Medication info

Arucas Granule 4 mg (Montelukast Sodium)

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
(주)아리제약
Appearance
A homogeneous and white granule without foreign matter
Packaging
4 mg/packet [4 mg/packet x 28]
Approval status
Active

MFDS item code 201908599 · Approved 2019.12.24

Summary

Main use
Treatment for asthma prevention and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This medication is to be taken once daily, preferably in the evening for asthma patients. For allergic rhinitis patients, the dosing time should be determined according to the patient's condition. For patients with both asthma and allergic rhinitis, take 1 tablet, 1 packet, or 1 dose in the evening once daily. The 4 mg granules can be taken directly or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge at room temperature or below.
Child dose
For children aged 2–5 years, Montelukast 4 mg is administered orally once daily. For infants aged 12 months to less than 2 years, 4 mg is administered orally once daily in the evening. For infants aged 6 months to less than 2 years, 4 mg is administered orally once daily.

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Treatment for asthma prevention and relief of allergic rhinitis symptoms

  • Symptoms of asthma
  • allergic rhinitis
View approved original text

This medication helps prevent asthma and manage symptoms in the long term when they persist. It is also effective in relieving various symptoms of seasonal and perennial allergic rhinitis. Therefore, it is used for continuous treatment in patients with asthma and allergic rhinitis.

How to take

Adult dose

This medication is to be taken once daily, preferably in the evening for asthma patients. For allergic rhinitis patients, the dosing time should be determined according to the patient's condition. For patients with both asthma and allergic rhinitis, take 1 tablet, 1 packet, or 1 dose in the evening once daily. The 4 mg granules can be taken directly or mixed with a small amount (about 5 mL) of soft food, breast milk, or porridge at room temperature or below.

Child dose

For children aged 2–5 years, Montelukast 4 mg is administered orally once daily. For infants aged 12 months to less than 2 years, 4 mg is administered orally once daily in the evening. For infants aged 6 months to less than 2 years, 4 mg is administered orally once daily.

Precautions

This medication is used to prevent and treat asthma and allergic rhinitis. During treatment, significant neuropsychiatric symptoms may occur, so patients and caregivers should closely observe any changes in behavior or mental state such as anxiety, agitation, depression, hallucinations, or suicidal thoughts. If these symptoms occur, discontinue use immediately and consult a doctor, with continuous management needed until symptoms improve. Do not take this medication if you have a hypersensitivity to it or its components. Diverse adverse reactions such as fatigue, headache, dyspepsia, rash, nasal congestion, and cough may occur after taking it, and while safety has been evaluated in both children and adults, caution for adverse reactions is required. This medication is not for use during acute asthma attacks, so for acute symptoms, a rapid-acting inhaled bronchodilator should be used, and this medication should be taken consistently as directed by a physician. Patients with hypersensitivity to aspirin should avoid aspirin or non-steroidal anti-inflammatory drugs while taking this medication. It should only be used during pregnancy if absolutely necessary, and nursing mothers should use it with caution. No significant interactions have been reported when using this medication with other asthma treatments or multiple drugs, but it should be used according to a doctor’s guidance when taken with certain medications. There is no specific antidote for overdose, so symptomatic treatment should be provided under medical supervision. This medication is sensitive to light, so do not open the packaging until just before use, and it is advisable to take it immediately after opening. Keep it out of the reach of children, and be cautious as transferring it to another container may change its quality. Consult a doctor if asthma symptoms worsen, or persist during treatment, and do not arbitrarily discontinue use or adjust dosages of other medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, breathing difficulties, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities accompanied by cough and fever, yellowing of skin or eyes, severe lethargy, sudden and extremely severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, marked decrease in urination

Mild side effects

  • Weakness
  • fatigue
  • fever
  • abdominal pain
  • 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
  • rhinitis
  • chickenpox
  • gastroenteritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • runny nose
  • ear pain
  • enteritis
  • eczema
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract infection

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

Storage

This medication should be stored in a tightly sealed container to protect it from air, moisture, and light. The storage temperature should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

A homogeneous and white granule without foreign matter

Package unit

4 mg/packet [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

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.