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PREVOMIT FT

Manufacturer

PT. Dexa Medica, Indonesia

Applicant company

PT Dexa Medica

Active ingredient

Domperidone

Content

10mg

Shelf life

24 months

Dosage Form

Fast Melting tablets

Package

Box of 5 blisters x 10 Fast Melting tablets

Visa Number

899110185725

Issuing Date

22/04/2025

Therapeutic area

Gastro-Intestinal

Indication

PREVOMIT® FT is indicated for the symptomatic treatment of vomiting and nausea.

Dosage

PREVOMIT® FT should only be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. PREVOMIT® FT should be taken before meals. If taken after meals, the absorption of the drug may be delayed.
Patients should take the medication at scheduled times. If a dose is missed, that dose can be skipped, and the regular dosing schedule continued. The dose should not be doubled to make up for a missed dose.
The maximum treatment duration should not exceed 1 week.
Adults and adolescents (12 years of age and older and weighing 35 kg or more): 10 mg tablet, can be taken up to 3 times a day, with a maximum dose of 30 mg/day. The fast-dissolving tablet can rapidly disintegrate in the mouth with the help of saliva and can be taken with or without water. When taken without water, the tablet should be placed on the tongue to disperse in the mouth before swallowing. For convenience, water may be taken afterwards.
Children
The efficacy of PREVOMIT® FT in children under 12 years of age has not been established.
The efficacy of PREVOMIT® FT in adolescents 12 years of age and older weighing less than 35 kg has not been established.
Patients > 60 years of age
Patients over 60 years of age should consult a doctor before taking PREVOMIT® FT.
Patients with hepatic impairment
PREVOMIT® FT is contraindicated in patients with moderate or severe hepatic impairment (see Contraindications section). No dose adjustment is required for patients with mild hepatic impairment.
Patients with renal impairment
Because the elimination half-life of domperidone is prolonged in patients with severe renal impairment, upon repeated administration, the dosing frequency of PREVOMIT® FT should be reduced to 1 to 2 times daily, and the dose should be adjusted depending on the severity of the renal impairment. Patients with severe renal impairment must be monitored regularly.

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