Details for: MYLAN-NEVIRAPINE
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02387727 | MYLAN-NEVIRAPINE | NEVIRAPINE | 200 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
MYLAN-NEVIRAPINE is a medicine used to treat Human Immunodeficiency Virus (HIV) infection, the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
MYLAN-NEVIRAPINE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking MYLAN-NEVIRAPINE may still get infections common in people with HIV (opportunistic infections). Therefore, it is very important that you stay under the care of your doctor.
What it does
Nevirapine is a type of anti-HIV medicine called a "nonnucleoside reverse transcriptase inhibitor" (NNRTI). It works by lowering the amount of HIV in the blood ("viral load"). You must take nevirapine with other anti-HIV medicines. When taken with other anti-HIV medicines, nevirapine can reduce viral load and increase the number of CD4 cells ("T cells"). CD4 cells are a type of immune helper cell in the blood. Nevirapine may not have these effects in every patient
Nevirapine is not a cure for HIV infection.
When it should not be used
- If you are allergic (hypersensitive) to nevirapine or its components (see What the non-medicinal ingredients are).
- If you have a severe liver problem.
- If you have rare hereditary conditions of galactosemia, galactose intolerance, glucose/galactose malabsorption, Lapp lactase deficiency, as this product contains lactose.
- If you are allergic (hypersensitive) to nevirapine or its components (See What the non-medicinal ingredients are) or have used NEVIRAPINE and had a severe rash with associated symptoms such as malaise, fatigue, muscle/joint aches, blisters, facial edema (facial swelling), oral lesions, conjunctivitis, and/or hepatitis, eosinophilia (a lot of white blood cells called eosinophils in the blood), granulocytopenia (a decrease in white blood cells called granulocytes in the blood), lymphadenopathy, (swelling of the lymph nodes) and renal dysfunction (kidneys not working properly), you must permanently discontinue MYLAN-NEVIRAPINE and seek medical evaluation immediately. (See WARNINGS AND PRECAUTIONS)
- Do not take MYLAN-NEVIRAPINE with St. John’s wort (Hypericum perforatum) as it will reduce nevirapine blood levels.
What the medicinal ingredient is
MYLAN-NEVIRAPINE tablets contain the active ingredient nevirapine.
What the non-medicinal ingredients are
Non-medicinal Ingredients (in alphabetical order): colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
What dosage form it comes in
MYLAN-NEVIRAPINE (nevirapine) comes as an immediate release tablet containing 200 mg of nevirapine.
Warnings and precautions
Severe, life-threatening, and in some cases fatal liver toxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine, including pregnant women receiving chronic nevirapine therapy in conjunction with other antiretroviral medication. Female gender and higher CD4 counts at the start of therapy may increase the risk of liver problems (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
Severe skin and allergic reactions, including fatal cases have occurred with accompanying symptoms such as severe rash with fever, fatigue, muscle/joint pain, swelling of the face, hepatitis (liver inflammation), blood and kidney problems. If this occurs discontinue MYLAN-NEVIRAPINE and contact your doctor immediately
In rare cases liver problems have led to liver failure and can lead to a liver transplant or death. Therefore, if you develop any of the following symptoms of liver problems stop taking MYLAN-NEVIRAPINE and call your doctor right away:
- general ill feeling or “flu-like” symptoms
- yellowing skin or whites of your eyes
- tiredness
- dark urine (tea colored)
- nausea (feeling sick to your stomach)
- pale stools (bowel movements)
- lack of appetite
- pain, ache, or sensitivity to touch on your right side
- below your ribs
Your doctor should check you and do blood tests often to check your liver function during the first 18 weeks of therapy. Checks for liver problems should continue regularly during treatment with MYLAN-NEVIRAPINE.
Skin Reactions
Skin rash is the most common side effect of nevirapine.
Most rashes occur in the first 6 weeks of treatment. In a
small number of patients, rash can be serious and result
in death. Therefore, if you develop a rash with any of
the following symptoms, stop using nevirapine and call
your doctor right away:
- general ill feeling or “flu-like” symptoms
- blisters
- fever
- mouth sores
- muscle or joint aches
- swelling of your face
- conjunctivitis (red or inflamed eyes, like “pink eye”)
- tiredness
- any symptoms of liver problems discussed above
If your doctor tells you to stop treatment with MYLAN-NEVIRAPINE because you have experienced the serious liver or skin reactions described above, never take MYLAN-NEVIRAPINE again.
These are not all the side effects of MYLAN-NEVIRAPINE. See the section SIDE EFFECTS AND WHAT TO DO ABOUT THEM for more information. Tell your doctor if you have any side effects from MYLAN-NEVIRAPINE.
BEFORE you use MYLAN-NEVIRAPINE talk to your doctor or pharmacist
- If you have or have had any diseases of the liver particularly hepatitis B or C infection;
- If you are pregnant or intend to become pregnant;
- If you are a breast-feeding mother. It is recommended that HIV infected women not breast-feed, to avoid transmission of the virus to the infant;
- If you are taking any medications, including prescription; non-prescription, herbal or homeopathic remedies;
- If you have any allergies to foods or drugs;
- If you are undergoing dialysis.
Interactions with this medication
Drugs that may interact with nevirapine:
Nevirapine may change the effect of other medicines, and
other medicines can change the effect of nevirapine. Tell
your doctors and pharmacists about all medicines you take,
including non-prescription medicines, vitamins and herbal
supplements.
Do not take ketoconazole, rifampin, efavirenz, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat), or boceprevir; with nevirapine.
Tell your doctor if you take clarithromycin, fluconazole, methadone, rifabutin, indinavir, lopinavir/ritonavir combination, saquinavir or itraconazole.
Nevirapine may not be right for you, or you may need careful monitoring.
You should be aware that nevirapine may change the effectiveness of oral contraceptives. Therefore oral contraceptives and other hormonal methods of birth control should not be used as a method of contraception in women taking nevirapine; other methods (barrier) must be used.
Proper use of this medication
Usual dose
Adult:
Follow the directions exactly as given to you by your
doctor or pharmacist regarding the amount and frequency
of dosing. The label will usually tell you this information
as well. If you are not sure about dosing, ask your doctor
or pharmacist.
As a general guide, swallow one tablet (200 mg) once a day for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash) followed by one 200 mg tablet twice daily as part of a multi-drug treatment program. MYLAN-NEVIRAPINE tablets can be taken with or without food
It is important to strictly follow the once daily dose for the first 14 days. Do not start taking MYLAN-NEVIRAPINE twice a day if you have any symptoms of liver problems or skin rash (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
The manufacturer’s recommended dosage and monitoring for the other administered anti-retroviral drugs should be followed.
Overdose
Missed Dose
If you miss a dose: If you forget to take your medicine, take it as soon as you remember. Then continue as before; do not double your next dosage.
If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking the next dose at its regular time.
If you stop taking MYLAN-NEVIRAPINE for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to start with once-a-day 200 mg MYLAN-NEVIRAPINE tablet dosing.
Avoid doing things that can spread HIV infection, as MYLAN-NEVIRAPINE does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
This medicine is for you. Never give it to someone else, as it may harm them even if their symptoms are the same as yours.
Take your medications exactly as prescribed by your doctor. Do not change the dose without consulting your doctor
Do not take any other medication including prescription, non-prescription, herbal or homeopathic remedies without your doctor’s advice. Also, inform any other doctor, dentist or pharmacist you consult that you are taking this medication
Keep out of reach of children.
If you have any other questions about MYLAN-NEVIRAPINE, contact your doctor or pharmacist.
Side effects and what to do about them
Nevirapine can cause serious liver damage and skin reactions that can cause death. Any patients can experience such side effects, but some patients are more at risk than others. See WARNINGS AND PRECAUTIONS.
Other common side effects of nevirapine include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, skin rash and itching, myalgia (muscle pain) and arthralgia (joint pain). This list of side effects is not complete. Ask your doctor or pharmacist for more information.
Abnormal liver function test results, decrease in red blood cells or white blood cells called granulocytes, decrease in blood phosphorus, increase in blood pressure and hypersensitivity including severe allergic reaction with facial swelling may also occur
If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.
Sleepiness can occur. Do not drive or operate machinery if you become drowsy
Always tell your doctor or pharmacist about any undesirable effects you experience after taking nevirapine, even those not mentioned above.
Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
Consult your doctor immediately if you experience any symptoms as listed above, or any symptoms that you do not understand.
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-NEVIRAPINE, contact your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Severe liver disease with symptoms such as nausea, abdominal pain, aches, tiredness, lack of appetite, dark urine, pale stools (bowel movement), yellowing of skin and eyes, and a general ill feeling or “flu-like” symptoms. | ✔ | ||
| Severe skin reactions such as rash, blistering accompanied by symptoms such as fever, muscle/joint pain, tiredness, mouth sores, swelling of the face, conjunctivitis, and a general ill feeling or “flulike” symptoms. | ✔ | ||
How to store
Store MYLAN-NEVIRAPINE tablets at normal room temperature (between 15°C and 30°C). As with all medicines, keep MYLAN-NEVIRAPINE tightly closed and out of reach of children. Do not take your medicine after the expiry date shown on the bottle.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared
for health professionals can be found at:
http://www.mylan.ca
This leaflet was prepared by
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON M8Z 2S6
1-800-575-1379
Prepared on: February 13, 2014