Each VENTEK 5 mg (chewable tablet) contains: Active ingredient: Montelukast Sodium 5.2 mg equivalent to Montelukast Acid 5 mg.
Each VENTEK 10 mg (film coated tablet) contains: Active ingredient: Montelukast Sodium 10.4 mg equivalent to Montelukast Acid 10 mg.
Excipients/Inactive Ingredients: 5 mg chewable tab: Hydroxypropyl cellulose, Microcrystalline cellulose, Mannitol, Croscarmellose sodium, Aspartame, Strawberry powder flavour, Magnesium stearate, F.D. & C Red No. 3 Lake.
10 mg FC tab: Hydroxypropyl Cellulose, Microcrystalline Cellulose, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Hydroxy Propyl Methyl Cellulose, Polyethylene Glycol 400, Polyethylene Glycol 6000, Talc, Titanium Dioxide, Red Iron Oxide.
Pharmacology: Pharmacodynamics: Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD4- induced bronchoconstriction. In a placebo-controlled, crossover study (n=12), Montelukast inhibited early- and late-phase bronchoconstriction due to antigen challenge by 75% and 57%, respectively.
Pharmacokinetics: Montelukast is rapidly absorbed following oral administration. After administration of the 5-mg chewable tablet to fasted adults, the mean peak montelukast plasma concentration (Cmax) is achieved in 3 to 4 hours (Tmax). The mean oral bioavailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal in the morning.
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-I (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process.
VENTEK is indicated in adult and pediatric patients 6 years of age and older for the prophylaxis and chronic treatment of asthma, including prevention of day and night time symptoms, the treatment of allergic rhinitis, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction.
VENTEK is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
VENTEK should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patient needs.
Adults and adolescents 15 years of age and older: The dosage is one 10 mg film coated tablet daily.
Pediatric patients 6 to 14 years of age: The dosage is one 5 mg chewable tablet daily.
Pediatric patients 2 to 5 years of age: The dosage is one 4 mg chewable tablet daily.
No specific information is available on the treatment of over dosage with Montelukast Acid. In chronic asthma studies, Montelukast Acid 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.
In the event of overdose, it is reasonable to employ the usual supportive measures: e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experiences observed were thirst, somnolence, mydriasis, and abdominal pain.
Hypersensitivity to any component of this product.
Children under 2 years of age.
Montelukast Sodium is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus.
Patients should be advised to take VENTEK daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled.
Patients should be advised that while using VENTEK, medical attention should be sought if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24 hour period are needed.
Patients receiving VENTEK should be instructed not to decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.
General precautions: Montelukast Sodium should not be abruptly substitued for inhaled or oral corticosteroids. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring is recommended when corticosteroid reduction is considered in patients receiving Montelukast Sodium.
Montelukast Sodium should not be used as monotherapy for the treatment and management of exercise-induced asthma. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled β-agonists as prophylaxis and should have it available as and when required.
Patients with known aspirin sensitivity should continue avoidance of aspirin or other nonsteroidal anti-inflammatory agents while taking Montelukast Sodium. Although VENTEK is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.
In rare cases, patiens with asthma on therapy with Montelukast Sodium may present with systemic eosinophillia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. A causal association between Montelukast Sodium and these underlying conditions has not been established.
Pediatric Use: Safety and efficacy of Montelukast Sodium have been established in adequate and well-controlled studies in pediatric patients with asthma and seasonal allergic rhinitis.
Geriatric Use: In clinical studies, no overall differences in safety or effectiveness were observed in geriatrics, but greater sensitivity of some older individuals can not be ruled out.
Use in Pregnancy: Montelukast Sodium has not been studied in pregnant women. It should be used during pregnancy only if clearly needed.
In animal studies, no teratogenicity was observed at oral doses up to 400mg/kg/ day.
Use in Nursing Mothers: It is not known if Montelukast Sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VENTEK is given to a nursing mother.
Montelukast Sodium is generally well tolerated. However, following are the adverse effects reported which usually were mild and did not require discontinuation of therapy.
Hypersensitivity reactions (including angioedema, rash, pruritus, urticaria and very rarely, hepatic eosinophillic infiltration).
Dream abnormalities, hallucinations, palpitations, drowsiness, irritability, restlessness, asthenia/fatigue, insomnia, increased sweating, dizziness, headache, mydriasis.
Nausea, vomiting, dyspepsia, diarrhea, abdominal pain.
Myalgia including muscle cramps.
Nasal congestion, ALT (Alanine aminotransferase) increased, AST (Aspartate aminotransferase) increased, pyuria.
Increased bleeding tendency, bruising edema.
Tremor, dry mouth, vertigo, arthralgia.
Inform a doctor in case of any adverse reactions related to drug use.
Montelukast Acid: Did not cause clinically significant changes in the kinetics of a single intravenous dose of theophylline.
Did not change the pharmacokinetic profile of warfarin or influence the effect of a single 30 mg oral dose of warfarin on prothrombin time or the INR (International Normalized Ratio).
Did not change the pharmacokinetic profile or urinary excretion of digoxin.
Did not change the plasma concentration profile of terfenadine or fexofenadine, its carboxylated metabolite, and did not prolong the QTc interval following coadministration with terfenadine 60 mg twice daily.
Did not significantly alter the plasma concentrations of either component of an oral contraceptive containing norethindrone 1mg/ethinyl estradiol 35 mcg.
Did not cause any clinically significant change in plasma profiles of prednisone or prednisone following administration of either oral prednisone or intravenous prednisone.
Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast Acid approximately 40% following a single 10 mg dose of Montelukast Acid. No dosage adjustment for Montelukast Acid is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as Phenobarbital or rifampin, are co-administered with Montelukast Acid.
Montelukast Acid may inhibit the metabolism of drugs primarily metabolized by CYP 2C8 e.g., paclitaxel, rosiglitazone, repaglinide; however, no in vivo interaction studies have been performed.
Store below 30°C, protect from sunlight and moisture.
Shelf-Life: 24 months from the manufacturing date.
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Chewable tab 5 mg 2 x 7's. FC tab 10 mg x 2 x 7's.