Fluticasone Propionate And Salmeterol Xinafoate (Advair Hfa)

Trade Name : ADVAIR HFA

GlaxoSmithKline LLC

AEROSOL, METERED

Strength 4521 ug/1ug/1

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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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 And Salmeterol Xinafoate (Advair Hfa) which is also known as ADVAIR HFA and Manufactured by GlaxoSmithKline LLC. It is available in strength of 45; 21 ug/1; ug/1 per ml. Read more

Fluticasone Propionate And Salmeterol Xinafoate (Advair Hfa) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • ADVAIR HFA is indicated for the twice-daily treatment of asthma in patients aged 12u00a0years and older. ADVAIR HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta-adrenergic agonist (LABA).
  • Important Limitation of Use
  • ADVAIR HFA is NOT indicated for the relief of acute bronchospasm.
  • ADVAIR HFA is a combination product containing a corticosteroid and a long-acting betau2011adrenergic agonist (LABA) indicated for the twice-daily treatment of asthma in patients aged 12 years and older. ()
  • Important limitation of use: Not indicated for relief of acute bronchospasm. ()
  • ADVAIR HFA should be administered as 2 inhalations twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
  • More frequent administration or a greater number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of ADVAIR HFA is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using ADVAIR HFA should not use additional LABA for any reason. n
  • If asthma symptoms arise in the period between doses, an inhaled, short-acting beta-agonist should be taken for immediate relief.
  • For patients aged 12u00a0years and older, the dosage is 2 inhalations twice daily, approximately 12u00a0hours apart.
  • When choosing the starting dosage strength of ADVAIR HFA, consider the patientsu2019 disease severity, based on their previous asthma therapy, including the ICS dosage, as well as the patientsu2019 current control of asthma symptoms and risk of future exacerbation.
  • The maximum recommended dosage is 2 inhalations of ADVAIR HFA 230/21 twice daily.
  • Improvement in asthma control following inhaled administration of ADVAIR HFA can occur within 30u00a0minutes of beginning treatment, although maximum benefit may not be achieved for 1u00a0week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
  • For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of ADVAIR HFA with a higher strength may provide additional improvement in asthma control.
  • If a previously effective dosage regimen fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of ADVAIR HFA with a higher strength, adding additional ICS, initiating oral corticosteroids) should be considered.
  • Prime ADVAIR 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 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray.
  • Inhalation aerosol: Purple plastic inhaler with a light purple strapcap containing a pressurized metered-dose aerosol canister containing 60 or 120 metered inhalations and fitted with a counter. Each actuation delivers a combination of fluticasone propionate (45, 115, or 230 mcg) and salmeterol (21 mcg) from the mouthpiece.
  • Inhalation aerosol: Inhaler containing a combination of fluticasone propionate (45, 115, or 230 mcg) and salmeterol (21 mcg) as an aerosol formulation for oral inhalation. n
  • The use of ADVAIR HFA is contraindicated in the following conditions:
  • No data
  • Candida albicans
  • 5.16n- 5.18
  • Use of LABA may result in the following:
  • Systemic and local corticosteroid use may result in the following:
  • Most common adverse reactions (incidence u22653%) include: upper respiratory tract infection or inflammation, throat irritation, dysphonia, headache, dizziness, nausea and vomiting. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • ADVAIR HFA has been used concomitantly with other drugs, including short-acting beta-agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma without adverse drug reactions . No formal drug interaction trials have been performed with ADVAIR HFA.
  • Hepatic impairment: Monitor patients for signs of increased drug exposure. n
  • No human overdosage data has been reported for ADVAIR HFA.
  • ADVAIR HFA contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to ADVAIR HFA. Treatment of overdosage consists of discontinuation of ADVAIR HFA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
  • ADVAIR HFA 45/21, ADVAIR HFA 115/21, and ADVAIR HFA 230/21 are combinations of fluticasone propionate and salmeterol xinafoate.
  • One active component of ADVAIR HFA 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.
  • The other active component of ADVAIR HFA is salmeterol xinafoate, a beta-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-u03b1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure:
  • Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is CHNOu2022CHO. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.
  • ADVAIRu00a0HFA is a purple plastic inhaler with a light purple strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of micronized fluticasone propionate and micronized salmeterol xinafoate 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 250u00a0mcg of fluticasone propionate and 25u00a0mcg of salmeterol in 75u00a0mg of suspension from the valve. Each actuation delivers 45, 115, or 230u00a0mcg of fluticasone propionate and 21u00a0mcg of salmeterol from the actuator. Twenty-one micrograms (21u00a0mcg) of salmeterol base is equivalent to 30.45u00a0mcg of salmeterol xinafoate. 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 ADVAIRu00a0HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5u00a0seconds before each spray. In cases where the inhaler has not been used for more than 4u00a0weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5u00a0seconds before each spray.
  • No data
  • No data
  • ADVAIR HFA has been studied in subjects with asthma aged 12u00a0years and older. ADVAIRu00a0HFA has not been studied in subjects younger than 12u00a0years or in subjects with COPD. In clinical trials comparing ADVAIRu00a0HFA with its individual components, improvements in most efficacy endpoints were greater with ADVAIRu00a0HFA than with the use of either fluticasone propionate or salmeterol alone. In addition, clinical trials showed comparable results between ADVAIR HFA and ADVAIR DISKUS.
  • ADVAIR HFA 45/21 is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0715-20) and 8-g pressurized aluminum canisters containing 60 metered actuations in institutional pack boxes of 1 (NDC 0173-0715-22).
  • ADVAIR HFA 115/21 is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0716-20) and 8-g pressurized aluminum canisters containing 60 metered actuations in institutional pack boxes of 1 (NDC 0173-0716-22).
  • ADVAIR HFA 230/21 is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0717-20) and 8-g pressurized aluminum canisters containing 60 metered actuations in institutional pack boxes of 1 (NDC 0173-0717-22).
  • Each canister is fitted with a counter and supplied with a purple actuator with a light purple strapcap. Each inhaler is sealed in a plastic-coated, moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each inhaler is packaged with a Patient Information leaflet.
  • The purple actuator supplied with ADVAIR HFA should not be used with any other product canisters, and actuators from other products should not be used with an ADVAIR 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 FOR 5u00a0SECONDS BEFORE EACH SPRAY.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Serious Asthma-Related Events
  • Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with ADVAIR HFA, there is not a significant increase in the risk of these events.
  • Not for Acute Symptoms
  • Inform patients that ADVAIR HFA is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Advise patients to treat acute asthma symptoms with an inhaled, short-acting beta-agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.
  • Instruct patients to seek medical attention immediately if they experience any of the following:
  • Tell patients they should not stop therapy with ADVAIR HFA without physician/provider guidance since symptoms may recur after discontinuation.
  • Do Not Use Additional Long-acting Beta-agonists
  • Instruct patients not to use other LABA for asthma.
  • 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 ADVAIR HFA, but at times therapy with ADVAIR 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.
  • Pneumonia
  • Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia.
  • 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 ADVAIR 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 ADVAIR HFA.
  • Immediate Hypersensitivity Reactions
  • Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ADVAIR HFA. Patients should discontinue ADVAIR 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 fluticasone propionate, 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.
  • Risks Associated with Beta-agonist Therapy
  • Inform patients of adverse effects associated with betau2011agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
  • Trademarks are owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • ADH:14PI
  • No data
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0715-20
  • ADVAIR HFA 45/21
  • (fluticasone propionate 45 mcg and salmeterol 21 mcginhalation aerosol)
  • Arrayn- 12 g
  • For oral inhalation with ADVAIR HFA actuator only.
  • Arrayn- *
  • Each actuation delivers 45 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.
  • See prescribing information for dosage information.
  • R only
  • With Counter
  • 120 Metered Actuations
  • u00a92019 GSK group of companies or its licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0716-20
  • ADVAIR HFA 115/21
  • (fluticasone propionate 115 mcg and salmeterol 21 mcginhalation aerosol)
  • Arrayn- 12 g
  • For oral inhalation with ADVAIR HFA actuator only.
  • Arrayn- *
  • Each actuation delivers 115 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.
  • See prescribing information for dosage information.
  • R only
  • With Counter
  • 120 Metered Actuations
  • u00a92019 GSK group of companies or its licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0717-20
  • ADVAIR HFA 230/21
  • (fluticasone propionate 230 mcg and salmeterol 21 mcginhalation aerosol)
  • Arrayn- 12 g
  • For oral inhalation with ADVAIR HFA actuator only.
  • Arrayn- *
  • Each actuation delivers 230 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.
  • See prescribing information for dosage information.
  • R only
  • With Counter
  • 120 Metered Actuations
  • u00a92019 GSK group of companies or its licensor.

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