Each film-coated tablet contains: Montelukast (as sodium), 10mg and Levocetirizine hydrochloride 5mg.
There is no data to prove the overdosage of this combination. However, overdosage has been reported with individual molecules. Montelukast: There have been reports of acute overdosage in post-marketing experience and clinical studies with Montelukast. These include reports in adults and children with a dose as high as 1000mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients. There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. It is not known whether Montelukast is removed by the peritoneal dialysis or hemodialysis. Levocetirizine: Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness followed by drowsiness in children. There is no known specific antidote to Levocetiriane. Shoould overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by dialysis and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
Patients who are hypersensitive to any component of this product or to Montelukast sodium, Levocetirizine or Cetirizine. Patients with completely impaired renal function (Anuria).
Montelukast: Eosinophilic Conditions: In rare cases, patients on therapy with Montelukast may present with systemic, eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Levocetirizine: Precautions is recommended with intake of alcohol and in those who are on CNS depressants. Patients with rare hereditary problems of galactose intolerance the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
ASIA PACIFIC – PHILIPPINES
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