Medication info

Samsung Montelukast Chewable Tablet 5mg (Montelukast Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Montelukast Sodium›5.2mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Pink chewable tablet, round and biconvex on both sides
Packaging
30 tablets (10 tablets/PTP X 3), 28 tablets (7 tablets/PTP X 4)
Approval status
Expired

MFDS item code 201901795 · Approved 2019.03.26

This product's status changed to Expired on 2024.03.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and relief of symptoms of allergic rhinitis
Who takes it
Adults · Children
Adult dose
This medication is taken once daily, in the evening for asthma patients, and the timing for allergic rhinitis patients is determined according to their condition. Patients with both asthma and allergic rhinitis should take 1 tablet, 1 pack, or 1 slice in the evening once daily. This medication should be administered 1 hour before a meal or 2 hours after a meal.
Child dose
Children aged 6 to 14 years: Take 5 mg of Montelukast once daily, chewed.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Prevention of asthma and relief of symptoms of allergic rhinitis

  • Asthma
  • symptoms of allergic rhinitis
View approved original text

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

How to take

Adult dose

This medication is taken once daily, in the evening for asthma patients, and the timing for allergic rhinitis patients is determined according to their condition. Patients with both asthma and allergic rhinitis should take 1 tablet, 1 pack, or 1 slice in the evening once daily. This medication should be administered 1 hour before a meal or 2 hours after a meal.

Child dose

Children aged 6 to 14 years: Take 5 mg of Montelukast once daily, chewed.

Precautions

This medication contains the artificial sweetener aspartame and should not be used by patients with phenylketonuria, a genetic disorder that requires restriction of phenylalanine intake. The daily intake of aspartame included in this product is controlled to be below the World Health Organization's recommended levels, and adults can consume a maximum of 2.4g per day. Individuals who are allergic to this medication or any of its components should not take it. This medication is not intended for use as a rescue treatment for acute asthma attacks; thus, patients experiencing sudden worsening of asthma should have appropriate emergency medications on hand. Patients using inhaled corticosteroids should reduce their dosage gradually according to their doctor's instructions and should not switch to this medication abruptly. During treatment, psychiatric symptoms such as anxiety, depression, hallucinations, and suicidal thoughts may occur; if these symptoms arise, consult a physician immediately. Do not use this medication alone for exercise-induced bronchospasm; continue to use inhaled beta-agonists as needed. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid taking these medications concurrently with this drug. Rarely, this medication may lead to systemic eosinophilia related to vasculitis, and monitoring is required if relevant symptoms occur. There are no reported specific drug interactions when using this medication with various other asthma treatments; however, caution is advised when used with drugs that induce certain hepatic metabolic enzymes. Administer to pregnant women only when necessary, and nursing mothers should be cautious as this drug may be secreted in breast milk. Safety and efficacy for children under 6 months have not been established, so use is not recommended. In the case of overdose, since there is no specific antidote, general supportive care should be provided, and immediate medical attention is required for abnormal symptoms. This drug is sensitive to light, so open it immediately before use, and take it right after preparation. Store in a place out of the reach of children and avoid transferring it to other containers. This medication should be taken daily consistently, even during symptom-free periods; if symptoms worsen, consult a doctor without delay. If the need for fast-acting inhalers increases during treatment, consult healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • chest tightness
  • difficulty breathing
  • anaphylaxis
  • cold sweats
  • pallor
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
Show 14 more
  • severe rash with fever
  • blisters
  • skin peeling
  • pain in mouth/eyes mucosa
  • vasculitis
  • vasculitic rash
  • worsening lung symptoms
  • cardiac complications
  • neuropathy
  • liver abnormalities (jaundice)
  • increased ALT and AST
  • acute hepatitis
  • cholestatic hepatitis
  • hepatocellular injury

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • trauma
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
Show 26 more
  • cough
  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear pain
  • viral infection
  • laryngitis
  • runny nose
  • earache
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased frequency of bleeding
  • thrombocytopenia
  • aggressive behavior

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

Storage

This medication can deteriorate due to air, humidity, or light, so it should be stored in a tightly sealed container. Additionally, it is best to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for an extended period.

Appearance and packaging

Appearance

Pink chewable tablet, round and biconvex on both sides

Package unit

30 tablets (10 tablets/PTP X 3), 28 tablets (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.