Medication info

Montelukast 10 mg Tablets (Montelukast Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Montelukast Sodium›10.4mg / 1 tablet
Manufacturer / importer
(주)킴스제약
Appearance
Beige, corner-rounded square film-coated tablets
Packaging
PTP - 30 tablets/PTP [30 tablets (10 tablets/PTP x 3)], PTP - 28 tablets/PTP [28 tablets (7 tablets/PTP x 4)]
Approval status
Expired

MFDS item code 201907781 · Approved 2019.11.06

This product's status changed to Expired on 2024.11.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
For adults and adolescents over 15 years old, take 10 mg of montelukast orally once daily. 10 mg oral disintegrating film: Place 10 mg on the tongue once daily until dissolved without water. This medication should be taken once daily, and asthma patients should take it in the evening. It should be administered 1 hour before meals or 2 hours after meals.
Child dose
For children aged 6 to 14 years, take 5 mg of montelukast once daily by chewing or placing it on the tongue to dissolve without water. 5 mg oral disintegrating film: Place 5 mg on the tongue once daily.

Ingredients

Manufacturer
(주)킴스제약

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps to prevent and continuously treat asthma. It is also used to alleviate symptoms of seasonal and year-round allergic rhinitis. Therefore, it is effective in improving the management of asthma and allergic rhinitis.

How to take

Adult dose

For adults and adolescents over 15 years old, take 10 mg of montelukast orally once daily. 10 mg oral disintegrating film: Place 10 mg on the tongue once daily until dissolved without water. This medication should be taken once daily, and asthma patients should take it in the evening. It should be administered 1 hour before meals or 2 hours after meals.

Child dose

For children aged 6 to 14 years, take 5 mg of montelukast once daily by chewing or placing it on the tongue to dissolve without water. 5 mg oral disintegrating film: Place 5 mg on the tongue once daily.

Precautions

This medication contains the artificial sweetener aspartame, and should not be administered to patients with phenylketonuria, as they require a process to break down phenylalanine in the body. The daily intake of aspartame should be limited based on body weight, so adults should be cautious not to exceed the maximum allowable limit. Patients with an allergy to any ingredient in this medication should avoid use, and those with lactose intolerance or certain genetic gastrointestinal disorders should also refrain from taking it. This medication is used for both asthma and allergic rhinitis patients, but side effects such as fatigue, headache, dyspepsia, and rash may occur, so consultation with a physician should be sought if such symptoms arise. In particular, serious symptoms such as rare vasculitis or eosinophilia may occur, so immediate notification to healthcare personnel is necessary if respiratory symptoms, skin rashes, or heart abnormalities arise. This medication is not a treatment for acute asthma attacks, so separate emergency medication should be used during acute symptoms, and inhaled corticosteroid dosage should be adjusted according to the physician's instructions. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid using these medications during treatment with this medication, although drug interactions are generally limited; caution is needed if combined with specific liver metabolic enzyme inducers. During pregnancy or breastfeeding, animal studies have shown no abnormal findings; however, as sufficient research in humans is lacking, it should only be administered when necessary. Children and the elderly may also use this medication, but safety and dosage differ by age, so it is essential to follow a physician's instructions, and safety has not been established in infants under 6 months of age. In cases of overdose, there is no specific antidote, making it important to receive general symptomatic relief treatment and clinical monitoring. This medication is sensitive to light, so it should be opened and taken immediately before use, and kept out of reach of children. If symptoms of worsening asthma or neurological symptoms occur during treatment, immediate consultation with a doctor is necessary, and doses of other asthma medications should not be arbitrarily reduced or discontinued.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • angioedema
  • thrombocytopenia
  • anaphylaxis
  • severe allergic reactions
  • toxic epidermal necrolysis
  • inflammatory skin rashes
  • exacerbation of pulmonary symptoms
Show 5 more
  • cardiac complications
  • neuropathy
  • hepatocellular liver damage
  • cholestatic hepatitis
  • mixed liver damage

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
  • cough
Show 27 more
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear pain
  • viral infections
  • laryngitis
  • runny nose
  • earache
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory tract infection
  • increased frequency of bleeding
  • thrombocytopenia
  • aggressive behavior
  • restlessness
  • anxiety
  • depression
  • disorientation

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

Storage

This medication is sensitive to air, moisture, and light, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 degree and 30 degrees. By storing it this way, the drug's efficacy and safety can be maintained.

Appearance and packaging

Appearance

Beige, corner-rounded square film-coated tablets

Package unit

PTP - 30 tablets/PTP [30 tablets (10 tablets/PTP x 3)], PTP - 28 tablets/PTP [28 tablets (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.