Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
NEVIRAPINE (UNII: 99DK7FVK1H) (NEVIRAPINE - UNII:99DK7FVK1H)
Cipla Ltd.
NEVIRAPINE
NEVIRAPINE 200 mg
ORAL
PRESCRIPTION DRUG
Nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2] . Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with CD4+ cell counts greater than 250 cells/mm3 or - adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)] . Nevirapine tablets are contraindicated: - in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7)] - for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions (5.1)] . Teratogenic Effects Pregnancy Exposur
Nevirapine Tablets USP, 200 mg, are white oval shaped biconvex tablets (9.3 mm x 19.10 mm) with central break line on one side and 'N' debossed on the other side. Nevirapine Tablets USP, 200 mg are available as follows: Bottle of 60 tablets (NDC 53104 0166 2) Bottle of 1000 tablets (NDC 53104 0166 6) Storage Store at 20°C-25°C (68°F-77°F) [See USP Controlled room temperature]. Keep out of the reach of children.
Abbreviated New Drug Application
Cipla Ltd. ---------- MEDICATION GUIDE Nevirapine Tablets USP, 200mg (ne-VIR-a-peen) What is the most important information I should know about nevirapine? Nevirapine can cause severe liver and skin problems that may lead to death. These problems can happen at any time during treatment, but your risk is higher during the first 18 weeks of treatment. Nevirapine can cause serious side effects, including: • Severe liver problems. Some people taking nevirapine may develop severe liver problems that can lead to liver failure and the need for a liver transplant, or death. If you have liver problems you may get a rash • Women have a higher risk of developing liver problems during treatment with nevirapine than men. • People who have abnormal liver test results before starting nevirapine and people with hepatitis B or C also have a greater risk of getting liver problems. People who have higher CD4+ cell counts when they begin nevirapine have a higher risk of liver problems, especially: • Women with CD4+counts higher than 250 cells/mm3. This group has the highest risk. • Men with CD4+counts higher than 400 cells/mm3. Stop taking nevirapine and call your doctor right away if you have any of the following symptoms of liver problems with or without a skin rash: • dark (tea colored) urine • yellowing of your skin or whites of your eyes • light-colored bowel movements (stools) • fever • feeling sick to your stomach (nausea) • feel unwell or like you have the flu • pain or tenderness on your right side below your ribs • tiredness • loss of appetite • Severe skin reactions and rash. Some skin reactions and rashes may be severe, life-threatening, and in some people, may lead to death. Most severe skin reactions and rashes happen in the first 6 weeks of treatment with nevirapine. • Women have a higher risk of developing a rash during treatment with nevirapine than men. Stop taking nevirapine and call your doctor right away if you get a rash with any of the following symptoms: blisters muscle or join Կարդացեք ամբողջական փաստաթուղթը
NEVIRAPINE- NEVIRAPINE TABLET CIPLA LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NEVIRAPINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEVIRAPINE TABLETS. NEVIRAPINE TABLETS USP, 200 MG, FOR ORAL USE INITIAL U.S. APPROVAL: 1996 WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY AND SKIN REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FATAL AND NON-FATAL HEPATOTOXICITYHAVE BEEN REPORTED IN PATIENTS TAKING NEVIRAPINE. DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR TRANSAMINASE ELEVATIONS COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART NEVIRAPINE AFTER RECOVERY.(5.1) FATAL AND NON-FATAL SKIN REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS, HAVE BEEN REPORTED. DISCONTINUE IMMEDIATELY IF SEVERE SKIN REACTIONS, HYPERSENSITIVITY REACTIONS, OR ANY RASH WITH SYSTEMIC SYMPTOMS OCCUR. CHECK TRANSAMINASE LEVELS IMMEDIATELY FOR ALL PATIENTS WHO DEVELOP A RASH IN THE FIRST 18 WEEKS OF TREATMENT. DO NOT RESTART NEVIRAPINE AFTER RECOVERY.(5.2) MONITORING DURING THE FIRST 18 WEEKS OF THERAPY IS ESSENTIAL. EXTRA VIGILANCE IS WARRANTED DURING THE FIRST 6 WEEKS OF THERAPY, WHICH IS THE PERIOD OF GREATEST RISK OF THESE EVENTS. (5.1, 5.2). INDICATIONS AND USAGE Nevirapine is an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. (1) Limitations of Use: _ _ Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4 cell counts greater than 250 cells/mm adult males with CD4 cell counts greater than 400 cells/mm (1, 5.1) DOSAGE AND ADMINISTRATION The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency Կարդացեք ամբողջական փաստաթուղթը