| a) Generic Name |
Domperidone Maleate
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| b) Trade/Brand Name |
To be submitted at the time of inclusion.
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| 04. Product Data Sheet : |
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| a) Presentation |
Film Coated Tablet.
Each tablet contains Domperidone Maleate equivalent to Domperidone 10 mg.
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| b) Indications |
Stimulation of gut mobility: Non-ulcer dyspepsia, esophageal reflux, reflux esophagitis and gastritis, diabetic gastric stasis, speeding barium transit in follow through radiological studies. Prevention and symptomatic relief of acute nausea and vomiting from any cause but specifically cytotoxic therapy, radio therapy and anti-parkinsonism therapy. Functional dyspepsia.
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| c) Dosage & administration |
Adults: 10 to 20 mg every 4-8 hours daily. Children: 0.2- 0.4 mg/kg body weight every 4-8 hours daily. Domperidone should be taken 15-30 minutes before a meal. For acute nausea and vomiting, maximum period of treatment is 12 weeks.
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| d) Contraindications |
Domperidone is contraindicated to patients who have known hypersensitivity to this drug and in case of neonates.
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| e) Side Effects |
Domperidone may produce hyperprolactinemia. This may result in galactorrhoea, breast enlargement and soreness and reduced libido. Dry mouth, thirst headache, nervousness, drowsiness, diarrhoea, skin rash and itching, may occur during treatment with domperidone. Extrapyramidal reactions are seen in 0.05% of patients in clinical studies.
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| f) Warnings & Precautions |
Domperidone should be used with absolute caution in case of children because there may be an increased risk of extrapyramidal reactions in young children because of an incompletely developed blood brain barrier.
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| g) Drug Interactions |
Domperidone may reduce the hypoprolactinemic effect of bromocriptine. The action of domperidone of GI function may be antagonized by antimuscarinics and opioid analgesics.
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| h) Use in Pregnancy & Lactation |
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 foetus.
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| i) Package Quantity |
To be submitted at the time of inclusion.
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