Medication info
Montelukast Sodium Orally Disintegrating Tablets 4mg (Montelukast Sodium)

Montelukast Sodium Orally Disintegrating Tablets 4mg (Montelukast Sodium)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Biconvex oval orally disintegrating tablet, white to light yellow
Packaging
28 tablets/box [(7 tablets/Alu-Alu) x 4]
Approval status
Active

MFDS item code 201005127 · Notified 2010.08.24 · Insurance code 642903940

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 a day, with asthma patients taking it in the evening and allergic rhinitis patients determining the time of administration based on their condition. Patients who have both asthma and allergic rhinitis should take 1 tablet once daily in the evening. The 4 mg orally disintegrating tablet should be taken 1 hour before meals or 2 hours after meals.
Child dose
For children aged 2 to 5 years, place 4 mg of montelukast on the tongue once a day and allow it to dissolve without water. This medication should be taken 1 hour before meals or 2 hours after meals.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis
View approved original text

This medication helps prevent asthma and manage it continuously. It is also used to relieve symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

This medication should be taken once a day, with asthma patients taking it in the evening and allergic rhinitis patients determining the time of administration based on their condition. Patients who have both asthma and allergic rhinitis should take 1 tablet once daily in the evening. The 4 mg orally disintegrating tablet should be taken 1 hour before meals or 2 hours after meals.

Child dose

For children aged 2 to 5 years, place 4 mg of montelukast on the tongue once a day and allow it to dissolve without water. This medication should be taken 1 hour before meals or 2 hours after meals.

Precautions

This medication contains the artificial sweetener aspartame, which should not be used by patients with phenylketonuria, a genetic disorder. Care should be taken to ensure that the intake of aspartame does not exceed the recommendations set by WHO, and should not exceed 2.4 grams per day for adults. Individuals who have hypersensitivity to this medication should not take it, and those with lactose intolerance or certain genetic conditions should also avoid its use. Caution is necessary as various adverse reactions such as fatigue, headache, fever, abdominal pain, and rash may occasionally occur in users of different ages, including asthma and allergic rhinitis patients. Especially, if any neuropsychiatric symptoms or behavioral changes occur while taking this medication, consult a doctor immediately. During an acute asthma attack, this medication is not an immediate treatment, so emergency medications should always be carried. Patients who have hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not take these medications while taking this drug. Pregnant or nursing women must consult a doctor regarding the use of this medication and it should only be administered if necessary. For children, safety and efficacy may vary by age, so the recommended dosage and usage by age should be strictly followed. This medication is sensitive to light, so it should be taken immediately after opening, and stored out of reach of children. There is no specific antidote for overdose; treatment should be symptomatic and according to a doctor's guidance. Do not arbitrarily reduce or discontinue other asthma treatments while taking this medication; this should always be done according to a doctor's recommendations.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, breathing difficulty, cold sweat, pallor, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, respiratory problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion, vision changes

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • influenza
  • rash
  • ALT increase
  • AST increase
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • appetite loss
  • ear inflammation
  • viral infections
  • laryngitis
  • runny nose
  • ear pain
  • gastrointestinal inflammation
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased bleeding frequency
  • thrombocytopenia
  • aggressive behavior
  • insomnia

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and should be kept away from direct sunlight or strong light. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Biconvex oval orally disintegrating tablet, white to light yellow

Package unit

28 tablets/box [(7 tablets/Alu-Alu) 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.