Domperidone

Visa No.: 893110179824

Product: PymePelium

API: Domperidone

Product Category: Gastrointestinal

Version approved leaflet: 424/QÐ-QLD_05/09/2016_155

INDICATIONS

PYMEPELIUM is indicated for the symptomatic treatment of nausea and vomiting. 

DOSAGE AND ADMINISTRATION

Dosage: 
For oral use. PYMEPELIUM should be taken before meals. If taken after meals, absorption may be delayed.
PYMEPELIUM should be used at the lowest effective dose for the shortest possible duration to control nausea and vomiting.
Patients should take the medicine at regular times each day. If a dose is missed, the missed dose should be skipped and the next dose taken as scheduled. Do not take a double dose to make up for a missed dose.
The maximum treatment duration should not exceed one week.

Method of administration:
Adults and adolescents (≥12 years of age and body weight ≥35 kg): PYMEPELIUM 10 mg tablet may be taken up to three times daily. The maximum dose is 30 mg per day.

Infants, young children, children (<12 years), and adolescents weighing <35 kg: Due to the need for precise dosing, PYMEPELIUM tablets are not suitable for young children and adolescents weighing less than 35 kg. 

Patients with hepatic impairment: PYMEPELIUM is contraindicated in patients with moderate and severe hepatic impairment (see Contraindications). No dose adjustment is required in patients with mild hepatic impairment. 

Patients with renal impairment: As the elimination half-life of domperidone is prolonged in severe renal impairment, if repeated dosing is required, the dosing frequency should be reduced to once or twice daily, with dose adjustment depending on the severity of renal impairment. 

CONTRAINDICATIONS

Domperidone is contraindicated in the following cases:

• Hypersensitivity to any component of the product.
• Patients with prolactin-releasing pituitary tumor (prolactinoma)
• Gastrointestinal hemorrhage or mechanical intestinal obstruction.
• Moderate and severe hepatic impairment.
• Patients with cardiac conduction disorders, particularly QT interval prolongation, significant electrolyte disturbances, or underlying cardiac diseases such as congestive heart failure.
• Concomitant use with medicines known to prolong the QT interval (see Drug Interactions).
• Concomitant use with potent CYP3A4 inhibitors, regardless of their effect on QT prolongation (see Drug Interactions).
• Children under 12 years of age or adults weighing less than 35 kg, as the 10 mg tablet strength is not suitable.
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.