Medication info
Montelukast Chewable Tablets 4 mg (Montelukast Sodium)

Montelukast Chewable Tablets 4 mg (Montelukast Sodium)

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

MFDS item code 201500943 · Approved 2015.02.24 · Insurance code 645208640

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 and older: Take 10 mg of montelukast orally once daily. 10 mg orally disintegrating film: Place 10 mg on the tongue, let it dissolve, and take it without water. This medication should be taken once daily; asthma patients should take it in the evening, while allergic rhinitis patients can determine the dosing time according to their condition. For patients with both asthma and allergic rhinitis: Take 1 tablet, 1 pack, or 1 film once daily in the evening.
Child dose
Children aged 6-14 years: Chew 5 mg of montelukast once daily. 5 mg oral tablet: Place 5 mg on the tongue, let it dissolve, and take it without water. 5 mg orally disintegrating tablet.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent asthma attacks and provides continuous treatment. It is also used to relieve symptoms caused by seasonal and perennial allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 and older: Take 10 mg of montelukast orally once daily. 10 mg orally disintegrating film: Place 10 mg on the tongue, let it dissolve, and take it without water. This medication should be taken once daily; asthma patients should take it in the evening, while allergic rhinitis patients can determine the dosing time according to their condition. For patients with both asthma and allergic rhinitis: Take 1 tablet, 1 pack, or 1 film once daily in the evening.

Child dose

Children aged 6-14 years: Chew 5 mg of montelukast once daily. 5 mg oral tablet: Place 5 mg on the tongue, let it dissolve, and take it without water. 5 mg orally disintegrating tablet.

Precautions

This medication contains the artificial sweetener aspartame, which is broken down in the body to phenylalanine. Therefore, patients with the hereditary disease phenylketonuria should not take this medication. Additionally, this medication contains lactose; patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not use this medication. While this medication helps alleviate asthma or allergic rhinitis symptoms, it is not a treatment used during acute asthma attacks. Therefore, individuals with acute symptoms should always have appropriate emergency medications on hand. During treatment, rare but serious vascular symptoms such as eosinophilia may occur; thus, a doctor should carefully monitor for skin rashes, worsening pulmonary symptoms, heart problems, or neuropathy. It is advisable to avoid taking this medication concurrently with aspirin or non-steroidal anti-inflammatory drugs, particularly for patients with hypersensitivity to aspirin. Safety has been confirmed in clinical trials for children, adolescents, and adults; however, safety and efficacy have not been established in infants under 6 months of age. Women who are pregnant or breastfeeding should consult with a physician before taking this medication, and it should only be used when clearly necessary. In case of overdose, there is no specific antidote, so general symptomatic treatment and clinical monitoring are necessary, and immediate medical attention should be sought if symptoms occur. This medication is sensitive to light, so it should be opened just before use, and it is best taken within 15 minutes after preparation. If neuropsychiatric symptoms such as anxiety, depression, hallucinations, or sleep disturbances occur during treatment, immediate consultation with a physician is required. Do not arbitrarily reduce or discontinue other asthma treatments while taking this medication, and always follow a doctor's instructions. Finally, keep this medication out of the reach of children and be careful not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, severe swelling (edema), 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 abnormal reactions, shortness of breath or difficulty breathing, asthma attack, respiratory problems with cough and fever, jaundice (yellowing of the skin or eyes)

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • trauma
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
Show 26 more
  • cough
  • influenza
  • rash
  • elevated ALT
  • elevated AST
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear inflammation
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • increased bleeding frequency
  • thrombocytopenia
  • aggressive behavior

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 in a dry, dark place. A storage temperature between 1 and 30 degrees Celsius is recommended. Additionally, it must be kept in a tightly sealed container to maintain its efficacy.

Appearance and packaging

Appearance

Pink, oval-shaped, chewable tablet that is convex on both sides

Package unit

28 tablets/PTP (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.