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fexofenadine hydrochloride

   Also found in: Wikipedia 0.01 sec.
fex·o·fen·a·dine hydrochloride (fks-fn-dn)
n.
A nonsedating antihistamine used to treat allergic rhinitis and allergic skin disorders.

fexofenadine hydrochloride

Allegra, Telfast (UK)

Pharmacologic class: Peripherally selective piperidine, selective histamine1-receptor antagonist

Therapeutic class: Antihistamine (nonsedating type), second-generation

Pregnancy risk category C

Action

Blocks effects of histamine at peripheral histamine1-receptor sites, decreasing allergy signs and symptoms

Availability

Capsules: 60 mg

Tablets: 30 mg, 60 mg, 180 mg

Indications and dosages

Seasonal allergic rhinitis; chronic idiopathic urticaria

Adults and children older than age 12: 60 mg P.O. b.i.d. or 180 mg once daily

Children ages 6 to 12: 30 mg P.O. b.i.d.

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug, terfenadine, or their components

Precautions

Use cautiously in:
• renal impairment
• concurrent ketoconazole or erythromycin therapy
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 12 (safety not established).

Administration

• Don't give with apple, orange, or grapefruit juice.
• Don't give antacids within 2 hours of fexofenadine.

RouteOnsetPeakDuration
P.O.Within 1 hr2-3 hr12-24 hr

Adverse reactions

CNS: drowsiness, fatigue, headache

EENT: otitis media

GI: nausea, dyspepsia

Metabolic: dysmenorrhea

Respiratory: upper respiratory tract infection

Other: viral infection

Interactions

Drug-drug. Antacids containing aluminum and magnesium: decreased absorption and efficacy of fexofenadine

Drug-diagnostic tests. Skin allergy tests: false-negative results

Drug-food. Apple, orange, and grapefruit juice: decreased absorption and efficacy of fexofenadine

Patient monitoring

• Monitor renal function.
• Watch for signs and symptoms of viral infection.

Patient teaching

• Tell patient to stop taking drug 4 days before diagnostic skin tests, to avoid interference with test results.
• Advise patient to report signs or symptoms of viral infection, especially upper respiratory tract infection.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise female patient to inform prescriber if she is pregnant or breastfeeding.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.



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for a preliminary injunction related to Teva's Fexofenadine Hydrochloride Tablets, the AB-rated generic equivalent of Aventis' antihistamine Allegra(R) Tablets.
IMPAX Laboratories previously announced FDA acceptance of the Company's ANDA filing for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60mg/120mg Extended Release Tablets in February 2002 and commented on the filing of a lawsuit by Aventis alleging patent infringement relating to the ANDA in April 2002.
In addition to a strong increase in our net contract revenue, we also received significant revenue from royalties, milestone payments, and licensing fees from our patents related to fexofenadine hydrochloride, the active ingredient in Allegra(TM), the non- sedating antihistamine marketed by Hoechst Marion Roussel.
 
 
 
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