PAFINUR 10/MG TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of allergic rhinitis (seasonal/perennial) and urticaria (including chronic spontaneous urticaria) in adults and adolescents ≥12 years.

Dosage & Administration

Initial Dose

10 mg once daily.

Maintenance Dose

10 mg once daily.

Maximum Dose

10 mg once daily.

Children's Dosage

Approved for children aged 2-11 years (weight-based oral solution formulation): 2.5 mg once daily (10-25 kg), 5 mg once daily (>25 kg). Tablet 10 mg approved for adolescents ≥12 years

Dose Adjustment Notes

Renal or hepatic impairment: use is generally not recommended due to limited clinical data; if used, exercise caution (especially in hepatic impairment) and avoid in severe hepatic impairment.

Side Effects

Side Effect Frequency

Common (1-10%): somnolence (~9.5%), headache (~6.9%), fatigue (~3.2%), dizziness, dry mouth; other reactions are generally uncommon/rare depending on the specific event and data source.

Safety & Warnings

Warnings & Precautions

Avoid with strong CYP3A4 inhibitors and grapefruit juice; caution with alcohol/CNS depressants and when driving if somnolence occurs; not recommended in renal or hepatic insufficiency; use caution in patients with known QT prolongation, electrolyte abnormalities (e.g., hypokalemia), or proarrhythmic conditions.

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin/erythromycin, ritonavir) - markedly increase rupatadine exposure; avoid. MODERATE: Grapefruit juice; other CYP3A4 inhibitors; alcohol/CNS depressants (additive sedation). CAUTION: Concomitant QT-prolonging drugs in high-risk patients.

Food Interaction

May be taken with or without food; avoid grapefruit juice.

Alcohol Interaction

Avoid

Special Populations

Children

Approved for children aged 2-11 years (weight-based oral solution formulation): 2.5 mg once daily (10-25 kg), 5 mg once daily (>25 kg). Tablet 10 mg approved for adolescents ≥12 years

Elderly

Use with caution. Although no overall differences in safety or effectiveness were observed, higher sensitivity of some older individuals cannot be excluded.

Kidney Impairment

Renal impairment: not recommended (insufficient data), particularly in moderate-severe renal insufficiency; if used, do so with caution and monitoring.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep the blisters in the outer carton in order to protect from light.

Stopping the Medicine

May be stopped at any time; no tapering required.

Overdose

Most common: somnolence; possible tachycardia and other anticholinergic-like symptoms; management is symptomatic/supportive (consider decontamination if very recent ingestion) and seek urgent medical care/poison center advice.

Monitoring Requirements

No routine laboratory monitoring required; consider ECG/clinical monitoring in patients with risk factors for QT prolongation or when combined with QT-prolonging agents.

Pharmacology

Onset of Action

Onset typically within ~1 hour.

Half-Life

Terminal half-life of rupatadine is ~5.9 hours.

Metabolism

Extensive hepatic metabolism, primarily via CYP3A4, producing multiple metabolites (some with antihistaminic activity).

Product Information

Composition per Dose

Each tablet: 10 mg rupatadine as rupatadine fumarate

Generic Availability

Yes

OTC Alternatives

OTC alternatives for similar indications (country-dependent): cetirizine, loratadine, and fexofenadine.

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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