Doiz: Dosage & Side Effects

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

The information highlighted (if any) are the most recent updates for this brand.

Full Prescribing Info

Contents

Itopride hydrochloride.

Description

A white to off-white, round, biconvex film-coated tablet, with "

Click on icon to see table/diagram/image
" logo on one side and "I" on the other side.
Each tablet contains 50 mg of Itopride hydrochloride.

Action

Pharmacology: Pharmacodynamics: Itopride is a substituted benzamide that has been used for prokinetic agent and antiemetic agent. Itopride acts as the dopamine receptor (D₂ subtype) antagonist. It also acts as acetylcholine esterase inhibitor leading to the elevation of acetylcholine level and gastrointestinal motility.
Pharmacokinetics: Absorption: Itopride is absorbed rapidly by oral administration. The peak plasma concentration occurred within 0.50-0.66 hour. The bioavailability is calculated to be 60%.
Distribution: 96% of Itopride is bound to plasma proteins.
Metabolism: Itopride undergoes N-oxidation via flavine monooxygenase enzymes (FMO1 and FMO3).
Elimination: Itopride is excreted into urine as main metabolite and unchanged drug, in amount of 68% and 4% respectively. The half-life elimination of Itopride is 5.7±0.3 hours.

Indications/Uses

Itopride is used for management of gastrointestinal symptoms of functional (non-ulcer) dyspepsia, chronic gastritis and symptoms cause by gastric dysmotility and delayed gastric emptying, like sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting.

Dosage/Direction for Use

Administer orally before meals. Itopride should be given 50 mg 3 times daily.

Overdosage

There have been no reports of overdose in humans. The oral single dose LD₅₀ was more than 2000 mg/kg in mice and rats and about 600 mg/kg in dogs. In case of excessive overdose, the usual measures of gastric lavage and symptomatic therapy should be applied.

Contraindications

Itopride should be avoided in patients who are hypersensitive to Itopride and any component in the formulation.
Patients with gastrointestinal hemorrhage, mechanical obstruction or gastrointestinal perforation may also avoid using Itopride.

Special Precautions

Itopride enhances the action of acetylcholine and may produce cholinergic side effects.
Use in the Elderly: Use caution in elderly due to increased risk of adverse effect; may require dose reduction.

Use In Pregnancy & Lactation

Pregnancy: There are no published safety data in pregnant women. If treatment of GI symptoms is required during pregnancy, other agent may be preferred.
Lactation: It is not known if Itopride is excreted in breast milk. If use of Itopride is required, breast-feeding should be avoided.

Adverse Reactions

Abdominal pain, constipation, diarrhea, increased serum prolactin, nausea, skin rash, headache, irritability, tremor, increased serum alkaline phosphatase, increased blood urea nitrogen, increased serum creatinine, back pain, chest pain, fatigue, erythema, anaphylaxis, gynecomastia, hepatic insufficiency, increased gamma-glutamyl transferase, increased serum ALT, increased serum AST, jaundice, leukopenia, pruritus, sialorrhea, shock, sleep disorder, thrombocytopenia.

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Drug Interactions

There are no known interactions where it is recommended to avoid concomitant use.
The effect of Itopride may be decreased by anticholinergic agents.

Storage

Store below 30°C.

MIMS Class

GIT Regulators, Antiflatulents & Anti-Inflammatories / Antiemetics

ATC Classification

A03FA07 - itopride ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.

Thai FDA Category

Presentation/Packing

Form

Doiz FC tab 50 mg

Packing/Price

1 × 10's

Doiz

itopride

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical