Full Prescribing Info
Each film coated tablet contain: Montelukast sodium equivalent to montelukast 10 mg.
Pharmacology: Mechanism of Action: The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro-ashmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT), receptor is found in the human airway (including airway smooth muscle cell and airway macrophage) and on other pro-inflamatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma. In asthma, leukotriene-mediated effects include a number of airway actions, including bronchoconstriction, mucous secretion, vascular permeability and eosinophil recruitment.
Montelukast is orally active compound that significantly improves parameters of asthmatic inflammation. Based on biochemical and pharmacological bioassays, it binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors such as the prostanoid, cholinergic, or β-adrenergic receptor). Montelukast potently inhibits physiologic actions of LTC4, LTD4 and LTE4 at the CysLT1 receptor without any agonist activity.
Isivas is indicated in adult for prophylaxis and chronic treatment of asthma, including the prevention of exercise-induced bronchoconstriction.
Dosage/Direction for Use
Asthma: Isivas should be taken once daily in the evening (one-10 mg tablet).
Exercise-Induced Bronchoconstriction (EIB): For prevention of EIB, a single dose (one-10 mg tablet) of Isivas should be taken at least 2 hours before exercise.
An additional dose of Isivas should not be taken within 24 hours of previous dose. Patients already taking Isivas daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist.
No specific information is available on the treatment of overdosage with Isivas. In chronic asthma studies, Isivas has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
There have been reports of acute overdosage in postmarketing experience and clinical studies with Isivas. These include reports in adults and children with a dose as high as 1000 mg. 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 Isivas and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. It is not known whether montelukast is dialyzable by peritoneal or hemodialysis.
Hypersensitivity to any component of this product.
Special Precautions
The efficacy of oral Isivas for the treatment of acute asthma attacks has not been established. Therefore, oral Montelukast should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Isivas should not be abruptly substituted for inhaled or oral corticosteroids.
Neuropsychiatric events have been reported in patients taking Isivas (see SIDE EFFECTS). Since other factors may have contributed to these events, it is not known if they are related to Isivas. Physician should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these changes occur.
In rare cases patients receiving anti-asthma agents, including leukotriene receptor antagonists, have experienced one or more of the following: eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended in patients receiving Isivas.
Isivas should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continues to use their usual regimen of inhaled-agonist as prophylaxis and have available for rescue a short-acting inhaled-agonist.
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal antiinflamatory agent while taking Montelukast. Although Isivas is effective in improving airway function in asthmatic with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other NSAIDs in aspirin-sensitive asthmatic patients.
Use in Children: Isivas 10 mg tablets should not be prescribed to patients <15 years of age.
Use in Elderly: In clinical studies, there were no age-related differences in the efficacy or safety profiles of Isivas.
Use In Pregnancy & Lactation
Pregnancy: Isivas has not been studied in pregnant women. Isivas should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known if Isivas is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast is given to a nursing mother.
Side Effects
Isivas has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy.
Postmarketing Experience: (See table.)

Click on icon to see table/diagram/image

Drug Interactions
Isivas may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinatics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethynil estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
There are area under the plasma concentration-time curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of Phenobarbital. No dosage adjustment for Isivas is recommended.
Store below 30°C.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Isivas tab 10 mg
30's (Rp180,000/boks)
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