Medication info

Esmonte 4 mg (Montelukast Sodium)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
코오롱제약(주)
Appearance
White, homogeneous granules without foreign substances
Packaging
28 sachets
Approval status
Active

MFDS item code 201109282 · Approved 2011.10.31 · Insurance code 670303391

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This 4 mg granule formulation can be taken by mouth directly or mixed with a small amount (about 5 mL) of soft food such as room temperature baby food, breast milk, or porridge. The packaging should not be opened until just before taking; after opening, it should be taken immediately (within 15 minutes) mixed with baby food, breast milk, or food or taken entirely as is. Do not leave this medication mixed with baby food, breast milk, or food for a long time, and any leftover should be discarded. This medication is not formulated to be taken mixed with drinks other than baby food or breast milk, but it is acceptable to consume a drink immediately after taking this medication. This medication can be taken regardless of meal times.
Child dose
Children aged 2–5 years: Administer 4 mg of montelukast orally once daily. Infants aged 12 months to less than 2 years: Administer 4 mg of this medication orally once daily in the evening. Infants aged 6 months to less than 2 years:

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Symptoms of asthma and allergic rhinitis
View approved original text

This medication is used to prevent asthma and to treat asthma symptoms over a long period. It also helps relieve the symptoms of seasonal and perennial allergic rhinitis. Therefore, it is effective in improving discomfort caused by asthma and allergic rhinitis.

How to take

Adult dose

This 4 mg granule formulation can be taken by mouth directly or mixed with a small amount (about 5 mL) of soft food such as room temperature baby food, breast milk, or porridge. The packaging should not be opened until just before taking; after opening, it should be taken immediately (within 15 minutes) mixed with baby food, breast milk, or food or taken entirely as is. Do not leave this medication mixed with baby food, breast milk, or food for a long time, and any leftover should be discarded. This medication is not formulated to be taken mixed with drinks other than baby food or breast milk, but it is acceptable to consume a drink immediately after taking this medication. This medication can be taken regardless of meal times.

Child dose

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

Precautions

This medication is used for treating asthma and allergic rhinitis. During treatment with this medication, psychiatric symptoms may appear, such as anxiety, depression, hallucinations, and suicidal thoughts; if any of these symptoms occur, consult your doctor immediately. Patients with a known allergy to this medication or its components should not take it. Side effects such as fatigue, headache, indigestion, cough, and rash may occur after taking this medication; if abnormal symptoms persist, inform your doctor. This medication is not intended for use as an immediate treatment for acute asthma attacks, so always carry an emergency inhaler. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid using these medications while taking this drug. If you are pregnant or breastfeeding, you must consult a doctor before taking this medication, and it is advisable to avoid use if the necessity is not clear. When administering to children, safety and efficacy may vary based on age; therefore, follow your doctor's instructions. In case of overdose, there is no specific antidote, so appropriate treatment based on symptoms is important. This medication is sensitive to light, so do not open the package until right before taking it, and if opened, take it immediately. Store in a place out of reach of children and do not transfer to another container. While taking this medication, do not reduce or stop other asthma treatments without a doctor's direction, and consult your doctor immediately if asthma symptoms worsen.

Side effects and when to seek care immediately

Serious side effects

Urticaria, Severe swelling (edema), Toxic epidermal necrolysis, Stevens-Johnson syndrome, Severe allergic reactions, Severe dermatological reactions, Angioedema, Stevens-Johnson syndrome, Jaundice, Elevated ALT and AST, Cholestatic hepatitis, Hepatocellular damage, Mixed-type liver damage, Acute bronchitis, Difficulty breathing, Suicidal thoughts and behavior (including suicide), Suicidal thoughts, Thunderclap headache, Seizures, Confusion of consciousness, Visual disturbances, Coma

Mild side effects

  • Weakness/Fatigue
  • Fever
  • Abdominal pain
  • Trauma
  • Indigestion
  • Infectious gastroenteritis
  • Toothache
  • Dizziness
  • Headache
  • Nasal congestion
Show 28 more
  • Cough
  • Influenza
  • Rash
  • Pyuria
  • Pharyngitis
  • Sinusitis
  • Nausea
  • Diarrhea
  • Loss of appetite
  • Otitis
  • Viral infection
  • Laryngitis
  • Runny nose
  • Ear pain
  • Gastroenteritis
  • Eczema
  • Chickenpox
  • Pneumonia
  • Dermatitis and conjunctivitis
  • Drowsiness
  • Sensory disturbances/hypoesthesia
  • Palpitations
  • Nosebleed
  • Diarrhea
  • Nausea
  • Vomiting
  • Arthralgia
  • Muscle spasm

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, dark place. The optimal storage temperature is between 1 and 30 degrees Celsius, and it should be kept in a container that seals well to prevent air from entering.

Appearance and packaging

Appearance

White, homogeneous granules without 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.