Montelukast Sodium

Montelukast Sodium is indicated for:

Prophylaxis and chronic treatment of asthma

Acute prevention of Exercise-Induced Bronchoconstriction (EIB)

Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults and adolescents with asthma or seasonal allergic rhinitis:

The dosage for adults and adolescents 15 years of age and older: Montelukast 10 mg tablet once daily.

Pediatric patients with asthma or seasonal allergic rhinitis:

The dosage for pediatric patients 6 to 14 years of age: Montelukast 5 mg tablet once daily.

The dosage for pediatric patients 2 years to 5 years of age: Montelukast 4 mg tablet once daily.

The dosage for pediatric patients 6 months to 5 years of age: Montelukast 4 mg oral granules once daily. This can be administered either directly in the mouth, or mixed with a spoonful of cold water or soft food at room temperature

Use in the pediatric patient: The safety and efficacy of Montelukast have been established in adequate and well-controlled studies in pediatric patients with asthma 6 months to 14 years of age. Safety and efficacy profiles in this age group are similar to those seen in adults.

Hepatic Insufficiency: No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency.

Renal Insufficiency: No dosage adjustment is recommended in patients with renal insufficiency.

Elderly use: The pharmacokinetic profile and the oral bioavailability of a single 10-mg oral dose of montelukast are similar in elderly and younger adults. The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.

Montelukast Sodium has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug interaction studies, the recommended clinical dose of Montelukast Sodium did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), terfenadine, digoxin, and warfarin. Although additional specific interaction studies were not performed, Montelukast Sodium was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions. These medications included thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines and decongestants. Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast Sodium approximately 40% following a single 10mg dose of Montelukast Sodium. No dosage adjustment for Montelukast Sodium 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 Sodium.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast crosses the placenta following oral dosing in rats and rabbits. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Montelukast should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Montelukast is given to a nursing mother.

Montelukast Sodium is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast Sodium can be continued during acute exacerbations of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast Sodium should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast Sodium should not be used as monotherapy for the treatment and management of exercise induced bronchospasm. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast Sodium. Although Montelukast Sodium 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.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast Sodium and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. 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.

Leukotriene receptor antagonists

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Molecular Formula : C35H36ClNO3S

Chemical Structure :

What is Montelukast Sodium 10 mg Tablet?Montelukast Sodium 10 mg Tablet is a selective and orally active leukotriene receptor antagonist.What is Montelukast Sodium 10 mg Tablet used for?Montelukast Sodium 10 mg Tablet is commonly used to treat asthma or allergic rhinitis. It helps keep airways open and easy breathing by blocking leukotrienes.How soon can the effect of Montelukast Sodium 10 mg Tablet be observed?The effect of Montelukast Sodium 10 mg Tablet can be observed after 1-3 hours of administration. Montelukast Sodium 10 mg Tablet is not a fast-acting rescue medicine for asthma attacks and needs to be taken daily to work properly.How long does the effect of Montelukast Sodium 10 mg Tablet last?The effect of Montelukast Sodium 10 mg Tablet lasts for an average duration of 24 hours.Should I use Montelukast Sodium 10 mg Tablet empty stomach?Montelukast Sodium 10 mg Tablet may be taken with or without food as prescribed by your doctor.What if I miss a dose of Montelukast Sodium 10 mg Tablet?If you miss a dose, you may take it as soon as possible. But if it is almost time for your next dose, just skip that dose. Do not double up on doses.Are there any pregnancy warnings for Montelukast Sodium 10 mg Tablet?Use of Montelukast Sodium 10 mg Tablet in pregnant women should be avoided unless clearly needed.General Instructions

Take Montelukast Sodium 10 mg Tablet exactly as prescribed by your doctor.

Do not change your Montelukast Sodium 10 mg Tablet dose or stop using asthma medication without your doctor's advice.

Montelukast Sodium 10 mg Tablet is not a fast-acting rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.

Avoid situations or activities that may trigger an asthma attack.

Talk to your doctor before using Montelukast Sodium 10 mg Tablet if you're pregnant or breastfeeding. They can help you decide if it's the right choice for you.