Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
NEVIRAPINE (UNII: 99DK7FVK1H) (NEVIRAPINE - UNII:99DK7FVK1H)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m2 or greater [see Clinical Studies (14.1, 14.2)] . Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are 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 extended-release 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-exp
Nevirapine Extended-Release Tablets USP 400 mg are light yellow to yellow, oval, biconvex tablets debossed with “L” on one side and “55” on the other side. Bottles of 30 NDC 65862-933-30 Bottles of 90 NDC 65862-933-90 Bottles of 500 NDC 65862-933-05 Bottles of 1,000 NDC 65862-933-99 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.
Abbreviated New Drug Application
Aurobindo Pharma Limited ---------- MEDICATION GUIDE Nevirapine Extended-Release Tablets USP (ne vir' a peen) What is the most important information I should know about nevirapine extended-release tablets? Nevirapine extended-release tablets 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 extended-release tablets can cause serious side effects, including: • Severe liver problems. Some people taking nevirapine extended-release tablets 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 extended-release tablets than men. • People who have abnormal liver test results before starting nevirapine extended-release tablets 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 extended-release tablets 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 extended-release tablets 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 • light-colored bowel movements (stools) • feeling sick to your stomach (nausea) • pain or tenderness on your right side below your ribs • loss of appetite • yellowing of your skin or whites of your eyes • fever • feel unwell or like you have the flu • tiredness • 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 nevirapi Izlasiet visu dokumentu
NEVIRAPINE - NEVIRAPINE TABLET, EXTENDED RELEASE AUROBINDO PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NEVIRAPINE EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEVIRAPINE EXTENDED-RELEASE TABLETS. NEVIRAPINE EXTENDED-RELEASE TABLETS, 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 HEPATOTOXICITY HAVE BEEN REPORTED IN PATIENTS TAKING NEVIRAPINE EXTENDED-RELEASE TABLETS. DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR TRANSAMINASE ELEVATIONS COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART NEVIRAPINE EXTENDED-RELEASE TABLETS 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 EXTENDED-RELEASE TABLETS 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 extended-release tablets are an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a BSA of 1.17 m or greater. (1) Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with C Izlasiet visu dokumentu