* Treatment of vomiting and nausea. Prokinetic action. Solution for I.M. or I.V. injection.* Composition: Each 2 ml ampoule contains: Metoclopramide hydrochloride 10.5 mg Equivalent to Metoclopramide hydrochloride anhydrous 10 mg.* Therapeutic indications: Symptomatic treatment of nausea and vomiting.* Dosage and administration: – For adults: 1ampoule (10mg) every 8 hours (I.M. or I.V.). – For children: Metoclopramide Hydrochloride should not exceed 0.5 mg / kg / day (oral, I.V. or I.M.) – Radiological examination of gastrointestinal tract: 1 or 2 ampoules, I.M. or I.V., 10 minutes before starting the procedure. – Delayed nausea and vomiting induced by certain treatments: The initial two doses should be 2 mg/kg if highly emetogenic drugs are used alone or in combination. For less emetogenic regimens, 1 mg/kg metoclopramide per dose may be adequate. If extrapyramidal symptoms (EPS) should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly and EPS usually will subside. – INTRAVENOUS INFUSIONS SHOULD BE MADE OVER A PERIOD OF NOT LESS THAN 15 MINUTES, 30 MINUTES BEFORE BEGINNING CANCER CHEMOTHERAPY AND REPEATED EVERY 2 HOURS FOR TWO DOSES, THEN EVERY 3 HOURS FOR THREE DOSES. – Route of administration: Oral, intramuscular, intravenous. – Frequency and time of administration: Leave an interval of at least 6 hours between doses.* Contraindications: – Hypersensitivity to metclopramide or any of the components. – Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk. – History of neuroleptic or metoclopramide-induced tardive dyskinesia. – Confirmed or suspected pheochromocytoma, because of the risk of severe hypertension episodes. – Combination with levodopa because of mutual antagonism.* Special warning and precautions for use: – Extrapyramidal disorders may occur, particularly in children and young adults. These adverse reactions resolve completely after treatment discontinuation. A symptomatic treatment may be necessary (benzodiazepines in children and/or anticholinergic anti-parkinsonian drugs in adults). – In the case of vomiting with rejection of the dose, respect the specified interval before re-administering metoclopramide. – Metoclopramide is not recommended in epileptic patients as benzamide may decrease the epileptic threshold. – In patients with renal or hepatic impairment a dose reduction is recommended. – As with neuroleptics, Neuroleptic Malignant Syndrome (NMS) characterized by hyperthermia, extrapyramidal disorders, autonomic nervous instability and elevated CPK, may occur. Therefore cautions have to be taken if fever, one of the symptoms of NMS, occurs and metoclopramide has to be stopped if a NMS is supected. – Methemoglobinemia, which could be related to NADH cytochrome b5 reductase deficiency, has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated.* Pregnancy and lactation: – Metoclopramide should be be used only if needed during pregnancy. – Metoclopramide passes into breast milk. In consequence, breast-feeding should be avoided.* Not to be used without medical supervision.* Contraindicated In Children Below 18 Years.* Store at a temperature not exceeding 25 degrees C.* Produced by: sanofi-aventis Egypt s.a.e. Under license of: sanofi-aventis – France.
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