Molax/Molax-M: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Molax-M Each tab Domperidone maleate equiv to Domperidone 10 mg. Molax Each mL Domperidone 1 mg

Indications/Uses

Symptomatic treatment associated w/ upper GI motility disorders or dyspepsia: upper abdominal pain, abdominal distension feeling, bloating, flatulence & nausea; caused by gastritis, diabetic gastroparesis, or drug therapy eg, dopaminergic agents. Short-term treatment of nausea & vomiting from various origins.

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Dosage/Direction for Use

Molax-M Adult & adolescent (≥12 yr weighing ≥35 kg) Treatment of nausea & vomiting, symptomatic treatment of dyspepsia 10-20 mg bid or qid. Max daily dose: 80 mg. Molax Paed 0.25-0.5 mg/kg bid or qid. Max daily dose: 2.4 mg/kg, not to exceed 80 mg.

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Overdosage

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Administration

Should be taken on an empty stomach: Take 15-30 min before meals to avoid absorption delay. May take before bedtime if necessary.

Contraindications

Sensitivity. GI hemorrhage, mechanical obstruction or perforation (or whenever stimulation of gastric motility); prolactinoma. Moderate or severe hepatic impairment.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Molax/Molax-M detailed prescribing information

Special Precautions

Patient w/ hypokalemia & hypomagnesemia; QT prolongation & history of QT prolongation. Concomitant use w/ drug-induced QT prolongation eg, cisapride, erythromycin & ketoconazole; CYP3A4 inhibitors eg, ketoconazole, erythromycin, cimetidine & omeprazole. Pregnancy & lactation. Neonates, infants, & small childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dry mouth.

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Drug Interactions

Increased plasma conc w/ potent CYP3A4 inhibitors, including azole antifungals eg, fluconazole, itraconazole, ketoconazole, voriconazole; macrolide antibiotics eg, clarithromycin & erythromycin, HIV PIs eg, amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir & saquinavir; Ca antagonists eg, diltiazem & verapamil; amiodarone, aprepitant, nefazodone, telithromycin. Slight QT interval prolongation w/ fluconazole, ketoconazole, voriconazole, clarithromycin, erythromycin, amiodarone, telithromycin. May antagonize hypoprolactinaemia effect of bromocriptine. May suppress unwanted peripheral effect of bromocriptine & L-dopa. Enhanced gastric & small intestinal motive w/ SR & EC drug formulations. Molax susp: Lowered oral availability w/ antacids & antisecretory drugs.

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Storage

View Molax/Molax-M storage conditions for details to ensure optimal shelf-life.

Description

View Molax/Molax-M description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

GIT Regulators, Antiflatulents & Anti-Inflammatories / Antiemetics

ATC Classification

A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.

Thai FDA Category

Presentation/Packing

Form

Molax-M FC tab 10 mg

Packing/Price

10 × 10's

Form

Molax oral susp 1 mg/mL

Packing/Price

30 mL x 1's

Molax/Molax-M

domperidone

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical