Domne

Domne

domperidone

Manufacturer:

Raptakos Brett

Distributor:

Raptakos Brett
Full Prescribing Info
Contents
Domperidone.
Description
Each 1 mL contains: Domperidone 1 mg.
Action
Pharmacology: Domperidone is a dopamine-receptor blocking agent. Its action on the dopamine receptors in the chemoreceptor trigger zone (CTZ) produces anti-emetic effect.
Domperidone is chemically unrelated to the butyrophenones, phenothiazines, or metoclopramide. However, it shares pharmacological properties with these agents. In the medulla, it produces a direct blocking effect of dopamine receptors in the CTZ like metoclopramide and haloperidol, domperidone is a peripheral dopamine antagonist; however it contrasts in that it does not cross the blood-brain barrier and produce CNS effects. It selectively blocks dopamine receptors in the GI wall, thus enhancing normal synchronized GI peristalsis and motility in the proximal portion of the GI tract. It may also counteract anticholinergic-induced relaxation of the lower esophageal sphincter (LES).
Domperidone does not alter gastric secretions and has no effect on the intracranial pressure or on the cardiovascular system.
Domperidone has been shown to increase the duration of antral and duodenal contractions to increase gastric emptying.
Pharmacokinetics: Domperidone is rapidly absorbed after oral administration, but the absolute bioavailability is low (about 15%) due to first-pass hepatic and intestinal metabolism. Peak plasma level with immediate release formulation are achieved within 30 minutes following oral administration. Domperidone is 91-93% bound to plasma proteins. The plasma half-life after a single oral dose of an immediate release formulation is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency. Approximately 40% of a dose is rapidly distributed into peripheral compartments. Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. Domperidone is eliminated in the urine, primarily as conjugates, and in feces. Less than 1% appears in the urine as unchanged drug. Excretion is almost complete within 4 days.
Indications/Uses
Domperidone is used as an anti-emetic for short-term treatment of nausea and vomiting of various etiologies, including such associated with cancer therapy and nausea and vomiting associated by levodopa or bromocriptine therapy for Parkinsonism. Domperidone is also used for its prokinetic action for dyspepsia and has been tried in diabetic gastroparesis.
Dosage/Direction for Use
Chronic indigestion: Adults: 10 ml thrice daily, 15-30 minutes before meals. If needed, 10 ml can be taken before bedtime.
Children: 2.5 ml/10 kg body weight before meals. If needed, 2.5 ml can be taken before bedtime.
Nausea or vomiting: Adults: 20 ml thrice daily, 15-30 minutes before meals. If needed, 10 ml can be taken before bedtime.
Children over 5 years of age: 5 ml/10 kg body weight before meals. If needed, 2.5 ml can be taken before bedtime.
Children under 5 years of age: as directed by the physician.
Overdosage
Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions especially in children.
Treatment: Anticholinergic, anti-parkinson medicines or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. There is no specific antidote to Domperidone but in the event of overdosage, gastric lavage as well as the administration of activated charcoal may be useful. Symptomatic and supportive measures are recommended.
Contraindications
Known sensitivity to any ingredients of the products. Domperidone should not be used whenever stimulation of gastric motility is to be avoided or could be harmful; e.g. gastrointestinal hemorrhage, obstruction or perforation, epilepsy, pheochromocytoma, and extrapyramidal symptoms.
Special Precautions
Domperidone is not recommended for chronic administration or for the routine prophylaxis of post operative nausea and vomiting. The safety of use during pregnancy and lactation has not been established.
Since domperidone is highly metabolised in the liver, Domperidone should be used with caution in patients with hepatic impairment and in the elderly.
Domperidone on should be used with caution in patients with renal impairment or in those at risk of fluid retention. In patients with severe renal insufficiency (serum creatinine more than 6 mg/100 mL or 0.6 mmol/L) the elimination half-life of domperidone may be increased. Patients on prolonged therapy should be reviewed regularly.
Use In Pregnancy & Lactation
Contraindicated to pregnant women. Use with caution in lactating women
Side Effects
Rarely, Domperidone causes central anti-dopaminergic effects such as sedation, extrapyramidal dystonic reactions, parkinsonism, and tardive dyskinesia. They are usually seen in the young and elderly and may be treated with the anti-parkinsonian drugs.
Allergic reactions such as rash or urticaria have been reported.
Abdominal cramps have been reported as well.
Reversible raised serum prolactin levels have been observed.
In neonates (mainly young babies) where blood-brain barrier is not fully developed or is impaired, the possible occurrence of neurological side-effect cannot be totally excluded.
Drug Interactions
Domperidone may reduce the hypoprolactinaemic effect of bromocriptine.
Concomitant administration of anti-cholinergic drugs may inhibit the anti-dyspeptic effects of Domperidone. Anti-muscarinic agents and opioid analgesics may antagonise the effect of Domperidone.
Domperidone suppresses the peripheral effects (digestive disorders, nausea and vomiting) of dopaminergic agonists.
Since Domperidone has gastro-kinetic effects, it could influence the absorption of concomitantly orally administered medicines, particularly those with sustained release or enteric-coated formulations.
As Domperidone interferes with serum prolactin levels, it may interfere with other hypoprolactinaemic agents and with some diagnostic tests.
Antacids and anti-secretory agents lower the oral bioavailability of domperidone. They should be taken after meals and not before meals, i.e. they should not be taken simultaneously with Domperidone. Reduced gastric acidity impairs the absorption of Domperidone.
Oral bioavailability is decreased by prior administration of cimetidine or sodium carbonate.
Storage
Store at temperature not exceeding 30°C. Protect from light.
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Oral susp 1 mg/mL x 30 mL x 1's.
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