Asthator 10mg Tab 30'S

Product Description:

• Asthator contains montelukast sodium, a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.


• It is a hygroscopic, optically active, white to off-white powder, freely soluble in ethanol, methanol, and water, and practically insoluble in acetonitrile.

How To Use:

• Adolescents and adults 15 years of age and older: One 10-mg tablet daily, taken in the evening.


• Pediatric patients 6 to 14 years of age: One 5-mg tablet daily, taken in the evening. No dosage adjustment is necessary within this age group.


• Safety and effectiveness in pediatric patients younger than 6 years have not been established.


• The medication can be taken without regard to the timing of food ingestion, as demonstrated in clinical trials.

Warnings And Precautions:

Contraindications:

• Hypersensitivity to montelukast sodium or any excipients.

 Precautions:

• Patients should not use montelukast to treat acute asthma attacks and should keep rescue medication (short-acting inhaled β-agonist) available.


• If more inhalations than usual are needed, medical advice should be sought. Montelukast should not abruptly replace inhaled or oral corticosteroids.


• Rare cases of systemic eosinophilia, sometimes with vasculitis consistent with Churg-Strauss syndrome, have been reported, especially with reduction or withdrawal of oral corticosteroids.


• Physicians should monitor for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and neuropathy.


• Asthator contains aspartame, so caution is advised in patients with phenylketonuria.

Side Effects:

• Commonly reported (≥1/100, <1/10) in clinical studies: abdominal pain, thirst, headache in adults and pediatric patients. Post-marketing reports include very rare cases of asthenia/fatigue, malaise, oedema, hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, pruritus, rash), dizziness, dream abnormalities, hallucinations, drowsiness, insomnia, irritability, agitation, seizure, arthralgia, myalgia, diarrhoea, dry mouth, dyspepsia, nausea, vomiting, elevated serum transaminases, cholestatic hepatitis, increased bleeding tendency, bruising, palpitations, and very rare cases of Churg-Strauss Syndrome.

Ingredients:

• Active Ingredient: Montelukast sodium.