Medication info
Montelukast Tablet 10 mg (Montelukast Sodium)

Montelukast Tablet 10 mg (Montelukast Sodium)

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

MFDS item code 201500962 · Approved 2015.02.25 · Insurance code 645208660

Summary

Main use
Treatment for 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 10 mg of montelukast once daily orally. This should be taken 1 hour before meals or 2 hours after meals. For the 10 mg orally disintegrating film formulation, take 10 mg once daily, placed on the tongue to dissolve without water.
Child dose
For children aged 6 to 14 years, 5 mg of montelukast should be taken once daily, either chewed or placed on the tongue to dissolve without water. The 5 mg orally disintegrating film formulation should be taken at a dose of 5 mg once daily, placed on the tongue.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Treatment for prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • symptoms of allergic rhinitis
View approved original text

This medication helps prevent asthma attacks and manage asthma on an ongoing basis. It is also used to relieve symptoms of seasonal and perennial allergic rhinitis.

How to take

Adult dose

Adults and adolescents aged 15 years and older should take 10 mg of montelukast once daily orally. This should be taken 1 hour before meals or 2 hours after meals. For the 10 mg orally disintegrating film formulation, take 10 mg once daily, placed on the tongue to dissolve without water.

Child dose

For children aged 6 to 14 years, 5 mg of montelukast should be taken once daily, either chewed or placed on the tongue to dissolve without water. The 5 mg orally disintegrating film formulation should be taken at a dose of 5 mg once daily, placed on the tongue.

Precautions

This medicine contains aspartame, an artificial sweetener, which is broken down into phenylalanine in the body. Therefore, patients with phenylketonuria, a genetic disorder that requires restriction of phenylalanine intake, should not take this medication. Additionally, this medication contains lactose and should not be administered to patients with genetic issues such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption. This drug is used for the treatment of asthma or allergic rhinitis but cannot be used during an acute asthma attack, and separate emergency medications should always be kept on hand for acute symptom relief. Do not abruptly stop or replace inhaled corticosteroids while taking this medication, and dosage should be adjusted gradually according to a physician's instructions. During treatment, unusual reactions such as fatigue, headache, dyspepsia, cough, rash may occur, and if these symptoms arise, one should consult healthcare professionals. Patients taking this medication may experience neuropsychiatric symptoms, such as anxiety, depression, hallucinations, or suicidal thoughts, and should immediately inform a physician if such changes occur. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid using these medicines while taking this medication, and it is unclear whether this medication can treat asthma attacks in aspirin-sensitive asthma patients. If pregnant or breastfeeding, the safety of this medication has not been fully established, so it should be used only as deemed necessary by a physician. This medicine is also available for use in children and the elderly, but particularly in young children, the established age range for safety and efficacy should be followed, and caution is needed as seniors may respond differently to the medication. In the case of overdose, there is no specific antidote, so general treatment based on symptoms should be carried out and managed appropriately according to a physician's instructions. This medication is sensitive to light, so it should be taken immediately after opening, and stored out of reach of children. Finally, this medication should be taken consistently, even when asymptomatic, and dosages of other asthma treatments should not be decreased or discontinued arbitrarily while taking this.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweats, paleness, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe allergic reactions, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion

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
  • otitis
  • viral infection
  • laryngitis
  • runny nose
  • ear pain
  • 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 should be stored in a tightly sealed container to protect it from air, moisture, and light. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Beige film-coated tablet in a rounded square shape

Package unit

28 tablets/PTP (7 tablets x 4 PTP)

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.

Related searches

Search tags

Suggested searches

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.