1 aprepitant 125 MG Oral Capsule 2 aprepitant 80 MG Oral Capsule Pack
1 INDICATIONS AND USAGE Aprepitant is a substance P/neurokinin 1 (NK 1 ) receptor antagonist. Aprepitant capsules are indicated • in combination with other antiemetic agents, in patients 12 years of age and older for prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1 ) • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1 ) • for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2 ) Limitations of Use : ( 1.3 ) • Aprepitant has not been studied for treatment of established nausea and vomiting. • Chronic continuous administration of aprepitant is not recommended. 1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Aprepitant capsules, in combination with other antiemetic agents, are indicated in patients 12 years of age and older for the prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). 1.2 Prevention of Postoperative Nausea and Vomiting (PONV) Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting. 1.3 Limitations of Use • Aprepitant has not been studied for the treatment of established nausea and vomiting. • Chronic continuous administration of aprepitant is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.
glenmark pharmaceuticals inc., usa
CAPSULE PINK G 585
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16 HOW SUPPLIED/STORAGE AND HANDLING
APREPItanT capsules USP, 125 mg: hard gelatin capsules with a pink opaque colored cap imprinted with a Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '585' in black ink. They are supplied as follows: NDC 68462-585-76 Carton of 6 capsules (containing 1 x 6 unit-dose blisters)
APREPItanT capsules USP, 80 mg: hard gelatin capsules with a white opaque colored cap imprinted with a Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '584' in black ink. They are supplied as follows: NDC 68462-584-76 Carton of 6 capsules (containing 1 x 6 unit-dose blisters) NDC 68462-584-58 Blister card of 2 capsules (2-day pack containing two 80 mg capsules)
APREPItanT capsules USP, 3-day pack (125 mg/80 mg/80 mg): NDC 68462-112-33 Blister card of 3 capsules (3-day pack containing one 125 mg capsule and two 80 mg capsules)
APREPItanT capsules USP, 40 mg: hard gelatin capsules with a mustard yellow colored cap imprinted with a Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '583' in black ink. They are supplied as follows: NDC 68462-583-11 Carton of 10 capsules (containing 1 x 10 unit-dose blisters) NDC 68462-583-85 Carton of 5 capsules (containing 5 x 1 unit-dose blisters) NDC 68462-583-40 Carton of 1 capsule (containing 1 unit-dose blisters) Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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