Dysnov Syrup 100ml

Product Information

DYSNOV

Dysnov®(domperidone)

Presentation

Dysnov tablet: White, shield shaped, film coated, scored tablet, having engraved on one side; each tablet contains Domperidone

Maleate BP equivalent to Domperidone 10mg.

Dysnov suspension: White, lemon-lime flavored, sugar free suspension; each 5ml suspension contains Domperidone BP 5mg.

Dysnov paediatric drops: White, lemon-orange flavored, sugar free drops; each 1ml drops contains Domperidone BP 5mg.

Indications:

1. The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastrooesophageal  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 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 (such as L-dopa and

bromocriptine).

Dosage and administration

1. Chronic dyspepsia

Adults: 10mg (1 tablet or 10ml suspension) 3 times daily, 15-30 minutes before meals and, if necessary, once more before retiring.

Children: 2.5mg (2.5ml suspension or 0.5ml drops) per 10kg 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)

Adults: 20mg (2 tablets or 20ml suspension) 3-4 times daily before meals and before bedtime.

Children: 5mg (5ml suspension or 1ml drops) per 10kg body weight, 3-4 times daily before meals and before bedtime.

Remarks: Domperidone 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.

Contra-indications, warnings, etc.

Contra-indications: Domperidone is contra-indicated in patients with known intolerance to the drug. Domperidone should not be used

whenever stimulation of gastric motility might be dangerous, e.g. in the presence of gastro-intestinal haemorrhage, mechanical

obstruction or perforation. Domperidone is also contra-indicated in patients with a prolactin-releasing pituitary tumour

(prolactinoma). Special warnings and precautions: When antacids or antisecretory agents are used concomitantly, they should

betaken after meals and not before meals, i.e. they should not be taken simultaneously with domperidone.

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 domperidone 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 liver disorders: Since

domperidone is highly metabolised in the liver, domperidone should be used with caution in patients with hepatic impairment. Use

in kidney disorders: In patients with severe renal insufficiency (serum creatinine > 6mg/100ml, i.e. > O.6mmol/I) the

elimination half-life of domperidone as 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.

Drug interactions and other forms of interaction: Concomitant administration of anticholinergic drugs may antagonise the

antidyspeptic effect of domperidone: Antacids and antisecretory drugs should not be given simultaneously with domperidone as they

lower its oral bioavailability. The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that

the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. Examples

of CYP3A4 inhibitors include: azole antifungals, macrolide antibiotics. HIV protease inhibitors, nefazodone, etc. Theoretically,

since domperidone has gastro-kinetic effects it could influence the absorption of concomitantly orally administered drugs,

particularly 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.

– neuroleptics, the action of which it does not potentiate,

– dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects such as

digestive disorders, nausea and vomiting it suppresses without counteracting their central

properties.

Use in pregnancy and lactation: Domperidone given to animals at doses up to 160 mg/kg/day did not produce teratogenic effects.

However, as most medicines, domperidone 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 who are taking domperidone, unless the expected benefits outweigh any potential risk. Effects on ability to drive and

use machines: Domperidone does not affect the mental alertness.

Side-effects: 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, domperidone may induce an increase in the

plasma prolactin level. In rare case this hyperprolactinaemia may give rise to neuroendocrinological 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.

Overdose: Symptoms: Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions, especially in

children. Treatment: In case of overdosage, the administration of activated charcoal, and close observation of the patients are

recommended. Anticholinergic, antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in

controlling the extrapyramidal reactions.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Dysnov tablet: Cartons containing 100 tablets in blister.

Dysnov suspension: Cartons containing 60ml and 100ml suspension in bottle.

Dysnov paediatric drops: Cartons containing 15ml drops in bottle with droper.