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Fluticasone Propionate And Salmeterol - Diskus (Advair)

Trade Name : ADVAIR

GlaxoSmithKline LLC

POWDER

Strength 50100 ug/1ug/1

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],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 And Salmeterol - Diskus (Advair) which is also known as ADVAIR and Manufactured by GlaxoSmithKline LLC. It is available in strength of 50; 100 ug/1; ug/1 per ml. Read more

Fluticasone Propionate And Salmeterol - Diskus (Advair) 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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  • ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta-adrenergic agonist (LABA) indicated for:
  • Important limitation of use: Not indicated for relief of acute bronchospasm. (, )
  • ADVAIR DISKUS should be administered as 1 inhalation 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 1 inhalation twice daily) of the prescribed strength of ADVAIR DISKUS is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using ADVAIR DISKUS should not use additional LABA for any reason. n
  • Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains a combination of fluticasone propionate 100, 250, or 500 mcg and salmeterol 50 mcg per blister.
  • Inhalation powder: Inhaler containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as a powder formulation for oral inhalation. ()
  • The use of ADVAIR DISKUS 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:
  • 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 another drug and may not reflect the rates observed in practice.
  • Most common adverse reactions (incidence u22653%) include:
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • ADVAIR DISKUS has been used concomitantly with other drugs, including short-acting beta-agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions . No formal drug interaction trials have been performed with ADVAIR DISKUS.
  • Hepatic impairment: Monitor patients for signs of increased drug exposure. ()
  • No human overdosage data has been reported for ADVAIR DISKUS.
  • ADVAIR DISKUS contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to ADVAIR DISKUS. Treatment of overdosage consists of discontinuation of ADVAIR DISKUS 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 DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate.
  • One active component of ADVAIR DISKUS 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 DISKUS 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.
  • ADVAIR DISKUS is a purple plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100, 250, or 500u00a0mcg) and micronized salmeterol xinafoate salt (72.5u00a0mcg, equivalent to 50u00a0mcg of salmeterol base) in 12.5u00a0mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece.
  • Under standardized inu00a0vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465u00a0mcg of fluticasone propionate and 45u00a0mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50, respectively, when tested at a flow rate of 60u00a0L/min for 2u00a0seconds.
  • In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4u00a0L/min (range: 46.1 to 115.3u00a0L/min).
  • Inhalation profiles for adolescent (Nu00a0=u00a013, aged 12 to 17u00a0years) and adult (Nu00a0=u00a017, aged 18 to 50u00a0years) subjects with asthma inhaling maximally through the DISKUS inhaler show mean PIF of 122.2u00a0L/min (range: 81.6 to 152.1u00a0L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through the DISKUS inhaler show a mean PIF of 75.5u00a0L/min (range: 49.0 to 104.8u00a0L/min) for the 4-year-old subject set (Nu00a0=u00a020) and 107.3u00a0L/min (range: 82.8 to 125.6u00a0L/min) for the 8-year-old subject set (Nu00a0=u00a020).
  • The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
  • No data
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  • ADVAIR DISKUS 100/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0695-00). ADVAIR DISKUS 100/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0695-04).
  • ADVAIR DISKUS 250/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0696-00). ADVAIR DISKUS 250/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0696-04).
  • ADVAIR DISKUS 500/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). ADVAIR DISKUS 500/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0697-04).
  • 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 in a dry place away from direct heat or sunlight. Keep out of reach of children.
  • ADVAIR DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard ADVAIR DISKUS 1 month after opening the foil pouch or when the counter reads u201c0u201d (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)n
  • 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 DISKUS, there is not a significant increase in the risk of these events.
  • Not for Acute Symptoms
  • Inform patients that ADVAIR DISKUS is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Advise patients to treat acute 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 DISKUS 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 and COPD.
  • 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 DISKUS, but at times therapy with ADVAIR DISKUS 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 DISKUS 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 DISKUS.
  • Immediate Hypersensitivity Reactions
  • Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ADVAIR DISKUS. Patients should discontinue ADVAIR DISKUS if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take ADVAIR DISKUS.
  • 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 beta-agonists, 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.
  • ADD:16PI
  • This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: January 2019
  • This Instructions for Use has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: January 2019
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0695-00
  • ADVAIR DISKUS 100/50
  • (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)
  • FOR ORAL INHALATION ONLY
  • R only
  • Arrayn- 100/50
  • 1 DISKUS Inhalation Device Containing 1 Foil Strip of 60 Blisters
  • u00a92018 GSK group of companies or its licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0696-00
  • ADVAIR DISKUS 250/50
  • (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)
  • FOR ORAL INHALATION ONLY
  • R only
  • Arrayn- 250/50
  • 1 DISKUS Inhalation Device Containing 1 Foil Strip of 60 Blisters
  • u00a92018 GSK group of companies or its licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0697-00
  • ADVAIR DISKUS 500/50
  • (fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)
  • FOR ORAL INHALATION ONLY
  • R only
  • 1 DISKUS Inhalation Device Containing 1 Foil Strip of 60 Blisters
  • u00a92018 GSK group of companies or its licensor.

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