Medication info

Samsung Montelukast Granules 4mg (Montelukast Sodium)

Prescription medication경구Expired
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
삼성제약(주)
Appearance
A homogeneous granule that is white and free from foreign matter
Packaging
4mg/unit, 4mg/unit x 28
Approval status
Expired

MFDS item code 201904222 · Approved 2019.06.18

This product's status changed to Expired on 2024.06.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and relief of allergy rhinitis symptoms
Who takes it
Adults · Children
Adult dose
The medication is to be taken once daily. Asthma patients should take it in the evening, while allergy rhinitis patients should determine the timing based on their condition. For patients with both asthma and allergic rhinitis, take 4 mg once daily, either 1 tablet, 1 unit, or 1 sachet in the evening. This 4 mg granule can be taken orally or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge kept below room temperature.
Child dose
Children aged 2 to 5 years should take 4 mg of montelukast orally once daily. Infants aged 12 months to less than 2 years should take 4 mg orally in the evening once daily. Infants aged 6 months to less than 2 years should take 4 mg once daily.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Prevention of asthma and relief of allergy rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps in the prevention and ongoing treatment of asthma. It is also used to alleviate the symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

The medication is to be taken once daily. Asthma patients should take it in the evening, while allergy rhinitis patients should determine the timing based on their condition. For patients with both asthma and allergic rhinitis, take 4 mg once daily, either 1 tablet, 1 unit, or 1 sachet in the evening. This 4 mg granule can be taken orally or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge kept below room temperature.

Child dose

Children aged 2 to 5 years should take 4 mg of montelukast orally once daily. Infants aged 12 months to less than 2 years should take 4 mg orally in the evening once daily. Infants aged 6 months to less than 2 years should take 4 mg once daily.

Precautions

This medication should not be used in patients who have an allergic reaction to this medication or its components. Various side effects such as fatigue, headache, abdominal pain, fever, cough, nasal congestion, rash, etc. may occur during the use of this medication; if abnormal symptoms persist or worsen, consultation with a physician is recommended. Particularly, it is also usable in children and adolescents, but caution is needed as the dosage and frequency of side effects may vary by age. This medication is not intended for the treatment of acute asthma attacks; separate emergency medications should be used when acute symptoms arise, and it is important to always carry a rescue inhaler. Inhaled corticosteroids should not be abruptly discontinued or rapidly switched to this medication; they should be gradually adjusted according to a physician's instructions. To prevent exercise-induced bronchospasms, this medication should not be used alone; it is necessary to use an inhaled beta-agonist concurrently. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not take these medications while on this medication. Rarely, systemic eosinophilia associated with vasculitis may appear during the use of this medication; if skin rashes, worsening pulmonary symptoms, or cardiac issues occur, immediate medical attention should be sought. No specific drug interactions have been reported when this medication is used with other asthma treatments, but caution is needed when taking it with drugs that induce certain liver metabolic enzymes. Safety during pregnancy or breastfeeding has not been fully established; consultation with a physician is necessary before taking this medication. It is also usable in children and the elderly, but caution is needed as drug responses may vary by age. In case of overdose, there is no specific antidote, so general supportive treatment and medical monitoring are necessary. This medication is light-sensitive; it should not be opened until just before use, and it is preferable to mix it with soft foods or milk and consume it immediately. It must be stored in a secure place out of the reach of children, and transferring it to other containers helps maintain its quality. This medication must be taken continuously even when asthma symptoms are absent to prevent symptoms; if symptoms worsen, immediate consultation with a physician is necessary. If symptoms related to the nervous system or mental state, such as anxiety, depression, or changes in behavior occur during treatment, the physician must be informed immediately. While taking this medication, do not reduce or discontinue the dosage of other asthma treatments without a physician's instructions, and always carry a rescue inhaler.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • chest tightness
  • difficulty breathing
  • anaphylaxis
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • severe allergic reactions
  • severe skin adverse reactions
Show 11 more
  • severe skin reactions
  • thrombocytopenia
  • liver abnormalities (jaundice)
  • elevated ALT and AST
  • cholestatic hepatitis
  • hepatocellular liver damage
  • mixed liver damage
  • hives
  • severe neurological symptoms (seizures)
  • vasculitis
  • systemic eosinophilia

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
Show 27 more
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear infection
  • viral infection
  • laryngitis
  • (infectious) rhinitis
  • chickenpox
  • gastroenteritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • runny nose
  • ear pain
  • enteritis
  • eczema
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract infection

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

Storage

This medication is sensitive to air, moisture, and light, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. Proper storage preserves the medication's effectiveness.

Appearance and packaging

Appearance

A homogeneous granule that is white and free from foreign matter

Package unit

4mg/unit, 4mg/unit x 28

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.