Medication info
Azeltine Tablet (Azelastine Hydrochloride)

Azeltine Tablet (Azelastine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Azelastine Hydrochloride›1mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
Bright yellow round film-coated tablet
Packaging
30 tablets/bottle, 600 tablets/bottle
Approval status
Active

MFDS item code 201604176 · Approved 2016.07.06

Summary

Main use
Improvement of respiratory and skin diseases including bronchial asthma, allergic rhinitis
Who takes it
Adults
Adult dose
As Azelastine Hydrochloride, 1 mg once for general use; for bronchial asthma, 2 mg once, administered orally twice daily after breakfast and before bedtime. Adjust dose appropriately based on age and symptoms.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Improvement of respiratory and skin diseases including bronchial asthma, allergic rhinitis

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

This medication is used for allergic and inflammatory diseases such as bronchial asthma, allergic rhinitis, urticaria, and atopic dermatitis. It also helps relieve itching associated with skin conditions such as eczema, dermatitis, and pruritus. It is effective in improving various allergic symptoms and skin diseases.

How to take

Adult dose

As Azelastine Hydrochloride, 1 mg once for general use; for bronchial asthma, 2 mg once, administered orally twice daily after breakfast and before bedtime. Adjust dose appropriately based on age and symptoms.

Precautions

This medication should not be used in children under 6 years of age. It contains lactose, so patients with a genetic disorder that prevents lactose digestion should not take it. Drowsiness may occur during use, so driving or operating hazardous machinery should be avoided. It can affect the mental or nervous system, leading to symptoms such as drowsiness, fatigue, tingling in the hands and feet, or unsteadiness. Gastrointestinal issues may include dry mouth, nausea, vomiting, decreased appetite, abdominal pain, constipation, and diarrhea. Occasionally, symptoms such as facial flushing or shortness of breath may occur, so caution is advised. Dryness of the nasal passages may occur as a respiratory side effect. It can affect liver function, potentially elevating liver enzyme levels, requiring regular monitoring. If a rash appears as an allergic reaction, discontinue use immediately. Urinary symptoms such as difficulty urinating, hematuria, or urinary frequency may appear. Rarely, there may be an increase in white blood cell count, so report any unusual symptoms. Edema or menstrual irregularities may also occur, so caution is needed. If undergoing long-term steroid treatment, it is essential to taper steroids cautiously when using this medication. When used for treating bronchial asthma, it is not a fast-acting medication for already occurring attacks, so patients should be adequately informed. For seasonal allergies, it's recommended to start taking this medication before symptoms worsen and to continue until the symptoms resolve. Alcohol consumption may enhance drowsiness, so avoid drinking alcohol. There may be interactions when taken with specific medications, so consult with a physician or pharmacist. Pregnant women or those who may become pregnant should carefully consider the risks and benefits of this medication, and nursing mothers should avoid taking it if possible or discontinue breastfeeding. Safety for premature infants, newborns, infants, and children has not been established, so caution is required in their use. Elderly patients may have decreased body function, so dosage adjustments may be necessary. Bitterness may be experienced upon administration. For storage, keep out of reach of children, avoid direct sunlight, and store in a cool, dry place. Do not transfer the medication to another container and keep it in its original packaging to prevent misuse and maintain its quality.

Side effects and when to seek care immediately

Serious side effects

  • Shortness of breath
  • elevated transaminase activity
  • increased AST
  • increased ALT
  • increased Al-P

Mild side effects

  • Drowsiness
  • fatigue
  • limb paralysis
  • unsteadiness
  • dry mouth
  • nausea
  • vomiting
  • cough in the mouth
  • decreased appetite
  • abdominal pain
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  • constipation
  • diarrhea
  • gastric discomfort
  • facial flushing
  • nasal dryness
  • rash
  • difficulty urinating
  • hematuria
  • urinary frequency
  • increased white blood cells
  • edema
  • menstrual irregularities
  • bitterness

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 container that does not allow light in. It is also recommended to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/bottle, 600 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.