FEXODINE 120/MG TAB 14/TAB

Indications

Approved Uses

Seasonal allergic rhinitis, chronic idiopathic urticaria

Off-Label Uses

Chronic inducible urticarias (e.g., dermographism, cold urticaria) and other histamine‑mediated pruritic conditions; allergic conjunctivitis symptom relief is also commonly treated with oral antihistamines.

Dosage & Administration

Dosing by Condition

Seasonal Allergic Rhinitis (Adults and children ≥12 years): 60mg twice daily or 180mg once daily. Chronic Idiopathic Urticaria (Adults and children ≥12 years): 60mg twice daily or 180mg once daily. The 120mg strength is not listed as a standard dosing option in FDA-approved prescribing information.

Initial Dose

120mg once daily

Maintenance Dose

120mg once daily

Maximum Dose

180mg once daily or 60mg twice daily

Children's Dosage

Seasonal Allergic Rhinitis (2 to 11 years): 30mg twice daily. Chronic Idiopathic Urticaria (6 months to 11 years): 15mg twice daily for 6 months to <2 years; 30mg twice daily for 2 to 11 years.

Dose Adjustment Notes

Renal impairment: 60 mg once daily

How to Take

Swallow the film‑coated tablet whole with water; avoid taking with fruit juices (apple, orange, grapefruit). If using aluminum/magnesium antacids, separate by at least 2 hours.

Side Effects

Common Side Effects

Headache, nausea, dizziness, drowsiness/fatigue (usually low incidence).

Side Effect Frequency

Common (≥1% to <10%): headache, drowsiness/somnolence, dizziness, nausea; Uncommon (≥0.1% to <1%): fatigue/tiredness

Safety & Warnings

Contraindications

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

Warnings & Precautions

Use with caution in renal impairment; avoid taking with fruit juices (grapefruit/orange/apple) due to reduced absorption; discontinue if hypersensitivity occurs; cardiovascular warnings (tachycardia/palpitations) are not a routine class warning for fexofenadine but advise caution if symptoms occur.

Age Restriction

For this product (fexofenadine 120 mg film‑coated tablet): use is generally for adults and children ≥12 years; not recommended for children <12 years with this tablet strength/form (younger children require age-appropriate formulations/doses).

Driving Warning

Does not cause drowsiness

Drug Interactions

Drug Interactions

Antacids containing aluminum/magnesium can reduce absorption (separate by ~2 hours); erythromycin and ketoconazole can increase fexofenadine plasma concentrations; fruit juices (e.g., grapefruit, orange, apple) can reduce bioavailability (OATP inhibition).

Interaction Severity

MODERATE: aluminum/magnesium antacids (decrease absorption-separate by ≥2 hours); erythromycin and ketoconazole (increase fexofenadine exposure). Fruit juices: clinically relevant decrease in absorption-avoid (often categorized as moderate in practice).

Food Interaction

Avoid fruit juices (apple/orange/grapefruit) around dosing as they decrease absorption; food may reduce/slow absorption modestly, so take consistently (preferably with water).

Alcohol Interaction

Safe

Special Populations

Children

Seasonal Allergic Rhinitis (2 to 11 years): 30mg twice daily. Chronic Idiopathic Urticaria (6 months to 11 years): 15mg twice daily for 6 months to <2 years; 30mg twice daily for 2 to 11 years.

Elderly

Standard adult dosing, but adjust for renal function as clearance may be decreased.

Kidney Impairment

Renal impairment: start with 60 mg once daily in adults/adolescents (≥12 years) when renal function is reduced; the 120 mg tablet is not ideal for dose adjustment (use 60 mg strength if needed).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose; do not double the dose

Stopping the Medicine

Safe to stop anytime

Overdose

Symptoms may include dizziness, drowsiness, and dry mouth; management is symptomatic/supportive, consider decontamination if appropriate, and hemodialysis does not effectively remove fexofenadine; seek medical attention/poison center guidance.

Patient Counseling

Take once daily as directed and swallow whole with water; avoid apple/orange/grapefruit juice around the dose; separate aluminum/magnesium antacids by ≥2 hours; usually non‑sedating but use caution with driving if drowsy; seek urgent care for signs of hypersensitivity (e.g., facial/lip/throat swelling) and consult a clinician if you have kidney disease.

Monitoring Requirements

No routine monitoring required.

Pharmacology

Mechanism of Action

Selective peripheral H1‑receptor antagonist that blocks histamine‑mediated symptoms with minimal CNS effects due to limited blood-brain barrier penetration.

Onset of Action

About 1 hour; peak effect typically 2-3 hours.

Duration of Effect

Approximately 24 hours (supports once‑daily dosing).

Metabolism

Minimal metabolism; ~5% metabolized (negligible hepatic metabolism) with most eliminated unchanged in feces and urine

Product Information

Available Dosage Forms

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

Composition per Dose

Each film-coated tablet: 120mg fexofenadine hydrochloride

Generic Availability

Yes

OTC Alternatives

Cetirizine 10 mg, loratadine 10 mg, levocetirizine 5 mg, desloratadine 5 mg (OTC availability may vary by country).

Symptom Target

Allergy

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 21-06-2026