Medication info

Ingulair Granules 4mg (Montelukast Sodium)

Prescription medication경구Expired
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
(주)인트로바이오파마
Appearance
Homogeneous white granules free from foreign substances
Packaging
4mg/packet, 4mg/packet x 28
Approval status
Expired

MFDS item code 201902651 · Approved 2019.04.25

This product's status changed to Expired on 2024.04.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and alleviation of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 years and older should take 10 mg of Montelukast orally once daily. The 10 mg oral disintegrating film should be placed on the tongue to dissolve without drinking water, taken once daily. Patients with asthma and allergic rhinitis should take one tablet, packet, or film in the evening, once daily.
Child dose
Children aged 6 to 14 years should take 5 mg of Montelukast once daily, chewed or placed on the tongue to dissolve without water. Children aged 2 to 5 years should take 4 mg of Montelukast once daily, chewed.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Prevention of asthma and alleviation of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps prevent asthma attacks and manage the condition persistently. It also alleviates the symptoms of seasonal and perennial allergic rhinitis, thereby improving the patients' quality of life. Therefore, it is used for asthma and allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 years and older should take 10 mg of Montelukast orally once daily. The 10 mg oral disintegrating film should be placed on the tongue to dissolve without drinking water, taken once daily. Patients with asthma and allergic rhinitis should take one tablet, packet, or film in the evening, once daily.

Child dose

Children aged 6 to 14 years should take 5 mg of Montelukast once daily, chewed or placed on the tongue to dissolve without water. Children aged 2 to 5 years should take 4 mg of Montelukast once daily, chewed.

Precautions

This medicine should not be used in patients who are allergic to this drug or its components. Side effects such as fatigue, headache, abdominal pain, cough, and rash may occur while taking this medicine, so caution is necessary. Particularly, various adverse reactions have been reported in children, adolescents, and adults, so if symptoms are severe or persist, consult a doctor. It is not a medication for acute asthma attacks, so appropriate emergency medications should always be prepared and used when acute symptoms arise. Inhaled corticosteroids should not be abruptly discontinued or switched to this medication, and dosage should be adjusted gradually according to a doctor's instructions. Neuropsychiatric symptoms such as anxiety, depression, insomnia, and hallucinations may occur during treatment with this drug, so notify a doctor immediately if such changes occur. It should not be used alone for treating exercise-induced bronchospasm; inhaled bronchodilators should be used as needed. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid these medications while taking this drug. In asthma patients taking this drug, vasculitis or eosinophilia may rarely occur, so if symptoms like skin rash or worsening pulmonary symptoms appear, a medical check-up should be conducted. No specific interactions have been reported when used with other medications; however, careful monitoring should be conducted when used in combination with certain medications as per a doctor's advice. Pregnant or breastfeeding women should always consult a doctor before taking this drug. Caution should be exercised in children, especially infants under 6 months, as the safety and efficacy of this drug have not been fully established for this age group. In case of overdose, there is no specific antidote, so visit a medical institution immediately for appropriate treatment, and general symptomatic management is necessary. This drug is sensitive to light, so it should only be opened immediately before consumption, taken right after preparation, and kept out of reach of children. This drug should be taken continuously even during periods without asthma symptoms, and if symptoms worsen or side effects appear during treatment, consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, severe rash with high fever, blistering, peeling skin, mucosal pain in the mouth/eyes, difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output, severe systemic reactions.

Mild side effects

  • Asthenia/fatigue
  • fever
  • abdominal pain
  • trauma
  • dyspepsia
  • infectious gastroenteritis
  • dental pain
  • dizziness
  • headache
  • nasal congestion
Show 27 more
  • cough
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • otitis
  • viral infection
  • laryngitis
  • (infectious) rhinitis
  • chickenpox
  • gastroenteritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • rhinorrhea
  • ear pain
  • gastrointestinal inflammation
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis

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

Storage

Store this medication in a tightly sealed container to protect it from exposure to air, moisture, and light. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help preserve the medication's efficacy.

Appearance and packaging

Appearance

Homogeneous white granules free from foreign substances

Package unit

4mg/packet, 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

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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.