MedPath

Fluticasone Propionate and Salmeterol

These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS.Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation useInitial U.S. Approval: 2000

Approved
Approval ID

2dfadeac-6599-41c5-8e25-5f78cba17f00

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fluticasone propionate and salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-4211
Application NumberNDA021077
Product Classification
M
Marketing Category
C73605
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 7, 2019
FDA Product Classification

INGREDIENTS (3)

LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 100 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM

Drug Labeling Information

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 7/31/2020

6 ADVERSE REACTIONS

Use of LABA may result in the following:

•

Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1)]

•

Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12)]

Systemic and local corticosteroid use may result in the following:

•

 Candida albicans infection [see Warnings and Precautions (5.4)]

•

Pneumonia in patients with COPD [see Warnings and Precautions (5.5)]

•

Immunosuppression [see Warnings and Precautions (5.6)]

•

Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8)]

•

Reduction in bone mineral density [see Warnings and Precautions (5.13)]

•

Growth effects [see Warnings and Precautions (5.14)]

•

Glaucoma and cataracts [see Warnings and Precautions (5.15)]

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.

6.1 Clinical Trials Experience in Asthma

Adult and Adolescent Subjects Aged 12 Years and Older

The incidence of adverse reactions associated with fluticasone propionate/salmeterol DISKUS in Table 2 is based upon two 12-week, placebo- controlled, U.S. clinical trials (Trials 1 and 2). A total of 705 adult and adolescent subjects (349 females and 356 males) previously treated with salmeterol or ICS were treated twice daily with fluticasone propionate/salmeterol DISKUS (100/50- or 250/50-mcg doses), fluticasone propionate inhalation powder (100- or 250-mcg doses), salmeterol inhalation powder 50 mcg, or placebo. The average duration of exposure was 60 to 79 days in the active treatment groups compared with 42 days in the placebo group.

Table 2. Adverse Reactions with Fluticasone Propionate/Salmeterol DISKUS with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with Asthma

Adverse Event

Fluticasone Propionate/
Salmeterol DISKUS

100/50 mcg

(n = 92)

%

Fluticasone Propionate/
Salmeterol DISKUS

250/50 mcg

(n = 84)

%

Fluticasone Propionate

100 mcg

(n = 90)

%

Fluticasone Propionate

250 mcg

(n = 84)

%

Salmeterol

50 mcg

(n = 180)

%

Placebo

(n = 175)

%

Ear, nose, and throat

 
 Upper respiratory tract infection

27

21

29

25

19

14

 Pharyngitis

13

10

7

12

8

6

 Upper respiratory inflammation

7

6

7

8

8

5

 Sinusitis

4

5

6

1

3

4

 Hoarseness/dysphonia

5

2

2

4

<1

<1

 Oral candidiasis

1

4

2

2

0

0

Lower respiratory

 
 Viral respiratory infections

4

4

4

10

6

3

 Bronchitis

2

8

1

2

2

2

 Cough

3

6

0

0

3

2

Neurology

 
 Headaches

12

13

14

8

10

7

Gastrointestinal

 
 Nausea and vomiting

4

6

3

4

1

1

 Gastrointestinal discomfort and pain

4

1

0

2

1

1

 Diarrhea

4

2

2

2

1

1

 Viral gastrointestinal infections

3

0

3

1

2

2

Non-site specific

 
 Candidiasis unspecified site

3

0

1

4

0

1

Musculoskeletal

 
 Musculoskeletal pain

4

2

1

5

3

3

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

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with fluticasone propionate/salmeterol DISKUS compared with subjects treated with placebo include the following: lymphatic signs and symptoms; muscle injuries; fractures; wounds and lacerations; contusions and hematomas; ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; keratitis and conjunctivitis; dental discomfort and pain; gastrointestinal signs and symptoms; oral ulcerations; oral discomfort and pain; lower respiratory signs and symptoms; pneumonia; muscle stiffness, tightness, and rigidity; bone and cartilage disorders; sleep disorders; compressed nerve syndromes; viral infections; pain; chest symptoms; fluid retention; bacterial infections; unusual taste; viral skin infections; skin flakiness and acquired ichthyosis; disorders of sweat and sebum.

Pediatric Subjects Aged 4 to 11 Years

The safety data for pediatric subjects aged 4 to 11 years is based upon 1 U.S. trial of 12 weeks’ treatment duration. A total of 203 subjects (74 females and 129 males) who were receiving ICS at trial entry were randomized to either fluticasone propionate/salmeterol DISKUS 100/50 mcg or fluticasone propionate inhalation powder 100 mcg twice daily. Common adverse reactions (≥3% and greater than placebo) seen in the pediatric subjects but not reported in the adult and adolescent clinical trials include: throat irritation and ear, nose, and throat infections.

Laboratory Test Abnormalities

Elevation of hepatic enzymes was reported in ≥1% of subjects in clinical trials. The elevations were transient and did not lead to discontinuation from the trials. In addition, there were no clinically relevant changes noted in glucose or potassium.

6.2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

Short-term (6 Months to 1 Year) Trials

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

Table 3. Overall Adverse Reactions with Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg with ≥3% Incidence in Subjects with Chronic Obstructive Pulmonary Disease Associated with Chronic Bronchitis

Adverse Event

Fluticasone Propionate/
Salmeterol DISKUS
250/50 mcg

(n = 178)

%

Fluticasone Propionate
250 mcg

(n = 183)

%

Salmeterol
50 mcg

(n = 177)

%

Placebo

(n = 185)

%

Ear, nose, and throat

 
 Candidiasis mouth/throat

10

6

3

1

 Throat irritation

8

5

4

7

 Hoarseness/dysphonia

5

3

<1

0

 Sinusitis

3

8

5

3

Lower respiratory

 
 Viral respiratory infections

6

4

3

3

Neurology

 
 Headaches

16

11

10

12

 Dizziness

4

<1

3

2

Non-site specific

 
 Fever

4

3

0

3

 Malaise and fatigue

3

2

2

3

Musculoskeletal

 
 Musculoskeletal pain

9

8

12

9

 Muscle cramps and spasms

3

3

1

1

In the two 1-year trials, fluticasone propionate/salmeterol DISKUS 250/50 mcg was compared with salmeterol in 1,579 subjects (863 males and 716 females). The mean age of the subjects was 65 years, and the majority (94%) was Caucasian. To be enrolled, all of the subjects had to have had a COPD exacerbation in the previous 12 months. In this trial, 88% of the subjects treated with fluticasone propionate/salmeterol DISKUS and 86% of the subjects treated with salmeterol reported an adverse event. The most common events that occurred with a frequency of >5% and more frequently in the subjects treated with fluticasone propionate/salmeterol DISKUS were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia. Overall, 55 (7%) of the subjects treated with fluticasone propionate/salmeterol DISKUS and 25 (3%) of the subjects treated with salmeterol developed pneumonia.

The incidence of pneumonia was higher in subjects older than 65 years, 9% in the subjects treated with fluticasone propionate/salmeterol DISKUS compared with 4% in the subjects treated with fluticasone propionate/salmeterol DISKUS younger than 65 years. In the subjects treated with salmeterol, the incidence of pneumonia was the same (3%) in both age groups. [See Warnings and Precautions (5.5), Use in Specific Populations (8.5).]

Long-term (3 Years) Trial

The safety of fluticasone propionate/salmeterol DISKUS 500/50 mcg was evaluated in a randomized, double-blind, placebo-controlled, multicenter, international, 3-year trial in 6,184 adult subjects with COPD (4,684 males and 1,500 females). The mean age of the subjects was 65 years, and the majority (82%) was Caucasian. The distribution of adverse events was similar to that seen in the 1-year trials with fluticasone propionate/salmeterol DISKUS 250/50 mcg. In addition, pneumonia was reported in a significantly increased number of subjects treated with fluticasone propionate/salmeterol DISKUS 500/50 mcg and fluticasone propionate 500 mcg (16% and 14%, respectively) compared with subjects treated with salmeterol 50 mcg or placebo (11% and 9%, respectively). When adjusted for time on treatment, the rates of pneumonia were 84 and 88 events per 1,000 treatment-years in the groups treated with fluticasone propionate 500 mcg and with fluticasone propionate/salmeterol DISKUS 500/50 mcg, respectively, compared with 52 events per 1,000 treatment-years in the salmeterol and placebo groups. Similar to what was seen in the 1-year trials with fluticasone propionate/salmeterol DISKUS 250/50 mcg, the incidence of pneumonia was higher in subjects older than 65 years (18% with fluticasone propionate/salmeterol DISKUS 500/50 mcg versus 10% with placebo) compared with subjects younger than 65 years (14% with fluticasone propionate/salmeterol DISKUS 500/50 mcg versus 8% with placebo). [See Warnings and Precautions (5.5), Use in Specific Populations (8.5).]

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with COPD treated with fluticasone propionate/salmeterol DISKUS compared with subjects treated with placebo include the following: syncope; ear, nose, and throat infections; ear signs and symptoms; laryngitis; nasal congestion/blockage; nasal sinus disorders; pharyngitis/throat infection; hypothyroidism; dry eyes; eye infections; gastrointestinal signs and symptoms; oral lesions; abnormal liver function tests; bacterial infections; edema and swelling; viral infections.

Laboratory Abnormalities

There were no clinically relevant changes in these trials. Specifically, no increased reporting of neutrophilia or changes in glucose or potassium was noted.

6.3 Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of any formulation of fluticasone propionate/salmeterol, fluticasone propionate, and/or salmeterol regardless of indication. 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 either their seriousness, frequency of reporting, or causal connection to fluticasone propionate/salmeterol DISKUS, fluticasone propionate, and/or salmeterol or a combination of these factors.

Cardiac Disorders

Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.

Endocrine Disorders

Cushing’s syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism.

Eye Disorders

Glaucoma.

Gastrointestinal Disorders

Abdominal pain, dyspepsia, xerostomia.

Immune System Disorders

Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk protein allergy.

Infections and Infestations

Esophageal candidiasis.

Metabolic and Nutrition Disorders

Hyperglycemia, weight gain.

Musculoskeletal, Connective Tissue, and Bone Disorders

Arthralgia, cramps, myositis, osteoporosis.

Nervous System Disorders

Paresthesia, restlessness.

Psychiatric Disorders

Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Reproductive System and Breast Disorders

Dysmenorrhea.

Respiratory, Thoracic, and Mediastinal Disorders

Chest congestion; chest tightness; dyspnea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.

Skin and Subcutaneous Tissue Disorders

Ecchymoses, photodermatitis.

Vascular Disorders

Pallor.

Key Highlight

Most common adverse reactions (incidence ≥3%) include:

•

Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. (6.1)

•

COPD: Pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

NONCLINICAL TOXICOLOGY SECTION

LOINC: 43680-8Updated: 12/20/2017

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluticasone Propionate

Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 5 and 10 times the MRHDID for adults and children, respectively, on a mcg/m2 basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (less than and approximately equivalent to the MRHDID for adults and children, respectively, on a mcg/m2 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 0.5 times the MRHDID for adults on a mcg/m2 basis).

Salmeterol

In an 18-month carcinogenicity study in CD-mice, salmeterol at oral doses of 1,400 mcg/kg and above (approximately 20 times the MRHDID for adults and children based on comparison of the plasma AUCs) caused a dose-related increase in the incidence of smooth muscle hyperplasia, cystic glandular hyperplasia, leiomyomas of the uterus, and ovarian cysts. No tumors were seen at 200 mcg/kg (approximately 3 times the MRHDID for adults and children based on comparison of the AUCs).

In a 24-month oral and inhalation carcinogenicity study in Sprague Dawley rats, salmeterol caused a dose-related increase in the incidence of mesovarian leiomyomas and ovarian cysts at doses of 680 mcg/kg and above (approximately 66 and 35 times the MRHDID for adults and children, respectively, on a mcg/m2 basis). No tumors were seen at 210 mcg/kg (approximately 20 and 10 times the MRHDID for adults and children, respectively, on a mcg/m2 basis). These findings in rodents are similar to those reported previously for other beta‑adrenergic agonist drugs. The relevance of these findings to human use is unknown.

Salmeterol produced no detectable or reproducible increases in microbial and mammalian gene mutation in vitro. No clastogenic activity occurred in vitro in human lymphocytes or in vivo in a rat micronucleus test.

Fertility and reproductive performance were unaffected in male and female rats at oral doses up to 2,000 mcg/kg (approximately 195 times the MRHDID for adults on a mcg/m2 basis).

13.2 Animal Toxicology and/or Pharmacology

Preclinical

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical relevance of these findings is unknown.

SPL PATIENT PACKAGE INSERT SECTION

LOINC: 42230-3Updated: 7/31/2020

PATIENT INFORMATION

Fluticasone Propionate/Salmeterol DISKUS inhalation powder

for oral inhalation use

What is Fluticasone Propionate/Salmeterol DISKUS?

•

Fluticasone Propionate/Salmeterol DISKUS combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the long-acting beta2-adrenergic agonist (LABA) medicine salmeterol.

o

ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.

o

LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

•

**Fluticasone Propionate/Salmeterol DISKUS is not used to relieve sudden breathing problems** and will not replace a rescue inhaler.

•

It is not known if Fluticasone Propionate/Salmeterol DISKUS is safe and effective in children younger than 4 years.

•

Fluticasone Propionate/Salmeterol DISKUS is used for asthma and COPD as follows:
**Asthma:**

o

Fluticasone Propionate/Salmeterol DISKUS is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children aged 4 years and older.

o

Fluticasone Propionate/Salmeterol DISKUS contains salmeterol, the same medicine found in SEREVENT DISKUS (salmeterol xinafoate inhalation powder). LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. Fluticasone Propionate/Salmeterol DISKUS contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

o

Fluticasone Propionate/Salmeterol DISKUS is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose of an ICS medicine. Fluticasone Propionate/Salmeterol DISKUS is for adults and children with asthma who need both an ICS and LABA medicine.
**COPD:**
Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg is used long term as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Do not use Fluticasone Propionate/Salmeterol DISKUS:

•

to relieve sudden breathing problems.

•

as a rescue inhaler.

•

if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.

•

if you are allergic to fluticasone propionate, salmeterol, or any of the ingredients in Fluticasone Propionate/Salmeterol DISKUS. See the end of this Patient Information for a complete list of ingredients in Fluticasone Propionate/Salmeterol DISKUS.

Before using Fluticasone Propionate/Salmeterol DISKUS, tell your healthcare provider about all of your medical conditions, including if you:

•

have heart problems.

•

have high blood pressure.

•

have seizures.

•

have thyroid problems.

•

have diabetes.

•

have liver problems.

•

have weak bones (osteoporosis).

•

have an immune system problem.

•

have or have had eye problems such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.

•

are allergic to milk proteins.

•

have any type of viral, bacterial, or fungal infection.

•

are exposed to chickenpox or measles.

•

are pregnant or plan to become pregnant. It is not known if Fluticasone Propionate/Salmeterol DISKUS may harm your unborn baby.

•

are breastfeeding. It is not known if the medicines in Fluticasone Propionate/Salmeterol DISKUS pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Fluticasone Propionate/Salmeterol DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Fluticasone Propionate/Salmeterol DISKUS?

Read the step-by-step instructions for using Fluticasone Propionate/Salmeterol DISKUS at the end of this Patient Information.

•

**Do not** use Fluticasone Propionate/Salmeterol DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

•

Children should use Fluticasone Propionate/Salmeterol DISKUS with an adult’s help, as instructed by the child’s healthcare provider.

•

Fluticasone Propionate/Salmeterol DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.

•

Use Fluticasone Propionate/Salmeterol DISKUS exactly as your healthcare provider tells you to use it.**Do not** use Fluticasone Propionate/Salmeterol DISKUS more often than prescribed.

•

Use 1 inhalation of Fluticasone Propionate/Salmeterol DISKUS 2 times each day. Use Fluticasone Propionate/Salmeterol DISKUS at the same time each day, about 12 hours apart.

•

If you miss a dose of Fluticasone Propionate/Salmeterol DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.

•

If you take too much Fluticasone Propionate/Salmeterol DISKUS, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

•

**Do not use other medicines that contain a LABA for any reason.** Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.

•

**Do not stop** using Fluticasone Propionate/Salmeterol DISKUS, even if you are feeling better, unless your healthcare provider tells you to.

•

**Fluticasone Propionate/Salmeterol DISKUS does not relieve sudden breathing problems.** Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

•

Rinse your mouth with water**without swallowing** after each dose of Fluticasone Propionate/Salmeterol DISKUS. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.

•

Call your healthcare provider or get medical care right away if:

o

your breathing problems get worse.

o

you need to use your rescue inhaler more often than usual.

o

your rescue inhaler does not work as well to relieve your symptoms.

o

you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.

o

you use 1 whole canister of your rescue inhaler in 8 weeks.

o

your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

o

you have asthma and your symptoms do not improve after using Fluticasone Propionate/Salmeterol DISKUS regularly for 1 week.

What are the possible side effects of Fluticasone Propionate/Salmeterol DISKUS?

Fluticasone Propionate/Salmeterol DISKUS can cause serious side effects, including:

•

**fungal infection in your mouth or throat (thrush).** Rinse your mouth with water**without swallowing** after using Fluticasone Propionate/Salmeterol DISKUS to help reduce your chance of getting thrush.

•

**pneumonia.** People with COPD have a higher chance of getting pneumonia. Fluticasone Propionate/Salmeterol DISKUS may increase the chance of you getting pneumonia. Call your healthcare provider right away if you have any of the following symptoms:

o

increase in mucus (sputum) production

o

change in mucus color

o

fever

o

chills

o

increased cough

o

increased breathing problems

•

**weakened immune system and increased chance of getting infections (immunosuppression).**

•

**reduced adrenal function (adrenal insufficiency).** Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as Fluticasone Propionate/Salmeterol DISKUS). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.

Symptoms of adrenal insufficiency include:

o

feeling tired

o

lack of energy

o

weakness

o

nausea and vomiting

o

low blood pressure (hypotension)

•

**sudden breathing problems immediately after inhaling your medicine.** If you have sudden breathing problems immediately after inhaling your medicine, stop using Fluticasone Propionate/Salmeterol DISKUS and call your healthcare provider right away.

•

**serious allergic reactions.** Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

o

rash

o

hives

o

swelling of your face, mouth, and tongue

o

breathing problems

•

**effects on heart.**

o

increased blood pressure

o

a fast or irregular heartbeat

o

chest pain

•

**effects on nervous system.**

o

tremor

o

nervousness

•

**bone thinning or weakness (osteoporosis).**

•

**slowed growth in children.** Your child’s growth should be checked regularly by the healthcare provider while using Fluticasone Propionate/Salmeterol DISKUS.

•

**eye problems**including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using Fluticasone Propionate/Salmeterol DISKUS.

•

**changes in laboratory blood levels (sugar, potassium, certain types of white blood cells).**

Common side effects of Fluticasone Propionate/Salmeterol DISKUS include:

Asthma:

•

upper respiratory tract infection

•

throat irritation

•

hoarseness and voice changes

•

thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.

•

bronchitis

•

cough

•

headache

•

nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

COPD:

•

thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.

•

throat irritation

•

hoarseness and voice changes

•

viral respiratory infections

•

headache

•

muscle and bone pain

These are not all the possible side effects of Fluticasone Propionate/Salmeterol DISKUS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Fluticasone Propionate/Salmeterol DISKUS?

•

Store Fluticasone Propionate/Salmeterol DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.

•

Store Fluticasone Propionate/Salmeterol DISKUS in the unopened foil pouch and only open when ready for use.

•

Safely throw away Fluticasone Propionate/Salmeterol DISKUS in the trash 1 month after you open the foil pouch or when the counter reads**0**, whichever comes first.

•

**Keep Fluticasone Propionate/Salmeterol DISKUS and all medicines out of the reach of children.**

General information about the safe and effective use of Fluticasone Propionate/Salmeterol DISKUS.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fluticasone Propionate/Salmeterol DISKUS for a condition for which it was not prescribed. Do not give Fluticasone Propionate/Salmeterol DISKUS to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Fluticasone Propionate/Salmeterol DISKUS that was written for health professionals.

What are the ingredients in Fluticasone Propionate/Salmeterol DISKUS?

Active ingredients: fluticasone propionate, salmeterol xinafoate

Inactive ingredient: lactose monohydrate (contains milk proteins)

For more information about Fluticasone Propionate/Salmeterol DISKUS, call 1-866-525-0688.

Trademarks are owned by or licensed to the GSK group of companies.

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Manufactured by:

GlaxoSmithKline

Research Triangle Park, NC 27709

©2020 GSK group of companies or its licensor.

ADD-PS:6PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: July 2020

SPL MEDGUIDE SECTION

LOINC: 42231-1Updated: 5/15/2017

MEDICATION GUIDE

ADVAIR DISKUS**®**** [ad′ vair disk′ us]**

(fluticasone propionate and

salmeterol inhalation powder)

for oral inhalation

What is the most important information I should know about ADVAIR DISKUS?

ADVAIR DISKUS can cause serious side effects, including:

People with asthma who take long-acting beta**2***-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems.** It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with LABA medicines. *It is not known if LABA medicines such as salmeterol increase the risk of death in people with COPD. *Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment. *Get emergency medical care if: * your breathing problems worsen quickly. * you use your rescue inhaler, but it does not relieve your breathing problems.

  • ADVAIR DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid. When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR DISKUS. Your healthcare provider will decide if you can stop ADVAIR DISKUS without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

What is ADVAIR DISKUS?

  • ADVAIR DISKUS combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the LABA medicine salmeterol.
  • ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
  • 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.
  • ADVAIR DISKUS is used for asthma and COPD as follows: *Asthma:
    1. ADVAIR DISKUS is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children aged 4 years and older.
    2. ADVAIR DISKUS contains salmeterol, the same medicine found in SEREVENT ® DISKUS ® (salmeterol xinafoate inhalation powder). LABA medicines such as salmeterol increase the risk of death from asthma problems.
    3. ADVAIR DISKUS is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose of an inhaled corticosteroid medicine. *COPD:
  • ADVAIR DISKUS 250/50 is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. ADVAIR DISKUS 250/50 is used long term as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Who should not use ADVAIR DISKUS?

Do not use ADVAIR DISKUS if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR DISKUS. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.

What should I tell my healthcare provider before using ADVAIR DISKUS?

Tell your healthcare provider about all of your health conditions, including if you:

  • have heart problems.
  • have high blood pressure.
  • have seizures.
  • have thyroid problems.
  • have diabetes.
  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if ADVAIR DISKUS may harm your unborn baby.
  • are breastfeeding. It is not known if the medicines in ADVAIR DISKUS pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADVAIR DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use ADVAIR DISKUS?

Read the step-by-step instructions for using ADVAIR DISKUS at the end of this Medication Guide.

What should I avoid while using ADVAIR DISKUS?

*Do not use ADVAIR DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

  • Children should use ADVAIR DISKUS with an adult’s help, as instructed by the child’s healthcare provider.
  • ADVAIR DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use ADVAIR DISKUS exactly as your healthcare provider tells you to use it.Do not use ADVAIR DISKUS more often than prescribed.
  • Use 1 inhalation of ADVAIR DISKUS 2 times each day. Use ADVAIR DISKUS at the same time each day, about 12 hours apart.
  • If you miss a dose of ADVAIR DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • If you take too much ADVAIR DISKUS, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. *Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
  • Do not stop using ADVAIR DISKUS unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed. *ADVAIR DISKUS does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
    • you have asthma and your symptoms do not improve after using ADVAIR DISKUS regularly for 1 week.

What are the possible side effects of ADVAIR DISKUS?

ADVAIR DISKUS can cause serious side effects, including:

*See “What is the most important information I should know about ADVAIR DISKUS?” *fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush. *pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:

• increase in mucus (sputum) production • chills

• change in mucus color • increased cough

• fever • increased breathing problems

*weakened immune system and increased chance of getting infections (immunosuppression). *reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR DISKUS). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.

  • Symptoms of adrenal insufficiency include:

• feeling tired • nausea and vomiting

• lack of energy • low blood pressure

• weakness

*sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR DISKUS and call your healthcare provider right away. *serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

• rash • swelling of your face, mouth and tongue

• hives • breathing problems

*effects on heart.

• increased blood pressure • chest pain

• a fast or irregular heartbeat

*effects on nervous system.

• tremor • nervousness

*bone thinning or weakness (osteoporosis). *slowed growth in children. A child’s growth should be checked often. *eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS. *changes in laboratory blood levels (sugar, potassium, certain types of white blood cells)

Common side effects of ADVAIR DISKUS include:

Asthma:

• upper respiratory tract infection • bronchitis

• throat irritation • cough

• hoarseness and voice changes • headache

• thrush in your mouth or throat. Rinse your •nausea and vomiting

mouth with water without swallowing after
use to help prevent this.

In children with asthma, infections in the ear, nose, and throat are common.

COPD:

• thrush in your mouth or throat. Rinse your mouth with water •viral respiratory infections

without swallowing after use to help prevent this. •headache

• throat irritation •muscle and bone pain

• hoarseness and voice changes

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with ADVAIR DISKUS. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ADVAIR DISKUS?

  • Store ADVAIR DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store ADVAIR DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away ADVAIR DISKUS in the trash 1 month after you open the foil pouch or when the counter reads0, whichever comes first. *Keep ADVAIR DISKUS and all medicines out of the reach of children.

General information about the safe and effective use of ADVAIR DISKUS.

Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use ADVAIR DISKUS for a condition for which it was not prescribed. Do not give your ADVAIR DISKUS to other people, even if they have the same condition that you have. It may harm them.

This Medication Guide summarizes the most important information about ADVAIR DISKUS. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ADVAIR DISKUS that was written for healthcare professionals.

What are the ingredients in ADVAIR DISKUS?

Active ingredients: fluticasone propionate, salmeterol xinafoate

Inactive ingredients: lactose monohydrate (contains milk proteins)

For more information about ADVAIR DISKUS, call 1-888-825-5249 or visit our website at www.advair.com.

ADVAIR DISKUS, DISKUS, and SEREVENT are registered trademarks of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2017 the GSK group of companies. All rights reserved.

ADD:10MG

  1. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2017

INSTRUCTIONS FOR USE

ADVAIR DISKUS**®**** [ad′ vair disk′ us]**

(fluticasone propionate and

salmeterol inhalation powder)

for oral inhalation

Read this Instructions for Use before you start using ADVAIR DISKUS and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Your ADVAIR DISKUS inhaler

Figure A

Important information about your ADVAIR DISKUS inhaler:

*ADVAIR DISKUS is for oral inhalation use only.

  • Take ADVAIR DISKUS out of the foil pouch just before you use it for the first time. Safely throw away the pouch. The DISKUS ® will be in the closed position.
  • Write the date you opened the foil pouch in the first blank line on the label.See Figure A.
  • Write the “use by” date in the second blank line on the label.See Figure A. That date is 1 month after the date you wrote in the first line.
  • The counter should read60. If you have a sample (with “Sample” on the back label) or institutional (with “INSTITUTIONAL PACK” on the foil pouch) pack, the counter should read14.

How to use your ADVAIR DISKUS inhaler

Follow these steps every time you use ADVAIR DISKUS.

Step 1. Open your ADVAIR DISKUS.

  • Hold the DISKUS in your left hand and place the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place.See Figure B.

Figure B

Step 2. Slide the lever until you hear it click.

Hold the DISKUS in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks.See Figure C.

Figure C

  • The number on the counter will count down by 1. The DISKUS is now ready to use.

Follow the instructions below so you will not accidentally waste a dose:

*Do notclose the DISKUS. *Do nottilt the DISKUS. *Do notmove the lever on the DISKUS.

Step 3. Inhale your medicine.

  • Before you breathe in your dose from the DISKUS, breathe out (exhale) as long as you can while you hold the DISKUS level and away from your mouth.See Figure D. Do not breathe into the mouthpiece.
  • Put the mouthpiece to your lips.See Figure E. Breathe in quickly and deeply through the DISKUS. Do not breathe in through your nose.

Figure D

Figure E

  • Remove the DISKUS from your mouthand hold your breath for about 10 seconds, or for as long as is comfortable for you. *Breathe out slowly as long as you can. See Figure D.
  • The DISKUS delivers your dose of medicine as a very fine powder that you may or may not taste or feel.Do not take an extra dose from the DISKUS even if you do not taste or feel the medicine.

Step 4. Close the DISKUS.

  • Place your thumb in the thumb grip and slide it back towards you as far as it will go.See Figure F. Make sure the DISKUS clicks shut and you cannot see the mouthpiece.

Figure F

  • The DISKUS is now ready for you to take your next scheduled dose in about 12 hours.When you are ready to take your next dose, repeat Steps 1 through 4.

Step 5. Rinse your mouth.

*Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it.See Figure G.

Figure G

When should you get a refill?

The counter on top of the DISKUS shows you how many doses are left. After you have taken55 doses (9 doses from the sample or institutional pack), the numbers5 to0 will show in red.See Figure H. These numbers warn you there are only a few doses left and are a reminder to get a refill.

Figure H

For correct use of the DISKUS, remember:

  • Always use the DISKUS in a level, flat position.
  • Make sure the lever firmly clicks into place.
  • Hold your breath for about 10 seconds after inhaling. Then breathe out fully.
  • After each dose, rinse your mouth with water and spit it out. Do not swallow the water. *Do not take an extra dose, even if you did not taste or feel the powder. *Do not take the DISKUS apart. *Do not wash the DISKUS.
  • Always keep the DISKUS in a dry place. *Do notuse the DISKUS with a spacer device.

If you have questions about ADVAIR DISKUS or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.advair.com.

ADVAIR DISKUS and DISKUS are registered trademarks of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2017 the GSK group of companies. All rights reserved.

ADD:2IFU

  1. This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: February 2017

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Fluticasone Propionate and Salmeterol - FDA Drug Approval Details