M-Lucas 10mg Tablet 1 Strip

✔️ For Asthma & Seasonal Allergic Rhinitis

🔹 Adults & Adolescents (15 years and older):
✔ Montelukast 10 mg tablet once daily in the evening.

🔹 Pediatric Patients:
✔ 6 to 14 years: Montelukast 5 mg tablet once daily.
✔ 2 to 5 years: Montelukast 4 mg tablet once daily.
✔ 6 months to 5 years: Montelukast 4 mg oral granules once daily.

Administration of Montelukast Oral Granules:

• Can be taken directly in the mouth or mixed with a spoonful of cold water or soft food (at room temperature).
• Must be consumed immediately after mixing; do not store for later use.

✔️ ✔ Pediatric Use:

• Montelukast has been proven safe and effective for children aged 6 months to 14 years based on clinical studies.
• Safety and efficacy profiles in children are similar to adults.

✔️ ✔ Elderly Patients:

• Montelukast’s pharmacokinetics and bioavailability remain comparable between younger adults and elderly patients.
• The plasma half-life is slightly prolonged in the elderly, but no dosage modification is necessary.

✔️ ✔ Renal Impairment:

• No dose adjustment is needed for patients with renal insufficiency.

✔️ ✔ Hepatic Impairment:

• No dosage adjustment is required for mild-to-moderate hepatic insufficiency.
• Caution is advised in patients with severe liver impairment due to potential altered drug metabolism.

✔️ Overdose Effects

✔ No serious adverse effects reported in overdose cases.
✔ Common overdose symptoms:

• Gastrointestinal discomfort – Abdominal pain, nausea, vomiting
• Neurological effects – Somnolence, headache, psychomotor hyperactivity
• Increased thirst

✔ Management:

• Gastric decontamination (removal of unabsorbed drug)
• Supportive therapy & clinical monitoring

✔️ Drug Interactions

Montelukast (M-Lucas) has been used alongside other common asthma treatments without an increase in adverse reactions.

✔ No significant interaction was observed with:

• Theophylline
• Prednisone & Prednisolone
• Oral Contraceptives (Norethindrone 1mg/Ethinyl Estradiol 35mcg)
• Terfenadine, Digoxin, Warfarin

✔ Safe concurrent use was also reported with:

• Thyroid hormones
• Sedative-hypnotics & benzodiazepines
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Decongestants

✔ Caution is advised when co-administering Montelukast with:

• Phenobarbital & Rifampin – These potent cytochrome P450 enzyme inducers may reduce Montelukast plasma levels by 40%, requiring clinical monitoring. However, dose adjustment is not necessary.

✔️ Contraindications

🚫 Montelukast is contraindicated in patients with hypersensitivity to any of its components.

✔️ Side Effects

🔹 Common Side Effects:

• Gastrointestinal issues – Diarrhea, nausea, vomiting, abdominal pain
• Respiratory infections – Upper respiratory tract infection
• Neurological symptoms – Headache, dizziness
• Skin reactions – Rash, pruritus
• Fever & fatigue

🔹 Uncommon Side Effects:

• Psychological effects – Anxiety, depression, abnormal behavior, irritability
• Neurological effects – Seizures, drowsiness, sleep disturbances, abnormal sensations
• Musculoskeletal issues – Arthralgia, muscle pain
• Blood disorders – Hemorrhage
• Edema & malaise

🔹 Rare Side Effects:

• Severe allergic reactions – Angioedema, erythema nodosum
• CNS effects – Hallucinations, memory loss, concentration impairment, disorientation
• Respiratory effects – Pulmonary eosinophilia
• Cardiac effects – Palpitations
• Liver dysfunction – Hepatic disorders
• Severe psychiatric effects – Suicidal tendencies, tremors

✔️ Pregnancy & Lactation

✔ Montelukast crosses the placenta in animal studies (rats and rabbits), but no adequate human studies exist.
✔ Use only if clearly needed during pregnancy.
✔ Montelukast may be excreted in breast milk – caution is advised when prescribing to lactating mothers.

✔️ Precautions & Warnings

⚠ Not for acute asthma attacks – Montelukast is NOT a substitute for rescue inhalers. Patients should keep short-acting bronchodilators available.
⚠ Corticosteroid Tapering: Montelukast should not replace inhaled or oral corticosteroids abruptly – dose reduction should be gradual under medical supervision.
⚠ Not for monotherapy in exercise-induced bronchospasm – Should be used alongside other asthma medications.
⚠ Aspirin-Sensitive Asthma: Patients must continue avoiding NSAIDs & aspirin, as Montelukast does not prevent aspirin-induced bronchospasm.

✔️ Storage Conditions

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