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Antiemetic FORMULATION Each tablet contains Metoclopramide (as Hydrochloride) 10 mg. DESCRIPTION Metoclopramide (Vomaine), is an antagonist at D2 dopamine receptors, resulting in the inhibition of gastrointestinal relaxation. It accelerates the function of antrum by relaxation of the stomach, causes relaxation of the duodenal bulb and helps intestinal transit. Metoclopramide (Vomaine) is an antiemetic drug, increases peristalsis of the duodenum and jejunum, resulting in accelerated gastric emptying and intestinal transit. INDICATIONS Metoclopramide (Vomaine) is indicated in nausea, vomiting, flatulence, heart burn, distention of stomach in diabetes, hiatus hernia, reflux esophagitis, dyspepsia due to X-ray or biliary tract operation, vomiting due to migraine and postanesthetic vomiting. PHARMACOKINETICS Metoclopramide is rapidly and almost completely absorbed from the gastrointestinal tract following a dose by mouth, although conditions such as vomiting or impaired gastric motility may reduce absorption. However, it undergoes hepatic first-pass metabolism, which varies considerably between subjects, and hence absolute bioavailability and plasma concentrations are subject to wide interindividual variation. On average, the bioavailability of oral metoclopramide is about 75%, but it varies between about 30 and 100%. Peak plasma concentrations of metoclopramide occurs about 1 to 2 hours after an oral dose. Bioavailability is equally variable following rectal or intranasal administration, although it may be somewhat better if the drug is given intramuscularly. Metoclopramide is widely distributed in the body, with an apparent volume of distribution of about 3.5 litres per kg. It readily crosses the blood-brain barrier into the CNS. It also freely crosses the placenta, and has been reported to attain concentrations in fetal plasma about 60 to 70% of those in maternal plasma. Concentrations higher than those in maternal plasma may be reached in the breast milk of lactating mothers, particularly in the early puerperium, although concentrations decrease somewhat in the late puerperium. Elimination of metoclopramide is biphasic, with a terminal elimination half-life of about 4 to 6 hours, although this may be prolonged in renal impairment, with consequent elavation of plasma concentrations. It is excreted in the urine, about 85% of a dose being eliminated in 72 hours, 20 to 30% as unchanged metoclopramide and the remainder as sulfate or glucuronide conjugates, or as metabolites. About 5% of a dose is excreted in faeces via the bile. DOSAGE AND ADMINISTRATION Adults: Over 20 years: 1 tablet 3 times daily. 14-20 years: ½-1 tablet 3 times daily. OR AS DIRECTED BY THE PHYSICIAN. ADVERSE EFFECTS Metoclopramide is a dopamine antagonist and may cause extrapyrimidal symptoms which usually occur as acute dystonic reactions; these are more common in children and young adults, especially if female, and at daily doses above 500 mcg per kg body-weight. Parkinsonism and tardive dyskinesia have occasionally occurred, usually during prolonged treatment in elderly patients. Other adverse effects include restlessness, drowsiness, and diarrhoea. Hypotension, hypertension, dizziness, headache, and depression may occur and there are isolated reports of blood disorders, hypersensitivity reactions (rash, bronchospasm), and neuroleptic malignant syndrome. Disorders of cardiac conduction have been reported with intravenous metoclopramide. Metoclopramide stimulates prolactin secretion and may cause galactorrhoea or related disorders. Transient increase in plasma-aldosterone concentrations have been reported. PRECAUTIONS Metoclopramide (Vomaine) should not be used when stimulation of muscular contractions might adversely affect gastrointestinal conditions as in gastrointestinal haemorrhage, obstruction, perforation, or immediately after surgery. There have been reports of hypertensive crises in patients with phaeochromocytoma given metaclopramide (Vomaine), thus its use is not recommended in such patients. Children, young patients, and the elderly should be treated with care as they are at increased risk of extrapyrimidal reactions. Patients on prolonged therapy should be reviewed regularly. Care should also be taken when metoclopramide (Vomaine) is administered to patients with renal impairment, epilepsy. Parkinson's disease, or a history of depression. Metoclopramide (Vomaine) may cause drowsiness or impaired reactions; patients so affected should not drive or operate machinery. CONTRAINDICATION Metoclopramide (Vomaine) is contraindicated in patients with known hypersensitivty to the drug. Metoclopramide (Vomaine) should not be used in patients receiving other drugs which are likely to cause extra-pyrimidal reactions. Metoclopramide (Vomaine) should not be administers in stomach or intestinal obstruction and immediately after operation. It should not be used in meningitis. Driving a motor vehicle or operating machinery should be avoided during administration. CAUTION Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription. AVAILABILITY Foil strip of 10's; Box of 100's. STORAGE Store in temperature not exceeding 30°C. Keep all medicines out of reach of children. Manufactured by: The ACME Laboratories Ltd. 55 Satmasjid Rd.,Dhanmondi Dhaka-1209, Bangladesh Imported and Distributed by: Euro Generics International Phils. City Land 5 Suite Unit 803 South Star Plaza, Bangkal St., Makati City, Philippines |