Medication info

Gunil Montelukast Granules 4 mg (Montelukast Sodium)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
건일제약(주)
Appearance
Uniform white granules without any foreign substances
Packaging
28 packets/case
Approval status
Active

MFDS item code 201701987 · Approved 2017.04.19 · Insurance code 646802830

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
The 4 mg granule form of this medication can be taken orally as is or mixed with a small amount (about 5 mL) of soft food such as room temperature puree, breast milk, or porridge. The package should not be opened until just before administration, and once opened, it should be mixed with or consumed entirely within 15 minutes with the soft food, breast milk, or other food. It should not be left mixed for an extended period, and any remaining should be discarded. Although this medication is not formulated to be taken with liquids other than soft food or breast milk, drinking something right after taking it is fine. This medication can be taken regardless of meal times.
Child dose
Children aged 2 to 5 years: 4 mg of montelukast is administered orally once daily. Infants aged 12 months to under 2 years: 4 mg is administered orally in the evening once daily. Infants aged 6 months to under 2 years: 4 mg is administered orally once daily.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent asthma and continuously treat its symptoms. It is also used to relieve the symptoms of allergic rhinitis that occur seasonally or throughout the year. It is very effective in improving the respiratory health of patients.

How to take

Adult dose

The 4 mg granule form of this medication can be taken orally as is or mixed with a small amount (about 5 mL) of soft food such as room temperature puree, breast milk, or porridge. The package should not be opened until just before administration, and once opened, it should be mixed with or consumed entirely within 15 minutes with the soft food, breast milk, or other food. It should not be left mixed for an extended period, and any remaining should be discarded. Although this medication is not formulated to be taken with liquids other than soft food or breast milk, drinking something right after taking it is fine. This medication can be taken regardless of meal times.

Child dose

Children aged 2 to 5 years: 4 mg of montelukast is administered orally once daily. Infants aged 12 months to under 2 years: 4 mg is administered orally in the evening once daily. Infants aged 6 months to under 2 years: 4 mg is administered orally once daily.

Precautions

This medication is used to relieve symptoms of asthma and allergic rhinitis. During treatment, neuropsychiatric symptoms may occur, so it is important to closely observe for changes in mental state such as nervousness, anxiety, depression, hallucinations, and suicidal impulses. If these symptoms occur, stop taking the medication immediately and consult a physician. This medication must not be taken if you are allergic to this drug or its components. Common side effects include fatigue, headache, abdominal pain, dyspepsia, cough, rash, etc., and if symptoms are severe or persistent, consult a physician. It can be safely used by children or elderly patients, but caution is required as drug reactions may differ by age. Pregnant or breastfeeding women should take it only under the guidance of a doctor if necessary, as its effects on the fetus or infant have not yet been fully confirmed. This medication is not for treating acute asthma attacks, so separate emergency medication must be kept and used during acute symptoms. Patients who are sensitive to aspirin or non-steroidal anti-inflammatory drugs should avoid using those medications while taking this drug. When using with other asthma treatments, the dosage should be adjusted according to a doctor's instructions, and should not be stopped or changed arbitrarily. In case of overdose, there is no specific antidote, so immediate medical attention must be sought, and general symptom management and monitoring are required. This medication is sensitive to light, so it should be taken immediately after opening and kept out of reach of children. During treatment, continuous observation for new abnormal symptoms or side effects is important, and if any occur, immediate consultation with medical staff is essential.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, nosebleeds, difficulty breathing (respiratory problems), cholestatic hepatitis, hepatocellular liver damage and mixed liver injury (liver abnormalities), convulsions, suicidal impulses and behaviors (including suicide), altered consciousness, severe edema or urinary abnormalities accompanied by increased blood pressure

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
  • otitis
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased bleeding frequency
  • thrombocytopenia
  • restlessness
  • anxiety

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 in a dry and dark place. Additionally, to keep the drug fresh, it should be stored in a sealed container at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Uniform white granules without any foreign substances

Package unit

28 packets/case

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.