Stebastin Sp.

Rx

Indications

Symptomatic treatment of:

• Allergic rhinitis (seasonal and perennial) with or without associated allergic conjunctivitis;
• Chronic idiopathic urticaria;
• Atopic dermatitis.

Dosage

• Adults and children over 12 years:
  10 ml once daily (10 mg ebastine).
• Children aged 6-11 years:
  5 ml once daily (5 mg ebastine).
• Children aged 2-5 years:
  2.5 ml once daily (2.5 mg ebastine).
• Children under 2 years:
  The safety of ebastine in children under 2 years of age has not been established.
• Elderly:
  No dose adjustment is necessary.
• Renal impairment:
  No dose adjustment is necessary in patients with mild, moderate, or severe renal impairment.
• Hepatic impairment:
  No dose adjustment is necessary in patients with mild or moderate hepatic impairment. Patients with severe hepatic impairment should not exceed the maximum recommended dose (10 mg ebastine/day).
• Treatment may continue until symptoms disappear.

Usage

• Oral administration, can be taken directly or mixed with water.
• Use only the graduated measuring cup provided in the packaging.

• Hypersensitivity to any ingredient of the drug.

Very common

• Headache.

Common

• Drowsiness;
• Dry mouth.

• Use with caution in patients with cardiovascular risk factors such as: patients with prolonged QT interval, hypokalemia, concomitant treatment with other drugs that prolong the QT interval or inhibit the CYP3A4 enzyme, azole antifungal drugs (such as ketoconazole and itraconazole), and macrolide antibiotics (such as erythromycin).
• Pharmacokinetic interactions may occur when ebastine is used with rifampicin.
• Use with caution in patients with severe hepatic impairment.
• Ebastine achieves therapeutic effect within 1 to 3 hours after administration and should only be used in cases of acute allergic reactions.
• Stebastin Sp. contains sorbitol. This medication should not be used in patients with hereditary fructose intolerance (HFI).
• Stebastin Sp. contains 100 mg of propylene glycol per ml of the preparation.
• Stebastin Sp. contains methylparaben which may cause allergic reactions (delayed onset).
• Avoid using ebastine during pregnancy and breastfeeding.
• In sensitive individuals who experience unusual reactions to ebastine, such as drowsiness or dizziness, it is recommended to monitor individual patient response before driving or operating machinery.