Medication info

Montelukast Granules 4mg (Montelukast Sodium)

Prescription medication경구Approval withdrawn
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
엔비케이제약(주)
Appearance
Homogeneous white granules without impurities
Packaging
4mg/packet, 4mg/packet x 28
Approval status
Approval withdrawn

MFDS item code 202002914 · Approved 2020.04.23

This product's status changed to Approval withdrawn on 2024.07.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and alleviation of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This 4 mg granule formulation can be taken orally directly or mixed with a small amount (about 5 mL) of soft food like room temperature baby food, breast milk, or porridge. The packaging should not be opened until just before administration, and it should be mixed into baby food, breast milk, or food immediately (within 15 minutes) after opening. This medication can be taken regardless of mealtime.
Child dose
Children aged 2 to 5 years: Administer 4 mg orally once daily. Infants aged 12 months to less than 2 years: Administer 4 mg orally once daily in the evening. Infants aged 6 months to less than 2 years: Administer 4 mg orally once daily.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Prevention of asthma and alleviation of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication is used to prevent asthma and assist in continued treatment. It is also used to alleviate the symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

This 4 mg granule formulation can be taken orally directly or mixed with a small amount (about 5 mL) of soft food like room temperature baby food, breast milk, or porridge. The packaging should not be opened until just before administration, and it should be mixed into baby food, breast milk, or food immediately (within 15 minutes) after opening. This medication can be taken regardless of mealtime.

Child dose

Children aged 2 to 5 years: Administer 4 mg orally once daily. Infants aged 12 months to less than 2 years: Administer 4 mg orally once daily in the evening. Infants aged 6 months to less than 2 years: Administer 4 mg orally once daily.

Precautions

This medication should not be used in patients allergic to this medication or its components. Fatigue, fever, abdominal pain, dizziness, headache, nasal congestion, cough, rash, and other symptoms may occur during treatment, so caution is advised. Especially in children and adolescents, various adverse reactions such as pharyngitis, influenza, fever, nausea, diarrhea, loss of appetite, and otitis media have been reported, so if symptoms occur, consult a doctor. This medication is not for treating acute asthma attacks; immediate emergency treatment is necessary during acute symptoms, and emergency inhalers should always be on hand. Do not abruptly discontinue inhaled corticosteroids or substitute with this medication; follow your doctor's instructions to gradually reduce the dose. Neuropsychiatric symptoms such as anxiety, agitation, depression, hallucinations, and suicidal thoughts may occur during treatment, so inform your doctor immediately if such symptoms occur. If bronchospasm triggered by exercise occurs, do not treat it only with this medication; continue using inhaled beta-agonists. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid those medications while taking this drug. Rarely, systemic eosinophilia and vasculitis symptoms may appear in asthma patients on this medication, so if symptoms such as eosinophilia, skin rash, or worsening respiratory symptoms occur, seek medical attention. Interactions with other medications are minimal, but caution is needed when taken with certain liver enzyme inducers, so consult your doctor or pharmacist. If pregnant or breastfeeding, avoid use unless clearly necessary, and discuss with a doctor before taking. This medication is intended for use by children and the elderly, but safety and efficacy have not been established in infants under 6 months. In case of overdose, there is no specific antidote, so seek proper medical treatment immediately, and general symptom management is required. Since it is sensitive to light, do not open the packaging until just before administration, and it is best to take it immediately after opening. Store in a place out of reach of children, and do not transfer to other containers. This medication should be taken consistently even if asthma symptoms are absent, and you must consult a doctor if symptoms worsen.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, severe allergic reactions, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
Show 27 more
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • otitis media
  • viral infection
  • laryngitis
  • (infectious) rhinitis
  • chickenpox
  • gastroenteritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract infection

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to moisture and light, so it should be stored at room temperature between 1°C and 30°C. Additionally, when not in use, it is important to tightly close the lid to prevent air from entering.

Appearance and packaging

Appearance

Homogeneous white granules without impurities

Package unit

4mg/packet, 4mg/packet x 28

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.