Otilonium Bromide Tablets

Brand Name:No brand name
Generic Name: Otilonium Bromide
Strength: 40 mg per tablet
Manufacturer: Jincheng Haisi Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Jincheng Haisi Pharmaceutical Co., Ltd.
Approval Date in China: 2006‑09‑22
Registration Number: National Medicine Approval No. H20066490
Storage: Store in tightly‑closed container, protected from light

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1. Indications and Usage
Gastrointestinal Disorders: Treatment of gastrointestinal functional disorders accompanied by pain, spasms, and abdominal distension (e.g., Irritable Bowel Syndrome).
2. Dosage and Administration
Adults: The usual dosage is 1 tablet (40 mg) taken 3 times daily.
Administration: Tablets should be swallowed whole with water, typically before meals.
Duration: The duration of treatment should be determined by the physician based on the patient’s symptoms.
3. Mechanism of Action
Smooth Muscle Relaxation: Otilonium bromide is a quaternary ammonium derivative that acts as a muscarinic antagonist.
Selectivity: It selectively acts on the smooth muscles of the gastrointestinal tract, reducing abnormal contractions and spasms without significantly affecting other organ systems.
4. Safety and Warnings
Contraindications: Contraindicated in patients with glaucoma, prostatic hyperplasia with urinary retention, or intestinal obstruction.
Hypersensitivity: Do not use in patients with a known allergy to quaternary ammonium compounds or any components of the formulation.
Special Populations: Use with caution in the elderly and in patients with hepatic or renal impairment.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Dry mouth, constipation, and nausea may occur occasionally.
Other Effects: Rarely, dizziness, headache, or skin rashes may be observed.
Management: If adverse reactions occur, the dosage may be reduced or the treatment discontinued.
6. Drug Interactions
Additive Effects: Concomitant use with other anticholinergic drugs may increase the risk of dry mouth, constipation, and urinary retention.
Gastrointestinal Absorption: Drugs that affect gastric emptying or intestinal transit time may alter the absorption of otilonium bromide.
7. Pharmaceutical Information
Active Ingredient: Otilonium Bromide.
Strength: Each tablet contains 40 mg of Otilonium Bromide.
Chemical Name: Bromide salt of 3,9-tris(1-methylpyridin-1-ium).
Storage: Store in a dry place, protected from light and moisture.

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