Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aprepitant
Accord-UK Ltd
A04AD12
Aprepitant
80mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5055565751725
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aprepitant Zentiva 80mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 80 mg capsule contains 80mg of aprepitant. Excipient with known effect Each 80mg capsule contains 80 mg of sucrose and 0.00022 mmol (0.005 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule) The 80mg hard capsules are presented as opaque hard gelatin capsules of size No 2, with a white cap and white body, imprinted in black ink with “80mg” on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12. Aprepitant 125mg/80 mg is given as part of combination therapy (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Aprepitant is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose is 125mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning. The following regimens are recommended in adults for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy: _Highly Emetogenic Chemotherapy Regimen _ Day 1 Day 2 Day 3 Day 4 Aprepitant 125mg orally 80mg orally 80mg orally none Dexamethasone 12mg orally 8mg orally 8mg orally 8mg orally 5-HT 3 antagonists Standard dose of 5-HT 3 antagonists. See the product information for selected 5-HT 3 antagonist for appropriate dosing information None None None Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Day 2 to 4. The dose of dexamethasone accounts for active substance interactions. _Moderately Emetogenic Chemotherapy Regimen _ Day 1 Day 2 Day 3 Aprepitant 125mg orally 80mg orally 80mg orally Dexamethasone 12mg orally None None 5-HT 3 antagonists Standard dose of 5-HT 3 antagon Прочитать полный документ