Composition: Each film-coated tablet contains Itopride Hydrochloride 50 mg.
Usage: Management of selected functional dyspepsia symptoms, including nausea and post-meal fullness, as prescribed.
Category: Generic Drugs and Medicine
Therapeutic category: Gastrointestinal prokinetic agent
SKU: Itopride Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Itopride Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufactured by: Healthy Life Pharma Pvt. Ltd. (company-supplied information)
Exported by: Healthy Inc (company-supplied information)
Healthy Life Pharma Pvt. Ltd. presents Itopride Hydrochloride 50 mg film-coated tablets for gastrointestinal motility-related symptoms. Itopride is a prokinetic medicine used in some countries for functional dyspepsia, including post-meal fullness, bloating, early satiety and nausea.
The supplied company profile identifies Healthy Life Pharma Pvt. Ltd. as manufacturer and Healthy Inc as exporter. Contract manufacturing and export inquiries are welcome; manufacturing site certifications, available markets and regulatory approvals should be confirmed against current documents.
| Product name | Itopride Tablets |
|---|---|
| Active ingredient | Itopride Hydrochloride 50 mg per tablet |
| Dosage form | Film-coated tablet |
| Therapeutic class | Gastrointestinal prokinetic agent |
| CAS number | 122898-67-3 (Itopride hydrochloride; verify against API documentation) |
| Pharmacopoeial standard | As per approved product specification |
| Packaging | Blister options subject to commercial confirmation |
| Shelf life | According to approved stability data and label |
| Manufacturer | Healthy Life Pharma Pvt. Ltd. (as supplied) |
| Exporter | Healthy Inc (as supplied) |
Film coating can improve tablet handling and help mask the unpleasant taste of the active ingredient. Manufacturing controls for a 50 mg tablet may include blend uniformity, compression parameters, coating integrity, dissolution and stability testing. The exact excipients, process technology and coating composition depend on the approved formulation and batch records.
Protective blister formats may be considered for humid export markets, subject to validated packaging suitability.
Appropriate release and stability controls include identity, assay, content uniformity, dissolution, related substances, microbiological quality where applicable and packaging integrity. Acceptance criteria must follow the registered specification; numerical assay and dissolution limits should not be advertised without approved supporting documents.
Itopride acts through dopamine D2 receptor antagonism and acetylcholinesterase inhibition, enhancing acetylcholine-mediated gastrointestinal motility. Depending on local approval, it may be prescribed for functional dyspepsia symptoms such as upper-abdominal fullness, early satiety, nausea and bloating.
It is not an acid-suppressing medicine and is not a universal treatment for heartburn. Its benefit for gastroparesis or other disorders depends on clinical assessment and local labeling. It should not be described as entirely free of cardiac, neurological or endocrine risks.
For business inquiries, potential documentation may include a Certificate of Analysis, product specifications, stability information and market-specific registration materials, subject to availability and legal requirements. WHO-GMP status, COPP, FSC, CTD/ACTD dossiers, export eligibility and delivery terms require documentary confirmation for each product and destination.
Q: What does Itopride 50 mg contain?
A: Each film-coated tablet contains Itopride Hydrochloride 50 mg.
Q: What is it used for?
A: It is used for selected symptoms of functional dyspepsia and impaired gastrointestinal motility where approved and prescribed.
Q: Is it the same as an antacid?
A: No. Itopride primarily affects gut motility rather than directly neutralizing or suppressing stomach acid.
Q: Can it cause side effects?
A: Yes. Gastrointestinal symptoms, headache, dizziness, and changes in prolactin can occur; seek medical advice for concerning symptoms.
Q: When is it taken?
A: Follow the product label and prescriber; some approved regimens are taken before meals.
For adults, a commonly referenced regimen is 50 mg up to three times daily before meals, but actual dose, duration and eligibility depend on the approved local label and prescriber. Do not self-medicate or change the prescribed schedule. Swallow tablets as instructed by the dispensing pharmacist.
Reported adverse effects may include diarrhea, abdominal discomfort, nausea, headache, dizziness, rash and increased prolactin (occasionally associated with breast-related symptoms). Use requires medical assessment in pregnancy or breastfeeding. Prokinetic treatment is generally inappropriate when increased gastrointestinal movement could be dangerous, such as suspected gastrointestinal bleeding, obstruction or perforation. Tell the clinician about all other medicines and relevant medical conditions.
Safety note: Claims that itopride never causes QT changes, extrapyramidal effects or other serious adverse reactions are too absolute and have not been included.
Store in the original packaging, protected from excessive heat and moisture, following the temperature and conditions printed on the approved product label. Keep out of reach of children.