Rupatadine Fumarate: Uses, Dosage, Side Effects | MedexInfo

Rupatadine Fumarate

Rx Only

Generic NameRupatadine Fumarate

Therapeutic ClassSecond-Generation Antihistamine

Common Dose10 mg once daily

Max / 24h10 mg

PregnancyCategory B

Indications ▼

Seasonal and perennial allergic rhinitis

Chronic spontaneous urticaria

Relief of nasal and ocular allergy symptoms

Mechanism & Pharmacokinetics ▼

Mechanism: Selective H1 receptor antagonist; also inhibits platelet-activating factor (PAF) to reduce allergic inflammation.

Pharmacokinetics: Rapid oral absorption; peak plasma concentration ~1 hour; metabolized by CYP3A4; half-life ~12 hours; primarily excreted in urine and feces.

Dosage & Administration ▼

Patient Category	Recommended Dose	Max / 24h
Adults & Adolescents ≥12 years	10 mg orally once daily	10 mg
Children 6–11 years	5 mg orally once daily	5 mg
Renal Impairment	No dose adjustment for mild to moderate; severe cases consult physician	10 mg
Hepatic Impairment	Reduce dose to 5 mg daily for moderate impairment; avoid in severe impairment	10 mg

Note: Take with water, preferably at the same time each day. Swallow whole; can be taken with or without food.

Side Effects ▼

Common: Headache, drowsiness, dry mouth

Occasional: Fatigue, nausea, dizziness

Rare: Palpitations, severe hypersensitivity reactions

Contraindications ▼

Hypersensitivity to Rupatadine or any excipients

Severe hepatic impairment

Children <6 years

Drug Interaction ▼

CYP3A4 inhibitors (e.g., ketoconazole) may increase plasma levels

Other CNS depressants may increase drowsiness

Concomitant alcohol use may enhance sedative effect

Pregnancy & Lactation ▼

Pregnancy Category B; use only if clearly needed

Unknown excretion in breast milk; caution advised

Clinical / Research Summary ▼

Effective for symptomatic relief of allergic rhinitis and urticaria

Well-tolerated with minimal sedation compared to first-generation antihistamines

Dual H1 and PAF antagonism may provide broader anti-allergic effect

Patient Counseling Points ▼

Take at the same time each day

May cause drowsiness; avoid driving if affected

Do not exceed prescribed dose

Report severe allergic reactions immediately

Storage & Handling ▼

Store at 20–25°C; protect from moisture and light

Keep out of reach of children

Brand Names (Bangladesh & Global) ▼

Bangladesh:

Rupadin® 10 mg Rupatrol® 10 mg Rupa® 10 mg Rata® 10 mg Rupatid® 10 mg Rupamine® 10 mg Rupadin® Syrup 5 mg/5 ml Rupa® Syrup 5 mg/5 ml Rupamine® Syrup 5 mg/5 ml Rupex® 5 mg/5 ml

Global:

Rupatadine (Generic) Rupafin®

Medical Disclaimer: This information is for educational purposes only. Consult a qualified healthcare professional for diagnosis and treatment.

Reference Hubs:

• Drug Class: Antihistamines • Condition: Allergic Rhinitis • Condition: Urticaria • Clinical Evidence & Trials