Medication info

Montelukast Chewable Tablets 4 mg (Montelukast Sodium)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Montelukast Sodium›4.16mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Pink, oval-shaped, chewable tablet with a biconvex surface on both sides
Packaging
28 tablets (7 tablets/PTP x 4), 30 tablets (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 202000802 · Approved 2020.02.11

This product's status changed to Approval withdrawn on 2023.10.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and treatment 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 orally once daily. This medication should be taken 1 hour before meals or 2 hours after meals. For those with both asthma and allergic rhinitis, take 1 tablet, 1 pack, or 1 film orally in the evening once daily.
Child dose
Children aged 6 to 14 years should take 5 mg of montelukast once daily by chewing or placing it on the tongue to dissolve without water. Children aged 2 to 5 years should take 4 mg of montelukast once daily by chewing or placing it on the tongue.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Prevention of asthma and treatment of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent asthma attacks and provides continuous treatment. It is also used to alleviate symptoms of allergic rhinitis that appear seasonally or throughout the year. Therefore, it effectively improves symptoms for patients with asthma and allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 years and older should take 10 mg of montelukast orally once daily. This medication should be taken 1 hour before meals or 2 hours after meals. For those with both asthma and allergic rhinitis, take 1 tablet, 1 pack, or 1 film orally in the evening once daily.

Child dose

Children aged 6 to 14 years should take 5 mg of montelukast once daily by chewing or placing it on the tongue to dissolve without water. Children aged 2 to 5 years should take 4 mg of montelukast once daily by chewing or placing it on the tongue.

Precautions

This medication contains aspartame, an artificial sweetener, so patients with phenylketonuria, a genetic disorder, should not take this medication. This medication contains lactose, so it should not be administered to patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Various adverse reactions such as fatigue, headache, abdominal pain, cough, and rash may occur during the use of this medication. If symptoms are severe or persist, consult a doctor. In particular, patients with asthma may rarely experience serious symptoms such as systemic eosinophilia or vasculitis. Therefore, if symptoms such as breathlessness or skin rash occur, immediately inform medical personnel. This medication is not for treating acute asthma attacks; appropriate emergency medications must be used during acute symptoms, and this medication should be taken continuously for asthma control. Patients who are hypersensitive to aspirin or non-steroidal anti-inflammatory drugs should avoid these medications while taking this medication. Women who are pregnant or breastfeeding should consult a doctor before taking this medication and should take it only if necessary. Children and the elderly can also safely use this medication, but careful observation for potential adverse reactions is required. When taking this medication, follow the prescribed dosage, and in the case of overdose, seek immediate medical treatment as there is no specific antidote. This medication is sensitive to light; therefore, it should not be opened until it’s ready for use, and should be taken immediately after opening. Finally, if neurological or psychiatric symptoms or changes in behavior occur during the use of this medication, inform medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, toxic epidermal necrolysis, skin and mucous membrane syndrome, angioedema, severe swelling (edema), increased bleeding frequency, thrombocytopenia, severe neurological symptoms including convulsions, pulmonary eosinophilia, liver abnormalities (increase in ALT and AST, cholestatic hepatitis, hepatocellular liver damage, and mixed liver injury), severe edema accompanied by elevated blood pressure, respiratory issues including wheezing, difficulty breathing, and respiratory distress.

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • indigestion
  • infectious gastroenteritis
  • tooth pain
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • otitis
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • wheezing
  • otitis media
  • tonsillitis
  • upper respiratory infection
  • increased bleeding frequency
  • blood

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

Storage

This medication is sensitive to moisture and light; store it at room temperature between 1°C and 30°C. It is also important to store it in a sealed container to keep out air.

Appearance and packaging

Appearance

Pink, oval-shaped, chewable tablet with a biconvex surface on both sides

Package unit

28 tablets (7 tablets/PTP x 4), 30 tablets (10 tablets/PTP x 3)

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.