Medication info

Montelukast Sodium 4 mg (Montelukast Granules)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
(주)대웅제약
Appearance
A white, homogeneous granule without foreign substances
Packaging
4 mg/pack x 28
Approval status
Active

MFDS item code 201106259 · Notified 2011.09.07

Summary

Main use
Prevention of asthma and relief of allergy rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This 4 mg granule can be taken directly by mouth or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge below room temperature. The package should not be opened until just before taking it, and it should be mixed with soft food, breast milk, or taken as is immediately (within 15 minutes) after opening. This medicine should not be left mixed in soft food, breast milk, or food for long periods, and any leftovers should be discarded.
Child dose
Children aged 2 to 5 years should take 4 mg montelukast orally once daily. Infants aged 12 months to under 2 years should take 4 mg of this medicine orally once daily in the evening. Infants aged 6 months to under 2 years should take 4 mg once daily.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Prevention of asthma and relief of allergy rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medicine helps to prevent asthma and continuously treat it. It is also used to relieve seasonal or year-round allergic rhinitis symptoms.

How to take

Adult dose

This 4 mg granule can be taken directly by mouth or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge below room temperature. The package should not be opened until just before taking it, and it should be mixed with soft food, breast milk, or taken as is immediately (within 15 minutes) after opening. This medicine should not be left mixed in soft food, breast milk, or food for long periods, and any leftovers should be discarded.

Child dose

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

Precautions

This medicine contains the artificial sweetener aspartame and should be restricted in patients with phenylketonuria, a genetic disease. The daily intake of aspartame should not exceed the WHO recommended amount, and for adults, it is safe to take a maximum of 2.4 g per day. Patients with allergic reactions to any of the ingredients in this medicine, or those with lactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption should not take this medication. This medicine is not for treating acute asthma attacks, so necessary emergency medication should always be kept on hand for acute symptoms. When reducing the dose of inhaled corticosteroids, it should be adjusted gradually under a doctor's guidance, and it should not be abruptly replaced with this medication. If bronchospasms occur due to exercise, this medicine should not be used alone; inhaled β-agonists should be continued, and a bronchodilator inhaler should be kept available for emergencies. Patients with hypersensitivity to aspirin should avoid taking aspirin or non-steroidal anti-inflammatory drugs while using this medication. If symptoms related to the neuropsychiatric system, such as anxiety, depression, or restlessness, appear while taking this medicine, a doctor should be consulted immediately. Children and the elderly can use this medicine, but special precautions are needed, and safety and efficacy have not been established for infants under 6 months. There is no specific antidote for overdose; therefore, general treatment and monitoring are required. This medicine is sensitive to light, so it should not be opened until preparation for taking it, and should be taken immediately upon opening. It should be stored in a safe place out of children's reach, and transferring it to another container should be avoided. This medication should be taken consistently even when there are no asthma symptoms, and if symptoms worsen, a doctor should be consulted. Do not arbitrarily reduce or stop other asthma treatment medications while taking this medicine, and if any abnormal symptoms occur while on medication, inform medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • Angioedema
  • Toxic Epidermal Necrolysis
  • Stevens-Johnson Syndrome
  • Thrombocytopenia
  • Anaphylaxis
  • Severe Allergic Reactions
  • Severe Skin Reactions
  • Severe Hives
  • Difficulty Breathing
Show 1 more
  • Generalized Edema

Mild side effects

  • Weakness/Fatigue
  • Fever
  • Abdominal Pain
  • Indigestion
  • Infectious Gastroenteritis
  • Toothache
  • Dizziness
  • Headache
  • Nasal Congestion
  • Cough
Show 27 more
  • Influenza
  • Rash
  • Pyuria
  • Pharyngitis
  • Sinusitis
  • Nausea
  • Diarrhea
  • Loss of Appetite
  • Ear Pain
  • Viral Infection
  • Laryngitis
  • Runny Nose
  • Earache
  • Gastroenteritis
  • Eczema
  • Chickenpox
  • Pneumonia
  • Dermatitis
  • Conjunctivitis
  • Upper Respiratory Infection
  • Increased Frequency of Bleeding
  • Thrombocytopenia
  • Aggressive Behavior
  • Restlessness
  • Anxiety
  • Depression
  • Disorientation

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air, moisture, and light. The appropriate storage temperature is between 1 degree Celsius and 30 degrees Celsius. Storing it this way helps maintain the medicine's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A white, homogeneous granule without foreign substances

Package unit

4 mg/pack 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.