Clearatadine

Generic name:

Clearatadine

Drug class:

Second-generation H1 antihistamine

Dosage form:

• Tablet: 10 mg
• Oral solution: 5 mg/5 mL

Route of administration:

Oral

Dose:

• Adults and adolescents ≥12 years: 10 mg once daily
• Children 6–11 years: 5 mg once daily
• Children 2–5 years: 2.5 mg once daily
• Adjust dose in moderate to severe hepatic impairment

Mechanism of action:

Selective inverse agonist at peripheral histamine H1 receptors, inhibiting allergic mediator release and reducing allergy symptoms without significant central nervous system penetration.

Drug usage cases:

• Seasonal allergic rhinitis
• Perennial allergic rhinitis
• Chronic idiopathic urticaria
• Off-label: allergic conjunctivitis
• Off-label: pruritus related to atopic dermatitis
• Off-label: cold-induced urticaria

Drug contra indications:

• History of hypersensitivity to clearatadine or any formulation excipients
• Severe hepatic impairment
• Concurrent use with potent CYP3A4 inhibitors in hepatic impairment

Side effects:

• Headache
• Somnolence
• Fatigue
• Dry mouth
• Nausea
• Dizziness
• Insomnia
• Pharyngitis
• Abdominal pain
• Diarrhea
• Rash
• Palpitations
• QT prolongation
• Urinary retention
• Blurred vision

Warnings:

• CNS depression: caution when driving or operating machinery
• May cause sedation, although incidence is low
• Use with caution in hepatic or renal impairment; dose adjustment may be required
• Potential for QT interval prolongation; avoid in patients with known QT prolongation or with concurrent QT-prolonging drugs
• Drug interactions via CYP3A4 inducers/inhibitors
• Use with caution in elderly patients
• Photosensitivity reactions have been reported

Use during pregnancy or breastfeeding:

Use in pregnancy only if the potential benefit justifies the potential risk to the fetus; animal studies have not demonstrated teratogenicity, but human data are limited. Clearatadine is excreted in breast milk; nursing mothers should weigh potential risks and benefits, and consider discontinuation or alternative therapy if necessary.