Monas 5 is a chewable tablet containing Montelukast Sodium USP equivalent to 5 mg of Montelukast. It is manufactured by The ACME Laboratories Ltd. in Bangladesh.

Indications:

Monas 5 (Montelukast) is a selective and orally active leukotriene receptor antagonist. It works by blocking the action of certain natural substances in the body called leukotrienes, which are involved in the inflammatory processes of asthma and allergic rhinitis. Monas 5 is indicated for:

• Prophylaxis and chronic treatment of asthma in pediatric patients aged 6 to 14 years. (For adults and adolescents 15 years and older, a 10 mg dose is typically used).
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB) in pediatric patients aged 6 to 14 years.
• Relief of symptoms of Allergic Rhinitis (AR): Both seasonal and perennial allergic rhinitis in pediatric patients aged 6 to 14 years.

Pharmacology:

Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are inflammatory mediators released from various cells, including mast cells and eosinophils. These leukotrienes contribute to airway edema, smooth muscle contraction, and altered cellular activity associated with inflammation in asthma and allergic rhinitis. Montelukast specifically inhibits the cysteinyl leukotriene receptor (CysLT1), thereby reducing these inflammatory responses and alleviating symptoms.

Dosage and Administration:

Monas 5 is a chewable tablet and can be administered either directly in the mouth or mixed with a spoonful of cold water or soft food at room temperature. It may be taken with or without food. For asthma, it is generally recommended to take it in the evening. Monas 5 is not indicated for use in the reversal of bronchospasm in acute asthma attacks; patients should have appropriate rescue medication available.

• Pediatric patients 6 years to 14 years of age: 5 mg (one tablet) once daily, in the evening.
• For prevention of Exercise-Induced Bronchoconstriction (EIB), a single dose should be taken at least 2 hours before exercise.

Side Effects:

Montelukast is generally well-tolerated. Common side effects include:

• Headache
• Upper respiratory infection
• Diarrhea, nausea, vomiting, abdominal pain
• Fever
• Rash

Less common or rare side effects can include:

• Neuropsychiatric events: Sleep disturbances (e.g., nightmares, insomnia), agitation, anxiety, depression, suicidal thoughts and behavior (rare, but important to monitor for).
• Dizziness, drowsiness.
• Increased bleeding tendency.
• Allergic reactions (e.g., swelling, hives).
• Elevated liver enzymes, hepatitis (rare).
• Muscle complaints (arthralgia, myalgia).

Contraindications:

Monas 5 is contraindicated in patients with:

• Known hypersensitivity to Montelukast or any component of the product.

Precautions and Warnings:

• Acute Asthma Attacks: Monas 5 is not a rescue medication for acute asthma attacks. Patients should continue to use their prescribed rescue inhaler for sudden breathing problems.
• Corticosteroid Substitution: Monas 5 should not be abruptly substituted for inhaled or oral corticosteroids. Any reduction in corticosteroid dose should be gradual and under medical supervision.
• Neuropsychiatric Events: Patients, parents, and caregivers should be monitored for neuropsychiatric symptoms (e.g., agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior). If such symptoms occur, a healthcare provider should be consulted.
• Aspirin Sensitivity: While Monas 5 can improve airway function in aspirin-sensitive asthmatics, it has not been shown to block the bronchoconstrictor response to aspirin or other NSAIDs. Patients with aspirin sensitivity should continue to avoid aspirin and NSAIDs.
• Phenylketonuria: Chewable tablets contain aspartame, a source of phenylalanine, which may be harmful to patients with phenylketonuria.
• Liver Impairment: Use with caution in patients with severe liver disease; no dosage adjustment is typically needed for mild-to-moderate impairment.
• Driving/Operating Machinery: May cause dizziness or drowsiness, which could impair the ability to drive or operate machinery.

Pregnancy and Lactation:

• Pregnancy: While available data from studies have not established a definitive drug-associated risk of major birth defects, Montelukast should be used during pregnancy only if clearly needed and after a thorough risk-benefit assessment by a doctor.
• Lactation: Montelukast is excreted in breast milk. Caution should be exercised when given to a nursing mother.

Drug Interactions:

Montelukast is metabolized by CYP enzymes (2C8, 2C9, 3A4).

• Phenobarbital, Phenytoin, Rifampicin: These drugs, which induce hepatic metabolism, may decrease the plasma concentration of Montelukast.
• Gemfibrozil (a CYP2C8 and 2C9 inhibitor): Can increase systemic exposure to Montelukast. No routine dosage adjustment is required, but awareness of potential for increased adverse reactions is advised.
• Other medications: Montelukast has been administered with other routine asthma and allergy therapies (e.g., thyroid hormones, sedative hypnotics, NSAIDs, benzodiazepines, decongestants) with no apparent increase in adverse reactions.

Storage Conditions:

Store in a cool and dry place below 30°C, protected from light and moisture. Keep out of reach of children.

Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.