Medication info

Singkast Granules 4 mg (Montelukast Sodium)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
(주)유한양행
Appearance
White homogeneous granules without foreign substances
Packaging
28 packets (0.5g/packet × 28)
Approval status
Active

MFDS item code 201006532 · Notified 2010.10.29 · Insurance code 642103961

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 directly by mouth or mixed with a small amount (about 5 mL) of soft food such as baby food, breast milk, or porridge at room temperature. The packaging must not be opened until right before administration, and after opening, it should be mixed with or taken entirely within 15 minutes. This medication can be taken regardless of meal times.
Child dose
Children aged 2 to 5 years: Montelukast 4 mg orally once daily. Infants aged 12 months to under 2 years: This medication 4 mg orally at bedtime once daily. Infants aged 6 months to under 2 years: This...

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent and manage asthma. It is also used to relieve symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

This 4 mg granule formulation can be taken directly by mouth or mixed with a small amount (about 5 mL) of soft food such as baby food, breast milk, or porridge at room temperature. The packaging must not be opened until right before administration, and after opening, it should be mixed with or taken entirely within 15 minutes. This medication can be taken regardless of meal times.

Child dose

Children aged 2 to 5 years: Montelukast 4 mg orally once daily. Infants aged 12 months to under 2 years: This medication 4 mg orally at bedtime once daily. Infants aged 6 months to under 2 years: This...

Precautions

This medication is used to treat respiratory diseases such as asthma and allergic rhinitis. Side effects related to the nervous system, such as restlessness, anxiety, depression, hallucinations, and suicidal thoughts may occur during treatment, so patients and caregivers should carefully observe these changes. If any new neurological or psychiatric symptoms or behavioral changes appear, consult a doctor immediately. Patients with hypersensitivity to this medication or its components should not take it. Side effects such as fatigue, headache, dyspepsia, fever, cough, and rash may occur, and while safety has been confirmed in children and elderly patients, caution is required. This medication is not used to treat acute asthma attacks; therefore, emergency medication should always be carried and used in case of acute symptoms. The dosage of inhaled corticosteroids should not be suddenly reduced or substituted, and it should not be used alone for exercise-induced bronchospasm treatment. Patients with aspirin hypersensitivity should avoid taking aspirin or NSAIDs while using this medication. Rarely, severe side effects such as systemic eosinophilia and vasculitis may occur, requiring medical observation. While drug interactions are uncommon, clinical monitoring is recommended when taken with specific medications. Pregnant or breastfeeding women should use this medication only when absolutely necessary, as safety data is limited and caution is advised. Safety and efficacy for pediatric patients have been confirmed depending on age, but safety has not been established for infants under 6 months. No specific antidote exists for overdose; general supportive care and clinical monitoring are needed. This medication is sensitive to light, so it should be opened just before ingestion and stored out of reach of children. During treatment, do not suddenly discontinue or reduce the dosage of other asthma medications without a doctor’s guidance, and consult a doctor immediately if symptoms worsen.

Side effects and when to seek care immediately

Serious side effects

Hives, Severe Swelling (Edema), Angioedema, Chest Tightness, Difficulty Breathing, Cold Sweat, Pallor, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Severe Rash with High Fever, Blisters, Skin Peeling, Mouth/Eye Mucosal Pain, Shortness of Breath or Breathing Difficulty, Asthma Attack, Respiratory Abnormalities with Cough and Fever, Yellowing of Skin or Eyes (Jaundice), Severe Systemic Lethargy, Sudden and Severe Headache, Lightning.

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
  • Pyuria
  • Pharyngitis
  • Sinusitis
  • Nausea
  • Diarrhea
  • Loss of Appetite
  • Ear Inflammation
  • Viral Infection
  • Laryngitis
  • Chickenpox
  • Gastroenteritis
  • Eczema
  • Pneumonia
  • Dermatitis
  • Conjunctivitis
  • Drowsiness
  • Sensory Disturbance/Sensation Decrease
  • Palpitations
  • Nosebleed
  • Eosinophilia
  • Diarrhea
  • Vomiting
  • Bile.

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 in a dry place protected from light. Additionally, it must be kept at room temperature between 1°C and 30°C and stored in a tightly sealed container to prevent air from entering.

Appearance and packaging

Appearance

White homogeneous granules without foreign substances

Package unit

28 packets (0.5g/packet × 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.