Medication info
Singulair Chewable Tablets 4 mg (Montelukast Sodium)

Singulair Chewable Tablets 4 mg (Montelukast Sodium)

Prescription medicationChewable Tablet경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Pink, biconvex oval chewable tablet
Packaging
28 tablets/box [(7 tablets/PTP x 4)]
Approval status
Active

MFDS item code 201207002 · Approved 2012.09.28 · Insurance code 653402590

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 daily. For asthma patients, it should be taken in the evening, and for allergic rhinitis patients, the dosing time should be determined by the patient's 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
For children aged 2 to 5 years, montelukast should be taken as 4 mg once daily, chewed. This medication should be administered 1 hour before or 2 hours after a meal.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

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

How to take

Adult dose

This medication should be taken once daily. For asthma patients, it should be taken in the evening, and for allergic rhinitis patients, the dosing time should be determined by the patient's 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

For children aged 2 to 5 years, montelukast should be taken as 4 mg once daily, chewed. This medication should be administered 1 hour before or 2 hours after a meal.

Precautions

This medication contains the artificial sweetener aspartame and should not be used by patients with phenylketonuria, a genetic disorder that restricts phenylalanine intake. It is important to keep the intake of aspartame included in this medication below the WHO recommended amount, and for a 60 kg adult, it should not exceed 2.4g per day. Patients with allergies to this medication or its ingredients, as well as those with lactose intolerance or hereditary lactose malabsorption disorders, should not take this medication. This medication is not used to treat acute asthma attacks; therefore, appropriate emergency medication should be used in the event of acute symptoms. Asthma patients should always have a fast-acting inhaler available to use during acute exacerbations while taking this medication. Do not suddenly stop or switch inhaled corticosteroid preparations; they should be adjusted gradually according to the physician's instructions. While taking this medication, various side effects such as dizziness, headache, abdominal pain, and rash may occur; consult a doctor if such symptoms arise. Particularly rare but serious side effects like systemic eosinophilia or vasculitis may occur, so report any signs of eosinophilia or vasculitis to medical personnel immediately. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid using these medications during treatment with this drug. The safety of this medication during pregnancy has not been fully established; thus, it should only be taken after consulting a doctor in necessary situations. Caution is also needed as this medication may be excreted in breast milk during nursing. It can be used in children and elderly patients, but appropriate dosages and precautions should be followed according to age, and its safety has not been confirmed in infants under 6 months of age. In cases of overdose, there are no specific antidotes, and general supportive treatment should be provided following a physician's instructions. This medication is sensitive to light, so it should be opened right before use and taken immediately after opening; store it in a container that is well sealed and out of reach of children. If asthma symptoms worsen or the use of a fast-acting inhaler increases while taking this medication, a doctor's examination should be obtained, and the doses of other asthma medications should not be arbitrarily reduced or stopped. Patients or guardians should immediately inform medical personnel if neuropsychiatric symptoms arise while taking this medication.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • respiratory distress
  • asthma attack
  • difficulty breathing
  • jaundice of skin or eyes
  • sudden and severe headache
  • thunderclap headache
Show 12 more
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • significant decrease in urination
  • generalized severe edema
  • elevated blood pressure
  • anaphylaxis
  • systemic eosinophilia
  • vasculitis
  • liver abnormalities
  • serious skin reactions

Mild side effects

  • Asthenia
  • fatigue
  • fever
  • abdominal pain
  • trauma
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
Show 27 more
  • nasal congestion
  • cough
  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • decreased appetite
  • earache
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract infection
  • increased frequency of bleeding
  • thrombocytopenia
  • anxiety

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°C and 30°C. Additionally, it is important to store it in a sealed container to prevent air exposure.

Appearance and packaging

Appearance

Pink, biconvex oval chewable tablet

Package unit

28 tablets/box [(7 tablets/PTP 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.