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Non-Sedating H₁ Antihistamine
Allergic Rhinitis: Relief of seasonal/perennial symptoms (sneezing, rhinorrhea, lacrimation, ocular/nasal/palatal pruritus) in adults and children ≥12 years
Chronic Idiopathic Urticaria: Treatment of uncomplicated skin manifestations
(Use under registered physician's guidance)
Inverse Agonist at H₁ receptors:
Stabilizes inactive receptor state → blocks histamine-induced allergic cascade
Suppresses cytokine release (IL-4, IL-13) from mast cells/basophils
Peripherally Selective:
Negligible BBB penetration → no sedation
No anticholinergic/antidopaminergic activity
| Parameter | Profile |
|---|---|
| Absorption | Rapid; Tₘₐₓ: 2.6 hr • Bioavailability: 33% |
| Distribution | Protein binding: 60-70% • Vd: 5.4-5.8 L/kg |
| Metabolism | Minimal hepatic involvement (CYP-independent) |
| Excretion | Renal (80% unchanged) • t½: 14.4 hr (healthy) → 23.9 hr (CrCl 40 mL/min) |
| Dialysis | Not removed by hemodialysis |
| Patient Group | Standard Dose | Renal Impairment Dose |
|---|---|---|
| Adults & ≥12 yrs | 120-180 mg once daily | 60 mg once daily |
| Children 6-11 yrs | 30 mg twice daily | 30 mg once daily |
| Children 2-5 yrs | 30 mg (5mL) twice daily | 30 mg (5mL) once daily |
| Infants 6-23 mos | 15 mg (2.5mL) twice daily | 15 mg (2.5mL) once daily |
Key Notes:
Tablet: ≥6 years • Suspension: 6 months-11 years
Administer 1 hour before or 2 hours after antacids
No food restrictions
(Follow registered physician's advice)
| Concomitant Agent | Effect | Management |
|---|---|---|
| Erythromycin/Ketoconazole | ↑ Fexofenadine AUC (2-3 fold) | Monitor for enhanced effects |
| Al/Mg Antacids | ↓ Bioavailability (40%) | Separate doses by 2+ hours |
| Omeprazole | No interaction | Safe coadministration |
Hypersensitivity to fexofenadine or formulation excipients
Common (≥1%):
Headache • Drowsiness • Nausea • Dizziness
Rare (Post-Marketing):
Hypersensitivity: Angioedema, anaphylaxis
Cardiac: Tachycardia, palpitations
Dermatologic: Urticaria, rash, pruritus
Psychiatric: Insomnia, nightmares
Pregnancy (Category C):
Avoid unless benefit > risk (limited human data)
Lactation:
Excreted in milk (terfenadine data) → contraindicated
Cardiovascular Risk:
Monitor for tachycardia in patients with pre-existing CVD
Renal Impairment:
Mandatory dose reduction (CrCl <80 mL/min)
Driving Alert:
Theoretical individual sensitivity → assess response before operating machinery
Hepatic Impairment:
No dose adjustment needed
| Group | Pharmacokinetics | Dosing Guidance |
|---|---|---|
| Elderly (≥65 yrs) | ↑ AUC (40-60%) | Standard dose; monitor for AEs |
| Renal Impairment | ↑ t½ proportional to ↓ CrCl | ↓ Dose by 50% |
| Hepatic Impairment | No significant change | No adjustment required |
Symptoms:
Drowsiness • Dry mouth • Fatigue
Treatment:
Activated charcoal if recent ingestion
Supportive care (no specific antidote)
Note: Hemodialysis ineffective
Second-Generation H₁ Antihistamine (Non-Sedating)
Tablets: Below 30°C • Protect from moisture
Suspension: Shake well • Discard after 30 days
Keep out of children's reach
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