AstraZeneca Pharmaceuticals LP. Zomig (zolmitriptan) tablets and Zomig-ZMT(zolmitriptan) orally disintegrating tablets prescribing information. Wilmington, DE; 2005 May.



2. Visser WH, Klein KB, Cox RC et al. 311C90, a new central and peripherally acting 5-HT1D receptor agonist in the acute oral treatment of migraine: a double-blind, placebo-controlled, dose-range finding study. Neurology. 1996; 46:522-6.



3. Dahlof C, Diener HC, Goadsby PJ et al. Zolmitriptan, a 5-HT1B/1D receptor agonist for the acute oral treatment of migraine: a multicentre, dose-range fnding study. Eur J Neurol 1998; 5:535-43. [PubMed 10210888]



4. Rapoport AM, Ramadan NM, Adelman JU et al. Optimizing the dose of zolmitriptan (Zomig, 311C90) for the acute treatment of migraine. A multicenter, double-blind, placebo-controlled, dose range-finding study. Neurology. 1997; 49:1210-8. [IDIS 397204] [PubMed 9371896]



5. Solomon GD, Cady RK, Klapper JA et al. Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine. Neurology. 1997; 49:1219-25. [IDIS 397205] [PubMed 9371897]



6. Dowson AJ, MacGregor EA, Purdy RA et al. Zolmitriptan orally disintegrating tablet is effective in the acute treatment of migraine. Cephalalgia. 2002; 22:101-6. [PubMed 11972576]



7. The International 311C90 Long-term Study Group. The long-term tolerability and efficacy of oral zolmitriptan (Zomig, 311C90) in the acute treatment of migraine. An international study. Headache. 1998; 38:173-83. [PubMed 9563207]



8. Tepper SJ, Donnan GA, Dowson AJ et al. A long-term study to maximize migraine relief with zolmitriptan. Curr Med Res Opin. 1999; 15:254-71. [PubMed 10640258]



9. Tuchman M, Edvinsson L, Geraud G et al. Zolmitriptan provides consistent migraine relief when used in the long-term. Curr Med Res Opin. 1999; 15:272-81. [PubMed 10640259]



10. Gallagher RM, Dennish G, Spierings ELH et al. A comparative trial of zolmitriptan and sumatriptan for the acute oral treatment of migraine. Headache. 2000; 40:119-28. [PubMed 10759911]



11. Gruffyd-Jones K, Kies B, Middleton A et al. Zolmitriptan versus sumatriptan for the acute oral treatment of migraine: a randomized, double-blind, international study. Eur J Neurol. 2001; 8:237-45.



12. Oldman AD, Smith LA, McQuay HJ et al. Pharmacological treatment for acute migraine: quantitative systematic review. Pain. 2002; 97:247-57.



13. Ferrari MD, Goadsby PJ, Roon KI et al. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002; 22:633-58. [PubMed 12383060]



14. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. From American Academy of Neurology web site ().



15. Silberstein SD, for the US Headache Consortium. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2000; 55:754-63. [IDIS 453389] [PubMed 10993991]



16. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA. 1985; 254:400-2. [IDIS 202002] [PubMed 2861297]



17. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm. 1984; 9:26,28-30.



18. Food and Drug Administration. Aspartame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist. 1983; 48:54993-5.



19. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist. 1983; 48:31376-82.



20. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther. 1982; 24:1-2.



21. Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine. A comparative review of pharmacology, pharmacokinetics, and efficacy. Drugs. 2000; 60:1259-87.



22. Deleu D, Hanssens Y. Current and emerging second-generation triptans in acute migraine therapy: a comparative review. J Clin Pharmacol. 2000; 40:687-700. [IDIS 449430] [PubMed 10883409]



23. Dowson AJ, Charlesworth B. Review of zolmitriptan and its clinical applications in migraine. Expert Opin Pharmacother. 2002; 3:993-1005. [PubMed 12083998]



24. Spencer CM, Gunasekara NS, Hills C. Zolmitriptan. A review of its use in migraine. Drugs. 1999; 58:347-74. [PubMed 10473025]



25. GlaxoSmithKline. Amerge (naratriptan hydrochloride) tablets prescribing information. Research Triangle Park, NC; 2002 Oct.



26. AstraZeneca, Wilmington, DE: Personal communication.



27. AstraZeneca. Zomig (zolmitriptan) nasal spray prescribing information. Wilmington, DE; 2006 July.



28. AstraZeneca. Zomig (zolmitriptan) nasal spray patient summary of information. Wilmington, DE; 2005 Jun.



29. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website: (, , and ).



30. Smith DA, Cleary EW, Watkins S et al. Zolmitriptan (311C90) does not interact with fluoxetine in healthy volunteers. Int J Clin Pharmacol Ther. 1998; 36:301-5. [PubMed 9660035]



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