APULDON

DOMPERIDONE MALEATE

It is used in the following indications: Stimulation of gut motility in non-ulcer dyspepsia, gastro-esophageal reflux disease, reflux esophagitis, diabetic gastroparesis & functional dyspepsia. Speeding barium transit in 'follow through' radiological studies. Prevention and symptomatic relief of acute nausea and vomiting due to cytotoxic therapy, anti-parkinsonism therapy, radio therapy or migraine.

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

Domperidone is a dopamine receptor antagonist. It gives gastroprokinetic action by blocking dopamine receptors located in the chemoreceptor trigger zone (CTZ) and stomach. Due to its weak penetration across the blood-brain barrier, it has almost no effect on the dopaminergic receptors in the brain, therefore excluding psychotropic and neurologic side effects.

Adults: 10-20 mg every 4-8 hours daily. Children: 0.2-0.4 mg/kg every 4-8 hours daily. For acute nausea and vomiting, maximum period of treatment is 12 weeks. It should be taken 15-30 minutes before a meal.

The action of Domperidone on gastro-intestinal function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when Domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.

It is contraindicated in patients with known hypersensitivity to Domperidone or any components of the preparation. Domperidone should not be used whenever gastro-intestinal stimulation might be dangerous (i.e., gastro-intestinal hemorrhage, mechanical obstruction or perforation). It is also contraindicated in prolactinoma.

It may produce hyperprolactinemia (1.3%). This may result in galactorrhea, breast enlargement & 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.

The safety of use of Domperidone has not been proven duing pregnancy; it is therefore not recommended during pregnancy. Animal studies have not demonstrated teratogenic effects on the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk in very small quantities which is insufficient to be considered harmful.

It should be used with absolute caution in case of children because there may be increased risk of extra-pyramidal reactions. Since Domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.

Keep in a dry place away from light and heat. Keep out of the reach of children.