Medication info

Singulair Oral Disintegrating Tablet 5 mg (Montelukast Sodium)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 200908369 · Notified 2009.11.30

This product's status changed to Approval withdrawn on 2023.05.30.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, in the evening for asthma patients, and the timing of administration for allergy rhinitis patients should be adjusted based on their condition. For patients with both asthma and allergic rhinitis, take 1 tablet once daily in the evening. This medication should be administered 1 hour before meals or 2 hours after meals.
Children's dosage
Children aged 6 to 14 years should take 5 mg of montelukast once daily by placing it on the tongue and allowing it to dissolve without water. This medication 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 helps to prevent and treat asthma continuously. It is also used to alleviate the symptoms of seasonal and perennial allergic rhinitis.

Dosage and Administration

Adult dosage

This medication should be taken once daily, in the evening for asthma patients, and the timing of administration for allergy rhinitis patients should be adjusted based on their condition. For patients with both asthma and allergic rhinitis, take 1 tablet once daily in the evening. This medication should be administered 1 hour before meals or 2 hours after meals.

Children's dosage

Children aged 6 to 14 years should take 5 mg of montelukast once daily by placing it on the tongue and allowing it to dissolve without water. This medication should be administered 1 hour before meals or 2 hours after meals.

Precautions

This medicine contains the artificial sweetener aspartame and should not be used by patients with phenylketonuria, a hereditary condition that requires a restriction of phenylalanine intake. Additionally, this medication contains lactose and should not be administered to patients with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medication is not to be used for acute asthma attacks; therefore, appropriate emergency medications should always be carried in case of acute symptoms, and asthma treatment should continue as directed by a physician. During treatment, psychiatric symptoms may occur, such as anxiety, depression, hallucinations, and suicidal thoughts; if these symptoms occur, consult a physician immediately. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not take these medications concomitantly while using this drug. While taking this medication, do not suddenly reduce or stop the dosage of inhaled corticosteroids without physician supervision. Children and elderly patients may also use this medicine, but caution is needed as safety and efficacy may vary by age. In case of overdose, there is no specific antidote; general symptomatic treatment should be performed, and if symptoms are severe, seek medical attention immediately. This medication is sensitive to light, so it should be opened just before use, and after opening, it should be taken as soon as possible. Store it out of reach of children. Pregnant or nursing women should consult a physician before using this medication and should only take it if necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, Severe Swelling (Edema), Angioedema, Chest Tightness, Difficulty Breathing, Cold Sweat, Paleness, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Severe Rash with High Fever, Blisters, Skin Peeling, Pain in Oral/Eye Mucosa, Difficulty Breathing, Asthma Attack, Respiratory Distress Accompanied by Cough and Fever, Yellowing of Skin or Eyes (Jaundice), Severe Lethargy, Sudden and Severe Headache, Thunderclap Headache, Seizures.

Mild side effects

  • Weakness/Fatigue
  • Fever
  • Abdominal Pain
  • Indigestion
  • Infectious Gastroenteritis
  • Toothache
  • Dizziness
  • Headache
  • Nasal Congestion
  • Cough
Show 26 more
  • Influenza
  • Rash
  • Increase in ALT
  • Increase in AST
  • Pyuria
  • Pharyngitis
  • Sinusitis
  • Nausea
  • Diarrhea
  • Loss of Appetite
  • Otitis
  • Viral Infection
  • Laryngitis
  • Runny Nose
  • Ear Pain
  • Gastroenteritis
  • Eczema
  • Chickenpox
  • Pneumonia
  • Dermatitis
  • Conjunctivitis
  • Upper Respiratory Tract Infection
  • Increased Bleeding Frequency
  • Thrombocytopenia
  • Aggressive Behavior
  • and Severe Symptoms.

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

Storage

Store this medication in a container that is well sealed from light and air, at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Pink round 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.