Medication info

Montelukast Sodium Chewable Tablets 5 mg (Montelukast Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Montelukast Sodium›5.2mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pink chewable tablets with a convex shape on both sides
Packaging
7 tablets/blister x 4
Approval status
Expired

MFDS item code 201506588 · Approved 2015.09.16

This product's status changed to Expired on 2025.09.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for asthma prevention and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 years and older should take montelukast 10 mg orally once daily. Administer one hour before meals or two hours after meals. Patients with asthma should take it once daily in the evening. Patients with both asthma and allergic rhinitis should take 1 tablet, 1 packet, or 1 sheet once daily in the evening.
Child dose
For children aged 6-14 years, montelukast is to be taken once daily at 5 mg, chewing or placing on the tongue until it dissolves or melts, taken without water. For children aged 2-5 years, montelukast is to be taken once daily at 4 mg, chewing or

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Treatment for asthma prevention and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps prevent and treat asthma. It is also used to relieve symptoms of seasonal and year-round allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 years and older should take montelukast 10 mg orally once daily. Administer one hour before meals or two hours after meals. Patients with asthma should take it once daily in the evening. Patients with both asthma and allergic rhinitis should take 1 tablet, 1 packet, or 1 sheet once daily in the evening.

Child dose

For children aged 6-14 years, montelukast is to be taken once daily at 5 mg, chewing or placing on the tongue until it dissolves or melts, taken without water. For children aged 2-5 years, montelukast is to be taken once daily at 4 mg, chewing or

Precautions

This medication contains the artificial sweetener aspartame, which metabolizes phenylalanine in the body. Therefore, patients with the hereditary disease phenylketonuria should not take this medication. Caution should be exercised to not exceed the daily acceptable intake of aspartame, and it is safe for adults to take a maximum of 2.4 grams per day. Patients with allergic reactions to this medication or any of its components should avoid taking it. Since this medication contains lactose, patients with lactose intolerance or related genetic diseases should not take it. This medication is not for treating acute asthma attacks; appropriate emergency medications should always be kept on hand during acute symptoms. Inhaled corticosteroid therapy should not be abruptly discontinued or replaced by this medication; it must be gradually adjusted according to a doctor's instructions. Do not use it alone for exercise-induced bronchospasm; inhaled beta-agonists should be used as needed. Patients with aspirin hypersensitivity should avoid taking aspirin or non-steroidal anti-inflammatory drugs while taking this medication, and this medication does not treat bronchoconstriction due to aspirin-sensitive asthma. Rarely, serious side effects such as systemic eosinophilia and vasculitis may occur during treatment, so if symptoms of eosinophilia, vasculitis, or worsening lung symptoms occur, immediate medical attention is required. While this medication has been proven safe and effective in various age groups, it should be administered with caution in children under 6 months and pregnant women. The elderly can use it without special dose adjustments, but caution is required as responses may vary. In case of overdose, there is no specific antidote, so general symptomatic treatment and clinical monitoring are necessary. This medication is sensitive to light, so it should be taken immediately after opening, and stored out of the reach of children. It should be taken continuously even when asthma symptoms are not present, and if symptoms worsen, consultation with a physician is necessary. It is important to notify healthcare professionals immediately if neuropsychiatric symptoms or adverse reactions occur during treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe dermatological reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, respiratory problems, yellowing of the skin or eyes

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • influenza
  • rash
  • pus in urine
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear pain
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastrointestinal inflammation
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased frequency of bleeding
  • thrombocytopenia
  • aggressive behavior
  • restlessness
  • anxiety
  • depression
  • disorientation

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

Storage

This medication is sensitive to air, moisture, and light, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. This will help keep the medication effective for a longer time.

Appearance and packaging

Appearance

Pink chewable tablets with a convex shape on both sides

Package unit

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.