Medication info

Montelukast Sodium Granules 4 mg

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
제일약품(주)
Appearance
A homogeneous white granule without any foreign substances
Packaging
28 sachets
Approval status
Active

MFDS item code 201309175 · Approved 2013.09.03 · Insurance code 645404621

Summary

Main use
Prevention of asthma and alleviation of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This 4 mg granule can be taken orally or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge below room temperature. Do not open the package until just before taking, and after opening, consume the entire amount mixed with soft food, breast milk, or food immediately (within 15 minutes). The medication should not be left mixed with soft food, breast milk, or food for a long time, and the remainder should be discarded. Although this medication is not formulated to be taken with drinks other than soft food or breast milk, it is acceptable to drink something immediately after taking it. This medication can be taken regardless of mealtime.
Child dose
Children aged 2 to 5 years: 4 mg of montelukast is administered orally once daily. Infants aged 12 months to less than 2 years: 4 mg is administered orally once daily in the evening. Infants aged 6 months to less than 2 years: 4 mg is administered orally once daily.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Prevention of asthma and alleviation of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medicine helps prevent asthma and manage asthma symptoms continuously. It is also used to alleviate the symptoms of seasonal and perennial allergic rhinitis. This helps improve the respiratory health of patients and reduce inconveniences in daily life.

How to take

Adult dose

This 4 mg granule can be taken orally or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge below room temperature. Do not open the package until just before taking, and after opening, consume the entire amount mixed with soft food, breast milk, or food immediately (within 15 minutes). The medication should not be left mixed with soft food, breast milk, or food for a long time, and the remainder should be discarded. Although this medication is not formulated to be taken with drinks other than soft food or breast milk, it is acceptable to drink something immediately after taking it. This medication can be taken regardless of mealtime.

Child dose

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

Precautions

This medication is used for the treatment of asthma and allergic rhinitis, and it must be taken continuously for a long time to be effective. During treatment, neuropsychiatric adverse effects may occur; if symptoms such as agitation, anxiety, depression, hallucinations, or suicidal thoughts develop, consult a physician immediately. Patients with allergic reactions to this medication or hypersensitivity to its components should not take it. This medication can be used in a variety of age groups from children to adults, but its safety and efficacy have not been established in infants under 6 months of age. It is not a medication for acute asthma attacks, so a separate emergency treatment medication is necessary for acute symptoms, and it is important to always carry it. If sudden behavioral changes or thoughts of suicide occur during treatment, discontinue immediately and consult healthcare professionals. If there is a hypersensitivity reaction to aspirin or non-steroidal anti-inflammatory drugs, avoid using such medications while taking this drug. Patients with liver or kidney functional issues should discuss with a physician, and drug interaction potential should be considered when using other medications. During pregnancy or breastfeeding, it must be administered only after consulting a physician, and should be taken only when clearly necessary. In case of an overdose, there is no specific antidote; general treatment and monitoring are required, and if symptoms are severe, seek hospital care immediately. This medication is sensitive to light; do not open until just before taking it, and consume immediately after opening. Store in a location out of reach of children and avoid transferring it to another container. During treatment, do not arbitrarily reduce or discontinue other asthma medications per the physician's instructions, and consult healthcare professionals if symptoms worsen.

Side effects and when to seek care immediately

Serious side effects

Urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, severe edema, liver abnormalities (increased ALT and AST, cholestatic hepatitis, hepatocellular liver damage, mixed liver injury), severe neurological symptoms (seizures), suicidal thoughts and behaviors (including suicide), respiratory issues (pulmonary eosinophilia), severe edema with increased blood pressure, severe allergic reactions (anaphylaxis), severe skin abnormalities

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
Show 27 more
  • influenza
  • rash
  • increased ALT
  • increased AST
  • hematuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear inflammation
  • viral infections
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • drowsiness
  • sensory disturbances/decreased sensation
  • seizures
  • palpitations
  • nosebleed
  • lungs

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 and 30 degrees Celsius. It is also important to store in a tightly sealed container to prevent air from entering.

Appearance and packaging

Appearance

A homogeneous white granule without any foreign substances

Package unit

28 sachets

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.