darunavir 600 mg

1 INDICATIONS AND USAGE Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14 )] . Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir tablets must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents. ( 1 )

Cipla USA Inc.

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] diarrhoea` `[4] fatigue` `[5] off label use` `[6] nausea` `[7] headache` `[8] pneumonia` `[9] dizziness` `[10] vomiting`

6 months ago

OVAL ORANGE C248

16 HOW SUPPLIED/STORAGE AND HANDLING

DARUNAVIR 600 mg tablets are supplied as beige, capsule-shaped, biconvex, film coated tablets containing

DARUNAVIR hydrate equivalent to 600 mg of

DARUNAVIR per tablet. Each tablet is debossed with "C248" on one side and "plain" on the other side.

DARUNAVIR 800 mg tablets are supplied as white to off-white, capsule-shaped, biconvex, film coated tablets containing

DARUNAVIR hydrate equivalent to 800 mg of

DARUNAVIR per tablet. Each tablet is debossed with "C244" on one side and "plain" on the other side.

DARUNAVIR tablets are packaged in bottles in the following configuration: 600 mg tablet – bottles of 60 (NDC 69097-248-03) 800 mg tablet – bottles of 30 (NDC 69097-244-02) Storage:

DARUNAVIR tablets Store at 25°C (77°F); with excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature.] Keep

DARUNAVIR tablets out of reach of children.

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darunavir 800 mg

Cipla USA Inc.

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