Treatment of dyspepsia (ie, nausea, vomiting, anorexia, abdominal fullness, upper abdominal discomfort and pain, heartburn, belching) caused by the following diseases and drugs: Adults: Chronic gastritis, gastric ptosis, reflux esophagitis, gastrectomy syndrome, use of anti-malignant tumor drugs or levodopa.
Children: Periodic vomiting, use of anti-malignant tumor drugs.
Adults: 1-2 tab (½-1 tab in patients receiving levodopa) 3 times a day, before meals.
Children: 1-2 mg/kg/day in 3 divided doses, before meals. Total Daily Dose: Should not exceed 30 mg. The dosage may be increased or decreased according to the age of patients and severity of symptoms.
Overdosage may produce drowsiness and disorientation or extrapyramidal reactions especially in children. Anticholinergic agents, antiparkinsonian agents or anticholinergic antihistamines can be used to control extrapyramidal reactions. There is no specific antidote to domperidone but in the case of overdosage, gastric lavage may be useful. These symptoms may disappear within 24 hrs.
Patients with intolerance to Dompel.
Domperidone should not be used whenever gastrointestinal stimulation might be dangerous eg, gastrointestinal hemorrhage, mechanical obstruction or perforation.
Patients with prolactin adenoma.
General Precautions: As domperidone is mainly metabolized in the liver, it should be administered cautiously in patients with liver injury.
In patients with severe renal impairment (serum creatinine 6 mg/100 mL). The elimination t½ is prolonged from 7.4 hrs to 20.8 hrs, but the plasma concentration of domperidone is lower than that in healthy volunteers. As very small proportion of domperidone is excreted in the urine as unchanged drug, it is unnecessary to control the dosage in the first administration. But in repeated administration, frequency of dosing and dosage should be decreased according to the severity of renal impairment. The condition of patients receiving decreased long-term therapy should be monitored regularly.
Use in pregnancy & lactation: Although studies in animals, with the dosage of 160 mg/kg/day and general clinical use of domperidone in human have not demonstrated teratogenic effects, Dompel should be used in pregnant women and suspected pregnant women only if the potential benefit justifies the potential risk.
It is reported that domperidone is secreted in milk mainly as metabolites in animal studies (rat): Following oral and IV administration of 2.5-mg/kg dose, maximum concentrations in the breast milk were 40 mcg/mL and 800 mcg/mL, respectively. A small proportion of Dompel can be excreted in human milk, but harm to neonates has not been reported. Therefore, Dompel should be used in nursing mothers only if the potential benefit justifies the potential risk.
Use in children: Care should be exercised when Dompel is used in children especially in infants <1 year. Repeated use over 7 days is not recommended in children <3 years.
As Dompel does not readily cross the blood-brain barrier, it does not produce the adverse central effects. However, adverse central effects may occur in infants <1 year with premature blood-brain barrier.
Although studies in animals, with the dosage of 160 mg/kg/day and general clinical use of domperidone in human have not demonstrated teratogenic effects, Dompel should be used in pregnant women and suspected pregnant women only if the potential benefit justifies the potential risk.
It is reported that domperidone is secreted in milk mainly as metabolites in animal studies (rat): Following oral and IV administration of 2.5-mg/kg dose, maximum concentrations in the breast milk were 40 mcg/mL and 800 mcg/mL, respectively. A small proportion of Dompel can be excreted in human milk, but harm to neonates has not been reported. Therefore, Dompel should be used in nursing mothers only if the potential benefit justifies the potential risk.
Endocrinological: Stimulation of mammary gland and delay sexual cycle, which are supposed to be derived from abnormal control of endocrine function of diencephalon in animal study, elevated serum prolactin, gynecomastia, breast enlargement, galactorrhea, in man may occur thus monitored carefully. When abnormality appears, discontinue therapy.
Extrapyramidal: Acute extrapyramidal dystonic reactions including rare instances of oculogyric crises have been reported. Should treatment of dystonic reactions be necessary, domperidone should be withdrawn and an anticholinergic antiparkinsonian drug should be used.
Gastrointestinal: Occasionally diarrhea, constipation, abdominal pain, rarely dry mount, heartburn, nausea, vomiting, abdominal fullness, borborygmi, transient enterospasm may occur.
Cardiovascular: Rarely palpitation may occur.
Skin: Allergic reactions eg, urticaria and eruption may occur.
Adverse central effects may occur if administered in patients with premature or impaired blood-brain barrier.
Miscellaneous: Rarely sweating, drowsiness and mount may occur.
The concomitant administration of domperidone with phenothiazines, butyrophenones and rauwolfia alkaloids may induce the endocrine disturbances or extrapyramidal disorders. If necessary, monitored carefully and administered cautiously.
Should be administered cautiously in patients receiving digitalis preparations.
The concomitant administration of domperidone with anticholinergic agents may compromise the beneficial effects of domperidone because of depressing the promoting action of gastrointestinal motility.
Theologically, domperidone may have an effect on the absorption of oral preparations, especially slow-releasing or enteric-coated preparations because of increasing gastric motility. But in patients stabilized with digoxin or acetaminophen, the concomitant administration of domperidone had no effect on plasma concentration of these drugs.
It is not reported that domperidone enhances the effect of neuroleptics.
Domperidone inhibits peripheral adverse reactions eg, dyspepsia, nausea, vomiting, induced by dopamine agonist (eg, bromocriptine, levodopa), but has no effect on central nervous system.
As the concomitant administration of domperidone with antacids or acid secretion inhibitors lowers biologic activity of domperidone, these drugs should not be used together.
The actions of domperidone on gastrointestinal function may be antagonised by antimuscarinics and opioid analgesics.
Store in a light-resistant, well-closed container at room temperature.
Shelf-Life: 3 years.
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Dompel tab 10 mg
50 × 10's
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