Leukast Plus

Leukast Plus

Manufacturer:

Cooper Pharma

Distributor:

GXI

Marketer:

Ambica
Concise Prescribing Info
Contents
Montelukast Na 10 mg, levocetirizine HCl 5 mg
Indications/Uses
Levocetirizine: Relief of nasal & ocular symptoms of seasonal & perennial allergic rhinitis; symptomatic relief of chronic idiopathic urticaria. Montelukast: Asthma as add-on therapy in patients 6 mth-5 yr w/ mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids & in whom "as-needed" short acting β-agonists provide inadequate clinical control of asthma. Alternative treatment option to low-dose inhaled corticosteroids for patients 2-5 yr w/ mild persistent asthma who do not have recent history of serious asthma attacks that required oral corticosteroid use, & who have demonstrated that they are not capable of using inhaled corticosteroids. Prophylaxis of asthma from ≥2 yr in which predominant component is exercise-induced bronchoconstriction.
Dosage/Direction for Use
Adult Allergic rhinitis & chronic asthma 10 mg once daily in the evening. Prophylaxis of exercise-induced asthma 10 mg at least 2 hr before exercise.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Severe renal impairment (CrCl <10 mL/min).
Special Precautions
Very rare cases of drowsiness or dizziness which may affect ability to drive & use machines. Renal & hepatic impairment. Pregnancy & lactation. Levocetirizine: Epileptic patients & patients at risk of convulsion. Concomitant use w/ alcohol. Not recommended in childn <6 yr. Montelukast: Not to be used to treat acute asthma attacks. Not to be abruptly substituted for inhaled or oral corticosteroids. Rare cases of systemic eosinophilia, sometimes presenting w/ clinical features of vasculitis consistent w/ Churg-Strauss syndrome. Reassess patients who develop eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, &/or neuropathy, & evaluate treatment regimens. Does not alter the need for patients w/ aspirin-sensitive asthma to avoid taking aspirin & other NSAIDs. Childn 6 mth-2 yr.
Adverse Reactions
Montelukast: Dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, fever, trauma, cough, nasal congestion. Levocetirizine: Somnolence, fatigue, nasopharyngitis, dry mouth, pharyngitis.
Drug Interactions
Montelukast: Decreased AUC w/ phenobarb. Employ appropriate clinical monitoring in co-administration w/ potent cytochrome P450 enzyme inducers eg, phenobarb or rifampin. Levocetirizine: Small decrease in clearance of cetirizine (racemate compd) w/ theophylline. Ritonavir increased plasma AUC of cetirizine accompanied by increase in t½ & decrease in clearance of cetirizine.
MIMS Class
Antiasthmatic & COPD Preparations / 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
Leukast Plus FC tab
Packing/Price
30's
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