Drug Interaction:
Reduces absorption of oral digoxin (solid dose). Increases absorption of aspirin, paracetamol and oral diazepam.
Effects antogonised by anticholinergic agents.
Enhances CNS depression by phenothiazine.
Antimuscarinic agents and opioids, antagonise G.I.effects.
Indication:
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Domperidone 10mg+ 22-11-2005
Activated dimethicone 125mg chewable
For Dyspepsia, Colicy pain and GERD
Acute nausea and vomiting.
Adverse Reaction:
Seen only on I.V.administration.
Dsyarryhthmaias and death in patients with CVS disease or hypokalaemias and patients on cancer chemotherapy.
Seizures,hypotensive crisis in patients with pheochromocytoma.
Drowsiness and extrapyrimidal reactions (lower incidence than metaclopromide), galactrorrhoea, gynaecomastia,
Constipation or diarrhoea, drowsiness, lassitude, skin and itch.
Contra-Indications:
Hypersensitivity, pregnancy,
GI haemorrhage, obstruction and perforation,or after surgery.
Special Precautions:
Pheochromocytoma,children,elderly,renal/hepatic impairment, cardiac arrhythmias and hypokalaemia.
Dosages/ Overdosage Etc:
New drug application (NDA)in 1985
Indications:
Acute nausea and vomiting. Dosage: 20 to 40mg 3 to 4 times a day.
Children - 0.3mg/kg 3 to 4 times a day.
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Pharmacology/ Pharmacokinetics:
Pharmacology:
Domperidone is chemically unrelated to the butyrophenones,phenothiazines or metoclopramide. Hoever, it shares pharmacolgical activity with these agents. Dompridone is a pheriphral dopamine antagonist, however it does not produce CNS effects. It selectively blocks peripheral dopamine receptors in the gastrointestinal wall, thus enhancing normal syncronized GI peristalsis effect.
Pharmacokinetics:
Peak plasma levels are reached within 30 minutes following IM or oral administration and between 1 to 4 hours after rectal administration. Metabolism: It is metabolised in the liver and eliminated in the urine,primarily in conjugates. Less than 1% appears in urine as unchanged drug.Excretion is complete in 4 days.
Interaction with Food:
Delayed absorption but higher bioavailabilty due to reduced first pass metabolism in gut wall.
Pregnancy and lactation:
Use during pregnancy contraindicated. Observe caution