Montezyd 4/Montezyd 5/Montezyd 10 Special Precautions

The efficacy of oral Montelukast tablets for the treatment of acute asthma attacks has not been established. Therefore, oral Montelukast tablets should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast tablets should not be abruptly substituted for inhaled or oral corticosteroids.
The reduction in systemic corticosteroid dose in patients receiving anti-asthma agents including leukotriene receptor antagonists has been followed in rare cases by the occurrence of one or more of the following: eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended when systemic corticosteroid reduction is considered in patients receiving Montelukast tablets.
Renal/Hepatic Impairment: No dosage adjustment is required for patients with renal insufficiency or mild to moderate hepatic impairment.
Carcinogenicity and Mutagenicity: There were no significant results seen with Montelukast sodium in carcinogenicity or mutagenicity studies.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: Montelukast tablets have been studied in paediatric patients 2 to 14 years of age. Safety and effectiveness in paediatric patients younger than 2 years of age have not been studied. Studies have shown that Montelukast tablets do not affect the growth rate of paediatric patients.
Use in the Elderly: In clinical studies, there were no age-related differences in the efficacy or safety profiles of Montelukast tablets.
Montezyd 4/Montezyd 5: Phenylketonurics꞉ Phenylketonuric patients should be informed that the 4 mg and the 5 mg chewable tablets contain phenylalanine (a component of aspartame) 674 and 842 mcg per 4 mg and 5 mg chewable tablet, respectively.
Montezyd 10: Reproduction: In pre-clinical studies, there were no significant results in reproduction studies conducted with Montelukast sodium.
Development: In developmental toxicity studies, there were no treatment related adverse effects at doses up to 400 mg/kg/day in rats and up to 100 mg/kg/day in rabbits. Fetal exposure of Montelukast sodium in rats and rabbits does occur and significant concentrations of medicine were observed in milk of lactating rats.
Effect on Ability to Drive and use Machines: There is no evidence that Montelukast tablets affect the ability to drive and use machines.