Medication info

Sandoz Montelukast Chewable Tablets 5 mg (Montelukast Sodium)

Prescription medicationCompany closed
Ingredient · strength
Montelukast Sodium›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
Round, pink, biconvex chewable tablet
Packaging
Manufacturer packaging unit
Approval status
Company closed

MFDS item code 201206474 · Approved 2012.08.16

This product's status changed to Company closed on 2023.07.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for asthma prevention and alleviation of allergic rhinitis symptoms
Who uses it
Adults · Children
Adult dosage
Adults and adolescents aged 15 years and older should take 10 mg of montelukast once daily orally. This medication should be taken 1 hour before meals or 2 hours after meals.
Children's dosage
Children aged 6 to 14 years should take 5 mg of montelukast once daily by chewing, or placing it on the tongue to dissolve without water. For children aged 2 to 5 years, 4 mg of montelukast should be taken once daily by chewing.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Treatment for asthma prevention and alleviation of allergic rhinitis symptoms

  • Asthma
  • allergic rhinitis symptoms
View approved original text

This medication helps prevent the occurrence of asthma and continuously manage its symptoms. It also alleviates the uncomfortable symptoms of allergic rhinitis that may occur seasonally or year-round. This maintains respiratory health and reduces discomfort in daily life. It is used to effectively improve symptoms of asthma and allergic rhinitis.

Dosage and Administration

Adult dosage

Adults and adolescents aged 15 years and older should take 10 mg of montelukast once daily orally. This medication should be taken 1 hour before meals or 2 hours after meals.

Children's dosage

Children aged 6 to 14 years should take 5 mg of montelukast once daily by chewing, or placing it on the tongue to dissolve without water. For children aged 2 to 5 years, 4 mg of montelukast should be taken once daily by chewing.

Precautions

This medication contains the artificial sweetener aspartame, and should not be taken by patients with phenylketonuria, a hereditary disorder. Aspartame is broken down into phenylalanine in the body, so patients with this condition must restrict their intake of phenylalanine. Also, care should be taken to not exceed the daily allowable intake of aspartame, which for adults should be no more than 2.4 grams per day. This medication should not be used by persons with hypersensitivity to any of its ingredients or by patients with lactose intolerance or certain hereditary metabolic disorders. During use, side effects such as fatigue, headache, indigestion, cough, and rash may occur, so it is important to monitor one’s health closely. Asthma patients should note that this medication is not an immediate treatment during an acute attack, and should always carry an emergency inhaler. Ensure not to abruptly discontinue or replace inhaled corticosteroids without a doctor's instruction. While using this medication, avoid taking aspirin or non-steroidal anti-inflammatory drugs, especially if there is an allergy to aspirin. Rarely, systemic eosinophilia or vasculitis symptoms may occur in asthma patients, and if such symptoms are suspected, contact a physician immediately. Pregnant women should always consult a doctor before taking this medication, and nursing mothers should also be cautious. Careful consideration must be given to dosage and administration for children and the elderly based on their age. In case of overdose, there are no specific antidotes, and immediate medical attention should be sought. This medication is sensitive to light, so do not open until right before use, and store out of reach of children. If any neuropsychiatric symptoms or adverse reactions occur during use, inform your doctor immediately and do not discontinue or change other asthma treatments without a doctor's prescription.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylaxis, cold sweats, pale skin, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe allergic reactions, severe skin reactions, severe rash, blisters, skin peeling, mucosal pain in mouth/eyes, respiratory issues, pulmonary eosinophilia, jaundice, liver abnormalities (increased ALT and AST, cholestatic hepatitis, hepatocellular damage, mixed-type liver damage)

Mild side effects

  • Weakness/fatigue
  • fever
  • abdominal pain
  • trauma
  • indigestion
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
  • nasal congestion
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  • cough
  • influenza
  • rash
  • 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 tract infection
  • aggressive behavior
  • agitation
  • anxiety
  • depression
  • disorientation
  • attention disorder
  • sleep disorder

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture, and keep it away from direct sunlight at room temperature between 1°C and 30°C. This storage method helps maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Round, pink, biconvex chewable tablet

Package unit

Manufacturer packaging unit

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.