Ruijian Trimebutine Maleate Capsules

Brand Name: 瑞健®(Ruijian®)
Generic Name: Trimebutine Maleate
Strength: 0.1 g per capsule
Manufacturer: Shanxi Zhendong Ante Biological Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Shanxi Zhendong Ante Biological Pharmaceutical Co., Ltd.
Approval Date in China: 2004‑05‑14
Registration Number: National Medicine Approval No. H20040713
Storage: Store in tightly‑closed container, protected from light, store in dry place

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1. Indications and Usage
Gastrointestinal Disorders: Treatment of abdominal pain, dyspepsia, and diarrhea associated with functional gastrointestinal disorders.
Biliary Disorders: Relief of spasms and pain related to the biliary tract.
2. Dosage and Administration
Adults: The usual dosage is 1 capsule (200 mg) taken 3 times daily.
Administration: The capsule should be taken orally with water.
3. Mechanism of Action
Neurologic Regulation: Trimebutine maleate acts on the enteric nervous system (both opioid receptors and muscarinic receptors) to regulate gut motility.
Spasm Relief: It has a dual effect: it relaxes contracted smooth muscles and stimulates sluggish ones, effectively normalizing gastrointestinal function.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with a known hypersensitivity to trimebutine maleate or any components of the formulation.
Special Populations: Use with caution in pregnant or breastfeeding women, as safety has not been fully established in these groups.
Monitoring: If significant adverse reactions occur, discontinue the medication immediately.
5. Adverse Reactions and Clinical Research
Gastrointestinal Effects: Occasionally, constipation, abdominal pain, or nausea may occur.
Other Effects: Rarely, dizziness, general fatigue, or skin rashes may be observed.
6. Drug Interactions
Anticholinergics: Concomitant use with anticholinergic agents may enhance the antispasmodic effects, potentially increasing the risk of urinary retention or constipation.
General Precaution: Caution is advised when combining with other medications affecting gut motility.
7. Pharmaceutical Information
Active Ingredient: Trimebutine Maleate.
Formulation: Capsules, typically 200 mg per capsule.
Storage: Store in a dry place.

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