Somolax

• Relief of symptoms associated with irritable bowel syndrome (IBS), including abdominal pain, cramping, and bloating.
• Treatment of spastic conditions of the gastrointestinal tract, such as intestinal colic and functional bowel disorders.
• Management of spasmodic abdominal pain related to functional disturbances of the gut.
• Adjunctive therapy in gastrointestinal motility disorders where smooth muscle spasm contributes to symptoms.

• Formulation: Oral capsules or tablets.
• Adults:
• Typical dose: 60 mg to 120 mg taken orally two or three times daily.
• Tablets/capsules should be swallowed with water, preferably before meals.
• Pediatrics: Safety and efficacy have not been established; use only if specifically prescribed by a physician.
• Elderly: No specific dose adjustment required; monitor for tolerability.
• Renal and Hepatic Impairment: No specific dosage adjustments are generally necessary; caution advised in severe impairment.
• Duration: Treatment duration varies depending on clinical response; often used for symptomatic relief.

Alverine citrate is a selective smooth muscle relaxant acting primarily on the gastrointestinal tract. It exerts a direct spasmolytic effect on the smooth muscle by inhibiting phosphodiesterase enzymes, resulting in increased cyclic AMP levels and reduced intracellular calcium release. This leads to relaxation of the visceral smooth muscle without affecting normal peristalsis. By reducing abnormal smooth muscle contractions and spasms, alverine alleviates pain and discomfort associated with functional bowel disorders such as irritable bowel syndrome.

• Absorption: Well absorbed orally with moderate bioavailability; peak plasma concentrations occur approximately 1–2 hours post-dose.
• Distribution: Widely distributed in body tissues; crosses biological membranes to exert action on smooth muscle.
• Metabolism: Extensively metabolized in the liver via hepatic enzymes into inactive metabolites.
• Elimination: Excreted mainly via urine and feces as metabolites.
• Half-life: Approximately 4–5 hours, supporting twice or thrice daily dosing.
• Onset of Action: Therapeutic effects typically noticed within 1 hour after oral administration.

• Pregnancy: Limited human data; use only if potential benefits justify potential risks. Classified as FDA Pregnancy Category C.
• Lactation: Insufficient data on excretion into breast milk; caution advised, and breastfeeding should be avoided or discontinued if treatment is necessary.

• Primary therapeutic class: Antispasmodic agent
• Subclass: Smooth muscle relaxant

• Known hypersensitivity to alverine citrate or any excipients.
• Severe hepatic impairment or active liver disease.
• Intestinal obstruction or severe gastrointestinal conditions requiring surgery.
• Myasthenia gravis due to potential worsening of muscle weakness.

• Use with caution in patients with moderate hepatic impairment.
• Monitor patients for allergic reactions such as rash or angioedema.
• Not recommended during pregnancy or lactation unless absolutely necessary.
• Avoid use in patients with mechanical gastrointestinal obstruction or severe motility disorders.

• Common:
• Mild gastrointestinal disturbances such as nausea, diarrhea, or constipation.
• Headache and dizziness.
• Uncommon:
• Allergic reactions including rash, pruritus, and urticaria.
• Rare:
• Hypotension or tachycardia.
• Severe hypersensitivity reactions (anaphylaxis) have been reported rarely.

• No significant drug interactions have been widely reported.
• Caution is advised when used concomitantly with other central nervous system depressants or hypotensive agents.
• No known CYP450 enzyme involvement significantly affecting other drug metabolism.

• No major recent changes in approved indications or dosing.
• Clinical guidelines continue to support use as symptomatic treatment for IBS-related smooth muscle spasm.
• Emphasis on individualized patient assessment before initiating therapy.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep the container tightly closed and out of reach of children.
• Do not freeze.