Medication info

Montelukast Sodium Granules 4 mg

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
한미약품(주)
Appearance
White homogeneous granules without foreign substances
Packaging
30 packets/box [500 mg/packet x 30]
Approval status
Active

MFDS item code 201109187 · Approved 2011.10.26 · Insurance code 643506081

Summary

Main use
Treatment for asthma prevention and relief of allergy rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This medication is taken once daily. Asthma patients should take it in the evening, while allergy rhinitis patients should determine the dosing time based on their condition. Patients with both asthma and allergic rhinitis should take 1 packet in the evening once daily. The 4 mg granules can be taken directly or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge. Do not open the package until ready to take it; open it right before consuming.
Child dose
Children aged 2 to 5 years should take 4 mg of Montelukast orally once daily. Infants aged 12 months to under 2 years should take 4 mg orally in the evening once daily. There is no established efficacy and safety for infants under 12 months for asthma.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment for asthma prevention and relief of allergy rhinitis symptoms

  • Asthma
  • allergy rhinitis symptoms
View approved original text

This medication helps to prevent and manage asthma effectively. It also alleviates symptoms of seasonal or perennial allergic rhinitis, aiding in maintaining a comfortable daily life. It is primarily used for asthma and allergic rhinitis.

How to take

Adult dose

This medication is taken once daily. Asthma patients should take it in the evening, while allergy rhinitis patients should determine the dosing time based on their condition. Patients with both asthma and allergic rhinitis should take 1 packet in the evening once daily. The 4 mg granules can be taken directly or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge. Do not open the package until ready to take it; open it right before consuming.

Child dose

Children aged 2 to 5 years should take 4 mg of Montelukast orally once daily. Infants aged 12 months to under 2 years should take 4 mg orally in the evening once daily. There is no established efficacy and safety for infants under 12 months for asthma.

Precautions

This medicine is used to alleviate symptoms of asthma and allergic rhinitis. While taking this drug, neuropsychiatric symptoms may occur. If there are any changes such as anxiety, restlessness, depression, sleep disturbances, hallucinations, or suicidal thoughts, consult a physician immediately. People who are allergic to this medication or any of its components should not take it. Be aware that side effects such as fatigue, headache, abdominal pain, fever, indigestion, cough, nasal congestion, and rash may occur. Especially children and the elderly can use this medication, but adverse reactions may vary according to age, so it is important to take it under a physician's guidance. This medication is not intended for use during acute asthma attacks; if acute symptoms arise, separate emergency medications must be prepared and used. Those with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not use such medications while taking this drug. During the course of taking this medicine, do not abruptly discontinue other asthma treatments without a doctor's instruction; adjust gradually as per their guidance. Pregnant or nursing women should only take this medication when necessary and under doctor's advice, as it may be excreted in breast milk. Drug interactions are rarely observed; however, it is recommended to consult with a doctor or pharmacist when taking alongside certain medications. In case of overdose, there is no specific antidote, so appropriate treatment must be received based on symptoms and a physician's assessment. This drug is sensitive to light; therefore, do not open the package until it is ready to be taken, and it is important to take it immediately upon opening. Keep out of reach of children and do not transfer to other containers for safety. This medication should be taken consistently to help prevent asthma, even if no symptoms are present, and consult a physician if symptoms worsen.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, breathing issues, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and...

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • traumas
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
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  • cough
  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear infection
  • viral infections
  • laryngitis
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • drowsiness
  • sensory abnormalities/sensory decrease
  • palpitations
  • nosebleeds
  • diarrhea
  • vomiting
  • etc.

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

Storage

This medication is sensitive to moisture and light; thus it should be stored at room temperature between 1°C and 30°C. Additionally, it is important to store it in a tightly closed container to prevent air ingress.

Appearance and packaging

Appearance

White homogeneous granules without foreign substances

Package unit

30 packets/box [500 mg/packet x 30]

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.