Therapeutic Group: Gastrointestinal Disorder
Makdom® 10 mg
Tablet: Each film-coated tablet contains Domperidone Maleate BP equivalent to
Domperidone 10 mg.
Domperidone is
a selective peripheral dopamine D2 receptor antagonist that principally blocks
the dopamine receptors located in the Chemoreceptor Trigger Zone (CTZ) and
stomach. Its gastroprokinetic action is based on its blocking effect of
dopamine receptors that have an influence on the motility of gastro-intestinal
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 gastro-intestinal 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.
1. Stimulation
of gut motility in Dyspeptic symptom complex
■
Non-ulcer dyspepsia
■
Delayed gastric emptying, gastro-esophageal reflux, reflux esophagitis &
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 & anti-parkinsonism therapy.
3. In the treatment of migraine.
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.
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.
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.
Domperidone may
reduce the hypoprolactinemic effect of Bromocriptine. Anti-muscarinics and
opioid analgesics may antagonize the action of Domperidone on GI function. Care
should be taken when Domperidone is administered in combination with MAO
(Monoamine oxidase) inhibitors.
There is no
reported case of overdosage.
Store in cool
& dry place below 30º C. Protect from light.
Makdom® 10 mg
Tablet: Each box contains 5X10‘s film-coated tablets in Alu-PVC blister strips.