fexofenadine hydrochloride

(redirected from Allegra ODT)

fexofenadine hydrochloride

Allegra, Allegra ODT, 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

Oral suspension: 30 mg/5 ml (6 mg/ml)

Tablets: 30 mg, 60 mg, 180 mg

Tablets (orally disintegrating): 30 mg

Indications and dosages

Seasonal allergic rhinitis; chronic idiopathic urticaria

Adults and children age 12 and older: 60 mg P.O. b.i.d. or 180 mg once daily (conventional tablets)

Children ages 6 to 11: 30 mg P.O. b.i.d. (conventional tablets or ODT tablets)

Seasonal allergic rhinitis

Children ages 2 to 11: 30 mg P.O. b.i.d. (oral suspension and ODT)

Chronic idiopathic urticaria

Children ages 6 months to less than 2 years: 15 mg P.O. b.i.d.(oral suspension and ODT)

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.

Administration

• Give capsules and conventional tablets with water; don't give with apple, orange, or grapefruit juice.
• Don't remove orally disintegrating tablets from original blister package until time of administration.
• Administer orally disintegrating tablets on an empty stomach; allow tablets to disintegrate on the tongue and then have patient swallow tablets with or without water.
• Don't break or use partial orally disintegrating tablets
• Know that orally disintegrating tablets contain phenylalanine.
• Don't give antacids within 2 hours of fexofenadine.

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

• Instruct patient to take conventional tablets with water, and not with apple, orange, or grapefruit juice.
• Instruct patient not to remove orally disintegrating tablets from original blister package until time of administration.
• Instruct patient to take orally disintegrating tablets on an empty stomach at least 1 hour before or 2 hours after a meal, to allow tablet to disintegrate on the tongue, and then to swallow with or without water. Advise patient not to chew tablets.
• Tell patient not to break or use partial orally disintegrating tablets.
• 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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References in periodicals archive ?
We also have diversified our product portfolio - with approximately 20% of the Company's revenues in the first half of 2008 derived from new products, which include Prenate DHA, Prandin, Fenoglide, Orapred ODT, Allegra OS and Allegra ODT, Twinject and Methylin CT.
Sciele has launched five new products through July 2008: Prandin, the new Sular GEOMATRIX formulation, Fenoglide, Allegra ODT and Twinject.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, stated, "The first quarter of 2008 marked the launch of four new products for Sciele: the new Sular formulation, Prandin, Fenoglide, and Allegra ODT.
The recent acquisition of Twinject, epinephrine auto-injector, from Verus Pharmaceuticals, the licensing of Allegra ODT from sanofi-aventis, and the launch upon FDA approval of LARx, a new prescription treatment for head lice, are expected to provide future revenue growth in the Pediatric product line.
the full line of pediatric Allegra, which includes Allegra ODT and Allegra OS.
A solid base of products, combined with new product launches, beginning with Allegra ODT in the first quarter of 2008 and a new prescription treatment for head lice anticipated in mid-year 2008, are expected to create additional Pediatric growth opportunities.
Sciele expects to launch Allegra ODT in March 2008 through its 100 pediatric sales representatives.
Allegra ODT, 30mg, treats the same seasonal allergy symptoms and CIU in children 6 to 11 years of age in a convenient formula that dissolves on the tongue and can be taken with or without water.
commented, "We are pleased to expand our alliance with sanofi-aventis, and are excited about the anticipated launch of Allegra ODT by our Pediatric sales force.