Medication info
Montelukast Sodium Chewable Tablets 4 mg

Montelukast Sodium Chewable Tablets 4 mg

Prescription medicationChewable Tablet경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Pink chewable tablets that are oval-shaped and convex on both sides
Packaging
28 tablets - 7 tablets/PTP [28 tablets/box (7 tablets/PTP x 4)]
Approval status
Active

MFDS item code 201908026 · Approved 2019.11.21 · Insurance code 057700510

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
This medication should be taken once daily, preferably in the evening for asthma patients. Patients with both asthma and allergic rhinitis should take one tablet in the evening once daily. This medication should be administered 1 hour before or 2 hours after meals.
Child dose
Children aged 2 to 5 years should chew 4 mg of montelukast once daily. This medication should be administered 1 hour before or 2 hours after meals.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Symptoms of asthma and allergic rhinitis
View approved original text

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

How to take

Adult dose

This medication should be taken once daily, preferably in the evening for asthma patients. Patients with both asthma and allergic rhinitis should take one tablet in the evening once daily. This medication should be administered 1 hour before or 2 hours after meals.

Child dose

Children aged 2 to 5 years should chew 4 mg of montelukast once daily. This medication should be administered 1 hour before or 2 hours after meals.

Precautions

This medication is used for the prevention and treatment of asthma and allergic rhinitis. Abnormal psychiatric symptoms may appear during treatment, so patients or caregivers should consult a doctor immediately if symptoms such as agitation, anxiety, depression, sleep disturbances, hallucinations, or suicidal thoughts occur. The artificial sweetener aspartame contained in this medication is broken down into phenylalanine, so patients with the genetic disorder phenylketonuria should not take this medication. Formulations containing lactose should not be administered to patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. This medication is not a treatment for acute asthma attacks, and appropriate emergency medications must be on hand in case of emergencies. When reducing the dose of inhaled corticosteroids, this should be done gradually under a doctor's supervision, as sudden changes can be dangerous. It should not be used alone for exercise-induced bronchospasm treatment, and β-agonists for inhalation should continue to be used if necessary. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not take these medications while on this drug. Rarely, generalized eosinophilia and vasculitis symptoms may occur while taking this medication, so careful observation and consultation with a doctor are necessary upon symptom occurrence. Although no special interactions have been reported when used with other medications, caution is needed when used concurrently with some strong enzyme inducers. It should only be used during pregnancy if absolutely necessary, and caution is required during breastfeeding. Safe use has been established for children and elderly patients, but there is insufficient safety data for children under 6 months of age. In case of overdose, there is no specific antidote, so general symptomatic treatment and clinical monitoring are necessary. This medication should be stored out of reach of children, and it should not be transferred to another container. It should be taken regularly even if there are no symptoms, and immediate consultation with a doctor is necessary if symptoms worsen or unusual symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, skin or eyes turning yellow, extreme lethargy, liver issues (jaundice), sudden and severe headaches, etc.

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • coughing
Show 27 more
  • influenza
  • rash
  • increased ALT
  • increased AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear pain
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • increased frequency of bleeding
  • thrombocytopenia
  • aggressive behavior
  • agitation
  • anxiety
  • and others

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 to 30 degrees Celsius. It is also important to keep it in a tightly sealed container to prevent air ingress.

Appearance and packaging

Appearance

Pink chewable tablets that are oval-shaped and convex on both sides

Package unit

28 tablets - 7 tablets/PTP [28 tablets/box (7 tablets/PTP x 4)]

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.