Domperidone is a selective peripheral dopamine D2 receptor antagonist that principally blocks the dopamine receptors located in the Chemoreceptor Trigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of gastro-intestinal tract. Due to its weak penetration across the blood-brain-barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastro-intestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis, and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
Each film coated tablet contains Domperidone Maleate BP equivalent to 10 mg Domperidone.
Domperidone should be taken 15-30 minutes before a meal. The recommended oral dose for Adults: 10-20 mg every 4-8 hours daily. Maximum dose of Domperidone is 80 mg daily. Children: 0.2-0.4 mg/kg body weight every 4-8 hours daily. For acute vomiting and nausea, maximum period of treatment is 12 weeks. Use in children is restricted to nausea and vomiting following cytotoxics or radiotherapy.
Domperidone may produce hyperprolactinemia (1.3% frequency). This may result in galactorrhea, breast enlargement and soreness, and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. Domperidone should not be used whenever gastro intestinal stimulation might be dangerous, like in the case of gastro-intestinal hemorrhage, mechanical obstruction or perforation. It is also contraindicated in patients with prolactin-releasing pituitary tumor (prolactinoma).
Pregnant women: The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated teratogenic effects on the fetus. Lactating mother: Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Domperidone may reduce the hypoprolactinemic effect of Bromocriptine. Anti muscarinics and opioid analgesics may antagonize the action of Domperidone on GI function. Care should be taken when Domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
There is no reported case of overdosage.
Store in cool and dry place, protect from light and moisture. Keep out of reach of children.
Efodio™ 10 mg Tablet: Each box contains 100 film coated tablets (10 x 10’s) in Alu-PVC blister strips.