FLOVENT DISKUS Inhalation powder (2020)

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GlaxoSmithKline LLC

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1. Indications and Usage

Flovent DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use: FLOVENT DISKUS is NOT indicated for the ...

2. Dosage and Administration

2.1 Administration Information FLOVENT DISKUS should be administered by the orally inhaled route in patients aged 4 years and older. After inhalation, the patient should rinse his/her mouth with water ...

3. Dosage Forms and Strengths

Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains fluticasone propionate 50, 100, or 250 mcg per blister.

4. Contraindications

The use of FLOVENT DISKUS is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings ...

5. Warnings and Precautions

5.1 Local Effects of Inhaled Corticosteroids In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with FLOVENT ...

6. Adverse Reactions

Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.1)] Immunosuppression [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

6.2. Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of fluticasone propionate. Because these reactions are reported ...

7. Drug Interactions

7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, ...

8.1. Pregnancy

Risk Summary There are insufficient data on the use of FLOVENT DISKUS in pregnant women. There are clinical considerations with the use of FLOVENT DISKUS in pregnant women (See Clinical Considerations) ...

8.2. Lactation

Risk Summary There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been ...

8.4. Pediatric Use

The safety and effectiveness of FLOVENT DISKUS in children aged 4 years and older have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)]. The ...

8.5. Geriatric Use

Safety data have been collected on 280 subjects (FLOVENT DISKUS n=83, FLOVENT Rotadisk n=197) aged 65 years and older and 33 subjects (FLOVENT DISKUS n=14, FLOVENT ROTADISK n=19) aged 75 years and older ...

8.6. Hepatic Impairment

Formal pharmacokinetic studies using FLOVENT DISKUS have not been conducted in patients with hepatic impairment. Since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment ...

8.7. Renal Impairment

Formal pharmacokinetic studies using FLOVENT DISKUS have not been conducted in patients with renal impairment.

10. Overdosage

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. Inhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate ...

11. Description

FLOVENT DISKUS inhalation powder is a dry powder inhaler for oral inhalation. The active component of FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg is fluticasone propionate, ...

12.1. Mechanism of Action

Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid ...

12.2. Pharmacodynamics

In clinical trials with fluticasone propionate inhalation powder using dosages up to and including 250 mcg twice daily, occasional abnormal short cosyntropin tests (peak serum cortisol <18 mcg/dL assessed ...

12.3. Pharmacokinetics

Absorption Fluticasone propionate acts locally in the lung; therefore, plasma levels do not predict therapeutic effect. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 2 and 10 times the MRHDID for adults and children aged 4 to 11 years, respectively, ...

14. Clinical Studies

14.1 Adult and Adolescent Subjects Aged 12 Years and Older Four randomized, double-blind, parallel-group, placebo-controlled, U.S. clinical trials were conducted in 1,036 adult and adolescent subjects ...

16.1. How Supplied

FLOVENT DISKUS 50 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC ...

16.2. Storage and Handling

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Local Effects Inform patients that localized infections with Candida albicans occurred ...