FEXOFIN 180/MG TAB 30/TAB

Indications

Approved Uses

Seasonal allergic rhinitis, chronic idiopathic urticaria

Dosage & Administration

Dosing by Condition

Seasonal allergic rhinitis (adults and children ≥12 years): 180mg once daily. Chronic idiopathic urticaria (adults and children ≥12 years): 180mg once daily. Children 6-11 years: 30mg twice daily (using 30mg or 60mg formulations)

Initial Dose

180mg once daily

Maintenance Dose

180mg once daily

Maximum Dose

180mg per day

Children's Dosage

Seasonal Allergic Rhinitis (6-11 years): 30mg twice daily. Chronic Idiopathic Urticaria (6-11 years): 30mg twice daily. (2-11 years): 30mg twice daily. (6 months-2 years): 15mg twice daily. The 180mg strength is not approved for children under 12 years.

Dose Adjustment Notes

Renal impairment: use a lower dose (commonly 60 mg once daily) in reduced renal function; no routine hepatic dose adjustment; avoid coadministration with fruit juices and separate Al/Mg antacids by ≥2 hours.

How to Take

Swallow the 180 mg film‑coated tablet whole with water; may be taken with or without food; avoid taking with fruit juices (apple/orange/grapefruit); if using Al/Mg antacids, separate by at least 2 hours.

Side Effects

Common Side Effects

Headache, nausea, dizziness, fatigue; less commonly drowsiness/somnolence, dyspepsia; may also include back pain and upper respiratory/viral infection symptoms.

Side Effect Frequency

Common (≥1% to <10%): headache, nausea, dizziness, somnolence/drowsiness; Uncommon (<1%): diarrhea, dry mouth, fatigue; Rare: palpitations/tachycardia, hypersensitivity reactions (e.g., angioedema/anaphylaxis)

Safety & Warnings

Contraindications

Hypersensitivity to fexofenadine (fexofenadine hydrochloride) or to any excipients in the product.

Warnings & Precautions

Use caution in renal impairment (consider lower starting dose); avoid/limit fruit juices that reduce absorption; discontinue and seek care if hypersensitivity occurs.

Age Restriction

For the 180 mg tablet: approved/appropriate for adults and adolescents ≥12 years; not recommended for children <12 years (use age-appropriate lower strengths/forms).

Drug Interactions

Drug Interactions

Antacids containing aluminum/magnesium reduce absorption (separate by ~2 hours); erythromycin/ketoconazole can increase fexofenadine exposure; fruit juices (apple/orange/grapefruit) reduce absorption-avoid or separate.

Interaction Severity

MODERATE: Aluminum/magnesium antacids (reduced absorption-separate by ≥2 hours); erythromycin or ketoconazole (increase fexofenadine exposure). MINOR to MODERATE (clinically relevant): fruit juices (reduced absorption-avoid).

Food Interaction

Take with water; avoid apple/orange/grapefruit juice (decreases absorption); may be taken with or without food (a high‑fat meal can reduce Cmax/AUC but usually not clinically significant for routine use).

Special Populations

Children

Seasonal Allergic Rhinitis (6-11 years): 30mg twice daily. Chronic Idiopathic Urticaria (6-11 years): 30mg twice daily. (2-11 years): 30mg twice daily. (6 months-2 years): 15mg twice daily. The 180mg strength is not approved for children under 12 years.

Kidney Impairment

Renal impairment: start with 60 mg once daily in adults/adolescents (including when using the 180 mg product, a lower-strength product is preferred); no adjustment is typically needed in mild impairment, but reduced starting dose is recommended in moderate-severe renal dysfunction.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime

Overdose

Possible symptoms: dizziness, drowsiness/fatigue, dry mouth; management is symptomatic/supportive (consider decontamination if recent), and hemodialysis is not effective-seek medical attention/poison center guidance.

Patient Counseling

Take 1 tablet (180 mg) once daily with water; avoid fruit juices; may take with or without food; separate aluminum/magnesium antacids by ≥2 hours; usually non‑drowsy but use caution with driving until you know your response; stop several days before allergy skin testing if instructed; store below 30°C.

Monitoring Requirements

No routine monitoring required

Pharmacology

Mechanism of Action

Selective peripheral H1‑receptor antagonist that blocks histamine at H1 receptors; limited blood-brain barrier penetration, so sedation is minimal.

Onset of Action

Onset typically within ~1 hour (often 30-60 minutes), with peak effect around 2-3 hours.

Duration of Effect

24 hours

Half-Life

11-16 hours (mean ~14.4 hours)

Excretion

Eliminated largely unchanged, mainly via feces (~80%) with a smaller renal component (~10-11% in urine).

Product Information

Available Dosage Forms

For this SFDA-registered product: film‑coated tablet (oral) 180 mg only.

Composition per Dose

Each film-coated tablet: 180mg fexofenadine hydrochloride

Generic Availability

Yes

OTC Alternatives

Other OTC second‑generation antihistamines: cetirizine 10 mg, loratadine 10 mg, levocetirizine 5 mg.

Symptom Target

Allergy, Runny Nose, Itching

Sedating

No

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