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Orion Pharma LtdProduct Description
**Etopride (Itopride Hydrochloride) Summary**
**Indications**
* Treatment of gastrointestinal symptoms associated with chronic gastritis, including upper abdominal pain, a feeling of abdominal fullness/enlargement, heartburn, anorexia, nausea, and vomiting.
**Mechanism & Pharmacology**
* **Class:** Prokinetic agent (Dopamine $D_2$ antagonist & Acetylcholinesterase inhibitor).
* **Action:** Increases acetylcholine levels in the gut wall by simultaneously blocking $D_2$ receptors and inhibiting acetylcholinesterase enzyme activity. This enhances gastrointestinal peristalsis, elevates lower esophageal sphincter pressure, accelerates gastric emptying, and improves gastroduodenal coordination.
**Dosage & Administration**
* **Adult Dose:** 50 mg orally 3 times daily, taken **before meals**. Dosage may be reduced depending on age and clinical response.
* **Elderly Patients:** Use with caution and monitor closely due to age-related physiological declines; reduce dose or discontinue if adverse effects occur.
* **Pediatric Use:** Safety and efficacy are not established in individuals under 18 years; use is not recommended.
**Contraindications**
* Known hypersensitivity to itopride or any of its formulation excipients.
* Conditions where increased GI motility would be hazardous (e.g., gastrointestinal hemorrhage, mechanical obstruction, or perforation).
**Drug Interactions**
* **Anticholinergic Agents (e.g., Scopolamine butylbromide, Tiquizium bromide):** Pharmacologically antagonize and reduce the prokinetic/gastrointestinal motility-enhancing effects of Itopride.
**Side Effects & Safety Precautions**
* **Precautions:** Exercise caution as itopride enhances acetylcholine action. Discontinue treatment if no improvement in GI symptoms is seen after an extended period.
* **Severe Reactions (Rare):** Shock, anaphylactoid reactions (hypotension, dyspnea, hives, diaphoresis), or hepatic dysfunction/jaundice with elevated liver enzymes (AST, ALT, $\gamma$-GTP). Discontinue immediately if these occur.
* **Pregnancy & Lactation:** Safety during pregnancy is not established; use only if therapeutic benefits clearly outweigh potential risks. Not recommended during breastfeeding (excreted in animal milk).
**Overdose Management**
* Standard emergency measures including gastric lavage and supportive symptomatic care should be initiated.
**Storage**
* Store below 30°C in a cool, dry place away from direct light. Keep out of reach of children.
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