- Tablets:Each tablet contains 10 mg domperidone.
- Suspension: Each 1 ml contains 1 mg domperidone.
- Adult suppositories: Each suppository contains 60 mg domperidone.
- Children suppositories:Each suppository contains 30 mg domperidone.
- Infant suppositories: Each suppository contains 10 mg domperidone.
The dyspeptic symptom comptex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagitis:
- epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain.
- bloating, eructation, flatulence.
- nausea and vomiting.
- heartburn with or without regurgitation of gastric contents in the mouth.
Nausea and vomiting of functional, organic, infectious or dietetic origin or induced by radiotherapy or drug therapy. A specific indication is nausea and vomiting induced by dopamine agonists, as used in Parkinson’s disease (such as L- dopa and bromocriptine).
DOSAGE AND ADMINISTRATION
Chronic dyspepsia (mainly oral administration)
- Chronic dyspepsia- Adults dosage: 10 mg( 1 tablet or 10 ml) 3 times daily, 15 to 30 minutes before meals and it necessary, once more before retiring.
- Chronic dyspepsia- Children dosage: Oral suspension: 2.5 ml per 10 kg body weight, 3 times daily before meals and, if necessary, once more in the evening.
When results are not satisfactory. the above dosage may be doubled in adults and children over 1 year of age.
Acute and subacute conditions(particularly nausea and vomiting)
- Acute and subacute conditions (particularly nausea and vomiting)- Adults dosage: 20 mg (2 tablets or 20 ml) 3 to 4 times daily before meals and before bedtime. Rectal: 2 to 4 suppositories “ adults”(= 60 mg) daily.
- Acute and subacute conditions (particularly nausea and vomiting)- children dosage: 5 ml per 10 kg body weight, 3 to 4 times daily before meals and before bedtime.
Acute and subacute conditions- children Rectal dosage
- Up to 2 years: 1 suppository ”babies”( 10 mg) 2 to 4 times daily.
- 2 to 4 years: 1 suppository “children”(30 mg) twice daily.
- 4 to 6 years: 1 suppository “children”(30 mg) 3 times daily.
- Older than 6 years: 1 suppository “children” (30 mg) 4 times daily.
- Oral Motinorm is recommended to be taken before meals. If taken after meals, absorption of the drug is somewhat delayed.
- The tablets are not intended to be administered to children below the age of 5 years.
- In patients with renal insufficiency, the dosing frequency should be reduced.
- suppositories should be inserted into an empty rectum. They should be inserted with the blunt end first as the form of the suppositoy is functionally determined; the anal sphincter will exert an inward pressure on the conical point of the suppository.
- Motinorm is contraindicated patients with known intolerance to the drug.
- Motinorm Should not be used whenever stimulation of gastric motility might be dangerous, e.g. in the presence of gastro-intestinal hemorrhage, mechanical obstruction or perforation.
- Motinorm is also contraindicated in patients with a prolactin-releasing pituitary tumour(Prorlactinoma).
SPECIAL WARNINGS AND PRECAUTIONS
Motinorm is not recommended for chronic use for the routine prophylaxis of postoperative nausea and vomiting.
When antacids or antisecretory agents are used Concomitantly, they should be taken after meals and not before meals, i.e. they should not be taken simultaneously with Motinorm.
Use in infants
- Because the metabolic and blood brain barrier functions are not fully developed during the first months of life, any drug should only be given to infants with great caution and under close medical supervision.
- Since the typical absence of neurological side effects with Motinorm is mainly due to its poor penetration through the blood- brain barrier, the possible occurrence of such effects cannot be totally excluded in infants under 1 years of age.
Use in liver disorders
Since domperidone is highly metabolised in the liver, Motinorm should be used with caution in patients with hepatic impairment.
Use in kidney disorders
In patients with severe renal insufficiency (serum creatinine 6 mg/ 100 ml, i.e. 0.6 mmol/L) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.
Since very little unchanged drug is excreted via the kidneys, it is unlikely that the dose of a single acute administration needs to be adjusted in patients with renal insufficiency.
However, on repeated administration, the dosing frequency should be reduced to once or twice daily, depending on the severity of the impairment, and the dose may need to be reduced. Generally, patients on prolonged therapy should be reviewed regularly.
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
- As with other Dopamine antagonists, there is theoretical potential that Motinorm may antagonise the hyperprolactinemic effect of drugs such as bromocriptine. In addition, the prokinetic effects of domperidone may alter the absorption of drugs.
- Opioid analgesics and antimuscarinics may antagonise the prokinetic effects of domperidone.
- Antacids and antisecretory drugs should not be given simultaneously with Motinorm as they lower its oral bioavailability.
Patient information leaflet
Category: ALIMENTARY TRACT AND METABOLISM.
Tags: DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS, PROPULSIVES, domperidone, ATC code: A03FA03.