Generic

Domperidone Maleate

Indications

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.

Pharmacology

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.

Dosage & Administration

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, the maximum period of treatment is 12 weeks. It should be taken 15-30 minutes before a meal.

Interactions

The action of Domilin 10 mg on gastrointestinal function may be antagonized by antimuscarinics and opioid analgesics. Care should be exercised when Domilin 10 mg is administered in combination with MAO (monoamine oxidase) inhibitors.

Contraindications

It is contraindicated in patients with known hypersensitivity to Domilin 10 mg or any components of the preparation. Domperidone should not be used whenever gastro-intestinal stimulation might be dangerous (i.e., gastrointestinal hemorrhage, mechanical obstruction, or perforation). It is also contraindicated in prolactinoma.

Side-Effects

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.

Pregnancy & Lactation

The safety of use of Domilin 10 mg has not been proven during 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

Precautions & Warnings

It should be used with absolute caution in the case of children because there may be an increased risk of extrapyramidal reactions. Since Domilin 10 mg is highly metabolized in the liver, it should be used with caution in patients with hepatic impairment.

Therapeutic Class

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

Storage Conditions

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

Pharmaceutical Name

General Pharmaceuticals Ltd.