Loctril 10 mg (Tablet)

Title

• Loctril 10 mg Tablet

Categories

• Medication
• Asthma Treatment
• Allergic Rhinitis Relief
• Leukotriene Receptor Antagonist

Description

• Loctril is indicated for prophylaxis and chronic treatment of asthma
• Loctril is indicated for acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Loctril is indicated for relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
• Loctril is a selective and orally active leukotriene receptor antagonist
• Montelukast inhibits the cysteinyl leukotriene receptor (CysLT1)
• Montelukast inhibits cysteinyl leukotrienes (LTC4, LTD4, LTE4)
• Cysteinyl leukotrienes and leukotriene receptor occupation are correlated with the pathophysiology of asthma & allergic rhinitis
• Loctril can be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma
• No apparent increase in adverse reactions when administered concomitantly with other therapies
• Loctril did not have clinically important effects on the pharmacokinetics of theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 3mcg), terfenadine, digoxin, and warfarin
• Loctril was used concomitantly with a wide range of commonly prescribed drugs without evidence of clinical adverse interactions
• Phenobarbital decreased the AUC of Loctril approximately 40% following a single 10mg dose of Loctril
• Loctril is contraindicated in patients who are hypersensitive to any component of this product
• Loctril common side effects include diarrhea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, and upper respiratory tract infection
• Loctril uncommon side effects include akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, and dry mouth
• Loctril rare side effects include angioedema, impaired concentration, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, and suicidal tendencies
• Montelukast should be used during pregnancy only if clearly needed
• Caution should be exercised when Montelukast is given to a nursing mother
• Loctril is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus
• Therapy with Loctril can be continued during acute exacerbations of asthma
• Loctril should not be used as monotherapy for the treatment and management of exercise induced bronchospasm
• Loctril should not be abruptly substituted for inhaled or oral corticosteroids
• Loctril can be stored in a cool and dry place below 30°C, protected from light and moisture
• Montelukast has a molecular formula C35H36ClNO3S

Indications

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Pharmacology

• Montelukast is a selective and orally active leukotriene receptor antagonist
• Montelukast inhibits the cysteinyl leukotriene receptor (CysLT1)
• 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

Dosage and administration

• Montelukast 10 mg tablet once daily for adults and adolescents 15 years of age and older
• Montelukast 5 mg tablet once daily for pediatric patients 6 to 14 years of age
• Montelukast 4 mg tablet once daily for pediatric patients 2 to 5 years of age
• Montelukast 4 mg oral granules once daily for pediatric patients 6 months to 5 years of age
• No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency
• No dosage adjustment is recommended in patients with renal insufficiency
• The pharmacokinetic profile and the oral bioavailability of a single 10-mg oral dose of montelukast are similar in elderly and younger adults

Interaction

• Loctril has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions
• Loctril did not have clinically important effects on the pharmacokinetics of theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 3mcg), terfenadine, digoxin, and warfarin
• Loctril was used concomitantly with a wide range of commonly prescribed drugs without evidence of clinical adverse interactions
• Phenobarbital, which induces hepatic metabolism, decreased the AUC of Loctril approximately 40% following a single 10mg dose of Loctril

Contraindications

• Loctril is contraindicated in patients who are hypersensitive to any component of this product

Side effects

• Common side effects include diarrhea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, and upper respiratory tract infection
• Uncommon side effects include akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, and haemorrhage
• Rare side effects include angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, and suicidal tendencies

Pregnancy and lactation

• Montelukast crosses the placenta following oral dosing in rats and rabbits
• There are no adequate and well-controlled studies in pregnant women
• Montelukast should be used during pregnancy only if clearly needed
• Caution should be exercised when Montelukast is given to a nursing mother

Precautions and warnings

• Loctril is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus
• Therapy with Loctril can be continued during acute exacerbations of asthma
• While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Loctril should not be abruptly substituted for inhaled or oral corticosteroids
• Loctril 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 Loctril

Overdose effects

• There were no adverse experiences in the majority of overdosage reports
• The most frequently occurring adverse experiences were consistent with the safety profile of Loctril and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity
• In the event of overdose, usual supportive measures should be employed

Therapeutic class

• Leukotriene receptor antagonists

Storage conditions

• Loctril can be stored in a cool and dry place below 30°C
• Loctril should be protected from light and moisture
• Loctril should be kept out of reach of children

Chemical structure

• Molecular Formula : C35H36ClNO3S

Commonly asked questions

• Loctril 10 mg Tablet is commonly used to treat asthma or allergic rhinitis
• The effect of Loctril 10 mg Tablet can be observed after 1-3 hours of administration
• The effect of Loctril 10 mg Tablet lasts for an average duration of 24 hours
• Loctril 10 mg Tablet may be taken with or without food as prescribed by your doctor
• 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
• Use of Loctril 10 mg Tablet in pregnant women should be avoided unless clearly needed

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