Components:

Domperidone

Method of action:

Antiemetic,Drugs For Functional Gastrointestinal Disorders

Treatment option:

Pain,Heartburn,Flatulence,Belching,Oral Cavity,Burping,Reflux,Morning Sickness,Esophagitis

Qualitative and quantitative composition

The information provided in Qualitative and quantitative composition of Vardom-DT is based on data of another medicine with exactly the same composition as the Vardom-DT. . Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Vardom-DT directly from the package or from the pharmacist at the pharmacy.

more...

Domperidone

Therapeutic indications

The information provided in Therapeutic indications of Vardom-DT is based on data of another medicine with exactly the same composition as the Vardom-DT. . Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Vardom-DT directly from the package or from the pharmacist at the pharmacy.

more...

Vardom-DT Suspension is indicated in adults and children for the relief of the symptoms of nausea and vomiting.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Vardom-DT is based on data of another medicine with exactly the same composition as the Vardom-DT. . Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Vardom-DT directly from the package or from the pharmacist at the pharmacy.

more...

Vardom-DT Oral Suspension should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.

It is recommended to take Vardom-DT Oral Suspension 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. The dose should not be doubled to make up for a 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).

10 ml (of 1mg/ml oral suspension) up to three times per day with a maximum dose of 30ml per day.

Neonates, infants and children (under 12 years of age and weighing less than 35kg)

The dose is 0.25mg/kg. This should be given up to three times per day with a maximum dose of 0.75mg/kg per day. For example, for a child weighing 10kg, the dose is 2.5mg and this can be given three times per day toa maximum dose of 7.5mg per day.

Hepatic Impairment

Vardom-DT Oral Suspension is contraindicated in moderate or severe hepatic impairment. Dose modification in mild hepatic impairment is however not needed.

Renal Impairment

Since the elimination half-life of Vardom-DT is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Vardom-DT Oral Suspension 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.

Vardom-DT suspension is contraindicated in the following situations:

-

- 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.

- 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

- co-administration with QT-prolonging drugs, with the exception of apomorphine

- co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects)

Precautions for use

Renal impairment:

The elimination half-life of Vardom-DT is prolonged in severe renal impairment. For repeated administration, the dosing frequency of Vardom-DT should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.

Cardiovascular effects:

Vardom-DT has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking Vardom-DT. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors.

Epidemiological studies showed that Vardom-DT was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30mg, and patients concurrently taking QT_prolonging drugs or CYP3A4 inhibitors.

Vardom-DT should be used at the lowest effective dose in adults and children.

Vardom-DT is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia. Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.

Treatment with Vardom-DT should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.

Patients should be advised to promptly report any cardiac symptoms.

Use in infants:

Although neurological side effects are rare , the risk of neurological side effects is higher in young children since metabolic functions and the blood-brain barrier are not fully developed in the first months of life. Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.

Use with Potent CYP3A4 Inhibitors:

Co-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QTc interval should be avoided.

Co-administration of levodopa:

Although no dosage adjustment of levodopa is deemed necessary, an increase of plasma levodopa concentration (max 30-40%) has been observed when Vardom-DT was taken concomitantly with levodopa.

Use with apomorphine:

Vardom-DT is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled. Please refer to the apomorphine SmPC.

Vardom-DT suspension contains 400mg of liquid sorbitol (non-crystallising, E420) per ml, which may have a mild laxative effect. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Vardom-DT suspension contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).