Class: Gastrointestinal System
Dosage Form: Tablets
Description: Gastroprokinetic and antiemetic
Manufacturer: GlaxoSmithKline (GSK)
Domperidone………………..5 mg/ 5 ml
The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-esophageal reflux and esophagitis:
- Epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain.
- Bloating, eructation, faltulence.
- Nausea and vomitting.
- Heartburn with or without regurgitations 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 vomitting induced by dopamine agonists, as used in Parkinson’s disease (such as L-dpoa and bromocriptine).
Motinorm is contraindicated in patients with known intolerance to the drug. It should not be used whenever stimulation of gastric motility might be dangerous, ex. in the presence of gastro-intestinal hemorrhage, mechanical obstruction or perforation.
Motinorm is also contraindicated in patients with a prolactin-releasing pituitary tumor (prolactinoma).
Concomitant administration of anticholinergic drugs may antagonize the anti-dyspeptic effect of Motinorm.
Antacids and antisecretory drugs should not be given simultaneously with Motinorm as they lower its oral bioavailability. Theoretically, since Motinorm has gastrokinetic effects it could influence the absorption of concomitantly orally adminstered drugs, particualry those with sustained release or enteric coated formulations. However, in patients already stabilised on digoxin or paracetamol, concomitant administration of domperidone did not influence the blood levels of these drugs.
Motinorm may also be associated with:
- Neuroleptics, the action of which it does not potentiate.
- Dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects such as digestive disorders, nausea and vomitting it suppresses withotu counteracting their central properties.
Side effects are rare; exceptionally some transient intestinal cramps have been reported.
Extrapyramidal phenomena are rare in young children and exceptional in adults; they reverse spontaneously and completely as soon as the treatment is stopped. As the pituitary gland is located outside the blood-brain barrier, Motinorm may induce an increase in the plasma prolactin level. In rare cases this hyperprolactinaemia may give rise to neuro-endocrinological phenomena such as galactorrhoea and gynaecomastia.
When the blood-brain barrier is immature (as in infants) or impaired, the possible occurrence of neurological side effects cannot be totally excluded. Rare allergic reactions, such as rash and urticaria, have also been reported.
Dosage and Administration:
Acute and Subacute Conditions: (Nausea & vomitting)
a) Adults rectal:
- 2 to 4 suppositories (10 mg) 2 – 4 times daily.
b) Children rectal:
- Up to 2 years: 1 suppository (10 mg) 2-4 times daily.
- 2-4 years: 1 suppository (30 mg ) twice daily.
- 4-6 years: 1 suppository (30 mg ) 2 times daily.
- Older than 6 years: 1 suppository (30 mg) 4 times daily.
Suppositories should preferably be inserted into an empty rectum. They should be inserted with the blunt end first as teh form of the suppository is functionally determined: the anal sphincter will exert an inward pressure on the conical point of the suppository.
Pregnancy and Lactation:
Domperidone given to animals at doses up to 160 mg/kg/day did not produce teratogenic effects.
However, as most medicines, Motinorm should only be used during the first trimester of pregnancy if this is justified by the anticipated therapeutic benefit.
Up to now, there has been no evidence of any increase in the risk of malformations in humans.
The drug is excreted in breast milk of lactating rats. In women, domperidone concentrations in breast milk is 4 times lower than corresponding plasma concentrations. It is not known whether this is harmful to the newborn. Therefore, nursing is not recommended for mothers wh are taking Motinorm, unless the expected benefits outweigh any potential risk.
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.
1. 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 year of age.
2. Use in Liver Disorders:
Since domperidone is highly metablised in the liver, Motinorm should be used with caution in paitents with hepatic impairment.
3. Use in Kidney Disorders:
In patients with severe renal insufficiency the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower then in healthy volunteers. Since very little unchanged drug is excreted via the kidneys, it is unlikely that the dose of a single acute administrations 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 prolongeed therapy should be reviewed regularly.
Bottle of 125 ml.
Pack of 3 strips of 10 tablets each.
Pack of 5 suppositories.
Store at room temperature, below 25°C.