Montelucaste Vitória (Montelukast Sodium)

Montelukast Sodium is used to treat conditions mediated by cysteinyl leukotrienes in the respiratory tract.

• Asthma: improves overall control of chronic asthma, decreases daytime symptoms and reduces the risk of severe exacerbations.
• Exercise‑induced bronchoconstriction: prevents airway narrowing that occurs during or after physical exertion, helping maintain exercise tolerance.
• Allergic rhinitis: reduces nasal congestion, sneezing, itching and rhinorrhea associated with seasonal or perennial allergic rhinitis.

• Montelukast Sodium selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth‑muscle cells, mast cells and eosinophils. By antagonizing the actions of leukotrienes D4, C4 and E4, it inhibits bronchoconstriction, vascular permeability and inflammatory cell recruitment, thereby reducing airway narrowing and inflammation. The inhibition is reversible and does not affect other bronchial receptors, allowing normal bronchodilator response to β2‑agonists. This selective antagonism contributes to long‑term improvement in airway function.

Montelukast Sodium may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

• Headache: mild to moderate headache, often transient.
• Upper respiratory infection: symptoms such as sore throat, nasal congestion and mild fever.
• Abdominal pain: mild stomach discomfort or cramping.
• Cough: occasional dry cough without sputum.
• Fever: low‑grade temperature increase, usually self‑limiting.
• Dyspepsia: indigestion, heartburn or a feeling of fullness.

Serious or Rare Side Effects

• Allergic reactions: rash, itching, swelling of lips or tongue, or anaphylaxis.
• Mood changes: depression, anxiety, suicidal thoughts or behavior.
• Hepatotoxicity: elevated liver enzymes, hepatitis or jaundice.
• Angioedema: rapid swelling of face, lips, tongue or throat, potentially airway‑obstructing.
• Blood disorders: neutropenia, eosinophilia or other abnormal blood cell counts.

When prescribing Montelukast Sodium, several precautions should be considered to ensure safe use.

• Pregnancy: Category B; use only if clearly needed.
• Breastfeeding: monitor infant; benefits may outweigh risks.
• Hepatic impairment: dose may need adjustment; monitor liver function.
• Neuropsychiatric effects: observe for mood changes, depression or suicidal ideation.
• Drug interactions: review concomitant medications for potential interactions.
• Store at ambient temperature: keep below 25°C, in original packaging, protect from moisture.

Montelukast Sodium can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

• Phenobarbital, rifampin, carbamazepine: strong enzyme inducers that may reduce montelukast plasma levels.
• Ritonavir: may increase exposure, leading to higher risk of adverse effects.

Moderate Interactions (Monitor Closely)

• Fluconazole, erythromycin: moderate CYP3A4 inhibitors that can modestly raise montelukast concentrations.
• Warfarin: potential alteration of anticoagulant effect; monitor INR.
• Theophylline: additive bronchodilator effect; observe for increased side effects.