Spasmonal Alverine Citrate Capsules

1. Indications and Usage
Gastrointestinal and Biliary: Relief of pain associated with irritable bowel syndrome, intestinal spasms, diverticular disease, and biliary tract spasms.
Obstetric and Gynecologic: Treatment of dysmenorrhea and uterine spasms.
Urologic: Relief of spasm-induced pain caused by urinary calculi or infections, as well as urinary frequency and bladder spasms associated with lower urinary tract infections or post-surgical conditions.
2. Dosage and Administration
Adults: The usual dosage is 1 to 2 capsules (60 mg each) taken 3 times daily.
Children (8-12 years): 1 capsule taken 3 times daily. The dosage for children under 8 years has not been established.
Surgical Patients: Administration should commence 1 hour prior to surgery.
Administration: The capsules should be swallowed whole.
3. Mechanism of Action
Smooth Muscle Relaxation: Alverine is a synthetic papaverine derivative that acts directly on visceral smooth muscles as a selective smooth muscle relaxant.
Selectivity: It selectively acts on the smooth muscles of the gastrointestinal, uterine, and genitourinary tracts. It has virtually no effect on bronchial or vascular smooth muscles at therapeutic doses.
Potency: Its antispasmodic effect is approximately 2.5 to 3 times that of papaverine.
4. Safety and Warnings
Contraindications: Contraindicated in patients with a known hypersensitivity to alverine or similar drugs, and those with paralytic ileus.
Special Populations: Should be used with caution in pregnant and lactating women. It is not recommended for patients with prostatic tumors.
Overdose: Exceeding the therapeutic dose may lead to gastrointestinal discomfort, drowsiness, dizziness, weakness, headache, dry mouth, or hypotension.
5. Adverse Reactions and Clinical Research
Tolerability: At therapeutic doses, the drug is generally well-tolerated with minimal side effects.
Overdose Effects: As noted, excessive dosing may cause gastrointestinal distress, CNS depression (drowsiness, dizziness), or mild anticholinergic-like effects (dry mouth).
6. Drug Interactions
Potentiating Agents: Concomitant use with tricyclic antidepressants, procaine and its derivatives, or antihistamines may enhance the effects of alverine.
Antagonistic Agents: Drugs such as fluconazole, miconazole, or systemic cholinergic agents may diminish the therapeutic effects of alverine.
7. Pharmaceutical Information
Active Ingredient: Alverine Citrate.
Strength: Each capsule typically contains 60 mg of alverine citrate.
Appearance: Hard capsules with a grey cap and blue body, marked with “SP60” in black. The contents are a white powder.
Storage: Store in a light-resistant container, in a cool (not exceeding 20°C) and dry place.