Motinorm composition :
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
Motinorm indications :
1 – The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagitis:
– Epigastric sense of fullness, wly satiety, feeling of abdominal distension, upper abdominal pain;
– Bloating, eructation, flatulence:
– Nausea and vomiting:
– Heartburn with or without regurgitations of gastric contents in the mouth.
2 – 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.
Motinorm dosage and administration :
1 – Chronic dyspepsia (mainly oral administration)
– Adults: 10 mg (1 tablet or 10 ml 3 times daily, 15-30 minutes before meals.
– Children: 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.
2. Acute and subacute conditions (particularly nausea and vomiting)
Oral: 20 mg (2 tablets. 2 sachets or 20 ml 3-4 times daily before meals and before bedtime;
Rectal: 2 to 4 suppositories “adults” ( 60mg) daily.
Oral: 5 ml per 10 kg body weight. 3-4 times daily before meals and before bedtime.
– Up to 2 years: 1 suppository “babies” (10 mg) 2-4 times daily
– 2-4 years: I suppository “children” (30 mg) twice daily
– 4-6 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 some what 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. The suppositories should preferably be inserted into an empty rectum. They should be inserted with the blunt end first as the form of the suppository is functionally determined: the anal sphincter will exert an inward pressure on the conical point of the suppository.
Motinorm contra-indications :
It is contraindicated in patients with known intolerance to the drug. It should not be used whenever stimulation of gastric motility might be dangerous. e.g. in the presence of qastro- intestinal haemorrhage, mechanical obstruction or perforation. Motinorm is also contraindicated in patients with a prolactin-releasing pituitary tumour (prolactinoma).
Motinorm special warnings and precautions :
It 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, ie. 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 year of age.
Use in fiver disorders:
Since domperidone is highly metabolised in the liver, it 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) 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.
Generally, patients on prolonged therapy should be reviewed regularly.
Motinorm pregnancy and lactation:
Domperidone: given to animals at doses up to 160 mg/kg/day did not produce teratogenic effects. However, as most medicines. It 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 (mostly as metabolitcs: peak concentration of 40 and 800 mg/ml after oral and i.v administration of 2.5 mg/kg respectively. In women, domperidone concentrations in breast milk are 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 who are taking it, unless the expected benefits outweigh any potential risk.
Effects on ability to drive and use machines :
Motinorm does not affect the mental alertness.
Motinorm adverse effects:
Side effects are rare: 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 gatactorrhoea and gynaecomastia. When the blood-brain barrier is immature (as in infants) or impaired, the possible occurrence of neurological side effects cannot be excluded. Rare allergic reactions, such as rash and urticaria, have also been reported.
Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions, especially in children.
In case of overdosaqe. the administration of activated charcoal, and close observation of the patient are recommended.
Motinorm pharmacokinetic properties :
In fasting subjects, domperidone is rapidly absorbed after oral administration, with peak plasma concentrations at approximatels 1 hour. The low absolute bioavailability of oral dompendone (approximately 15Gb) is due to an extensive first- pass metabolism in the gut wall and liver. Although dompendone’s bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15-30 minutes before a meal. Reduced gastric acidity impairs the absorption cf domperidone. Oral bioavailability is decreased by prior administration of sodium bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased when the oral drug is taken after a meal. Oral domperidone does not appear to accumulate or to induce its own metabolism; a peak plasma level after 90 minutes of 21 ng/ml after two weeks oral administration of 30 mg per day was almost the same as that of 18 ng/ml after the first dose. Domperidone is 91-93% bound to plasma proteins. Distribution studies with radiolabelled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of drug cross the placenta in rats. Domperidone concentrations in breast milk of lactating women are 4 times lower than corresponding plasma concentrations, Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors reveated that CYP 3A4 is a major form of cytochrome P-450 involved in the N-dealkytation of domperidone, whereas CYPJA4, CYP1A2 and CYP2El are involvtd in domperidone aromatic hydroxylation.
Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively. The proportion of the drug excreted unchanged is small. The plasma half-life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with renal insufficiency.
Motinorm pharmaceutical precautions :
Motinorm suppositories should be stored below 25 C in a dry place.
Motinorm tablets & suspensions should be stored between 15 to 30 C.
Keep out of the reach of children.
Tablets: Strips of 10 tablets in packs of 1 or z or a strips.
Suspension: Bottles of 125 ml (1 mgl ml)
Suppositories: Packs of 5 suppositories (10 mg, 30 mg or 60 mg)
Keep all medicaments out of the reach of Children