Nevirapine 200 MG Oral Tablet

1 INDICATIONS AND USAGE 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/mm 3 or • adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnings and Precautions (5.1) ] . • 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 3 • adult males with CD4 + cell counts greater than 400 cells/mm 3 ( 1 , 5.1 )

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug abuse` `[4] drug ineffective` `[5] overdose` `[6] death` `[7] drug interaction` `[8] intentional overdose` `[9] depression` `[10] nausea`

4 years ago

OVAL WHITE NE 200 M

16 HOW SUPPLIED/STORAGE AND HANDLING

NEVIRAPINE Tablets, USP are available containing 200 mg of

NEVIRAPINE, USP. The 200 mg tablets are white to off-white, oval, scored tablets debossed with NE to the left of the score and 200 to the right of the score on one side of the tablet and M to the left of the score and blank to the right of the score on the other side. They are available as follows: NDC 0378-4050-91 bottles of 60 tablets 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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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Nevirapine 200 MG Oral Tablet

FDA Reported Adverse Reactions [1] toxicity to various agents [2] completed suicide [3] drug abuse [4] drug ineffective [5] overdose [6] death [7] drug interaction [8] intentional overdose [9] depression [10] nausea

OVAL WHITE NE 200 M

More pills like OVAL NE 200 M

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug abuse` `[4] drug ineffective` `[5] overdose` `[6] death` `[7] drug interaction` `[8] intentional overdose` `[9] depression` `[10] nausea`