Medication info

Montelase Tablet 4mg (Montelukast Sodium)

Prescription medication경구Expired
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Homogeneous white granules without foreign substances
Packaging
4mg per packet, 4mg per packet x 28
Approval status
Expired

MFDS item code 201903845 · Approved 2019.06.13

This product's status changed to Expired on 2024.06.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents over 15 years old should take 10 mg of montelukast once daily. This medication should be taken 1 hour before or 2 hours after meals. For asthma patients, it should be taken once in the evening, and for patients having both asthma and allergic rhinitis, it should be taken once daily, 1 tablet, 1 packet, or 1 sheet in the evening.
Child dose
Children aged 6 to 14 years should take 5 mg of montelukast once daily, which can be chewed or placed on the tongue to dissolve without water. Children aged 4 to 5 years should take 4 mg of montelukast once daily.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent and manage asthma and is used to alleviate the symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

Adults and adolescents over 15 years old should take 10 mg of montelukast once daily. This medication should be taken 1 hour before or 2 hours after meals. For asthma patients, it should be taken once in the evening, and for patients having both asthma and allergic rhinitis, it should be taken once daily, 1 tablet, 1 packet, or 1 sheet in the evening.

Child dose

Children aged 6 to 14 years should take 5 mg of montelukast once daily, which can be chewed or placed on the tongue to dissolve without water. Children aged 4 to 5 years should take 4 mg of montelukast once daily.

Precautions

This medication contains the artificial sweetener aspartame, which should not be used by patients with phenylketonuria, a certain genetic disorder. Aspartame breaks down into phenylalanine in the body; therefore, its intake should be restricted in patients with phenylalanine intake limitations. Additionally, daily intake of aspartame should not exceed the World Health Organization's recommended limit, with a maximum of 2.4g for adults. This medication contains lactose, so it should not be used by patients with lactose intolerance or related genetic disorders. Patients with hypersensitivity to this medication should also avoid taking it, and caution should be exercised for asthma or allergic rhinitis patients as adverse reactions may occur. In particular, neuropsychiatric symptoms may appear, and patients or guardians should consult a doctor immediately if such changes occur. This medication is not a treatment for acute asthma attacks; therefore, appropriate emergency medications must be carried during acute symptoms. Patients with aspirin hypersensitivity should avoid taking aspirin or non-steroidal anti-inflammatory drugs while taking this medication, as it does not alleviate bronchoconstriction caused by aspirin. Pregnant or breastfeeding women should only take this medication after consulting a doctor if necessary, and careful monitoring is required for children and the elderly. In case of overdose, there is no specific antidote available, so general symptomatic treatment and clinical monitoring are required. This medication is sensitive to light, so it should not be opened until right before use, and if mixed with soft food or breast milk, it should be taken immediately. This medication should be stored out of reach of children and should not be transferred to other containers. Finally, this medication should be taken consistently even when asthma symptoms are absent, and if symptoms worsen or adverse reactions occur, immediate consultation with a doctor is necessary.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Weakness
  • fatigue
  • fever
  • abdominal pain
  • trauma
  • indigestion
  • infectious gastroenteritis
  • dental pain
  • dizziness
  • headache
Show 27 more
  • nasal congestion
  • cough
  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear pain
  • viral infection
  • laryngitis
  • runny nose
  • earache
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract infection
  • increased bleeding frequency
  • thrombocytopenia
  • anxiety

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. It is also important to store it in a sealed container to prevent air exposure.

Appearance and packaging

Appearance

Homogeneous white granules without foreign substances

Package unit

4mg per packet, 4mg per 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.