Butasiv

• Approved Indications:
• Symptomatic treatment of dry (non-productive) cough associated with acute respiratory tract infections such as common cold, bronchitis, and upper respiratory tract inflammation.
• Off-label or Clinically Accepted Uses:
• Adjunctive therapy to suppress cough in chronic respiratory conditions where cough is distressing but sputum production is minimal.
• Palliative treatment for cough in certain terminal or cancer-related conditions under specialist supervision.

• Adults and Adolescents (≥12 years):
• 30 mg orally, 3 to 4 times daily (total 90–120 mg per day).
• Children (6–12 years):
• 15 mg orally, 3 times daily.
• Elderly:
• Use standard adult dosing cautiously; monitor for increased sensitivity or side effects.
• Special Populations:
• No established dose adjustment needed for mild to moderate hepatic or renal impairment; use with caution.
• Not recommended for children under 6 years due to limited safety data.
• Route:
• Oral administration (tablets or syrup).
• Take with water, preferably after meals.
• Duration:
• Generally limited to short-term use, typically not exceeding 7 days unless directed by a physician.

Butamirate citrate is a centrally acting antitussive that suppresses the cough reflex by acting on the cough center located in the medulla oblongata of the brainstem. Unlike opioid antitussives, it selectively reduces cough without producing analgesic or addictive effects, thus decreasing cough frequency and severity without causing significant respiratory depression.

• Absorption:
• Rapid and almost complete oral absorption.
• Distribution:
• Widely distributed, crosses the blood-brain barrier to exert central effects.
• Metabolism:
• Extensively metabolized in the liver through hydrolysis and conjugation.
• Half-life:
• Approximately 6 to 8 hours, supporting multiple daily dosing.
• Excretion:
• Mainly eliminated via renal excretion of metabolites; negligible amounts excreted unchanged.

• Pregnancy:
• Limited human data available; animal studies have not demonstrated teratogenicity. Use only if clearly needed and benefit outweighs risk.
• Lactation:
• Unknown if excreted in human milk. Caution advised during breastfeeding; monitor infants for any adverse reactions.

• Primary Class: Antitussive agent
• Subclass: Non-opioid, centrally acting cough suppressant

• Known hypersensitivity to butamirate citrate or any formulation excipients.
• Productive cough with significant sputum production (suppression not recommended).
• Severe respiratory insufficiency.
• Children under 6 years (due to insufficient safety data).

• Use with caution in patients with conditions causing excessive respiratory secretions to avoid retention.
• Not intended for prolonged use; persistent cough >7 days requires medical evaluation.
• Monitor for allergic reactions such as rash or urticaria.
• Caution in hepatic impairment due to metabolism considerations.
• Avoid concomitant use with alcohol or other CNS depressants due to risk of additive sedation.

• Common:
• Mild gastrointestinal upset (nausea, abdominal discomfort)
• Drowsiness or sedation
• Dry mouth
• Uncommon:
• Headache
• Dizziness
• Allergic skin reactions (rash, pruritus)
• Rare:
• Severe hypersensitivity reactions including anaphylaxis (very rare)

• Increased sedation when combined with CNS depressants (e.g., alcohol, benzodiazepines).
• No significant interactions involving CYP450 enzymes reported.
• Use caution if combined with other antitussives or expectorants.

• Guidelines emphasize short-term use for symptomatic relief of dry cough.
• Strong recommendation to evaluate underlying causes of persistent cough before prolonged use.
• Pediatric use limited to children older than 6 years, with safety monitoring advised.

• Store at 20°C to 25°C (room temperature).
• Protect from moisture and direct sunlight.
• Keep tablets in tightly closed containers.
• Syrups should be stored as per manufacturer instructions, avoiding freezing.
• Keep out of reach of children.