Medication info
Montelukast Sodium 10 mg Tablets

Montelukast Sodium 10 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Montelukast Sodium›10.4mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Beige film-coated tablet with a rounded rectangular shape
Packaging
28 tablets (7 tablets/blister x 4)
Approval status
Active

MFDS item code 201501422 · Approved 2015.03.18 · Insurance code 645604560

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 years and older should take montelukast once a day at 10 mg orally. It can be administered in the form of 10 mg tablets or 10 mg orally disintegrating film, and the orally disintegrating film should be placed on the tongue to dissolve without water. This medication should be taken one hour before a meal or two hours after a meal.
Child dose
Children aged 6 to 14 years should take montelukast once a day at 5 mg, chewing it or placing it on their tongue to dissolve without water, in the form of 5 mg chewable tablets, 5 mg orally disintegrating tablets, 5 mg orally disintegrating film, or 5 mg dry syrup.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication is used to prevent and maintain treatment for asthma. It also helps alleviate symptoms of allergic rhinitis that recur seasonally or throughout the year. Therefore, it is effective in managing respiratory-related allergic diseases.

How to take

Adult dose

Adults and adolescents aged 15 years and older should take montelukast once a day at 10 mg orally. It can be administered in the form of 10 mg tablets or 10 mg orally disintegrating film, and the orally disintegrating film should be placed on the tongue to dissolve without water. This medication should be taken one hour before a meal or two hours after a meal.

Child dose

Children aged 6 to 14 years should take montelukast once a day at 5 mg, chewing it or placing it on their tongue to dissolve without water, in the form of 5 mg chewable tablets, 5 mg orally disintegrating tablets, 5 mg orally disintegrating film, or 5 mg dry syrup.

Precautions

This medication contains the artificial sweetener aspartame, so patients with the genetic disorder phenylketonuria should avoid taking it. Care should be taken not to exceed the daily allowable intake of aspartame, and the appropriate dosage should be followed based on body weight. Individuals who are allergic or have hypersensitivity to the ingredients contained in this medication should not take it. Since it contains lactose, patients with genetic problems such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should also avoid taking it. This medication is not used for acute asthma attacks, and immediate emergency treatment is needed if asthma symptoms suddenly worsen. It is important to always carry an appropriate emergency inhaler in case of an asthma worsening. When reducing the dosage of inhaled corticosteroids, it must be gradually adjusted according to a doctor’s instructions as sudden changes can be dangerous. During treatment, neuropsychiatric symptoms such as anxiety, depression, hallucinations, or suicidal thoughts may occur, so if such symptoms arise, immediate consultation with a physician is necessary. Do not use this medication alone to treat exercise-induced bronchoconstriction, and continue to use inhaled beta-agonists as needed. Patients with aspirin hypersensitivity should avoid taking aspirin or nonsteroidal anti-inflammatory drugs while using this medication. Rarely, severe vascular inflammatory symptoms such as vasculitis may occur, so if there are signs of eosinophilia, rash, or exacerbation of lung symptoms, inform a doctor immediately. This medication can be used in conjunction with other asthma treatments without significantly increasing adverse reactions, but should be taken according to a physician's instructions when used with specific drugs. During pregnancy, it should only be used after consulting a physician and should be done with caution during breastfeeding. Children and the elderly can also take it, but they should follow the physician’s guidance regarding age-specific dosages and safety. There is no specific antidote for overdose, so immediate medical treatment should be sought. This medication is sensitive to light, so it should be taken immediately after opening and kept in a place out of the reach of children. During treatment, if asthma symptoms worsen or unusual symptoms occur, consult a physician immediately and do not stop taking or switch to another medication without professional advice.

Side effects and when to seek care immediately

Serious side effects

Hives, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, severe swelling (edema), severe allergic reaction, toxic epidermal necrolysis, Stevens-Johnson syndrome, systemic eosinophilia, vasculitis, liver adverse reactions (increased ALT and AST, cholestatic hepatitis, hepatocellular liver damage, mixed liver damage), severe allergic reaction, increased bleeding frequency, thrombocytopenia, angioedema, toxic epidermal necrolysis

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • trauma
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
Show 28 more
  • cough
  • influenza
  • rash
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear pain
  • viral infection
  • laryngitis
  • runny nose
  • ear discomfort
  • gastroenteritis
  • eczema
  • chickenpox
  • pneumonia
  • dermatitis
  • conjunctivitis
  • upper respiratory infection
  • thrombocytopenia
  • restlessness
  • anxiety
  • depression
  • disorientation
  • attention disorder
  • sleep disorder

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

Storage

This medication should be stored in a tightly closed container, protected from air, moisture, and light. Additionally, it is preferable to store it in a cool place at room temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for longer.

Appearance and packaging

Appearance

Beige film-coated tablet with a rounded rectangular shape

Package unit

28 tablets (7 tablets/blister 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.