Medication info

New Montelukast Tablets 10 mg (Sodium Montelukast)

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

MFDS item code 201603997 · Approved 2016.06.27

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults
Adult dose
This medicine should be taken once daily, preferably in the evening for patients with asthma. For patients with allergic rhinitis, the dosing time should be determined based on individual conditions. For patients with both asthma and allergic rhinitis, take 1 tablet once daily in the evening. Adults and adolescents aged 15 and older should take 10 mg of montelukast once daily orally.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Symptoms of asthma and allergic rhinitis
View approved original text

This medicine helps to prevent and manage asthma continuously. It is also used to relieve the symptoms of allergic rhinitis that occur seasonally or throughout the year.

How to take

Adult dose

This medicine should be taken once daily, preferably in the evening for patients with asthma. For patients with allergic rhinitis, the dosing time should be determined based on individual conditions. For patients with both asthma and allergic rhinitis, take 1 tablet once daily in the evening. Adults and adolescents aged 15 and older should take 10 mg of montelukast once daily orally.

Precautions

This medicine contains the artificial sweetener aspartame, which should not be administered to patients with the genetic disorder phenylketonuria. Because aspartame breaks down into phenylalanine in the body, patients who need to restrict phenylalanine intake should exercise caution. This medicine contains lactose, so patients with genetic conditions such as lactose intolerance or glucose-galactose malabsorption should not take it. Fatigue, headache, abdominal pain, fever, cough, nasal congestion, and rash may occur during treatment, so patients should consult a doctor if any adverse symptoms arise. This medicine is not intended for use during acute asthma attacks, so emergency inhalers should be used if asthma symptoms suddenly worsen. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid the use of these medications while taking this medicine. Neuropsychiatric symptoms, such as anxiety, depression, sleepwalking, and suicidal thoughts, may occur while taking this medicine, therefore patients should immediately inform their doctor if such symptoms arise. Pregnant or breastfeeding women should consult their doctor before taking this medicine and should use it only when necessary. Children and the elderly should also be closely monitored when taking this medicine, considering safety and efficacy associated with their age. In the case of an overdose, there is no specific antidote, so patients should visit a medical institution immediately for treatment that addresses the symptoms. This medicine is sensitive to light, so it should be opened just before administration and taken promptly after preparation. Keep the medicine out of the reach of children and do not transfer it to another container. If asthma or allergic rhinitis symptoms are not controlled, the treating physician should be consulted to adjust the treatment plan.

Side effects and when to seek care immediately

Serious side effects

Hives, Angioedema, Severe Swelling, Severe Allergic Reactions, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Severe Skin Adverse Reactions, Vasculitis, Worsening of Pulmonary Symptoms, Cardiac Complications, Neuropathy, Liver Abnormalities (Elevated ALT and AST, Cholestatic Hepatitis, Hepatocellular Liver Injury, Mixed Liver Injury)

Mild side effects

  • Weakness/Fatigue
  • Fever
  • Abdominal Pain
  • Indigestion
  • Infectious Gastroenteritis
  • Toothache
  • Dizziness
  • Headache
  • Nasal Congestion
  • Cough
Show 27 more
  • Influenza
  • Rash
  • Pyuria
  • Pharyngitis
  • Sinusitis
  • Nausea
  • Diarrhea
  • Loss of Appetite
  • Ear Inflammation
  • Viral Infections
  • 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 medicine is sensitive to moisture and light; therefore, it should be stored in a cool, dry place that does not receive light. Additionally, to maintain the effectiveness of the medicine, it should be stored at room temperature between 1 degree and 30 degrees Celsius. It is also important to keep the medicine in a sealed container to prevent contact with air.

Appearance and packaging

Appearance

Beige film-coated tablets in a rounded rectangular shape

Package unit

28 tablets (7 tablets/PTP packaging * 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.