TRADE NAME: VOMAWAY SUPPOSITORIES 10 MG GENERIC NAME: Metoclopramide COMPOSITION: Each suppository contains: Active ingredient: Metoclopramide 10 mg Excipients: Hard fat. PHARMACEUTICAL FORM: Suppositories PHARMACOLOGICAL ACTION: Pharmacotherapeutic group: stimulant of intestinal motility. Metoclopramide is a neuroleptic dopamine antagonist. It prevents vomiting by blocking dopamine sites. PHARMACOKINETICS: Absorption : Metoclopramide is rapidly absorbed from the gastrointestinal tract. Bioavailability is generally 80%, however there is an inter-individual variability linked to hepatic first-pass effect. Distribution : Metoclopramide is widely distributed in tissues. The volume of distribution is 2.2 to 3.4 l / kg. It attaches little to plasma proteins. It passes through the placenta and milk. Metabolism: Metoclopramide is poorly metabolized. Excretion: Metoclopramide is primarily eliminated in the urine as free or conjugated with sulphate. The half-life of elimination is 5 to 6 hours. It increases in the cases of renal or hepatic impairment. Renal Insufficiency The clearance of metoclopramide is decreased to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (about 10 hours for a creatinine clearance of 10-50 mL / minute 15 hours for a creatinine clearance <10 mL / minute). Hepatic Insufficiency Accumulation of metoclopramide has been observed in patients with hepatic cirrhosis, associated with a 50% decrease in plasma clearance. INDICATIONS: - In adults, Vomaway remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics). DOSAGE AND ADMINISTRATION: - For adults the maximum dose in 24 hours is 0.5 mg per kg body weight; in adults, the usual dose of conventional formulations is 10 mg up to 3 times daily. - The maximum recommended duration of treatment is 5 days. Mode of administration: A minimum interval of 6 hours between 2 administrations must be respected, even in case of vomiting or rejection of the dose. Special Populations Elderly (not more than 70years) In elderly patients, a dose reduction should be considered, taking into account the kidney and liver function and overall fragile health. Renal Insufficiency In patients with end-stage 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 between 15 and 60 ml / min), the dose should be reduced by 50%. Hepatic Insufficiency In patients with severe hepatic impairment, the dose should be reduced by 50%. Other pharmaceutical formulations / dosages may be more suitable for use in this population.
