Medication info
Montelukast Tablets 5mg (Montelukast Sodium)

Montelukast Tablets 5mg (Montelukast Sodium)

Prescription medicationChewable Tablet경구
Ingredient · strength
Montelukast Sodium›5.2mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Pink chewable tablets with a biconvex, round shape
Packaging
30 tablets/box [(10 tablets/PTP x 3)], 28 tablets/box [(7 tablets/PTP x 4)]
Approval status
Active

MFDS item code 201907868 · Approved 2019.11.12 · Insurance code 057700500

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This medication is to be taken once daily; in asthma patients, it should be taken in the evening, while in allergic rhinitis patients, the timing of dosage should be determined based on the patient's condition. Patients with both asthma and allergic rhinitis should take 1 tablet in the evening once daily. This medication should be taken 1 hour before or 2 hours after meals.
Child dose
Children aged 6–14 years: Chew 5 mg once daily as montelukast. This medication should be taken 1 hour before or 2 hours after meals.

Ingredients

Manufacturer
독립바이오제약(주)

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 continuously treat asthma. It is also used to relieve symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

This medication is to be taken once daily; in asthma patients, it should be taken in the evening, while in allergic rhinitis patients, the timing of dosage should be determined based on the patient's condition. Patients with both asthma and allergic rhinitis should take 1 tablet in the evening once daily. This medication should be taken 1 hour before or 2 hours after meals.

Child dose

Children aged 6–14 years: Chew 5 mg once daily as montelukast. This medication should be taken 1 hour before or 2 hours after meals.

Precautions

This medication is used for the prevention and treatment of asthma and allergic rhinitis. During the use of this medication, serious neuropsychiatric symptoms may occur, so patients and caregivers should closely monitor for changes in mental status such as agitation, anxiety, depression, hallucinations, and suicidal thoughts. If such symptoms or behavior changes occur, discontinue this medication immediately and inform a doctor. This medication contains the artificial sweetener aspartame, so patients with phenylketonuria should avoid taking it. Additionally, this medication contains lactose, hence patients with galactose intolerance or lactase deficiency should refrain from use. This medication is not for the treatment of acute asthma attacks, and appropriate emergency medication should be used for acute symptoms. Do not use alone for exercise-induced bronchospasm; continue using inhaled bronchodilators as needed. Patients with an allergy to aspirin should avoid taking aspirin or non-steroidal anti-inflammatory drugs during the use of this medication. This medication can rarely cause serious side effects such as eosinophilia and vasculitis, so doctors should carefully monitor patients. If pregnant or breastfeeding, consult a physician before use and only use if necessary; children and the elderly should also take it according to a physician's instructions. In case of overdose, there is no specific antidote, thus appropriate treatment and monitoring are required based on symptoms. This medication should be kept out of the reach of children, and it is advisable not to transfer it to other containers. During treatment, if symptoms worsen or new symptoms appear, consult a doctor, and do not abruptly discontinue other asthma medications without a doctor's instructions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin adverse reactions, feeling short of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound malaise, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures

Mild side effects

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

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

Storage

This medication is sensitive to moisture and light; therefore, it should be stored at room temperature between 1°C and 30°C. It is also important to store it in a tightly sealed container to prevent air ingress.

Appearance and packaging

Appearance

Pink chewable tablets with a biconvex, round shape

Package unit

30 tablets/box [(10 tablets/PTP x 3)], 28 tablets/box [(7 tablets/PTP 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.