Rx Item-Fluticasone Prop Gen Flovent HFA 220Mcg Inh 12Gm By Prasco Gen Flovent

FLOVENT HFA- fluticasone propionate aerosol, metered
Preferred Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

FLOVENT� HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years 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.

Important Limitation of Use

Flovent HFA is not indicated for the relief of acute bronchospasm.

2 DOSAGE AND ADMINISTRATION



FLOVENT HFA should be administered by the orally inhaled route only in patients aged 4 years and older. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

After asthma stability has been achieved, it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. 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 HFA when administered in excess of recommended dosages have not been established.

The recommended starting dosage and the highest recommended dosage of FLOVENT HFA, based on prior asthma therapy, are listed in Table 1.

Table 1. Recommended Dosages of FLOVENT HFA Inhalation Aerosol

NOTE: In all patients, it is desirable to titrate to the lowest effective dosage once asthma stability is achieved.

Previous Therapy

Recommended Starting Dosage

Highest Recommended Dosage

Adult and adolescent patients (aged 12 years and older)

Bronchodilators alone

Inhaled corticosteroids

Oral corticosteroidsb

88 mcg twice daily

88-220 mcg twice dailya

440 mcg twice daily

440 mcg twice daily

440 mcg twice daily

880 mcg twice daily

Pediatric patients (aged 4-11 years) c

88 mcg twice daily

88 mcg twice daily

a Starting dosages above 88 mcg twice daily 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 the specific agent.

b For patients currently receiving chronic oral corticosteroid therapy, prednisone should be reduced no faster than 2.5 to 5 mg/day on a weekly basis beginning after at least 1 week of therapy with FLOVENT HFA. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency [see Warnings and Precautions (5.4)]. Once prednisone reduction is complete, the dosage of FLOVENT HFA should be reduced to the lowest effective dosage.

c Recommended pediatric dosage is 88 mcg twice daily regardless of prior therapy. A valved holding chamber and mask may be used to deliver FLOVENT HFA to young patients.

Prime FLOVENT HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face.

3 DOSAGE FORMS AND STRENGTHS

Inhalation Aerosol. Dark orange plastic inhaler with a peach strapcap containing a pressurized metered-dose aerosol canister containing 120 metered inhalations and fitted with a counter. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the mouthpiece.

Prasco-Fluticasone Prop
Rx Item-Fluticasone Prop Gen Flovent HFA 220Mcg Inhaler 12Gm By Prasco Item No.:603069 RX603069 NDC No.66993-0080-96 66993-080-96 66993008096 6699308096 UPC/GTIN No. 3-66993-08096-3 366993-080963 366

Flovent HFA 220Mcg Inhaler 12Gm By Glaxo
BRAND: FLOVENT NDC: 00173-0720-20,173072020 UPC: 3-01730-72020-7,301730720207 Glaxosmithkline/Rx

FLUTICASONE PROPIONATE IN
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RX ITEM-Flovent HFA 220Mcg Inhaler 12Gm
NDC 00173-0720-20 UPC/GTIN No.3-01730-72020-7 Mfg.Part No.72020

Drug info from Dailymed
Drug info from Dailymed