Medication info

Singulair Oral Disintegrating Tablets 4 mg (Montelukast Sodium)

Prescription medicationApproval withdrawn
Ingredient · strength
Montelukast Sodium›Strength being verified
Manufacturer / importer
제이더블유신약(주)
Appearance
White or slightly yellow circular oral disintegrating tablet
Packaging
28 tablets (7 tablets x 4)
Approval status
Approval withdrawn

MFDS item code 201100491 · Notified 2011.01.31

This product's status changed to Approval withdrawn on 2023.05.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and alleviation of allergic rhinitis symptoms
Who uses it
Adults · Children
Adult dosage
This medication should be taken once daily; asthma patients should take it in the evening, while allergic rhinitis patients can adjust the time according to their condition. Patients with both asthma and allergic rhinitis should take one 4 mg tablet in the evening once daily. It should be administered 1 hour before meals or 2 hours after meals.
Children's dosage
Children aged 2 to 5 years should take 4 mg of montelukast once daily, placing it on the tongue to dissolve without water. It should be administered 1 hour before meals or 2 hours after meals.

Ingredients

Manufacturer
제이더블유신약(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 asthma attacks and to treat ongoing asthma symptoms. It also helps relieve symptoms of seasonal and perennial allergic rhinitis. Therefore, it is effective in managing respiratory allergic diseases.

Dosage and Administration

Adult dosage

This medication should be taken once daily; asthma patients should take it in the evening, while allergic rhinitis patients can adjust the time according to their condition. Patients with both asthma and allergic rhinitis should take one 4 mg tablet in the evening once daily. It should be administered 1 hour before meals or 2 hours after meals.

Children's dosage

Children aged 2 to 5 years should take 4 mg of montelukast once daily, placing it on the tongue to dissolve without water. It should be administered 1 hour before meals or 2 hours after meals.

Precautions

This medication contains the artificial sweetener aspartame, so patients with the hereditary condition phenylketonuria should avoid taking it. The daily intake of aspartame should be maintained below the WHO recommended levels, and adults should be careful not to exceed 2.4 g per day. Due to the lactose component in this medication, patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Various adverse reactions have been reported in patients with asthma and allergic rhinitis, including fatigue, headache, cough, rash, and dyspepsia; if symptoms worsen, consultation with a doctor is recommended. Severe symptoms such as vasculitis or systemic eosinophilia can occur rarely, so if there are symptoms of eosinophilia or worsening pulmonary symptoms, immediate notification to a healthcare provider is necessary. This medication is not intended for use during acute asthma attacks; an emergency inhaler should be kept on hand and used during asthma exacerbations. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid these medications during treatment with this drug, and it is important to inform a doctor if any neuropsychiatric symptoms (e.g., anxiety, depression, hallucinations) occur during treatment. During pregnancy or breastfeeding, there is insufficient information regarding the safety of this medication; it should only be used if deemed necessary by a doctor. This medication is also used in pediatric patients for asthma and allergic rhinitis; however, it should not be used in infants under 6 months of age as safety and efficacy have not been established. In cases of overdose, there is no specific antidote, so general symptomatic treatment and clinical monitoring are necessary, and use should be strictly according to the doctor's directions. This medication is sensitive to light; it should be opened just before use, taken immediately after opening, and stored in a place out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, toxic epidermal necrolysis, mucous membrane syndrome, difficulty breathing, shortness of breath, pneumonia, liver abnormal signs (increased ALT and AST, cholestatic hepatitis, hepatocellular damage, mixed liver damage), systemic eosinophilia and vasculitic rash, Churg-Strauss syndrome symptoms, severe swelling, nosebleeds, seizures, convulsions, suicidal thoughts, suicidal attempts, severe allergic reactions (anaphylaxis)

Mild side effects

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

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

Storage

This medication is sensitive to air, moisture, and light, so it must be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Storing it this way can help preserve the efficacy of the drug for a longer time.

Appearance and packaging

Appearance

White or slightly yellow circular oral disintegrating tablet

Package unit

28 tablets (7 tablets 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.