Medication info

Montelukast Chewable Tablets 4 mg (Sodium Montelukast)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Montelukast Sodium›4.16mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Pink, chewable tablets shaped like convex, oval pills
Packaging
28 tablets (7 tablets/blister x 4)
Approval status
Approval withdrawn

MFDS item code 201501420 · 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This product's status changed to Approval withdrawn on 2024.12.03.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 allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 years and older should take 10 mg of montelukast once daily. This medicine should be taken 1 hour before meals or 2 hours after meals.
Child dose
Children aged 6 to 14 years should chew 5 mg of montelukast once daily or place it on the tongue and swallow without water. Children aged 4 to 5 years should chew 4 mg of montelukast once daily.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medicine helps prevent and provide continuous treatment of asthma. Additionally, it alleviates symptoms of seasonal and perennial allergic rhinitis. Therefore, it is used by patients with asthma and allergic rhinitis to effectively manage their symptoms in daily life.

How to take

Adult dose

Adults and adolescents aged 15 years and older should take 10 mg of montelukast once daily. This medicine should be taken 1 hour before meals or 2 hours after meals.

Child dose

Children aged 6 to 14 years should chew 5 mg of montelukast once daily or place it on the tongue and swallow without water. Children aged 4 to 5 years should chew 4 mg of montelukast once daily.

Precautions

This medicine contains the artificial sweetener aspartame, and should not be used by patients with phenylketonuria, a hereditary condition that requires limiting phenylalanine intake. The daily allowable dose of aspartame is limited to 40 mg per kg of body weight; for a 60 kg adult, the maximum daily dose is up to 2.4 g. Patients with hypersensitivity to this medicine, lactose intolerance, lactase deficiency, or glucose-galactose absorption disorders should not take it. In patients with asthma or allergic rhinitis, various adverse reactions such as fatigue, headaches, cough, and rash may occur, and if symptoms arise, they should consult a doctor immediately. In particular, this medicine is not intended for use during acute asthma attacks; therefore, a short-acting inhaled bronchodilator must be carried and used in emergencies. Patients with hypersensitivity to aspirin are advised not to take aspirin or non-steroidal anti-inflammatory drugs during the use of this medicine. During treatment with this medicine, it is important not to suddenly stop or switch inhaled corticosteroids, and adjustments should be made gradually according to a doctor's instructions. Children, pregnant women, and breastfeeding mothers require special caution when using this medicine, and pregnant women should take it only under a doctor's supervision when necessary. In case of an overdose, there is no specific antidote; general treatment should be provided according to symptoms under the guidance of a doctor. This medicine is sensitive to light, so it should be taken immediately after opening during preparation, and kept in a safe place out of reach of children. If any neuropsychiatric symptoms or other unusual symptoms occur during treatment, they should be reported to and discussed with a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, angioedema, chest tightness, difficulty breathing, anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, nosebleeds, thrombocytopenia, vasculitis rash, exacerbation of pulmonary symptoms, cardiac complications, neuropathy, seizure disorders, liver abnormalities (increased ALT and AST, cholestatic hepatitis, hepatocellular damage and mixed hepatic injury).

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • 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
  • agitation
  • anxiety.

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

Storage

This medicine is sensitive to air and moisture, so it must be stored in a tightly sealed container. It should also be kept out of direct sunlight and stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, chewable tablets shaped like convex, oval pills

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.