Medication info
Azelastine Tablets (Azelastine Hydrochloride)

Azelastine Tablets (Azelastine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Azelastine Hydrochloride›1mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Bright yellow round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201405076 · Approved 2014.10.31 · Insurance code 669906050

Summary

Main use
Relief of symptoms associated with bronchial asthma, allergic rhinitis, etc. (respiratory and skin diseases)
Who takes it
Adults
Adult dose
Azelastine Hydrochloride: 1 mg orally 2 times a day after breakfast and before bedtime. For bronchial asthma, 2 mg orally 2 times a day after breakfast and before bedtime. Adjust dose appropriately according to age and symptoms.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Relief of symptoms associated with bronchial asthma, allergic rhinitis, etc. (respiratory and skin diseases)

  • Bronchial asthma
  • allergic rhinitis
  • urticaria
  • eczema
  • dermatitis
  • atopic dermatitis
  • pruritus
  • itching
View approved original text

This medication is used for major allergic and inflammatory diseases such as bronchial asthma, allergic rhinitis, urticaria, and atopic dermatitis.

How to take

Adult dose

Azelastine Hydrochloride: 1 mg orally 2 times a day after breakfast and before bedtime. For bronchial asthma, 2 mg orally 2 times a day after breakfast and before bedtime. Adjust dose appropriately according to age and symptoms.

Precautions

This medication should not be used in children under 6 years of age. This medication contains lactose, and should not be administered to patients with genetic disorders that impair lactose digestion. There is a dye called Yellow No. 5; patients allergic or hypersensitive to this component should use it with caution. Taking this medication may result in neurological symptoms such as drowsiness, lethargy, numbness in the limbs, and unsteadiness. Gastrointestinal symptoms may include dry mouth, nausea, vomiting, reduced appetite, abdominal pain, constipation, and diarrhea. There may be rare occurrences of facial flushing or shortness of breath that need to be monitored. Dry nasal symptoms may occur, and liver function test values may temporarily increase. If allergic reactions such as skin rashes occur, stop taking the medication immediately. Rare urological abnormalities such as difficulty urinating, hematuria, and increased urination frequency have been reported. Blood tests may show an increase in white blood cell count and other symptoms like swelling or menstrual irregularities may also occur. This medication may cause drowsiness, so avoid driving or operating hazardous machinery. Patients receiving steroid treatment should gradually adjust the steroid dose when taking this medication. Asthma patients should be informed that rapid symptom relief is unlikely once an attack has already occurred. Patients with seasonal allergies should start taking the medication before symptoms begin and continue during the period of symptoms. Caution is advised as alcohol may enhance drowsiness, and it is also important to be careful when taking with certain medications. Women who are pregnant or may become pregnant should only use this medication after carefully considering its risks and benefits. Breastfeeding mothers should avoid using this medication if possible, and if necessary, should stop breastfeeding while using this medication as it may be excreted in breast milk. The safety of this medication in infants, newborns, and very young children has not been established, and its use is not recommended. Elderly patients may have diminished bodily function, thus the dose should be adjusted and used carefully. This medication may have a bitter taste, so be aware when taking it. Store out of the reach of children, protect from direct sunlight, and keep in a cool, dry place.

Side effects and when to seek care immediately

Serious side effects

Shortness of breath (respiratory problems), rash (allergic reaction)

Mild side effects

  • Drowsiness
  • lethargy
  • limb paralysis
  • unsteadiness
  • dry mouth
  • nausea
  • vomiting
  • cough in the mouth
  • reduced appetite
  • abdominal pain
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  • constipation
  • diarrhea
  • gastrointestinal discomfort
  • facial flushing
  • shortness of breath
  • dry nose
  • increased transaminase activity
  • elevation of AST
  • ALT
  • Al-P
  • rash
  • difficulty urinating
  • hematuria
  • frequent urination
  • increased white blood cell count
  • swelling
  • menstrual irregularities

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

Storage

This medication is sensitive to light, so it should be stored in a special container that prevents light exposure. Additionally, when storing the medication, it is important to maintain room temperature, specifically between 1 to 30 degrees Celsius. This helps ensure the medication's effectiveness is preserved safely.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle

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.