Each 5 mL suspension contains: Domperidone BP 5 mg.
Pharmacology: Pharmacodynamics: Domperidone is a dopamine receptor (D2) antagonist. Domperidone is a selective peripheral dopamine antagonist at the D2 dopamine receptor in the Chemo-receptor Trigger Zone (CTZ) and stomach. Domperidone does not readily enter the central nervous system (the chemoreceptor trigger zone is considered to lie outside the blood-brain barrier). Domperidone increases spontaneous gastric activity and antagonizes dopamine inhibition of gastric emptying. Domperidone has been shown to increase lower esophageal sphincter pressure and promotes esophageal and antral peristalsis and also increases pyloric dilatation. Domperidone increases the frequency, amplitude, and duration of duodenal contraction and reduces the small bowel transit time. Domperidone has no acetylcholine-like effect.
Pharmacokinetics: Absorption: Domperidone is rapidly absorbed after oral administration occurring at approximately 1hr after dosing. Domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take Domperidone 15-30 minutes before meal as reduced gastric acidity impairs absorption of Domperidone.
Distribution: Domperidone is bound to plasma proteins.
Metabolism: Domperidone goes through rapid and extensive hepatic metabolism by hydroxylation and N dealkylation. In vitro metabolism experiments revealed that CYP3A4, a major form of cytochrome P-450, is involved in N-dealkylation while CYP3A4, CYP1A2 and CYP2E1 is involved in aromatic hydroxylation.
Excretion: Domperidone is eliminated in the urine and fecal excretions 7-9 hours after oral administration.
Domperidone is used as an antiemetic for the short-term treatment of nausea and vomiting of various aetiologies. It is also used for its prokinetic actions in dyspepsia and has been tried in diabetic gastroparesis.
Domperidone should be taken 15-30 minutes before a meal. The usual recommended oral dose is as follows: Tablet/Suspension: For Nausea and vomiting: Adult: 10-20 mg (1-2 tablet or 10-20 mL suspension) every 6-8 hours.
Elderly: 10-20 mg (1-2 tablet or 10-20 mL suspension) every 6-8 hours.
Children: 0.2-0.4 mg/kg body weight (2-4 mL suspension) every 6-8 hours.
For symptomatic management of non-ulcer dyspepsia: 10 mg taken up to 4 times daily.
OR AS DIRECTED BY THE PHYSICIAN.
Symptoms of over dosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions. Treatment there is no specific antidote to domperidone, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal, may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Close medical supervision and supportive therapy is recommended. Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. Domperidone should not be used when gastrointestinal stimulation might be dangerous i.e. gastrointestinal hemorrhage, obstruction, perforation or immediately after surgery.
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.
The safety of Domperidone has not been proven and it is, therefore, not recommended during pregnancy. Animal studies have not demonstrated teratogenic effect on the fetus. Domperidone may precipitate galactorrhea and improve postnatal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Domperidone is not recommended for chronic use or for the routine prophylaxis of postoperative nausea and vomiting.
The safety of Domperidone has not been proven and it is, therefore, not recommended during pregnancy. Animal studies have not demonstrated teratogenic effect on the fetus. Domperidone may precipitate galactorrhea and improve postnatal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Extrapyramidal reactions are seen in 0.05% of patients in clinical studies. Domperidone may produce hyperprolactinemia (1.3%). This may result in galactorrhea, breast enlargement, soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itch (0.1%) may all follow treatment with Domperidone. (See table.)
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Domperidone may reduce the risk of hypoprolactinemic effect of bromocriptine. The action of Domperidone on GI function may be antagonized by antimuscarinics and opioid analgesics.
Special Precautions for Handling and Disposal: In a gentle tilting motion, mix the contents of the bottle to avoid the formation of foam.
Any unused medicine should be disposed properly. Consult a pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.
Store at temperatures not exceeding 30°C.
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Donasea susp 5 mg/5 mL
60 mL x 1's
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