Medication info
Singulair Chewable Tablet 5 mg (Montelukast Sodium)

Singulair Chewable Tablet 5 mg (Montelukast Sodium)

Prescription medicationChewable Tablet경구
Ingredient · strength
Montelukast Sodium›5.2mg / 1 tablet
Manufacturer / importer
한화제약(주)
Appearance
Pink, round, chewable tablet with a biconvex shape on both sides
Packaging
28 tablets (7 tablets/PTP × 4)
Approval status
Active

MFDS item code 201501790 · Approved 2015.04.01 · Insurance code 651601830

Summary

Main use
Prevention of asthma and alleviation of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults should take this medication once daily, with asthma patients taking it in the evening and allergy rhinitis patients determining the dosing time according to their condition. Patients with both asthma and allergic rhinitis should take 1 tablet in the evening once daily. This medication should be administered 1 hour before or 2 hours after a meal.
Child dose
Children aged 6 to 14 years should chew 5 mg of montelukast once daily. This medication should be administered 1 hour before or 2 hours after a meal.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Prevention of asthma and alleviation of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication is used to prevent the occurrence of asthma and for ongoing treatment. It is also effective in alleviating symptoms of allergic rhinitis that occur seasonally or year-round. Thus, it helps manage symptoms for patients with asthma and allergic rhinitis.

How to take

Adult dose

Adults should take this medication once daily, with asthma patients taking it in the evening and allergy rhinitis patients determining the dosing time according to their condition. Patients with both asthma and allergic rhinitis should take 1 tablet in the evening once daily. This medication should be administered 1 hour before or 2 hours after a meal.

Child dose

Children aged 6 to 14 years should chew 5 mg of montelukast once daily. This medication should be administered 1 hour before or 2 hours after a meal.

Precautions

This medication contains the artificial sweetener aspartame, so its use should be limited in patients with the genetic disorder phenylketonuria. It is important to regulate the daily intake of aspartame to no more than the WHO recommended amount of 40 mg/kg, with a maximum of 2.4 g per day for adults. Patients who have allergies to any ingredients in this medication or genetic issues such as lactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption should not take it. Although the safety has been evaluated through clinical trials in various age groups with asthma or allergic rhinitis, adverse reactions such as fatigue, headache, abdominal pain, rash, and cough have been reported. In rare cases, systemic eosinophilia and vasculitis symptoms may occur, and if these symptoms arise, immediate consultation with healthcare professionals is necessary. This medication is not used for the treatment of acute asthma attacks, and fast-acting inhaled bronchodilators must always be on hand in emergencies. Corticosteroid medications should not be abruptly discontinued or substituted with this medication; they must be adjusted gradually under a doctor's supervision. Patients with aspirin hypersensitivity should avoid using aspirin or non-steroidal anti-inflammatory drugs while taking this medicine, and the effectiveness of this medication for treating aspirin-sensitive asthma has not been confirmed. Pregnant or breastfeeding women should consult a doctor before taking this medication and should only use it when necessary. Safety has been established in pediatric patients, but safety and efficacy have not been established in infants under 6 months. In case of overdose, there is no specific antidote, so general treatment based on symptoms is necessary, and it should be undertaken according to a doctor's instructions. This medication is sensitive to light, so it should be opened just before taking and used immediately once opened, and it should be stored out of reach of children. If asthma symptoms worsen or neuropsychiatric symptoms occur during use, inform a doctor immediately, and any adjustments to the dosage of other asthma medications should be made according to a doctor's guidance.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • severe swelling (edema)
  • difficulty breathing
  • chest tightness
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • severe rash with fever
  • blistering
  • peeling skin
Show 11 more
  • pain in mouth/eye mucosa
  • hives
  • severe allergic reactions
  • severe skin adverse reactions
  • breathing problems
  • liver abnormalities (jaundice)
  • serious neurological symptoms
  • severe edema or urinary issues
  • thrombocytopenia
  • anaphylaxis
  • systemic eosinophilia

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • otitis
  • viral infections
  • laryngitis
  • chickenpox
  • gastritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • ear pain
  • enteritis
  • eczema
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • frequency of bleeding disorders

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it should be kept in a cool, dry place away from direct sunlight, ideally at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, round, chewable tablet with a biconvex shape on both sides

Package unit

28 tablets (7 tablets/PTP × 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.