Medication info

Sandoz Montelukast Chewable Tablet 4 mg (Montelukast Sodium)

Prescription medicationCompany closed
Ingredient · strength
Montelukast Sodium›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
Pink, double-sided, convex oval chewable tablet
Packaging
Manufacturer packaging unit
Approval status
Company closed

MFDS item code 201208651 · Approved 2012.11.23

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
Prevention of asthma and relief of allergic rhinitis symptoms
Who uses it
Adults · Children
Adult dosage
Adults and adolescents 15 years and older should take 10 mg of montelukast orally once daily. This medication should be taken 1 hour before or 2 hours after meals. Patients with both asthma and allergic rhinitis are advised to take 1 tablet, 1 pack, or 1 film at dinner once daily. Adults and adolescents 15 years and older should place 10 mg of montelukast on the tongue and let it dissolve without water.
Children's dosage
Children aged 6 to 14 years should chew 5 mg of montelukast once daily. This medication should be administered 1 hour before or 2 hours after meals. Children aged 2 to 5 years should take montelukast 4 mg once daily.

Ingredients

Importer
한국산도스(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 the occurrence of asthma and for ongoing treatment. It is also effective in alleviating symptoms of both seasonal and perennial allergic rhinitis. Hence, it assists in managing respiratory-related allergic diseases.

Dosage and Administration

Adult dosage

Adults and adolescents 15 years and older should take 10 mg of montelukast orally once daily. This medication should be taken 1 hour before or 2 hours after meals. Patients with both asthma and allergic rhinitis are advised to take 1 tablet, 1 pack, or 1 film at dinner once daily. Adults and adolescents 15 years and older should place 10 mg of montelukast on the tongue and let it dissolve without water.

Children's dosage

Children aged 6 to 14 years should chew 5 mg of montelukast once daily. This medication should be administered 1 hour before or 2 hours after meals. Children aged 2 to 5 years should take montelukast 4 mg once daily.

Precautions

This medication contains the artificial sweetener aspartame, which is metabolized into phenylalanine in the body. Therefore, patients with phenylketonuria, a genetic disorder that requires limiting phenylalanine intake, should not take this medication. This medication contains lactose, so individuals with genetic issues like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication. In individuals of various ages with asthma or allergic rhinitis, minor side effects such as fatigue, headache, abdominal pain, cough, and rash may occur, and symptoms should be discussed with a doctor if they arise. This medication is not to be used as a treatment during acute asthma attacks; short-acting bronchodilators must be kept on hand and used in emergencies. Do not abruptly stop or switch inhaled or oral corticosteroids during treatment without consulting a physician; the dosage should be adjusted gradually as directed by a doctor. Individuals with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should not take these medications while taking this drug. During treatment, neuropsychiatric symptoms, such as anxiety, depression, hallucinations, and suicidal thoughts, may occur, so it is important to notify a doctor immediately if these symptoms develop. The use of this medication is limited for those who are pregnant or breastfeeding, and it should only be taken when necessary after consulting with a doctor. Children and the elderly can also use this medication, but they must adhere to age-appropriate dosages and methods of use, monitoring closely for any adverse reactions. In cases of overdose, no specific antidote is available, and immediate medical treatment for symptomatic management is necessary. This medication is sensitive to light; do not open the packaging until just before taking it, and it should be taken immediately after preparation. Store it out of reach of children. This medication should be taken consistently even during periods without asthma or allergy symptoms, and if symptoms worsen or any unusual symptoms occur during use, contact a physician promptly.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • anaphylaxis
  • severe allergic reactions
  • liver abnormalities (jaundice)
  • seizures
  • suicidal thoughts and behavior
  • thrombocytopenia
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  • vasculitis
  • worsening pulmonary symptoms
  • cardiac complications
  • neuropathy
  • severe edema
  • hypertension
  • vasculitic rash
  • pneumonia

Mild side effects

  • Weakness
  • fatigue
  • fever
  • abdominal pain
  • trauma
  • dyspepsia
  • infectious gastroenteritis
  • toothache
  • dizziness
  • headache
Show 27 more
  • nasal congestion
  • cough
  • influenza
  • rash
  • ALT increase
  • AST increase
  • pyuria
  • pharyngitis
  • sinusitis
  • nausea
  • diarrhea
  • loss of appetite
  • ear swelling
  • viral infection
  • laryngitis
  • rhinitis
  • chickenpox
  • gastroenteritis
  • atopic dermatitis
  • acute bronchitis
  • dental infection
  • skin infection
  • myopia
  • ear pain
  • gastroenteritis
  • eczema
  • pneumonia

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

Storage

This medication should be stored in a tightly sealed container away from air, moisture, and light. Maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Pink, double-sided, convex oval 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.