Siam Bheasach


Siam Pharmaceutical


Siam Pharmaceutical
Full Prescribing Info
Mosapride citrate dihydrate.
Each tablet contains Mosapride citrate dihydrate equivalent to Mosapride citrate anhydrous 5 mg.
Pharmacology: Pharmacodynamics: Mosapride is a substituted benzamide used for its prokinetic properties. Mosapride is the selective 5-HT4 receptors agonist. It stimulates 5-HT4 receptors in the gastrointestinal enteric plexus. Mosapride is increasing acetylcholine release and stimulating gastrointestinal motility, as well as the main active metabolite (M1 also known as des-4-fluorobenzyl) is reported to have 5-HT3 receptor antagonist activity.
Moreover Mosapride enhances the gastric emptying.
Pharmacokinetics: Absorption: Mosapride is rapidly absorbed with time to peak plasma concentrations occurring about 0.5 to 1.4 hours, and time to peak plasma concentrations of M1 is 0.5 hours.
Distribution: Mosapride's volume of distribution is 1.7 to 3.5 L/kg. 97% of Mosapride is bound to plasma protein.
Metabolism: Mosapride is metabolized by the liver via CYP3A4 (minor) and the principal metabolite is M1.
Elimination: Mosapride is excreted in the urine and faeces. Approximately 1% of an administered dose was excreted in urine as unchanged drug and 10% was excreted in urine as active metabolite. The mean elimination half-life of Mosapride is 1.4-2.5 hours and M1 is 4.3 hours.
Gastrointestinal symptoms: For the relief of symptoms associated with functional dyspepsia (chronic gastritis, heartburn, nausea and vomiting).
Dosage/Direction for Use
Mosapride can be administered orally both before and after meals. Mosapride is given as the citrate dihydrate but doses are expressed as the anhydrous citrate.
Adult: Administer 5 mg three times daily.
Geriatric: Administer 2.5 mg three times daily (use with caution).
Pediatric: Safety of Mosapride in children has not been established.
Mosapride citrate, when 100 to 330 times of the recommended clinical dose (30 to 100 mg/kg/day), was orally administered in rodents for long period (104 weeks in rats, 92 weeks in mice), increased incidence of hepatocellular adenoma and thyroid follicular cell adenoma were observed.
Since data regarding overdosage with this medication is limited, medical attention should be sought for any overdosage.
There are on contraindications for the use of Mosapride. However, patients who are hypersensitive to Mosapride or any ingredients in the formulation, do not use this drug.
Special Precautions
Liver function test should be monitored. Discontinue immediately if early signs/symptoms of hepatic toxicity or elevated liver enzymes occur.
Use with caution in situations where stimulated gastrointestinal (GI) motility may be dangerous, including mechanical GI obstruction, perforation, or hemorrhage.
Use with caution in elderly due to increase risk of adverse effects.
If any improvement in gastrointestinal symptoms does not occur after approximately 2 weeks of therapy, this drug should not be continue for a long period.
Use In Pregnancy & Lactation
Pregnancy: Safety has not been established in pregnant women. If treatment of GI symptoms is required during pregnancy, other agents may be preferred.
Lactation: It is not known if Mosapride is excreted in breast milk. Breast-feeding is not recommended. If administration is essential, nursing mothers should discontinue breast feeding during the treatment.
Adverse Reactions
Cardiovascular: edema, palpitations.
Central nervous system: dizziness, facial paralysis, headache, loss of balance.
Dermatologic: skin rash, urticaria.
Endocrine and Metabolic: increased serum triglycerides (1%).
Gastrointestinal: constipation (2%), loose stools (2%), abdominal distention, diarrhea, dysgeusia, nausea, stomach pain, vomiting, dry mouth, numbness of mouth including tongue and lip, etc.
Hematologic: eosinophilia (1%), leukopenia.
Hepatic: increased serum bilirubin.
Others (< 1%): abnormal lactation, dyspepsia, fulminant hepatitis, hepatic insufficiency, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased thirst, jaundice, malaise.
Drug Interactions
There are no known interactions where it is recommended to avoid concomitant use.
There are no known significant interactions involving an increase in effect.
The levels/effects of Mosapride may be decreased when coadministered with analgesics (opioid) and anticholinergic agents.
Storage below 30°C.
ATC Classification
A03FA09 - mosapride ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Tab 5 mg (white, oblong, biconvex, engraved with "
Click on icon to see table/diagram/image
" logo on one side and "M" on the other side) x 3 x 10's.
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