FRETINUM
FRETINUM
Active ingredient: Domperidone (as domperidone maleate) 10 mg.
Dosage form: Film-coated tablet.
Packaging: Box of 10 blisters x 10 tablets.
Expiry date: 36 months.
FRETINUM should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
It is recommended to take oral FRETINUM before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. Do not take two doses to make up for one missed dose.
Usually, the maximum treatment duration should not exceed one week.
Adults and adolescents (12 years of age and older and weighing 35 kg or more)
One 10mg tablet up to three times per day with a maximum dose of 30 mg per day.
Hepatic Impairment
FRETINUM is contraindicated in moderate or severe hepatic impairment (see section CONTRAINDICATIONS). Dose modification in mild hepatic impairment is however not needed.
Renal Impairment
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of FRETINUM should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly (see sections SPECIAL WARNINGS AND PRECAUTIONS FOR USE and PHARMACOKINETIC PROPERTIES).
Paediatric population
The efficacy of domperidone in children less than 12 years of age has not been established (see section Pharmacodynamic properties).
The efficacy of domperidone in adolescents 12 years of age and older and weighing less than 35 kg has not been established
INDICATIONS
FRETINUM is indicated for the relief of the symptoms of vomiting and nausea.
CONTRAINDICATIONS
Domperidone is contraindicated in the following situations:
- Known hypersensitivity to domperidone or any of the excipients.
- Prolactin-releasing pituitary tumour (prolactinoma).
- When stimulation of the gastric motility could be harmful e.g in patients with gastro-intestinal haemorrhage, mechanical obstruction or perforation.
- In patients with moderate or severe hepatic impairment (see section Pharmacokinetic properties).
- In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
- Co-administration with QT-prolonging drugs (see sections SPECIAL WARNINGS AND PRECAUTIONS FOR USEand INTERACTIONS).
- Co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section INTERACTIONS).
