Generic

Domperidone

Therapeutic Class

Gastro-Intestinal Regulators, Anti-Emetic

Pack Size

Efodio 10 mg tablet: Each box contains 100 tablets (10 x 10’s) in Alu-PVC blister pack.

Indications

1. Stimulation of gut motility in Dyspeptic symptom complex; • Non-ulcer dyspepsia; • Delayed gastric emptying, gastro-esophageal reflux, reflux esophagitis, and gastritis; • Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain; • Eructation, flatulence, early satiety; • Nausea and vomiting; • Heartburn with or without regurgitations of gastric contents in the mouth; • Diabetic gastroparesis • Functional dyspepsia; • Speeding barium transit in ‘follow-through’ radiological studies; 2. Prevention and symptomatic relief of acute nausea and vomiting from any cause including cytotoxic therapy, radio therapy and anti-parkinsonism therapy. 3. In the treatment of migraine.

Therapeutic Class

Gastro-Intestinal Regulators, Anti-Emetic

Dosage & Administration

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.

Contraindications

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).

Side Effects

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.

Pregnancy & Lactation

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.

Precautions

Domperidone should be used with absolute caution in case of children because there may be increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since Domperidone is highly metabolized in liver, it should be used with caution in patients with hepatic impairment.

Storage Conditions

Store in cool and dry place, protect from light and moisture. Keep out of reach of children.