Naitelan Pinaverium Bromide Tablets

1. Indications and Usage
Functional Bowel Disorders: Treatment of functional gastrointestinal disorders accompanied by pain, spasms, and abdominal distension (e.g., Irritable Bowel Syndrome).
2. Dosage and Administration
Adults: The usual dosage is 1 tablet (135 mg) taken three times daily.
Administration: Tablets must be swallowed whole with water, typically before meals. They should not be crushed or chewed.
Duration: Treatment duration should be determined by the physician based on the patient’s response.
3. Mechanism of Action
Calcium Channel Blockade: Pinaverium bromide is a divalent cation that acts by blocking calcium influx through voltage-dependent L-type calcium channels.
Smooth Muscle Relaxation: By inhibiting calcium entry, it reduces the depolarization of gastrointestinal smooth muscle cells, thereby relieving abnormal contractions, spasms, and visceral hypersensitivity.
4. Safety and Warnings
Contraindications: Contraindicated in patients with a known hypersensitivity to pinaverium bromide or any component of the formulation.
Special Populations: Use with caution in patients with hepatic or renal impairment. Safety in children has not been fully established.
Precautions: If symptoms persist or worsen, medical evaluation is necessary to rule out organic disease.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Abdominal pain, constipation, flatulence, and nausea may occur occasionally.
Rare Effects: Allergic reactions, including skin rashes, pruritus, and urticaria, have been reported.
Management: If severe adverse reactions occur, discontinue the medication and consult a physician.
6. Drug Interactions
General Precaution: No specific pharmacokinetic interactions with other drugs have been identified.
Co-administration: As with most oral medications, it is generally advisable to separate the administration of pinaverium bromide from other drugs to avoid potential absorption interference.
7. Pharmaceutical Information
Active Ingredient: Pinaverium Bromide.
Strength: Each film-coated tablet contains 135 mg of pinaverium bromide.
Appearance: Film-coated tablets are usually greyish or beige.
Storage: Store below 30°C in a dry place.