Medication info
Azelastine Hydrochloride 1mg Tablet

Azelastine Hydrochloride 1mg Tablet

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

MFDS item code 202000689 · Approved 2020.02.06 · Insurance code 073001200

Summary

Main use
Improvement of allergic symptoms such as bronchial asthma and allergic rhinitis
Who takes it
Adults
Adult dose
As Azelastine Hydrochloride, take 1mg once for general use, and 2mg once for bronchial asthma, taken orally twice a day after breakfast and before bedtime. Adjust dosage appropriately based on age and symptoms.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Improvement of allergic symptoms such as bronchial asthma and allergic rhinitis

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

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

How to take

Adult dose

As Azelastine Hydrochloride, take 1mg once for general use, and 2mg once for bronchial asthma, taken orally twice a day after breakfast and before bedtime. Adjust dosage appropriately based on age and symptoms.

Precautions

This medication should not be used in children under 6 years of age. Additionally, this medication contains lactose, so individuals with hereditary issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Taking this medication may cause central nervous system symptoms such as drowsiness, lethargy, numbness in the hands and feet, and unsteadiness. It may also affect the gastrointestinal system, leading to dry mouth, nausea, vomiting, loss of appetite, abdominal pain, constipation, diarrhea, and discomfort in the stomach. Rarely, circulatory system symptoms such as flushing of the face or shortness of breath may also occur. In the respiratory system, dryness of the nose may occur. The liver enzyme levels may increase, so caution is required regarding liver health. If allergic reactions such as itching or rash occur, medication should be discontinued immediately. Urinary symptoms such as difficulty urinating, hematuria, and frequency may rarely occur. In blood tests, there may be an increase in white blood cell count. Other reported side effects include swelling and menstrual irregularities. This medication can cause drowsiness, so it is advisable to avoid driving or operating dangerous machinery while taking it. Patients on long-term steroid treatment should gradually adjust the steroid dosage under professional supervision when using this medication. Patients with bronchial asthma should fully understand that this medication does not provide immediate relief of sudden attacks. Seasonal allergy patients are advised to start taking this medication before symptoms worsen and to continue taking it consistently during the symptom duration. Caution should be exercised when consuming alcohol as it may exacerbate drowsiness. Additionally, caution is required when taking this medication with cimetidine. Pregnant women or those who may become pregnant should take this medication only if its benefits outweigh risks, as high doses in animal studies have been associated with malformations. Breastfeeding women should avoid this medication if possible since it can be transferred into breast milk; if it must be taken, it is advisable to discontinue breastfeeding. The safety of this medication has not been sufficiently established in premature infants, newborns, babies, and young children. Elderly individuals may have reduced physical function; therefore, caution and dosage adjustment may be necessary. This medication may have a bitter taste, so it is advisable to be mindful of that while taking it. Finally, this medication should be kept out of reach of children and stored in a cool, dry place away from direct sunlight. It is important to not transfer the medication to another container, and to store it in the original container to prevent misuse and maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Shortness of breath
  • liver abnormalities due to elevated AST
  • ALT
  • and Al-P

Mild side effects

  • Drowsiness
  • lethargy
  • numbness in hands and feet
  • unsteadiness
  • dry mouth
  • nausea
  • vomiting
  • cough in the mouth
  • loss of appetite
  • abdominal pain
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  • constipation
  • diarrhea
  • discomfort in the stomach
  • flushing of the face
  • nasal dryness
  • rash
  • difficulty urinating
  • hematuria
  • frequent urination
  • increased white blood cell count
  • swelling
  • menstrual irregularities
  • bitter taste

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 prevents light exposure. Additionally, it is important to maintain a temperature between 1°C and 30°C during storage. Proper storage will help maintain the medication's efficacy and safety.

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.