Medication info

Montelukast Sodium 4 mg (Montelukast Sodium)

Prescription medication경구Expired
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
독립바이오제약(주)
Appearance
Homogeneous white granules without impurities
Packaging
30 sachets/box [(500 mg/sachet)]
Approval status
Expired

MFDS item code 202000178 · Approved 2020.01.10

This product's status changed to Expired on 2025.01.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for asthma prevention and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 and above should take Montelukast 10 mg orally once daily. This medication is taken once a day, preferably in the evening for asthma patients. It should be administered 1 hour before or 2 hours after meals.
Child dose
Children aged 6 to 14 years should take Montelukast 5 mg once daily, by chewing or placing on the tongue to dissolve, with no water. Additionally, a 5 mg dry syrup should be administered orally once daily, using one sachet in a cup.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Treatment for asthma prevention and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent and provide continuous treatment for asthma. It is also used to alleviate symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 and above should take Montelukast 10 mg orally once daily. This medication is taken once a day, preferably in the evening for asthma patients. It should be administered 1 hour before or 2 hours after meals.

Child dose

Children aged 6 to 14 years should take Montelukast 5 mg once daily, by chewing or placing on the tongue to dissolve, with no water. Additionally, a 5 mg dry syrup should be administered orally once daily, using one sachet in a cup.

Precautions

This medication should not be administered to patients with the genetic disorder phenylketonuria, as the artificial sweetener aspartame contained in this medication is broken down into phenylalanine in the body, which can be harmful to patients with phenylketonuria. Additionally, this medication contains lactose and should not be used by patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medication is not for the treatment of acute asthma attacks; therefore, appropriate rescue medications must always be available during an acute asthma attack. While taking this medication, do not suddenly stop or switch inhaled or oral corticosteroids without medical guidance; dosages should be adjusted gradually according to a doctor's instructions. Furthermore, neuropsychiatric symptoms (e.g., anxiety, depression, hallucinations) may occur while taking this medication, so it is important to immediately report any such symptoms to your doctor. Do not use this medication alone for the treatment of exercise-induced bronchospasm; continue using inhaled β-agonists if necessary, and always have a rapid-acting inhaler on hand. Patients with aspirin hypersensitivity should not take aspirin or non-steroidal anti-inflammatory drugs concurrently with this medication. Rarely, patients with asthma taking this medication may experience systemic eosinophilia and vasculitis symptoms, hence careful monitoring for eosinophilia, skin rashes, worsening respiratory symptoms, and cardiac complications is essential. This medication has not been reported to cause increased adverse reactions when used with other asthma prevention and treatment medications; however, caution is warranted when taken with specific liver enzyme-inducing medications. Pregnant women should only use this medication if clearly necessary, and breastfeeding mothers should be cautious as this medication can be excreted in breast milk. Caution is advised when using this medication in children, especially 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 it is crucial to take this medication immediately after opening due to its sensitivity to light. Finally, this medication should be taken consistently even when asthma symptoms are absent, and if symptoms worsen or adverse reactions occur, consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanying cough and fever, yellowing of the skin or eyes, extreme fatigue, sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • 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
  • gastroenteritis
  • eczema
  • rash
  • pneumonia
  • dermatitis
  • conjunctivitis

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. It is also important to keep the medication in a tightly sealed container to prevent exposure to air.

Appearance and packaging

Appearance

Homogeneous white granules without impurities

Package unit

30 sachets/box [(500 mg/sachet)]

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.

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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.