Monalast ODT 4 mg (Dispersible Tablet)

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

• Selective and orally active leukotriene receptor antagonist
• Inhibition of cysteinyl leukotriene receptor (CysLT1)
• Correlation with pathophysiology of asthma & allergic rhinitis
• Effects on airway edema, smooth muscle contraction, and altered cellular activity

Dosage & Administration

• Recommended dosage for adults and adolescents 15 years of age and older: Montelukast 10 mg tablet once daily
• Recommended dosage for pediatric patients 6 to 14 years of age: Montelukast 5 mg tablet once daily
• Recommended dosage for pediatric patients 2 years to 5 years of age: Montelukast 4 mg tablet once daily
• Use in the pediatric patient: Safety and efficacy established in pediatric patients with asthma 6 months to 14 years of age
• No dosage adjustment required in patients with mild-to-moderate hepatic insufficiency
• No dosage adjustment recommended in patients with renal insufficiency
• Similar pharmacokinetic profile and oral bioavailability in elderly and younger adults

Interaction

• No apparent increase in adverse reactions when administered with other therapies used in the prophylaxis and chronic treatment of asthma
• No clinically important effects on the pharmacokinetics of specified drugs
• Used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of adverse interactions

Contraindications

• Hypersensitivity to any component of the product

Side Effects

• 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

Pregnancy & Lactation

• Crosses the placenta following oral dosing in rats and rabbits
• No adequate and well-controlled studies in pregnant women
• Use during pregnancy only if clearly needed
• Caution should be exercised when given to a nursing mother

Precautions & Warnings

• Not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus
• Patients should have appropriate rescue medication available
• Can be continued during acute exacerbations of asthma
• Should not be abruptly substituted for inhaled or oral corticosteroids
• Not to 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
• Effective in improving airway function in asthmatics with documented aspirin sensitivity but not shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients

Overdose Effects

• No adverse experiences in the majority of overdosage reports
• Adverse experiences consistent with the safety profile of the product
• Usual supportive measures recommended in the event of overdose

Therapeutic Class

• Leukotriene receptor antagonists

Storage Conditions

• Store in cool & dry place below 30°C
• Protect from light & moisture
• Keep out of reach of children

Chemical Structure

• Molecular Formula: C35H36ClNO3S

Common Questions about Monalast ODT 4 mg Tablet

• What is Monalast ODT 4 mg DT?
• What is Monalast ODT 4 mg DT used for?
• How soon can the effect of Monalast ODT 4 mg DT be observed?
• How long does the effect of Monalast ODT 4 mg DT last?
• Should I use Monalast ODT 4 mg DT empty stomach?
• What if I miss a dose of Monalast ODT 4 mg DT?
• Are there any pregnancy warnings for Monalast ODT 4 mg DT?
• General Instructions

Related Brands

• Aeron FT 4 mg (Dispersible Tablet) - healthcare-pharmaceuticals-ltd
• Aeron FT 5 mg (Dispersible Tablet) - healthcare-pharmaceuticals-ltd
• Aeron 10 mg (Tablet) - healthcare-pharmaceuticals-ltd
• Montinex 4 mg (Chewable Tablet) - beacon-pharmaceuticals-plc
• Montinex 5 mg (Chewable Tablet) - beacon-pharmaceuticals-plc