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Active Pharma Ingredients / 01 Sep 2026

ASTEMIZOLE

Generic Name: ASTEMIZOLE

ABSTRACT -

Astemizole is a second-generation H1-antihistamine that was formerly used for allergic rhinitis and urticaria. It has been withdrawn or restricted in many markets because of serious QT prolongation, torsades de pointes, and potentially fatal arrhythmias, especially with overdose or CYP3A4-inhibiting medicines. It should not be used where safer antihistamines are available or where the product is not authorized.

DOSAGE -

Routine dosing is not recommended because the medicine has been withdrawn/restricted in many settings for safety reasons. If encountered historically, dosing must not be restarted without regulatory and specialist confirmation.

SIDE EFFECTS–

  • Possible or reported side effects may include:
  • QT prolongation
  • Torsades de pointes or ventricular arrhythmia
  • Syncope
  • Palpitations
  • Dizziness
  • Drowsiness or fatigue
  • Dry mouth
  • Increased appetite or weight gain
  • Nausea

ALLERGIC REACTIONS -

Allergy can cause rash, urticaria, swelling, wheeze, or anaphylaxis.

DRUG INTERACTIONS-

  • Strong CYP3A4 inhibitors such as azole antifungals and macrolides
  • Other QT-prolonging drugs
  • Grapefruit products may increase exposure for CYP3A4 substrates
  • Medicines causing electrolyte abnormalities
  • Patients should inform healthcare providers about all prescription medicines, over-the-counter medicines, herbal products, and supplements they are using.

PREAUTIONS–

Avoid in long-QT syndrome, arrhythmias, electrolyte disturbances, liver impairment, or concomitant QT-prolonging medicines.

Use safer alternatives for allergy treatment.

WARNINGS –

  • QT prolongation, torsades de pointes, ventricular arrhythmia, and sudden death have been associated with astemizole.
  • Avoid use with CYP3A4 inhibitors, macrolides, azole antifungals, grapefruit products, or other QT-prolonging agents.
  • Do not use if the product is withdrawn or not authorized in the local jurisdiction.
  • Keep out of reach of children.
  • In case of overdose, severe reaction, or clinical deterioration, seek immediate medical attention.

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