Montellion-L

Montellion-L

Manufacturer:

Stallion Labs

Distributor:

Ambica
Concise Prescribing Info
Contents
Montelukast Na 10 mg, levocetirizine HCl 5 mg
Indications/Uses
Symptomatic relief of allergic rhinitis [seasonal or perennial], as prophylaxis in seasonal allergic rhinitis & treatment of comorbid asthma & allergic rhinitis in childn ≥15 yr.
Dosage/Direction for Use
Adult, adolescent & childn ≥15 yr 1 tab once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Patients w/ severe renal impairment at CrCl <10 mL/min. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Special Precautions
Montelukast: Do not use to treat acute asthma attacks; If an acute attack occurs, a short-acting inhaled β-agonist should be used. Do not abruptly substitute for inhaled or oral corticosteroids. Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, &/or neuropathy may occur; patients who develop these symptoms should be reassessed & their treatment regimens evaluated. Patients w/ phenylketonuria. Neuropsychiatric events may occur. Concomitant use w/ oral corticosteroids. Levocetirizine: Patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia); epilepsy & patients at risk of convulsion. Response to allergy skin tests are inhibited & a wash-out period (of 3 days) is required before performing them. Pruritus may occur when levocetirizine is stopped. Concurrent intake of alcohol. Pregnancy & lactation. Childn <6 yr.
Adverse Reactions
Hypersensitivity reactions including anaphylaxis (over sensitivity reactions including severe allergic reaction). Montelukast: Churg-Strauss syndrome (inflammation of medium & small blood vessels); drug interaction w/ medicines that inhibit some liver enzymes (eg, phenobarb, phenytoin & rifampicin); hyperkinesia (hyperactivity); increase in hepatic (liver) enzymes ALAT & ASAT; hallucinations (seeing, hearing or feeling); irritability, anxiety (generalized fear), agitation, depression, suicidal thought & behavior; dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, fever, trauma, cough, nasal congestion. Levocetirizine: Impairment of kidney function (renal impairment); sedation; iridocyclitis; effects on the CNS when concomitantly administered w/ alcohol; urinary retention; somnolence, fatigue, nasopharyngitis, dry mouth, & pharyngitis.
Drug Interactions
Montelukast: Decreased AUC w/ phenobarb or rifampin. Levocetirizine: Decreased clearance w/ theophylline. Increased plasma AUC w/ ritonavir.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R03DC53 - montelukast, combinations ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Form
Montellion-L FC tab
Packing/Price
30's
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