Medication info

Monoka Tablet 10mg (Montelukast Sodium)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Montelukast Sodium›10.4mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Beige, rounded square film-coated tablets
Packaging
30 tablets (10 tablets/PTPX3), 28 tablets (7 tablets/PTPX4)
Approval status
Approval withdrawn

MFDS item code 202003916 · Approved 2020.05.27

This product's status changed to Approval withdrawn on 2024.11.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of asthma and relief of allergy rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 years and older: Montelukast 10 mg should be taken orally once daily. This medication should be taken 1 hour before or 2 hours after meals. 10 mg oral dissolving film: Place one 10 mg film on the tongue and allow it to dissolve without water once daily.
Child dose
Children aged 6 to 14 years: Montelukast 5 mg should be chewed once daily. 5 mg chewable tablet: Place one 5 mg tablet on the tongue and allow it to disintegrate without water.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Prevention of asthma and relief of allergy rhinitis symptoms

  • Asthma
  • allergy rhinitis symptoms
View approved original text

This drug helps prevent and continuously treat asthma. 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: Montelukast 10 mg should be taken orally once daily. This medication should be taken 1 hour before or 2 hours after meals. 10 mg oral dissolving film: Place one 10 mg film on the tongue and allow it to dissolve without water once daily.

Child dose

Children aged 6 to 14 years: Montelukast 5 mg should be chewed once daily. 5 mg chewable tablet: Place one 5 mg tablet on the tongue and allow it to disintegrate without water.

Precautions

This drug contains the artificial sweetener aspartame, and patients with the hereditary condition phenylketonuria should avoid taking it. Daily intake of aspartame should not exceed the recommended limits set by WHO, with a maximum intake of up to 2.4g for adults. Patients with allergies to any components of this drug or with genetic issues such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug. Rarely, patients with asthma or allergic rhinitis may experience various adverse reactions such as fatigue, headache, abdominal pain, and rash, so consult a physician if symptoms occur. Particularly, as this drug is not intended for the treatment of acute asthma attacks, patients should always carry a fast-acting inhaler for emergencies. Corticosteroid medications for inhalation or oral use should not be abruptly stopped or switched, but should be gradually adjusted according to the physician’s guidance. Patients who have hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not take these medications concurrently while taking this drug. Symptoms related to the nervous system, such as restlessness, anxiety, depression, and hallucinations, may occur during the use of this drug, and it is important to inform a physician immediately if such symptoms develop. Pregnant or breastfeeding women should consult a physician before taking this drug and should only use it when necessary. In children, the safety and efficacy may vary by age; therefore, it is essential to follow expert guidance when administering to pediatric patients. There is no specific antidote for overdose, so general symptomatic treatment and clinical monitoring are necessary, and if symptoms are severe, seek medical attention immediately. This drug is sensitive to light, so do not open the packaging until just before taking it, and it is best to take it immediately after opening. Store this drug out of reach of children, and take care not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, thrombocytopenia, anaphylaxis, eosinophilic infiltration of the liver, systemic eosinophilia, vasculitic rash, exacerbation of pulmonary symptoms, cardiovascular complications, neuropathy, suicidal thoughts, suicide, suicide attempts, seizure convulsions, nosebleed, liver abnormalities (increased ALT and AST, cholestatic hepatitis, hepatocellular liver damage, mixed liver injury)

Mild side effects

  • Weakness
  • fatigue
  • fever
  • abdominal pain
  • trauma
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
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  • nasal congestion
  • cough
  • influenza
  • rash
  • increased ALT
  • increased 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
  • aggressive behavior
  • restlessness
  • anxiety
  • depression
  • lethargy

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

Storage

This drug is sensitive to air, moisture, and light, so it should be stored in a tightly closed container. It is advisable to maintain storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help preserve the effectiveness of the drug for a prolonged period.

Appearance and packaging

Appearance

Beige, rounded square film-coated tablets

Package unit

30 tablets (10 tablets/PTPX3), 28 tablets (7 tablets/PTPX4)

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.