Medication info

Montela chewable tablet 5 mg (Montelukast Sodium)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Montelukast Sodium›5.2mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Pink chewable tablet with a double convex round shape
Packaging
28 tablets (7 tablets/PTP x 4), 30 tablets (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 202000806 · Approved 2020.02.11

This product's status changed to Approval withdrawn on 2024.07.25. 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 and older should take 10 mg once daily as montelukast orally. This drug should be administered 1 hour before meals or 2 hours after meals. Patients with asthma should take it in the evening, and those with both asthma and allergic rhinitis should take 1 tablet, 1 packet, or 1 film in the evening once daily.
Child dose
Children aged 6 to 14 years should chew 5 mg once daily as montelukast, or place it on the tongue and allow it to dissolve without water. Children aged 4 to 5 years should chew 4 mg once daily as montelukast.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent asthma attacks and provides ongoing treatment. It is also used to relieve symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 and older should take 10 mg once daily as montelukast orally. This drug should be administered 1 hour before meals or 2 hours after meals. Patients with asthma should take it in the evening, and those with both asthma and allergic rhinitis should take 1 tablet, 1 packet, or 1 film in the evening once daily.

Child dose

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

Precautions

This medicine contains the artificial sweetener aspartame and should not be used in patients with phenylketonuria, who have problems in metabolizing phenylalanine. Daily intake of aspartame should be monitored to not exceed WHO recommendations, with a maximum of 2.4 grams per day for adults. Patients with allergies to this drug or its ingredients, as well as those with genetic metabolic disorders such as lactose intolerance or galactose intolerance, should not use this medication. When using this medication in asthmatic patients, side effects such as systemic weakness, fatigue, abdominal pain, headache, cough, rash, etc., may occur, so symptoms should be carefully monitored. Various adverse reactions such as pharyngitis, fever, diarrhea, headache, and ear infections have also been reported in pediatric patients, therefore, the condition of children should be closely observed. This drug is not to be used for acute asthma attacks; during acute exacerbations, emergency inhalers should always be at hand. Inhaled or oral corticosteroid preparations should not be abruptly discontinued; they should be gradually adjusted as directed by a physician. Patients who are hypersensitive to aspirin or non-steroidal anti-inflammatory drugs should not use these medications concurrently while taking this drug due to the risk of asthma exacerbation. Rarely, severe symptoms such as vasculitis and eosinophilia may occur while taking this medication, so if skin rash or worsening respiratory symptoms appear, consult a physician immediately. While no specific interactions have been reported with other medications, caution is advised as drug concentration variability may occur when used with some liver enzyme inducers. Women who are pregnant or breastfeeding should consult a physician before taking this medication and should only take it with great caution if necessary. It is possible to use this drug in children and the elderly, but attention should be paid to the potential differences in drug response related to age. In case of overdose, there is no specific antidote, requiring supportive symptomatic treatment and clinical monitoring as needed. This drug is sensitive to light; do not open the package until just before taking and consume it soon after opening. Store in a place out of reach of children and do not transfer to another container for safety. This drug should be taken regularly even when asthma symptoms are not present; consult a physician immediately if symptoms worsen or abnormal symptoms appear. For exercise-induced asthma patients, it is recommended not to rely solely on this drug for prevention, but to use it with inhaled bronchodilators.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever accompanied by severe rash, blisters, skin peeling, pain in oral or ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory distress during cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice),

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • trauma
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
Show 28 more
  • cough
  • influenza
  • rash
  • pus in urine
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear infection
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased bleeding frequency
  • thrombocytopenia
  • restlessness
  • anxiety
  • depression
  • disorientation
  • attention

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 degree and 30 degrees Celsius. It is also important to store it in a tightly sealed container to prevent air ingress.

Appearance and packaging

Appearance

Pink chewable tablet with a double convex round shape

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.