COMPOSITION
Gutset Tablet: Each tablet contains Domperidone Maleate BP equivalent to Domperidone BP 10 mg. Gutset Pediatric Drop: Each ml contains Domperidone BP 5 mg
Gutset Suspension: Each 5 ml suspension contains
Domperidone BP 5 mg.
PHARMACOLOGY
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal 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 gastrointestinal 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.
INDICATION
- Dyspeptic symptom complex often associated with
delayed gastric emptying, gastroesophageal reflux and esophagitis: epigastric sense ofullness, flatulence, nausea and vomiting, diabetic gastroparesis, non-ulcerdyspepsia.
- Acute nausea and vomiting of functional, organic, infectious, induced by radiotherapy or drug therapy.
- Parkinson’s disease: In dopamine-agonist induced nausea and vomiting.
DOSAGE AND ADMINISTRATION
The recommended oral dose for
Adults : 10 – 20 mg every 4 – 8 hours daily
Children: 0.2-0.4 mg/kg (2-4 ml) every 4 – 8 hours daily.
Note: Gutset tablet, suspension and pediatric drop should be taken 15-30 minutes before a meal. For acute nausea and vomiting, maximum period of treatment is 12 weeks.
CONTRAINDICATION
Gutset (Domperidone) is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. Gutset (Domperidone) should not be used whenever gastro-intestinal stimulation might be dangerous i.e., gastro-intestinal hemorrhage, mechanical obstruction or perforation.
PRECAUTION
Gutset (Domperidone) should be used with absolute caution in case of children. Since Gutset (Domperidone) is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
SIDE EFFECTS
Gutset (Domperidone) may produce hyperprolactinemia. This may result in breast enlargement, soreness and reduced libido. Dry mouth, thirst, headache, nervousness, drowsiness, diarrhea, skin rash and itching may occur during treatment with Gutset (Domperidone).
DRUG INTERACTION
Gutset (Domperidone) may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Gutset (Domperidone) on GI function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when Gutset (Domperidone) is administered in combination with MAO (monoamine oxidase) inhibitors.
USE IN PREGNANCY AND LACTATION
Pregnant woman: The safety of Gutset (Domperidone) has not been proven and it is therefore not recommended during pregnancy. Lactating mother: Gutset (Domperidone) may precipitate galactorrhea and improve postnatal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
STORAGE
Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of children.
PACKING
Gutset Tablet: Each box contains 10×10’s tablets in blister pack.
Gutset Pediatric Drop: Bottle containing 15 ml pediatric drop.
Gutset Suspension: Bottle containing 60 ml suspension
