Mosapride
2.5 mg and 5 mg Film Coated Tablet
Generic name:
Mosapride citrate
Pharmaceutical form:
Film coated tablet
Composition:
Each film coated tablet
Active ingredient:
Mosapride citrate 2.5 mg
Mosapride citrate 5 mg
Inactive ingredient:
Lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, colloidal silicon dioxide, Talc uritied), .crosscarmellose sodium.
Pharmacodynamic action:
– Mosapride table stimulates serotonin receptors in the digestive tract and increases acetylcholine release in order to improve the function of enterokinase and gastric emptying,
– Mosapride is a selective 5-HT4 receptor agonist with no affinity to 5-HT 1 – 5-HT 2
– Mosapride improves esophageal motility for patient with (GERD).
– Mosapride increases esophageal bolus transit.
– Mosapride shortens gastric emptying time.
– Mosapride reduces acid reflux variables (assessed using ambulatory pH monitoring).
Pharmacokinetics:
– After oral administration of single dose of Mosapride 5-40 mg, peak Mosapride concentration (Cmax) were reached after-I hour. Mean elimination half-lives(t It,) were 1.4 – 2.0 hours.
– Plasma Cmax (52.0 ng/ml) of the active M I metabolite occurred 0.5 hours after a single dose ofmosapride 40 mg. Elimination of M 1 (t It, = 4.3 hours).
– Mosapnde is excreted in urine and feaces in 48 hours after administration of a single dose of Mo sap ride 5 mg.
Indications:
– Heartburn, nausea, and vomiting caused by chronic gastritis.
– As adjuvant therapy with orally gastrointestinallavage solution for barium enema x-ray examination,
Dosage and administration:
– General dosage regimen: I he reconunen<led usual dosage of Mosapride for adults is 5 .mg three times daily before or after meals.
– Missed dosage: Take the missed dose as soon as possible. However, if it is amlost time for the next dose, skip the missing dose and continue your-regular dosing schedule.
– Overdose: is you took much of this medicine (more than advised), check with your doctor.
– Other: Do not stop taking this medicine without doctor’s instructions.
Contraindications:
– Hypersensitivity to Mosapride or any of the components.
– Patients with hemorrhage or digestive blockage.
Side effects:
– No serious adverse events were reported, however in only 2.71 % of patients who had received mosapridc for more than 2 week show abdominal pain, diarrhea, dry mouth, loose stool, rash, hives, nausea and feeling fullness, generalized fatigability and loss of appetite.
– Elevated triglycrides in 1.0%, of patients and elevated AST, ALT and GGT in 1.4% of patients may occur.
– Rarely veritricular tachycardia may occur in patient with hypokalaemia.
– Jaundice. liver-dysfunction and fulminating hepatitis may rarely occur.
Drug interactions:
– Concurrent use with gnti Cholinergic agents (atropine, butylscopolamine bromide) decreases Mosapride action,
– Concurrent use with ketoconazole, itraconamle, macrolide-&iHibiotics,..HlY.protease inhibitors) may increase
plasma concentration of Mosapride.
Pregnancy and lactation:
Not be be used in pregnancy and lactation.
Storage condition:
– Store in dry place at Terrnperature not exceeding 3O”C.
– Keep out of reach of children.
– Discard the remainder. Do not store.
Package:
Cartoon box containing 1.2.3 (AI/PVC) blisters each of 10 tablets and inner leaflet.
Patient information :
Not to be used without physician instructions.
PRODUCED BY :
Western pharmaceutical industries
