Medication info

Singulair Granules 4mg (Montelukast Sodium)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Homogeneous granules that are white and free from foreign matter
Packaging
4mg/packet x 28
Approval status
Active

MFDS item code 201902838 · Approved 2019.05.02 · Insurance code 649104401

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 years and older are to take 10 mg of Montelukast orally once daily. The medication should be administered one hour before meals or two hours after meals. For a 10 mg orally disintegrating film, place it on the tongue to dissolve once daily without water.
Child dose
For children aged 6 to 14 years, take 5 mg of Montelukast once daily by chewing it or placing it on the tongue to dissolve without water. Alternatively, for a 5 mg orally disintegrating film, place it on the tongue to dissolve once daily.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps prevent and manage asthma effectively. It also alleviates symptoms of seasonal or perennial allergic rhinitis. Therefore, it is used to improve respiratory-related allergic conditions effectively.

How to take

Adult dose

Adults and adolescents aged 15 years and older are to take 10 mg of Montelukast orally once daily. The medication should be administered one hour before meals or two hours after meals. For a 10 mg orally disintegrating film, place it on the tongue to dissolve once daily without water.

Child dose

For children aged 6 to 14 years, take 5 mg of Montelukast once daily by chewing it or placing it on the tongue to dissolve without water. Alternatively, for a 5 mg orally disintegrating film, place it on the tongue to dissolve once daily.

Precautions

This medicine is used to treat asthma and allergic rhinitis. Serious neuropsychiatric symptoms may occur during use, so patients and caregivers should consult a doctor immediately if changes in mental health such as anxiety, aggressive behavior, depression, hallucinations, or suicidal thoughts occur. Do not take this medicine if you are allergic to it or any of its components. During the use of this medicine, side effects such as fatigue, headache, dyspepsia, rash, cough, and nasal congestion may occur. Inform healthcare professionals if symptoms are severe or persistent. This medication is not intended to treat acute asthma attacks; therefore, a separate emergency medication should always be kept and used in emergencies. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid using these medications while taking this medicine, and in cases of asthma exacerbated by exercise, this medication should not be used alone for treatment. Pregnant or breastfeeding individuals should take this medicine only if deemed necessary by a doctor, and special caution is required for young children and the elderly. In case of overdose, as there is no specific antidote, visit a medical facility immediately for appropriate treatment, and general symptom relief treatment will be administered. This medicine is sensitive to light, so it should be taken immediately when prepared and stored in a safe place out of reach of children. Do not arbitrarily reduce or discontinue doses of other asthma medications while taking this medicine, and all treatments should follow the instructions of the attending physician. If neuropsychiatric symptoms or abnormal behaviors occur while taking this medication, notify a doctor immediately, and regular observation and consultation are important.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • increased frequency of bleeding
  • thrombocytopenia
  • suicidal thoughts and behaviors
  • including suicide
  • seizures
  • pulmonary eosinophilia
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  • cholestatic hepatitis
  • hepatocellular liver damage
  • mixed liver injury
  • vasculitis
  • severe edema

Mild side effects

  • Asthenia/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
Show 25 more
  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • anorexia
  • ear infection
  • viral infection
  • laryngitis
  • urticaria
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • increased frequency of bleeding
  • thrombocytopenia
  • aggressive behavior
  • anxiety

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

Storage

This medicine is sensitive to air, moisture, and light; therefore, it must be stored in a tightly sealed container. It should be stored at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the effectiveness of the medicine for a longer period.

Appearance and packaging

Appearance

Homogeneous granules that are white and free from foreign matter

Package unit

4mg/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

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.