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Montene 10 Tablets ( Each tablet contains Montalukast Sodium 10mg)

Montalukast Sodium

FDA/SD.265-030409 Montalukast Sodium 10mg

What it does

Montalukast is a medication used to help manage breathing problems and allergies.

Commonly used for: asthma, seasonal allergies (hay fever), chronic obstructive pulmonary disease (COPD)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.265-030409
Registration date
2026-03-31
Expiry date
2031-04-01
Status
Valid
Active ingredient
Montalukast Sodium
Dosage form
Montalukast Sodium
Strength
10mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Square Pharmaceutical
Country of origin
INDIA
Manufacturer location
Unit no 202, RG Complex, DC Chowk, Rajapur, Sector 9, Rohini, New Delhi, Delhi, 110085, India

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:30 · updated 2026-10-20 04:00:05

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Montalukast is a medication used to help manage breathing problems and allergies.

What it treats

  • asthma
  • seasonal allergies (hay fever)
  • chronic obstructive pulmonary disease (COPD)

How it works

It works by blocking substances in the body that cause inflammation and tightening of the airways.

Who it's for

This medicine is for people with asthma or allergies, including children and adults.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: montalukast

Montelukast is a leukotriene receptor antagonist used primarily for the management of asthma and allergic rhinitis. It works by blocking the action of leukotrienes, which are inflammatory mediators that contribute to bronchoconstriction, mucus production, and airway edema. By inhibiting leukotriene receptors, montelukast helps to reduce inflammation and improve respiratory function.

Indications

  • Asthma
  • Allergic rhinitis
  • Exercise-induced bronchoconstriction

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

Montelukast selectively inhibits the cysteinyl leukotriene receptor 1 (CysLT1), preventing the action of leukotrienes such as LTC4, LTD4, and LTE4. This blockade leads to reduced bronchoconstriction, decreased mucus secretion, and diminished inflammatory responses in the airways, ultimately improving symptoms associated with asthma and allergic rhinitis.

Pharmacodynamics

The pharmacodynamic effects of montelukast include bronchodilation, reduction of airway inflammation, and decreased mucus secretion. The onset of action is typically observed within hours of administration, with peak effects occurring within 24 hours. It is effective in both the prevention and treatment of asthma symptoms, as well as in alleviating allergic rhinitis symptoms.

Pharmacokinetics

Montelukast is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 2 to 4 hours after oral administration. It is highly protein-bound (approximately 99%) and has a half-life of about 2.7 to 5.5 hours. The drug is extensively metabolized in the liver by cytochrome P450 enzymes, primarily CYP3A4 and CYP2C9, and is excreted mainly as metabolites in the urine and feces. Food does not significantly affect its absorption.

Contra-indications

  • Hypersensitivity to montelukast or any of its components

Adverse effects

  • Headache
  • Gastrointestinal disturbances (nausea, diarrhea)
  • Fatigue
  • Dizziness
  • Mood changes including agitation, aggression, anxiety, sleep disturbances

Interactions

  • May interact with CYP450 inducers such as phenobarbital, rifampicin, and certain herbal supplements, potentially reducing montelukast efficacy
  • Minimal interactions with other medications due to its specific metabolic pathway

Precautions

  • Monitor for neuropsychiatric events in patients with a history of mood disorders
  • Use caution in patients with hepatic impairment

Pregnancy

Montelukast is classified as pregnancy category B, indicating no evidence of risk in humans; however, it should only be used if clearly needed.

Breast-feeding

Montelukast is excreted in breast milk but is not expected to affect the nursing infant adversely; consult a healthcare provider for concerns.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets (10 mg)
  • Chewable tablets (4 mg, 5 mg)
  • Granules (4 mg)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.