Rupatadine Fumarate

Generic Details

Generic Name

Rupatadine Fumarate

Other Names

  • Rupatadine
  • Rupatadine Dihydrochloride

Drug Class

  • Second-generation antihistamine
  • Mast cell stabilizer

Chemical Formula

C26H26Cl2N2O4

Molecular Weight

502.402 g/mol

Mechanism of Action

  • Acts as a selective antagonist of histamine H1 receptors and exhibits anti-inflammatory and antiallergic properties.

Indications

  • Allergic rhinitis
  • Conjunctivitis
  • Urticaria
  • Atopic dermatitis

Common Dosage Forms

  • Tablet
  • Oral solution

Typical Dosage

  • 10 mg once daily

Pediatric Dosage

  • Children 6-11 years: 5 mg once daily

Geriatric Dosage

  • No dosage adjustment necessary

Side Effects

  • Drowsiness
  • Headache
  • Dry mouth
  • Fatigue

Contraindications

  • Hypersensitivity to rupatadine
  • Severe hepatic impairment

Pregnancy Category

  • Category C - Safety has not been established

Lactation Safety

  • Use with caution in breastfeeding women

Drug Interactions

  • Avoid concurrent use with strong CYP3A4 inhibitors

Overdose Symptoms

  • Sedation
  • Tachycardia
  • Agitation

Antidote for Overdose

  • No specific antidote, manage symptoms supportively

Storage Conditions

  • Store at room temperature away from moisture and heat

Pharmacokinetics

  • Absorption: Well absorbed after oral administration
  • Distribution: Highly protein-bound
  • Metabolism: Mainly hepatic via CYP3A4 and CYP2D6
  • Excretion: Primarily in feces

Precautions

  • Use with caution in patients with severe renal impairment

Warnings

  • May cause drowsiness, avoid driving or operating heavy machinery

Others

  • Not recommended for use in children under 6 years old