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FDA Approvals: Allegra Oral Solution, Noxafil, Mirapex

  • Authors: News Author: Yael Waknine
    CME Author: Yael Waknine
  • CME / CE Released: 11/16/2006
  • Valid for credit through: 11/16/2007
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Target Audience and Goal Statement

This article is intended for primary care clinicians, infectious disease specialists, neurologists, and other specialists who care for children with seasonal allergic rhinitis and chronic idiopathic urticaria and patients with oropharyngeal candidiasis or restless legs syndrome.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Identify appropriate dosing regimens for fexofenadine oral solution in the treatment of pediatric seasonal allergic rhinitis and chronic idiopathic urticaria.
  • Explain the appropriate use of posaconazole in the treatment of oropharyngeal candidiasis.
  • Explain the potential benefits of pramipexole for the treatment of restless legs syndrome.



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  • Yael Waknine

    Yael Waknine is a freelance writer for Medscape.


    Disclosure: Yael Waknine has disclosed no relevant financial relationships.


  • Laurie Barclay, MD

    Laurie Barclay is a freelance reviewer and writer for Medscape.


    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Author(s)

  • Yael Waknine

    Yael Waknine is a freelance writer for Medscape.


    Disclosure: Yael Waknine has disclosed no relevant financial relationships.

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FDA Approvals: Allegra Oral Solution, Noxafil, Mirapex

Authors: News Author: Yael Waknine CME Author: Yael WaknineFaculty and Disclosures

CME / CE Released: 11/16/2006

Valid for credit through: 11/16/2007


November 16, 2006 -- The US Food and Drug Administration (FDA) has approved fexofenadine 30-mg/5-mL oral suspension for the twice-daily treatment of seasonal allergic rhinitis in children aged 2 to 11 years and of uncomplicated chronic idiopathic urticaria in those aged 6 months to 11 years; posaconazole 40-mg/mL oral suspension for the treatment of oropharyngeal candidiasis, including cases refractory to itraconazole and/or fluconazole therapy; and pramipexole tablets for the treatment of moderate to severe primary restless legs syndrome.

Fexofenadine (Allegra) for Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria in Pediatric Patients

On October 10, the FDA approved fexofenadine HCl 30-mg/5-mL oral suspension ( Allegra, made by Aventis Pharmaceuticals, Inc) for the twice-daily treatment of seasonal allergic rhinitis in children aged 2 to 11 years and of uncomplicated chronic idiopathic urticaria in those aged 6 months to 11 years.

According to a company news release, the product will have an artificial raspberry-cream flavor and is expected to be commercially available in time for the 2007 spring allergy season.

The recommended dosing regimen for pediatric patients aged 2 to 11 years with seasonal allergic rhinitis is 30 mg (5 mL) twice daily. A 30-mg once-daily dose should be used for children with decreased renal function. Twice-daily 30-mg doses are also recommended for treating chronic idiopathic urticaria in pediatric patients aged 2 to 11 years. Those aged 6 months to 2 years should receive a reduced twice-daily dose of 15 mg (2.5 mL).

In clinical studies of children aged 6 months to 5 years, adverse events were similar to that of placebo and most commonly included vomiting, pyrexia, cough, otitis media, and diarrhea.

Fexofenadine was approved previously in tablet formulation for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children aged 6 years and older.

Posaconazole Oral Suspension (Noxafil) for the Treatment of Oropharyngeal Candidiasis

On October 20, the FDA approved a new indication for posaconazole 40-mg/mL oral suspension ( Noxafil, made by Schering-Plough Corp), allowing its use for the treatment of oropharyngeal candidiasis, including cases that are refractory to itraconazole and/or fluconazole therapy.

The FDA's approval was based in part on a study of HIV-infected patients with oropharyngeal candidiasis, showing that posaconazole therapy achieved similar rates of clinical success (complete or partial resolution of all ulcers and/or plaques and symptoms) and mycologic eradication (absence of colony-forming units) at 14 days vs fluconazole (91.7% vs 92.5% and 52.1% vs 50.0%, respectively). Clinical and mycologic relapse rates 4 weeks posttherapy were also comparable between groups (29.0% vs 35.1% and 55.6% vs 63.7%, respectively).

A second study performed in HIV-infected patients with refractory oropharyngeal candidiasis showed that clinical success rates were similar for patients administered posaconazole 400-mg twice-daily for 3 days followed by 400 mg/day for 25 days and those given 400-mg twice daily for 28 days (73.3% vs 75.0%). Inclusion criteria included oropharyngeal candidiasis that had failed to improve or worsened after a standard 10-day course of therapy with 100 mg/day or more of fluconazole or 200 mg of itraconazole. Treatment had been discontinued within 14 days of posaconazole initiation.

The recommended dosing regimen for patients with oropharyngeal candidiasis consists of a 100-mg (2.5-mL) twice-daily loading dose on the first day, followed by 100-mg once-daily dose for 13 days. Those with refractory oropharyngeal candidiasis do not require a loading dose and should receive 400 mg of posaconazole (10 mL) twice daily for a period deemed consistent with the severity of underlying disease and clinical response.

To optimize posaconazole absorption and plasma concentrations, each dose should be taken with a full meal or nutritional supplement. Patients who are unable to eat a full meal or tolerate supplementation should receive alternative antifungal therapy or closely be monitored for breakthrough fungal infections.

Because cimetidine, rifabutin, and phenytoin can decrease posaconazole plasma concentrations, their coadministration should generally be avoided unless the benefit outweighs the potential risk for breakthrough infection.

Concomitant use of posaconazole with the cytochrome-P450 3A4 (CYP3A4) substrates terfenadine, astemizole, cisapride, pimozide, halofantrine, or quinidine is contraindicated because of the risk for increased plasma concentrations that can lead to QTc prolongation and rare occurrences of torsades de pointes. Coadministration with ergot alkaloids is also contraindicated.

Dose reductions and more frequent clinical monitoring of cyclosporine, tacrolimus, and sirolimus are recommended on initiation of posaconazole therapy because of the risk for rare serious adverse events associated with their increased concentration in the blood.

Posaconazole previously was approved by the FDA for the prophylaxis of invasive Aspergillus and Candidas infections in high-risk, severely immunocompromised patients aged 13 years and older, including hematopoietic stem-cell transplant recipients with graft-vs-host disease and patients with hematologic malignancies with prolonged neutropenia from chemotherapy.

Pramipexole (Mirapex) for Moderate to Severe Restless Legs Syndrome

On November 7, the FDA approved a new indication for pramipexole dihydrochloride ( Mirapex tablets, made by Boehringer Ingelheim Pharmaceuticals, Inc), allowing its use in the treatment of moderate to severe primary restless legs syndrome.

The approval was based primarily on data from 2 of 4 double-blind, placebo-controlled trials in approximately 1000 patients. Patients were randomized to receive placebo or pramipexole, titrated from 0.125 mg to 0.25, 0.5, or 0.75 mg once daily, 2 to 3 hours before bedtime.

Results from a 12-week study (n = 344) showed that pramipexole therapy yielded significant decreases relative to placebo in severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living/mood, as scored on the International Restless Leg Syndrome Rating Scale (-13.6 vs -9.4 points). Pramipexole-treated patients also experienced significant clinical progress as evaluated on the Clinical Global Impressions--Improvement scale (72.0% vs 51.2%). Moreover, 74.7% of those receiving a low dose of 0.25 mg were classified as therapeutic responders.

Long-term efficacy of pramipexole was evaluated in a 9-month study (n = 147) that consisted of a 6-month open-label treatment period followed by a 12-week placebo-controlled withdrawal period. Results showed that 79% of patients continuing active treatment maintained their response through 9 months compared with 15% of those who were switched to placebo. The majority of treatment failures occurred within 10 days of randomization.

Adverse events related to pramipexole therapy were mild to moderate in intensity, with nausea (15% vs placebo, 5%), headache (16% vs 15%), fatigue (9% vs 7%), and somnolence (6% vs 3%) most commonly reported. Patients and caregivers should be cautioned that impulse control disorders/compulsive behaviors may occur with use of pramipexole.

The recommended starting dose for pramipexole in restless legs syndrome is 0.125 mg taken once daily 2 to 3 hours prior to bedtime. For patients requiring additional symptomatic relief, the dose may be increased at 4- to 7-day intervals to 0.25 and then 0.5 mg. In patients with moderate to severe renal impairment (creatinine clearance, 20 - 60 mL/minute), the titration period should be increased to 14 days. The FDA notes that although some patients were uptitrated to 0.75 mg in the long-term study, there was no evidence that the increased dose conferred additional benefit beyond the 0.5-mg dose of pramipexole.

Pramipexole tablets (marketed as Sifrol or Mirapexin tablets) were approved for this indication by the European Commission in April 2006. They also previously were approved by the FDA and European Commission for use alone or with levodopa in the treatment of idiopathic Parkinson's disease.

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