Jinling Pharma


Global Pharmatrade
Full Prescribing Info
Metoclopramide hydrochloride.
Each mL contains: Metoclopramide (as hydrochloride) 5 mg.
Pharmacology: Metoclopramide hydrochloride stimulates motility of the upper gastro-intestinal tract and is used in the management of some forms of nausea and vomiting, in gastro-esophageal reflux, and gastric stasis. It is a dopamine-receptor antagonist and may cause extrapyramidal symptoms, parkinsonism, and tardive dyskinesia; prolactin secretion may be stimulated causing galactorrhoea. Adverse effects are more common in children, young adults, and elderly.
Pharmacokinetics: Metoclopramide is rapidly absorbed from the gastro-intestinal tract but undergoes variable first-pass hepatic metabolism and plasma concentration show large interindividual variation. It is excreted mainly in the urine as free and as conjugated metoclopramide and as metabolites. It rapidly crosses the placenta and is readily excreted in human milk. The elimination half-life has been reported to be up to about 6 hours and to be prolonged with renal failure or hepatic cirrhosis.
It is used in disorders of reduced gastro-intestinal motility such as gastroparesis or ileus; in gastro-esophageal reflux and dyspepsia; and in nausea and vomiting associated with various gastro-intestinal disorders, with migraine following surgery and with cancer therapy; may also be used to stimulate gastric emptying during radiographic examination and to facilitate intubation of the small bowel.
Dosage/Direction for Use
Metoclopramide hydrochloride is a substituted benzamide which stimulates the motility of the upper gastro-intestinal tract without affecting gastric, biliary, or pancreatic secretion. Metoclopramide increases gastric peristalsis leading to accelerated gastric emptying. Duodenal peristalsis is also increased which decreases intestinal transit time. The resting tone of the gastro-esophageal sphincter is increased and the pyloric sphincter is relaxed. Metoclopramide possesses parasympathomimetic activity as well as being a dopamine-receptor (5HT3) antagonist properties. Metoclopramide is used in the treatment of some forms of nausea and vomiting such as that associated with migraine, cancer therapy, or that following surgery; it is of little benefit in the prevention or treatment of the motion sickness. Metoclopramide is also used for gastroesophageal reflux or gastric stasis. It may be used to facilitate small-bowel intubation procedures and to stimulate gastric emptying during radiographic examinations. It is used as the base or the hydrochloride and is usually administered by mouth in a dose equivalent to 10 mg of anhydrous metoclopramide hydrochloride three times daily but may also be given intramuscular or slow intravenous injection in the same dosage; in the US potency is expressed in terms of anhydrous metoclopramide and doses of 10 to 15 mg up to four times daily have been given. It is also given rectally by suppository in a dose of 10 to 20 mg of the base up to three times daily. Single doses should be considered where appropriate and single doses of up to 20 mg expressed as anhydrous base or anhydrous hydrochloride have been used. Doses should be reduced in young adults and in children. In the UK suggested doses for those aged 15 to 19 years are 5 mg three times daily for those weighing 30 to 59 Kg and 10 mg three times daily for those weighing 60 Kg and over; 9 to 14 years, 5 mg three times daily for those weighing 30 Kg and over; 5 to 9 years, 2.5 mg three times daily for those weighing 20 to 29 Kg; 3 to 5 years, 2 mg two or three times daily for those weighing 15 to 19 Kg; 1 to 3 years, 1 mg two or three times daily for those weighing up to 10 Kg. In general, the total daily dose should not exceed 0.5 mg per Kg body-weight; dosage reduction has been recommended in renal or hepatic failure. High doses are employed in the treatment of nausea and vomiting associated with cancer chemotherapy. The loading dose of metoclopramide given before cancer therapy is 2 to 4 mg per Kg body-weight administered as a continuous intravenous infusion over 15 to 30 minutes and is followed by a maintenance dose of 3 to 5 mg per Kg, again as a continuous intravenous infusion, administered over 8 to 12 hours. Alternatively, initial doses of up to 2 mg per kg by intravenous infusion over at least 15 minutes may be given before cancer therapy and repeated every 2 or 3 hours for 5 doses. The total dosage by either continuous or intermittent infusion should not normally exceed 10 mg per Kg in 24 hours.
This product contains sodium bisulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible reasons.
Special Precautions
Metoclopramide should not be used when stimulation of muscular contractions might adversely affect gastro-intestinal conditions as in gastro-intestinal haemorrhage, obstruction, perforation, or immediately after surgery. There have been reports of hypertensive crises in patients with pheochromocytoma given Metoclopramide, thus its use is not recommended in such patients. Children, young patients, and elderly should be treated with care; there are specific doses recommended for young people up to age of about 20 years and these are lower than doses for adults. Patients on prolonged therapy should be reviewed regularly. Care should also be taken when metoclopramide is administered to patients with renal impairment or to those at risk of fluid retention as in hepatic impairment.
Adverse Reactions
Metoclopramide is a dopamine antagonist and may cause extrapyramidal symptoms which usually occur as acute dystonic reactions especially in young female patients. The risk may be reduced by keeping the daily dose below 500 mcg per kg per weight. Parkinsonism and tardive dyskinesia have occasionally occurred, usually during prolonged treatment in elderly patients. Other adverse effects include restlessness, drowsiness, dizziness, headache, and bowel upsets such as diarrhoea. Hypotension, hypertension, and depression may occur and there are isolated reports of blood disorders, hypersensitivity reactions, neuroleptic malignant syndrome, and urinary incontinence. Metoclopramide stimulates prolactin secretion and may cause galactorrhoea or related disorders. Transient increases in plasma aldosterone concentrations have been reported.
Drug Interactions
Caution should be observed when using metoclopramide in patients taking other drugs that can also cause extrapyramidal reactions, such as the phenothiazines. The effects on CNS depressants may also be enhanced. Antimuscarinic agents and opioid analgesics antagonize the gastro-intestinal effects of metoclopramide.
The absorption of the other drugs may be affected by metoclopramide; it may either diminish absorption from the stomach or enhance absorption from the small intestine. It may prolong suxamethonium-induced neuromuscular blockade. Metoclopramide may also increase prolactin blood-concentrations and therefore interfere with drugs which have a hypoprolactinaemic effect.
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
A03FA01 - metoclopramide ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Soln for inj (amp) 5 mg/mL x 2 mL x 10's.
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