Advertisement
Advertisement
Glemont L

Glemont L

Manufacturer:

Glenmark

Distributor:

Glenmark
Concise Prescribing Info
Contents
Montelukast Na 10 mg, levocetirizine HCl 5 mg
Indications/Uses
Relief of symptoms associated w/ seasonal allergic rhinitis.
Dosage/Direction for Use
Adult & adolescent (≥15 yr) 1 tab in the evening.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Hypersensitivity to montelukast Na, levocetirizine HCl, hydroxyzine, or any other piperazine derivatives. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption. Severe renal impairment (CrCl <10 mL/min).
Special Precautions
Contains lactose. May affect ability to drive & use machines. Moderate to severe renal impairment (CrCl <79 to >10 mL/min). Pregnancy & lactation. Montelukast: Never use to treat acute asthma attacks & keep usual appropriate rescue medication readily available. Do not substitute abruptly for inhaled or oral corticosteroids. Does not alter the need for patients w/ aspirin-sensitive asthma to avoid taking aspirin & other NSAIDs. Neuropsychiatric events in adult, adolescent, & ped patients. Patients on therapy may present w/ 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. Levocetirizine: Occurrence of somnolence, fatigue, & asthenia in patients under therapy. Avoid concurrent use w/ alcohol or other CNS depressants. Patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia); epilepsy & at risk of convulsion. Inhibited response to allergy skin tests; require wash-out period (of 3 days) before performing allergy skin tests. Pruritus may occur when stopped even if not present before treatment initiation.
Adverse Reactions
Montelukast: Adult (≥15 yr): Headache; abdominal pain. Ped patients (6-14 yr): Headache. Upper resp infection. Diarrhoea, nausea, vomiting; elevated levels of serum transaminases (ALT, AST); rash; pyrexia. Levocetirizine: Adult & adolescent (>12 yr): Headache, somnolence, dry mouth, fatigue. Ped patients (6-11 mth & 1 to <6 yr): Diarrhoea, vomiting, constipation; somnolence.
Drug Interactions
Montelukast: Decreased AUC w/ phenobarb. Caution particularly in childn when co-administered w/ inducers of CYP 3A4, 2C8, & 2C9, eg, phenytoin, phenobarb & rifampicin. Increased systemic exposure w/ gemfibrozil or other potent inhibitors of CYP 2C8. Levocetirizine: Decreased rate of absorption w/ food. May cause additional reductions in alertness & impairment of performance w/ alcohol or other CNS depressants. Small decrease in clearance of cetirizine (racemate compd) w/ theophylline. Extent of exposure to cetirizine was increased while disposition of ritonavir was slightly altered. Ritonavir increased plasma AUC of cetirizine accompanied by increase in t½ & decrease in clearance of cetirizine.
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
Glemont L FC tab
Packing/Price
30's (P776.5/box)
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement