Medication info

Montelukast Chewable Tablets 5mg (Montelukast Sodium)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Montelukast Sodium›5.2mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Pink chewable tablets that are round and convex on both sides
Packaging
28 tablets (7 tablets/blister x 4)
Approval status
Approval withdrawn

MFDS item code 201501421 · Approved 2015.03.18

This product's status changed to Approval withdrawn on 2024.12.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and relief of allergy rhinitis symptoms
Who takes it
Adults · Children
Adult dose
For adults and adolescents 15 years and older, take 10 mg of montelukast orally once daily. The 10 mg orally disintegrating film should be placed on the tongue to dissolve without water and taken once daily. Asthma patients should take it once daily in the evening.
Child dose
For children aged 6 to 14 years, take 5 mg of montelukast once daily by chewing or placing it on the tongue to dissolve without water. For children aged 4 to 5 years, take 4 mg of montelukast once daily by chewing or placing it on the tongue.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Prevention of asthma and relief of allergy rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication is used to prevent and continuously treat asthma. It also helps relieve symptoms of seasonal and perennial allergic rhinitis. Therefore, it is useful for patients with asthma and allergic rhinitis to effectively manage symptoms.

How to take

Adult dose

For adults and adolescents 15 years and older, take 10 mg of montelukast orally once daily. The 10 mg orally disintegrating film should be placed on the tongue to dissolve without water and taken once daily. Asthma patients should take it once daily in the evening.

Child dose

For children aged 6 to 14 years, take 5 mg of montelukast once daily by chewing or placing it on the tongue to dissolve without water. For children aged 4 to 5 years, take 4 mg of montelukast once daily by chewing or placing it on the tongue.

Precautions

This medication contains the artificial sweetener aspartame, and patients with phenylketonuria, a genetic disorder that affects phenylalanine metabolism, should avoid taking it. The daily intake of aspartame in this medication should be limited to below WHO recommended levels, with adults advised not to exceed 2.4 grams per day. Persons with known allergic reactions to this medication or any of its components should not take it, and patients with genetic disorders such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome are also prohibited from use. This medication is not intended for use during acute asthma attacks, and appropriate emergency medication should always be available in case of worsening asthma. Inhaled corticosteroids should not be abruptly discontinued or replaced with this medication; instead, they should be gradually adjusted according to a physician’s instructions. While taking this medication, psychiatric symptoms such as anxiety, depression, hallucinations, or sleep disturbances may occur; if any of these symptoms arise, you should consult a physician immediately. It should not be used alone for the treatment of exercise-induced bronchospasm, and inhaled β-agonists should continue to be used as needed. Patients with aspirin hypersensitivity should avoid taking aspirin or nonsteroidal anti-inflammatory drugs while using this medication. Do not reduce or discontinue other asthma medications unless instructed by a physician while taking this medication. If pregnant or breastfeeding, you should thoroughly discuss the necessity of this medication with your physician, considering the potential impact on the fetus or newborn. Children and elderly patients can also take this medication, but they should follow physician recommendations as safety and efficacy may vary by age. In case of overdose, there is no specific antidote; therefore, appropriate treatment and monitoring according to symptoms are necessary. This medication is sensitive to light, so the package should be opened just before taking, and it should be used immediately after preparation, keeping it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • angioedema
  • increased bleeding tendency
  • thrombocytopenia
  • anaphylaxis
  • severe allergic reaction
  • hepatocellular liver damage
  • cholestatic hepatitis
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  • mixed liver damage
  • systemic eosinophilia
  • vasculitis-like rash
  • worsening pulmonary symptoms
  • cardiac complications
  • neuropathy
  • convulsions
  • suicidal thoughts
  • suicide
  • suicide attempts
  • severe headache
  • paralysis
  • altered consciousness
  • abnormal behavior
  • neuropsychiatric disorders

Mild side effects

  • Weakness
  • fatigue
  • fever
  • abdominal pain
  • trauma
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
Show 28 more
  • nasal congestion
  • cough
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear infection
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased bleeding tendency
  • thrombocytopenia
  • aggressive behavior
  • restlessness
  • anxiety
  • depression

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

Storage

This medication should be stored in a tightly closed container to protect it from air, moisture, and light. It is important to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink chewable tablets that are round and convex on both sides

Package unit

28 tablets (7 tablets/blister x 4)

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.