Metoclopramide hydrochloride.
Each mL contains: Metoclopramide hydrochloride 5 mg.
Metoclopramide hydrochloride is a substituted benzamine used for its prokinetic and antiemetic properties. It stimulates the motility of the upper gastrointestinal tract without affecting gastric, biliary, or pancreatic secretion and 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 antagonist with a direct effect on the chemoreceptor trigger zone. It may have serotonin-receptor (5-HT3) antagonist properties.
Metoclopramide is used in disorders of decreased gastrointestinal motility such as gastroparesis or ileus; in gastro-esophageal reflux disease and dyspepsia; and in nausea and vomiting associated with various gastrointestinal disorders, with migraine, following surgery, and with cancer therapy. Metoclopramide is of no value in the prevention or treatment of motion sickness. It may be used to stimulate gastric emptying during radiographic examinations, to facilitate intubation of the small bowel, and in the management of aspiration syndromes.
By intramuscular injection or by intravenous injection: Over 1-2 minutes, nausea and vomiting: Child up to 1 year (up to 10 kg): 100 mcg/kg (max. 1 mg), twice daily.
1 to 3 years old (10-14 kg): 1 mg, 2-3 times daily.
3 to 5 years old (15-19 kg): 2 mg, 2-3 times daily.
5 to 9 years old (20-29 kg): 2.5 mg, 3 times daily.
9 to 15 years old (30 kg and over): 5 mg, 3 times daily.
15 to 19 years old under 60 kg: 5 mg, 3 times daily.
Adults: 10 mg, 3 times daily.
For diagnostic procedures, as a single dose, 5 to 10 minutes before the examination: Child under 3 years: 1 mg.
3 to 5 years old: 2 mg.
5 to 9 years old: 2.5 mg.
9 to 14 years old: 5 mg.
15 to 19 years old: 10 mg.
Adult: 10 to 20 mg.
Pheochromocytomas due to the possibility of a hypertensive crisis, probably due to release of catecholamine from the tumor.
Patients in whom increased gastrointestinal motility might be dangerous, e.g. presence of gastrointestinal haemorrhage, mechanical obstruction or perforation.
Known hypersensitivity to metoclopramide. Note: patients sensitive to procaine and procainamide may be sensitive to metoclopramide.
Patients with porphyria.
Metoclopramide should not be used in patients with epilepsy since it may increase the frequency and severity of seizures.
Metoclopramide should not be administered to patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions may be increased.
Metoclopramide 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 metoclopramide, 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 extrapyramidal reactions; in the UK, use of metoclopramide is restricted in patients under 20 years. Patients on prolonged therapy should be reviewed regularly. Care should also be taken when metoclopramide is administered to patients with renal impairment, epilepsy, Parkinson's disease, or a history of depression.
Metoclopramide may cause drowsiness or impaired reactions; patients so affected should not drive or operate machinery.
Metoclopramide is a dopamine antagonist and may cause extrapyramidal 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 micrograms 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 diarrhea. 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 galactorrhea or related disorders. Transient increases in plasma-aldosterone concentrations have been reported.
Caution should be observed when using metoclopramide in patients taking other drugs that can also cause extrapyramidal reactions, such as the phenothiazines. Increased toxicity may occur if metoclopramide is used in patients receiving lithium, and caution is advisable with other centrally active drugs such as antiepileptics. Antimicrobics and opioid analgesics antagonize the gastrointestinal effects of metoclopramide.
The absorption of other drugs may be affected by metoclopramide; it may either diminish absorption from the stomach (as with digoxin) or enhance absorption from the small intestine (for example, with ciclosporin or paracetamol). It inhibits serum cholinesterase and may prolong neuromuscular blockade produced by suxamethonium and mivacurium. Metoclopramide may also increase prolactin blood concentrations and therefore interfere with drugs which have a hypoprolactinaemic effect such as bromocriptine. It has been suggested that it should not be given to patients receiving MAOIs.
Store at temperature not exceeding 30°C, protect from light.
A03FA01 - metoclopramide ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Metoclosil soln for inj 5 mg/mL
2 mL x 10 × 1's