Fluticasone Propionate - Hfa (Flovent)

Trade Name : FLOVENT

GlaxoSmithKline LLC

AEROSOL, METERED

Strength 44 ug/1

FLUTICASONE PROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluticasone Propionate - Hfa (Flovent) which is also known as FLOVENT and Manufactured by GlaxoSmithKline LLC. It is available in strength of 44 ug/1 per ml. Read more

Fluticasone Propionate - Hfa (Flovent) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

FLOVENT HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.
Important Limitation of Use
Flovent HFA is not indicated for the relief of acute bronchospasm.
FLOVENT HFA is an inhaled corticosteroid (ICS) indicated for:
Important limitation:

For oral inhalation only. ()

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.
Inhalation aerosol: Inhaler containing fluticasone propionate (44, 110, or 220 mcg) as an aerosol formulation for oral inhalation. n

The use of FLOVENT HFA is contraindicated in the following conditions:

No data

Candida albicans

Systemic and local corticosteroid use may result in the following:
Most common adverse reactions (incidence >3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or n

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with FLOVENT HFA is not recommended because increased systemic corticosteroid adverse effects may occur.
Ritonavir
A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushingu2019s syndrome and adrenal suppression.
Ketoconazole
Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. n

Hepatic impairment: Monitor patients for signs of increased drug exposure. n

Chronic overdosage may result in signs/symptoms of hypercorticism . Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

Flovent HFA is a pressurized metered dose inhaler for oral inhalation. The active component of FLOVENT HFA 44 mcg, FLOVENT HFA 110 mcg, and FLOVENT HFA 220 mcg is fluticasone propionate, a corticosteroid having the chemical name -(fluoromethyl) 6u03b1,9-difluoro-11u03b2,17-dihydroxy-16u03b1-methyl-3-oxoandrosta-1,4-diene-17u03b2-carbothioate, 17-propionate and the following chemical structure:
Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is CHFOS. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
Flovent HFA is a dark orange plastic inhaler with a peach strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.
After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system.
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.

No data

Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 3 and 10 times the MRHDID for adults and children aged 4 to 11 years, respectively, on a mcg/m basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately 0.3 times and approximately equivalent to the MRHDID for adults and children aged 4 to 11 years, respectively, on a mcg/m basis) for 104 weeks.
Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test.
Fertility and reproductive performance were unaffected in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 0.3 times the MRHDID for adults on a mcg/m basis).

No data

FLOVENT HFA 44 mcg is supplied in 10.6-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0718-20).
FLOVENT HFA 110 mcg is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0719-20).
FLOVENT HFA 220 mcg is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0720-20).
Each canister is fitted with a counter and supplied with a dark orange actuator with a peach strapcap. Each inhaler is packaged with a Patient Information leaflet.
The dark orange actuator supplied with FLOVENT HFA should not be used with any other product canisters, and actuators from other products should not be used with a FLOVENT HFA canister.
The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000.
Keep out of reach of children. Avoid spraying in eyes.
Contents under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120u00b0F may cause bursting. Never throw canister into fire or incinerator.
Store at room temperature between 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C); excursions permitted from 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. Shake well before EACH SPRAY.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Local Effects
Inform patients that localized infections with occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with FLOVENT HFA, but at times therapy with FLOVENT HFA may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.
Status Asthmaticus and Acute Asthma Symptoms
Inform patients that FLOVENT HFA is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations. Advise patients to treat acute asthma symptoms with an inhaled, short-acting beta-agonist such as albuterol. Instruct patients to contact their physicians immediately if there is deterioration of their asthma.
Immunosuppression
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Hypercorticism and Adrenal Suppression
Advise patients that FLOVENT HFA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to FLOVENT HFA.
Immediate Hypersensitivity Reactions
Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of FLOVENT HFA. Patients should discontinue FLOVENT HFA if such reactions occur.
Reduction in Bone Mineral Density
Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.
Reduced Growth Velocity
Inform patients that orally inhaled corticosteroids, including FLOVENT HFA, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route.
Glaucoma and Cataracts
Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.
Use Daily for Best Effect
Patients should use Flovent HFA at regular intervals as directed. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients not to stop use of FLOVENT HFA abruptly. Patients should contact their physicians immediately if they discontinue use of FLOVENT HFA.
Trademarks are owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92019 GSK group of companies or its licensor.
FLH:11PI

No data

PRINCIPAL DISPLAY PANEL
NDC 0173-0718-20
Arrayn- Flovent HFA 44 mcg
Arrayn- (fluticasone propionate 44 mcg inhalation aerosol)
For oral inhalation with FLOVENT HFA actuator only.
Contents:
Each actuation of the inhaler delivers 50 mcg of fluticasone propionate from the valve and 44 mcg from the actuator.
R only
Arrayn- Net Wt. 10.6 g
Arrayn- 120 Metered Actuations
Made in UK
u00a92019 GSK group of companies or its licensor.

PRINCIPAL DISPLAY PANEL
NDC 0173-0719-20
Arrayn- Flovent HFA 110 mcg
Arrayn- (fluticasone propionate 110 mcg inhalation aerosol)
For oral inhalation with FLOVENT HFA actuator only.
Contents:
Each actuation of the inhaler delivers 125 mcg of fluticasone propionate from the valve and 110 mcg from the actuator.
R only
Arrayn- Net Wt. 12 g
Arrayn- 120 Metered Actuations
Made in Singapore
u00a92019 GSK group of companies or its licensor.

PRINCIPAL DISPLAY PANEL
NDC 0173-0720-20
Arrayn- Flovent HFA 220 mcg
Arrayn- (fluticasone propionate 220 mcg inhalation aerosol)
For oral inhalation with FLOVENT HFA actuator only.
Contents:
Each actuation of the inhaler delivers 250 mcg of fluticasone propionate from the valve and 220 mcg from the actuator.
R only
With Counter
Arrayn- Net Wt. 12 g
Arrayn- 120 Metered Actuations
Made in Singapore
u00a92019 GSK group of companies or its licensor.

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Fluticasone Propionate - Hfa (Flovent)

Trade Name : FLOVENT

AEROSOL, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Fluticasone Propionate - Hfa (Flovent)

Trade Name : FLOVENT

AEROSOL, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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