Indus

Approved Indications:

• Functional Dyspepsia: Treatment of symptoms such as epigastric discomfort, bloating, nausea, early satiety, and postprandial fullness.
• Gastroesophageal Reflux Disease (GERD): Adjunct therapy for relief of reflux symptoms associated with impaired gastric motility.
• Gastrointestinal Motility Disorders: Including gastroparesis and delayed gastric emptying.
• Postoperative Ileus: To enhance recovery of gastrointestinal motility.
• Irritable Bowel Syndrome (IBS) with predominant dysmotility symptoms: Used off-label in some regions.

Off-Label / Clinically Accepted Uses:

• Nausea and Vomiting related to functional dyspepsia or GI motility issues.
• Helicobacter pylori eradication adjunct: Sometimes used to improve symptoms during treatment.
• Diabetic gastroparesis: Limited evidence supports symptomatic relief.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults:

• Typical Dose: 50 mg orally three times daily before meals.
• Duration: Usually prescribed for 4 to 8 weeks; may be extended based on clinical response.

Elderly:

• No specific dose adjustment required; monitor for increased sensitivity.

Pediatrics:

• Safety and efficacy not established; not routinely recommended for children.

Special Populations:

• Renal Impairment: No dose adjustment needed for mild to moderate impairment; caution advised in severe impairment.
• Hepatic Impairment: Use with caution; no established dose adjustment, but severe impairment may warrant monitoring.

Administration Notes:

• Administer orally 30 minutes before meals for optimal efficacy.
• Tablets should be swallowed whole with water.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Itopride hydrochloride is a prokinetic agent that acts via two principal mechanisms: It selectively inhibits dopamine D2 receptors in the gastrointestinal tract, which enhances acetylcholine release, promoting gastric motility and accelerating gastric emptying. Additionally, it inhibits acetylcholinesterase enzyme activity, increasing acetylcholine availability in enteric neurons, further stimulating gastrointestinal smooth muscle contractions and improving coordinated motility. This dual action improves gastric emptying, reduces visceral sensitivity, and alleviates dyspeptic symptoms.

• Absorption: Rapidly absorbed after oral administration with peak plasma concentration (Tmax) at approximately 1 hour.
• Bioavailability: Approximately 55–60%.
• Distribution: Volume of distribution ~130 L; moderately protein bound (~96%).
• Metabolism: Metabolized primarily in the liver via flavin-containing monooxygenase (FMO) system; minimal CYP450 involvement.
• Half-life: Approximately 6 hours.
• Excretion: Eliminated mainly via the urine (about 60%) and feces (around 30%) primarily as unchanged drug and metabolites.

• Pregnancy:
  No well-controlled human studies. Animal studies showed no significant teratogenicity. Use only if clearly needed and after risk-benefit assessment.
• Lactation:
  Unknown if excreted in human milk. Caution advised; breastfeeding is generally not recommended during treatment unless benefits outweigh risks.

• Primary Class: Gastroprokinetic Agent
• Subclass: Dopamine D2 Receptor Antagonist with Acetylcholinesterase Inhibitory Activity

• Known hypersensitivity to itopride hydrochloride or any formulation excipients.
• Mechanical gastrointestinal obstruction or perforation.
• Gastrointestinal hemorrhage or severe inflammatory conditions (e.g., active ulcers).
• Pheochromocytoma (risk of hypertensive crisis).
• Co-administration with medications contraindicated due to pharmacodynamic or pharmacokinetic interactions (see Section 10).

• Extrapyramidal Symptoms: Rare but possible due to dopamine antagonism; monitor especially in patients with Parkinsonism.
• Galactorrhea and Hyperprolactinemia: Due to dopamine antagonism, monitor patients for hormonal disturbances.
• Severe Hepatic or Renal Impairment: Use cautiously; monitor for accumulation.
• Cardiac Disorders: No significant QT prolongation reported, but caution advised with other QT-prolonging drugs.
• Monitoring: Watch for signs of allergic reactions or neuropsychiatric symptoms.

Common:

• Gastrointestinal: Abdominal cramps, diarrhea, nausea.
• Central Nervous System: Headache, dizziness.
• Endocrine: Hyperprolactinemia, galactorrhea (rare).

Less Common:

• Fatigue, somnolence.
• Extrapyramidal symptoms (tremor, rigidity).
• Allergic reactions (rash, itching).

Serious/Rare:

• Neuroleptic malignant syndrome (very rare).
• Severe hypersensitivity reactions.

Timing:
Usually appear within the first few weeks; dose-related and reversible upon discontinuation.

• Metoclopramide & Domperidone: Additive dopamine antagonism increases risk of extrapyramidal symptoms.
• Levodopa: Potential pharmacodynamic antagonism; monitor clinical response.
• Drugs affecting acetylcholine (e.g., anticholinergics): May reduce efficacy.
• CYP450 Interactions: Minimal, but avoid strong inhibitors of flavin-containing monooxygenase if possible.
• Alcohol: No significant interaction but may increase CNS side effects.

• Recognized in Asian and European guidelines as a preferred prokinetic agent for functional dyspepsia due to favorable efficacy and safety profile.
• No recent major changes in dosing or safety warnings.
• Increasing evidence supports use in diabetic gastroparesis and postoperative ileus, although not yet widely approved for these indications.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light; keep tablets in original container.
• Avoid freezing or excessive heat.
• No reconstitution or refrigeration required.