Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
METOCLOPRAMIDE HCl EQV ANHYDROUS METOCLOPRAMIDE HCl
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Pending
10 mg
TABLET
ORAL
Prescription Only
SANOFI WINTHROP INDUSTRIE
1989-05-05
PRIMPERAN ® 10MG TABLET [SANOFI LOGO] QUALITATIVE AND QUANTITATIVE COMPOSITION Anhydrous metoclopramide hydrochloride 10 mg Excipients to 1 scored tablet PHARMACEUTICAL FORM Scored tablet CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Adults: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) - Prevention of delayed radiotherapy induced nausea and vomiting (RINV) - Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. Children (aged 1-18 years): - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option POSOLOGY AND METHOD OF ADMINISTRATION Usual dosage: Adults: The recommended single dose is 10 mg, repeated up to three times daily. The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight. The maximum recommended treatment duration is 5 days. In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty. In patients with severe hepatic impairment, the dose should be reduced by 50%. In patients with severe renal impairment (creatinine clearance ≤ 15 mL/min), the daily dose should be reduced by 75. In patients with moderate to severe renal impairment (creatinine clearance 15-60 mL/min), the dose should be reduced by 50%. Children (aged 1-18 years); The recommended dose is 0.10 to 0.15 mg/kg body weight, repeated up to three times daily. The maximum dose in 24 hours is 0.5 mg/kg body weight. Dosing table Age Body Weight Dose Frequency 9-18 years 30-60 kg 5 mg Up to 3 times daily 15-18 years Over 60 kg 10 mg Up to 3 times daily The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV). Tablets are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms may be more appropriate for admini Preberite celoten dokument