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Flovent Rotadisk (Fluticasone Propionate Inhalation) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FLOVENT ROTADISK is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

FLOVENT ROTADISK is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

FLOVENT ROTADISK should be administered by the orally inhaled route in patients 4 years of age and older. Individual patients will experience a variable time to onset and degree of symptom relief. Generally, FLOVENT ROTADISK has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of fluticasone propionate can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

After asthma stability has been achieved (see Table 2), it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. Dosages as low as 50 mcg twice daily have been shown to be effective in some patients. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The safety and efficacy of FLOVENT ROTADISK when administered in excess of recommended dosages have not been established.

Rinsing the mouth after inhalation is advised.

The recommended starting dosage and the highest recommended dosage of FLOVENT ROTADISK, based on prior anti-asthma therapy, are listed in Table 2.

Table 2. Recommended Dosages of FLOVENT ROTADISK
Previous Therapy Recommended Starting Dosage Highest Recommended Dosage
Adults and Adolescents
Bronchodilators alone 100 mcg twice daily 500 mcg twice daily
Inhaled corticosteroids 100-250 mcg twice daily * 500 mcg twice daily
Oral corticosteroids # 1000 mcg twice daily & 1000 mcg twice daily &
Children 4 to 11 Years
Bronchodilators alone 50 mcg twice daily 100 mcg twice daily
Inhaled corticosteroids 50 mcg twice daily 100 mcg twice daily
*Starting dosages above 100 mcg twice daily for adults and adolescents and 50 mcg twice daily for children 4 to 11 years of age may be considered for patients with poorer asthma control or those who have previously required doses of inhaled corticosteroids that are in the higher range for that specific agent.
NOTE: In all patients, it is desirable to titrate to the lowest effective dosage once asthma stability is achieved.
# For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with FLOVENT ROTADISK. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency (see WARNINGS). Once prednisone reduction is complete, the dosage of fluticasone propionate should be reduced to the lowest effective dosage.
&This dosing recommendation is based on clinical data from a study conducted using FLOVENT Inhalation Aerosol. No clinical trials have been conducted in patients on oral corticosteroids using FLOVENT ROTADISK; no direct assessment of the clinical comparability of equal nominal doses for FLOVENT ROTADISK and FLOVENT Inhalation Aerosol in this population has been conducted.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with FLOVENT ROTADISK, efficacy and safety did not differ from that in younger patients. Consequently, no dosage adjustment is recommended.

Directions for Use: Illustrated Patient's Instructions for Use accompany each package of FLOVENT ROTADISK.

HOW SUPPLIED

FLOVENT ROTADISK 50 mcg is a circular double-foil pack containing 4 blisters of the drug. Fifteen (15) ROTADISKS are packaged in a white polypropylene tube, and the tube is packaged in a plastic-coated, moisture-protective foil pouch. A carton contains the foil pouch of 15 ROTADISKS and 1 dark orange and peach DISKHALER inhalation device (NDC 0173-0511-00).

FLOVENT ROTADISK 100 mcg is a circular double-foil pack containing 4 blisters of the drug. Fifteen (15) ROTADISKS are packaged in a white polypropylene tube, and the tube is packaged in a plastic-coated, moisture-protective foil pouch. A carton contains the foil pouch of 15 ROTADISKS and 1 dark orange and peach DISKHALER inhalation device (NDC 0173-0509-00).

FLOVENT ROTADISK 250 mcg is a circular double-foil pack containing 4 blisters of the drug. Fifteen (15) ROTADISKS are packaged in a white polypropylene tube, and the tube is packaged in a plastic-coated, moisture-protective foil pouch. A carton contains the foil pouch of 15 ROTADISKS and 1 dark orange and peach DISKHALER inhalation device (NDC 0173-0504-00).

Store at controlled room temperature (see USP), 20° to 25°C (68° to 77°F) in a dry place. Keep out of reach of children. Do not puncture any fluticasone propionate ROTADISK blister until taking a dose using the DISKHALER.

Use the ROTADISK blisters within 2 months after opening of the moisture-protective foil overwrap or before the expiration date, whichever comes first. Place the sticker provided with the product on the tube and enter the date the foil overwrap is opened and the 2-month use date.

GlaxoSmithKline, Research Triangle Park, NC 27709

©2004, GlaxoSmithKline. All rights reserved.

March 2004/RL-2068

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