Medication info

Montelukast Chewable Tablets 4 mg (Montelukast Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Montelukast Sodium›4.16mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Biconvex oval pink chewable tablet
Packaging
28 tablets (7 tablets/PTP X 4)
Approval status
Expired

MFDS item code 201904259 · Approved 2019.06.19

This product's status changed to Expired on 2024.06.19. 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
This medication should be taken once daily; for asthma patients, it should be taken in the evening, and for allergic rhinitis patients, the dosing time should be determined according to the patient's condition. Patients with both asthma and allergic rhinitis should take one tablet once daily in the evening. This medication should be taken 1 hour before meals or 2 hours after meals.
Child dose
Children aged 6 to 14 years: 5 mg of montelukast to be chewed once daily. Children aged 2 to 5 years: 4 mg of montelukast to be chewed once daily. This medication should be taken 1 hour before meals or 2 hours after meals.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication is effective in preventing and treating asthma continuously. It is also used to relieve symptoms of seasonal and perennial allergic rhinitis. Therefore, it helps improve respiratory symptoms in patients with asthma and allergic rhinitis.

How to take

Adult dose

This medication should be taken once daily; for asthma patients, it should be taken in the evening, and for allergic rhinitis patients, the dosing time should be determined according to the patient's condition. Patients with both asthma and allergic rhinitis should take one tablet once daily in the evening. This medication should be taken 1 hour before meals or 2 hours after meals.

Child dose

Children aged 6 to 14 years: 5 mg of montelukast to be chewed once daily. Children aged 2 to 5 years: 4 mg of montelukast to be chewed once daily. This medication should be taken 1 hour before meals or 2 hours after meals.

Precautions

This medication should not be administered to patients with phenylketonuria, a genetic disorder, as the artificial sweetener aspartame contained in the drug is broken down into phenylalanine in the body. The amount of aspartame used in this medication should be minimal so that it remains below the recommended level set by the World Health Organization. It is safe for adults to take a maximum of 2.4 g per day. Patients who are allergic to this medication or any of its components should not use it. This medication is not intended for the treatment of acute asthma attacks; appropriate emergency medication should always be available for acute exacerbations. When trying to reduce the dosage of inhaled corticosteroids, it should be done gradually under a doctor's supervision and should not be abruptly replaced with this medication. Do not use this medication alone for the treatment of exercise-induced bronchospasm; continue to use inhaled beta-agonists if needed. Patients with a history of allergy to aspirin should avoid taking aspirin or non-steroidal anti-inflammatory drugs while using this medication. Rarely, symptoms of systemic eosinophilia and vasculitis may occur while taking this medication, and these should be discussed with a physician if they arise. Pregnant women should use this medication only when absolutely necessary, and nursing mothers should exercise caution as this medication may be excreted in breast milk. Children and the elderly can also use this medication safely, but its safety and efficacy have not been established in children under 6 months of age. In the case of overdose, there is no specific antidote, and general symptomatic treatment and clinical observation are necessary. This medication should be kept out of reach of children and should not be transferred to other containers. If any neuropsychiatric symptoms or unusual reactions occur while taking this medication, patients should inform their physician immediately. This medication should be taken continuously, even in the absence of asthma symptoms, and if symptoms worsen, the attending physician should be consulted.

Side effects and when to seek care immediately

Serious side effects

Urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, severe edema, edema associated with elevated blood pressure, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, breathing problems, skin or eye discoloration

Mild side effects

  • Weakness
  • fatigue
  • fever
  • abdominal pain
  • trauma
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
Show 28 more
  • nasal congestion
  • cough
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • otitis
  • viral infection
  • laryngitis
  • rhinitis
  • chickenpox
  • gastroenteritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • ear pain
  • enteritis
  • eczema
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract symptoms

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 tightly sealed container to prevent air exposure.

Appearance and packaging

Appearance

Biconvex oval pink chewable tablet

Package unit

28 tablets (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

No questions yet.

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.