Pranlukast Hydrate

• Asthma:
  Prophylaxis and chronic treatment of bronchial asthma, including mild to moderate persistent asthma. Effective in reducing frequency and severity of asthma attacks.
• Exercise-induced bronchospasm:
  Prevention of bronchospasm triggered by exercise.
• Allergic rhinitis:
  Relief of symptoms associated with seasonal and perennial allergic rhinitis.
• Off-label uses:
  Adjunctive therapy in other allergic conditions involving leukotriene-mediated inflammation.

• Adults and adolescents (15 years and older):
  112.5 mg orally twice daily.
• Pediatrics:
  Safety and efficacy not established for children under 15 years; consult a specialist.
• Elderly:
  Use standard dosing; monitor for tolerability.
• Administration:
  Oral, with or without food. Tablets should be swallowed whole.
• Dose adjustments:
  Not required in mild to moderate hepatic or renal impairment; caution advised in severe impairment.
• Duration:
  Long-term treatment as prescribed; discontinuation should be guided by clinical response.

Pranlukast hydrate is a selective leukotriene receptor antagonist that competitively blocks the cysteinyl leukotriene receptor type 1 (CysLT1) on airway smooth muscle cells and inflammatory cells. By inhibiting the binding of leukotrienes (LTC4, LTD4, LTE4), which are potent bronchoconstrictors and promoters of airway inflammation, pranlukast reduces bronchial smooth muscle contraction, vascular permeability, mucus secretion, and eosinophilic inflammation, thereby improving airway function and reducing asthma symptoms.

• Absorption:
  Well absorbed orally, with peak plasma concentrations reached within 1–2 hours.
• Bioavailability:
  Approximately 40–50%.
• Distribution:
  Widely distributed; protein binding approximately 98%.
• Metabolism:
  Extensively metabolized in the liver mainly by CYP450 enzymes.
• Elimination:
  Excreted primarily via feces (major) and urine (minor).
• Half-life:
  Approximately 1.5 to 2.5 hours.
• Onset of action:
  Clinical effects may be observed within hours, with full benefit over days.

• Pregnancy:
  Category B. Animal studies have not demonstrated risk to the fetus; however, controlled human data are limited. Use only if clearly needed.
• Lactation:
  Unknown whether excreted in human milk. Use caution when administering to breastfeeding women.

• Leukotriene receptor antagonist
• Anti-asthmatic agent

• Known hypersensitivity to pranlukast or any of its excipients.
• Severe hepatic impairment (use caution).

• Use with caution in patients with hepatic dysfunction.
• Monitor for potential allergic reactions including rash or angioedema.
• Not intended for acute asthma attacks; use only for prophylaxis and maintenance therapy.
• May cause neuropsychiatric events such as agitation, hallucinations, or suicidal ideation—monitor patients closely.

• Common:
  Headache, gastrointestinal disturbances (nausea, diarrhea), elevated liver enzymes, cough.
• Serious (rare):
  Hypersensitivity reactions (rash, angioedema), neuropsychiatric symptoms, elevated liver function tests, eosinophilia.
• Side effects are generally mild and dose-related.

• Metabolized by CYP450 enzymes; co-administration with strong CYP450 inhibitors or inducers may alter pranlukast levels.
• No significant interactions with theophylline, corticosteroids, or beta-agonists.
• No known significant food or alcohol interactions.

• Recent guidelines continue to recommend leukotriene receptor antagonists like pranlukast as alternative or add-on therapy for asthma control, especially in patients with aspirin-sensitive asthma or allergic rhinitis.
• Safety monitoring recommendations updated to include vigilance for neuropsychiatric adverse effects.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep tablets in original packaging until use.
• Do not freeze.