Advair Diskus Generic Inhaler

111.00

ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50 and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol fluticasone propionate and salmeterol xinafoate.

  • Generic Name: Fluticasone Propionate
  • Brand Name: Advair Diskus
Dosage Quantity Price View
10 mg (EU2EU) 30
10 mg (EU2EU) 60
10 mg (EU2EU) 90
10 mg (EU2EU) 120
10 mg (EU2EU) 180

SKU: 323bf13d3962 Category:

ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50 and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate.

One of the active ingredients in ADVAIR DISKUS is fluticasone propionate, a corticosteroid which has the chemical name of S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:

Fluticasone propionate is a white powder with a molecular weight of 500.6, and its empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethylsulfoxide and dimethylformamide, and slightly soluble in methanol and ethanol at 95%

The other active ingredient in ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name of 4-hydroxy-α1-[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure:

asthma treatment

ADVAIR DISKUS is indicated for the treatment of asthma in patients 4 years of age or older.

LABAs, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS]. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS to patients who are not adequately controlled on long-term asthma control medication, such as a inhaled corticosteroid, or whose disease severity clearly justifies initiation of treatment with an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and reduce therapy (eg, discontinue ADVAIR DISKUS) if possible without losing asthma control and maintain the patient on an asthma controller medication long-term, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS in patients whose asthma is adequately controlled with low or medium dose inhaled corticosteroids.

Important limitation of use

ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

Maintenance treatment of chronic obstructive pulmonary disease

ADVAIR DISKUS 250/50 is indicated for twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).COPD), including chronic bronchitis me emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only dose approved for the treatment of COPD because an efficacy advantage of higher potency ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated.

Important limitation of use

ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

What is ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder) and how is it used?

  • ADVAIR DISKUS combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the LABA medicine salmeterol.
  • ICS medications, such as fluticasone propionate, help reduce inflammation in the lungs. Inflammation of the lungs can cause breathing problems.
  • LABA medications, such as salmeterol, help the muscles around the airways in the lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can occur when the muscles around the airways tighten. This makes breathing difficult.
  • ADVAIR DISKUS is not used to relieve sudden breathing problems.
  • It is not known if ADVAIR DISKUS is safe and effective in children younger than 4 years of age.
  • ADVAIR DISKUS is used for asthma and COPD.

ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS®, increase the risk of asthma-related death. Data from a large US placebo-controlled trial comparing the safety of salmeterol with placebo added to usual asthma treatment showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated over 28 weeks on salmeterol vs. 3 deaths out of 13,179 placebo subjects). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other drugs for long-term asthma control mitigates the increased risk of asthma-related death of LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS to patients who are inadequately controlled on long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity warrants clearly initiation of treatment with an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and reduce therapy (eg, discontinue ADVAIR DISKUS) if possible without losing asthma control and maintain the patient on an asthma controller medication long-term, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS in patients whose asthma is adequately controlled with low or medium dose inhaled corticosteroids.

DOSAGE AND ADMINISTRATION

ADVAIR DISKUS should be administered as 1 inhalation twice daily orally only. After inhalation, the patient should rinse the 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 LABAs for any reason.

Asthma

If asthma symptoms appear between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

  • Adult and adolescent patients 12 years of age and older
  • For patients 12 years of age and older, the dose is 1 inhalation twice daily, approximately 12 hours apart.
  • The recommended starting doses of ADVAIR DISKUS for patients 12 years of age and older are based on the severity of the patients' asthma.
  • The maximum recommended dose is ADVAIR DISKUS 500/50 twice daily.

Improvement in asthma control following inhaled administration of ADVAIR DISKUS may occur within 30 minutes of starting treatment, although maximum benefit may not be achieved for a week or more 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 initial dose after 2 weeks of treatment, replacement of the current strength of ADVAIR DISKUS with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen does not provide adequate improvement in asthma control, the therapeutic regimen should be reassessed and additional therapeutic options considered (eg, replacing the current strength of ADVAIR DISKUS with a higher potency, adding inhaled corticosteroids supplements, start oral corticosteroids).

Pediatric patients from 4 to 11 years

For patients with asthma aged 4 to 11 years who are not controlled with an inhaled corticosteroid, the dose is 1 inhalation of ADVAIR DISKUS 100/50 twice daily, approximately 12 hours apart.

Chronic obstructive pulmonary disease

The recommended dose for patients with COPD is 1 inhalation of ADVAIR DISKUS 250/50 twice daily, approximately 12 hours apart.

If shortness of breath occurs between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

HOW SUPPLIED

Pharmaceutical forms and dosage

Powder for inhalation. Inhaler containing a strip of powder foil for oral inhalation. The strip contains a combination of fluticasone propionate 100, 250 or 500 mcg and salmeterol 50 mcg per blister.

 

SIDE EFFECTS

LABAs, such as salmeterol, one of the active ingredients in Advair Diskus, increase the risk of asthma-related death. Data from a large US placebo-controlled trial comparing the safety of salmeterol or placebo added to usual asthma treatment showed an increase in asthma-related deaths in subjects receiving salmeterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other medications for long-term asthma control mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

The use of corticosteroids systemic and local can lead to the following

  • infection by Candida albicans
  • Pneumonia in COPD patients
  • immunosuppression
  • Hypercorticism and adrenal suppression
  • Reduction of Bone mineral density
  • effects on growth
  • Glaucoma and cataracts

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical trials. practice.

Additional adverse reactions

Other adverse reactions not listed above, considered drug-related or not by investigators, that were reported more frequently by subjects with asthma treated with ADVAIR DISKUS compared to subjects treated with placebo include the following signs and symptoms lymphatics:

  • muscle injuries
  • fractures
  • Wounds and lacerations
  • Bruises and bruises
  • ear signs and symptoms
  • Signs and symptoms nasal
  • disorders of the breasts nasal
  • keratitis Y conjunctivitis
  • dental discomfort and pain
  • Signs and symptoms gastrointestinal
  • oral ulcerations; oral discomfort and pain
  • lower respiratory signs and symptoms
  • pneumonia
  • muscular stiffness
  • tightness and stiffness
  • bone disorders and cartilaginous; sleep disorders
  • compressed nerve syndromes; viral infections
  • Pain
  • chest symptoms
  • Fluid retention
  • Bacterial infections
  • unusual taste; viral skin infections
  • Skin peeling and ichthyosis acquired
  • Disorders of sweat and of tallow.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to their severity, frequency of reporting, or causal connection to ADVAIR DISKUS, fluticasone propionate, and/or salmeterol, or a combination of these factors.

  • heart disorders
  • arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.
  • endocrine disorders
  • Cushing's syndrome, traits cushingoides, reduced growth velocity in children/adolescents, hypercorticism.
  • eye disorders
  • Glaucoma.
  • Gastrointestinal disorders
  • Abdominal pain, dyspepsia, xerostomia.
  • Immune system disorders
  • Immediate and delayed hypersensitivity reaction (including a very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with allergy severe to milk proteins.
  • infections and infestations
  • thrush thatphagic.
  • Metabolic and nutritional disorders
  • hyperglycemia, weight gain.
  • Musculoskeletal, connective tissue and bone disorders
  • Arthralgia, cramps, myositis, osteoporosis. nervous system disorders Paresthesia, concern.
  • Psychiatric disorders
  • Agitation, aggressiveness, depression. Behavioral changes have been reported, including hyperactivity and irritability, very rarely and mainly in children.
  • Reproductive system and breast disorders
  • Dysmenorrhea.
  • Respiratory, thoracic and mediastinal disorders
  • chest congestion; chest tightness; dyspnoea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of spasm, irritation, or inflammation laryngeal such as stridor or He drowned.
  • Skin and subcutaneous tissue disorders
  • Ecchymosis, photodermatitis.
  • vascular disorders
  • Pallor.

Storage and handling

ADVAIR DISKUS 100/50 se It comes as a purple plastic disposable inhaler containing a blister strip of 60 ampoules. The inhaler comes in a plastic-lined foil bag that protects from moisture (NDC 0173-0695-00). ADVAIR DISKUS 100/50 is also supplied in an institutional pack containing 14 ampoules (NDC 0173-0695-04).

ADVAIR DISKUS 250/50 se It comes as a purple plastic disposable inhaler containing a foil strip of 60 ampoules. The inhaler comes in a plastic-lined foil bag that protects from moisture (NDC 0173-0696-00). ADVAIR DISKUS 250/50 is also supplied in an institutional pack containing 14 ampoules (NDC 0173-0696-04).

ADVAIR DISKUS 500/50 It comes as a purple plastic disposable inhaler containing a foil strip of 60 ampoules. The inhaler comes in a plastic-lined foil bag that protects from moisture (NDC 0173-0697-00). ADVAIR DISKUS 500/50 is also supplied in an institutional pack containing 14 ampoules (NDC 0173-0697-04).

Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See controlled room temperature USP]. Store in a dry place and away from direct heat or sunlight. Keep out of the reach of children.

ADVAIR DISKUS should be stored in the unopened moisture-protective foil bag and should only be removed from the bag immediately prior to first use. Discard ADVAIR DISKUS 1 month after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not try to disassemble the inhaler.

The types of reactions and adverse events reported in Trial 3, a 28-week non-US clinical trial in 503 subjects previously treated with inhaled corticosteroids who were treated twice daily with ADVAIR DISKUS 500/50 propionate inhalation powder of fluticasone 500 mcg and salmeterol 50 mcg inhalation powder used simultaneously, or fluticasone propionate 500 mcg inhalation powder, were similar to those reported in Table 2.

Additional adverse reactions

Other adverse reactions not listed above, considered drug-related or not by investigators, that were reported more frequently by subjects with asthma treated with ADVAIR DISKUS compared to subjects treated with placebo include the following signs and symptoms lymphatics; muscle injuries; fractures; wounds and lacerations; bruises and bruises; ear signs and symptoms; Signs and symptoms nasals; disorders of the breasts nasals; keratitis Y conjunctivitis; dental discomfort and pain; Signs and symptoms gastrointestinal; oral ulcerations; oral discomfort and pain; lower respiratory signs and symptoms; pneumonia; muscle stiffness, tightness, and stiffness; bone disorders and cartilaginous; sleep disorders; compressed nerve syndromes; viral infections; pain; chest symptoms; fluid retention; bacterial infections; unusual taste; viral skin infections; skin peeling and ichthyosis acquired; disorders of sweat and of tallow.

Pediatric subjects from 4 to 11 years

Safety data for pediatric subjects 4 to 11 years of age are based on a US trial of 12-week treatment duration. A total of 203 subjects (74 women and 129 men) who were receiving inhaled corticosteroids at baseline were randomized to ADVAIR DISKUS 100/50 or fluticasone propionate inhalation powder 100 mcg twice daily. Common adverse reactions (greater than or equal to 3% and greater than placebo) observed in pediatric subjects but not reported in adult and adolescent clinical trials include: throat irritation and ear, nose, and throat infections.

Laboratory test abnormalities

Elevation of liver enzymes was reported in greater than or equal to 1% percentage of subjects in clinical trials. The elevations were transient and did not lead to trial discontinuation. In addition, no clinically relevant changes in glucose or potassium.

Experience in clinical trials in chronic obstructive pulmonary disease

Short-term trials (6 months to 1 year)

Short-term safety data is based on exposure to ADVAIR DISKUS 250/50 twice daily in one 6-month and two 1-year clinical trials. In the 6-month trial, a total of 723 adult subjects (266 women and 457 men) were treated twice daily with ADVAIR DISKUS 250/50, fluticasone propionate inhalation powder 250 mcg, salmeterol inhalation powder, or placebo. . The mean age of the subjects was 64 years, and the majority (93%) were Caucasian. In this trial, 70% in ADVAIR DISKUS-treated subjects reported one adverse reaction compared to 64% in placebo. The median duration of exposure to ADVAIR DISKUS 250/50 was 141.3 days compared to 131.6 days for placebo. The incidence of adverse reactions in the 6-month trial is shown in Table 3.

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