Myteka is overall well tolerated. Its common side effects include asthenia, dyspepsia, dizziness, headache and flu like symptoms. In children, diarrhea, laryngitis, pharyngitis, nausea etc. might occur. Side effects are usually mild and do not necessitate therapy withdrawal. The incidence of side effects is comparable to placebo.
Myteka tablets and sachets are contraindicated in case of history of hypersensitivity to montelukast or any other ingredient of the product.
- Since efficacy of montelukast sodium is not established as a treatment of acute asthma attacks, Myteka tablets and sachets should not be used alone as a treatment of acute asthma attacks.
- If the patient was on inhaled corticosteroid previously, the dose of inhaled corticosteroids can be gradually reduced or tapered off completely after getting adequate clinical response with the combination of inhaled corticosteroids with Myteka tablets and sachets. However, Myteka tablets and sachets should not be abruptly used as a replacement of inhaled corticosteroids.
Use during Pregnancy
Since montelukast has not been studied in pregnant women, Myteka tablets and sachets should be cautiously used only if benefits outweigh the risks.
Use during Lactation
It is not known whether montelukast is excreted in breast milk. Since many drugs are excreted in human milk, Myteka tablets and sachets should be cautiously prescribed when given to a lactating mother.
Uses in Children
Myteka has been studied in pediatric patients 6 months to 14 years of age (See Dosage and Administration). Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. Studies have shown that montelukast does not affect the growth rate of pediatric patients.
Use in Old Age Patients
No difference has been seen in the efficacy or safety of montelukast in different age groups.
Myteka may be co-administered with other drugs commonly used for the chronic treatment and prophylaxis of asthma. Since the therapeutic dose of montelukast has not been found to have clinically significant effects on the pharmacokinetics of theophylline, prednisolone, oral contraceptives (ethynyl estradiol/norethindrone), terfenadine, digoxin and warfarin, it can be safely co-prescribed with these drugs.
There is no report of overdosage with montelukast in doses as high as 900 mg/day. It is not known whether montelukast is dialyzable by peritoneal or hemo-dialysis.