Medication info

Singulair Granules 4 mg (Montelukast Sodium)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
알리코제약(주)
Appearance
White homogeneous granules without any foreign matter
Packaging
28 packets/box - 4 mg/packet [X 28]
Approval status
Active

MFDS item code 201902402 · Approved 2019.04.18 · Insurance code 656005001

Summary

Main use
Treatment for asthma prevention and alleviation of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This 4 mg granule can be taken orally directly or mixed with a small amount (about 5 mL) of food, breast milk, or porridge at room temperature or below. Do not open the packaging until just before taking, and after opening, administer immediately (within 15 minutes) by mixing with food, breast milk, or consume the entire amount directly. Do not leave the mixed food, breast milk, or food with this medication unattended for a long time, and discard any leftovers.
Child dose
Children aged 2 to 5 years: Administer 4 mg of Montelukast orally once daily. Infants aged 12 months to younger than 2 years: Administer 4 mg of this medication orally once daily in the evening. Infants aged 6 months to younger than 2 years:

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Treatment for asthma prevention and alleviation of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

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

How to take

Adult dose

This 4 mg granule can be taken orally directly or mixed with a small amount (about 5 mL) of food, breast milk, or porridge at room temperature or below. Do not open the packaging until just before taking, and after opening, administer immediately (within 15 minutes) by mixing with food, breast milk, or consume the entire amount directly. Do not leave the mixed food, breast milk, or food with this medication unattended for a long time, and discard any leftovers.

Child dose

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

Precautions

This medication is used to treat asthma and allergic rhinitis. During the treatment with this drug, there may be alterations in the neuropsychiatric system, so if symptoms such as agitation, aggressive behavior, anxiety, depression, sleep disorders, hallucinations, or suicidal impulses occur, consult a doctor immediately. Do not take this medication if you have an allergy to it or its ingredients. Various side effects such as dizziness, headache, indigestion, rash, cough, nasal congestion may occur during treatment, and if symptoms worsen, inform your doctor. Particularly, pediatric and elderly patients can also use this medication, but care should be taken due to differing side effects or reactions based on age. This medication is not intended for the treatment of acute asthma attacks, so an emergency inhaler must be kept and used in the case of acute symptoms. In cases of bronchoconstriction due to exercise, do not rely solely on this medication for treatment, and continue to use inhaled bronchial dilators as necessary. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid taking these medications while using this drug. This medication should only be used during pregnancy when absolutely necessary, and nursing mothers should use it with caution. There are no significant interactions when taken with other medications, but monitoring is required as per a doctor's guidance when used in conjunction with certain drugs. In case of overdose, there is no specific antidote, so general treatment should be provided based on symptoms and consult a doctor. This medication is sensitive to light, so do not open the packaging until just before taking, and store it in a place out of reach of children. For usage, take it consistently daily as directed by a physician, and if symptoms worsen or new symptoms appear, consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe allergic reactions, serious skin adverse reactions, thrombocytopenia, cholestatic hepatitis, hepatocellular injury, mixed liver injury, vasculitis rash, exacerbation of pulmonary symptoms, cardiac complications, neuropathy, seizure, suicidal thoughts and behaviors (including suicide), suicidal impulse, seizure, palpitations, pulmonary eosinophilia, increased bleeding frequency

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
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  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • earache
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • angioedema
  • bruising
  • erythema multiforme
  • nodular erythema
  • itching
  • urticaria

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°C and 30°C. Additionally, it is important to store it in a tightly sealed container to prevent air from entering.

Appearance and packaging

Appearance

White homogeneous granules without any foreign matter

Package unit

28 packets/box - 4 mg/packet [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.