Advair HFA

ADVAIR HFA is indicated for the treatment of asthma in patients aged 12 years and older.

LABA, such as salmeterol, one of the active ingredients in ADVAIR HFA, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA 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 HFA for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR HFA) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR HFA for patients whose asthma is adequately controlled on low-or medium-dose inhaled corticosteroids.

Important Limitation of Use

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

Dosage Forms And Strengths

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.

Storage And Handling

ADVAIR HFA 45/21 Inhalation Aerosol 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 Inhalation Aerosol 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 Inhalation Aerosol 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 Medication Guide 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 120°F may cause bursting. Never throw canister into fire or incinerator.

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [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 5 SECONDS BEFORE EACH SPRAY.

Glaxo SmithKline, Research Triangle Park, NC 27709. Revised: November 2014

Take Advair HFA exactly as prescribed.

Advair HFA comes in an inhaler form and is used twice a day, in the morning and evening, about 12 hours apart.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Advair HFA at the same time.

Advair HFA Inhaler Instructions:

• Take Advair HFA out of the foil pouch just before you use it for the first time.
• The counter should read 124 or 064 depending on which size inhaler you have.
• Safely throw away the pouch and the drying packet that comes inside the pouch.
• The inhaler should be at room temperature before you use it.

Before you use Advair HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it.

• To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well for 5 seconds.
• Then spray the inhaler 1 time into the air away from your face.
• Shake and spray the inhaler like this 3 more times to finish priming it.
• The counter should now read 120 or 060, depending on which size inhaler you have.
• You must prime your inhaler again if you have not used it in more than 4 weeks or if you drop it. Take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray it 1 time into the air away from your face. Shake and spray the inhaler like this 1 more time to finish priming it.

Before each use:

• Shake the inhaler well for 5 seconds before each spray.
• Take the cap off the mouthpiece of the actuator. Look inside the mouthpiece for foreign objects, and take out any you see.
• Hold the inhaler with the mouthpiece down.
• Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it
• Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth.
• After the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.
• Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly as long as you can.
• Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it
• Put the cap back on the mouthpiece after every time you use the inhaler. Make sure it snaps firmly into place.

Cleaning your Advair HFA inhaler:

• Clean your inhaler at least 1 time each week after your evening dose. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray.
• Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the canister out of the plastic actuator.
• Use a dry cotton swab to clean the small circular opening where the medicine sprays out of the canister. Carefully twist the swab in a circular motion to take off any medicine.
• Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.
• Put the cap back on the mouthpiece after the actuator has dried.

When the counter reads 020, you should refill your prescription or ask your healthcare provider if you need another prescription for Advair HFA.

When the counter reads 000, throw the inhaler away. You should not keep using the inhaler when the counter reads 000 because you may not receive the right amount of medicine.

Do not use the inhaler after the expiration date, which is on the packaging it comes in.

• Store Advair HFA at room temperature.
• Keep Advair HFA in a dry place away from heat and sunlight.
• Store Advair HFA in the unopened foil pouch and only open when ready for use.
• Safely throw away Advair HFA in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.
• Keep this and all medicines out of reach of children.
• Keep all appointments with your doctor.

You should not use this medicine if you are allergic to fluticasone or salmeterol (Serevent), or:

• if you have a severe allergy to milk proteins; or

• if you are having an asthma attack or severe COPD symptoms.

Salmeterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.

To make sure this medicine is safe for you, tell your doctor if you have:

• a food or drug allergy;

• heart disease or high blood pressure;

• epilepsy or other seizure disorder;

• any type of infection;

• a weak immune system;

• diabetes;

• glaucoma;

• tuberculosis;

• osteoporosis;

• a thyroid disorder; or

• liver disease.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

It is not known whether fluticasone and salmeterol is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

This medicine is not approved for use by anyone younger than 4 years old.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Advair® Diskus® to treat asthma in children older than 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Advair® HFA oral inhalation or Airduo™ Respiclick® in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone and salmeterol combination in the elderly. However, elderly people with heart and blood vessel problems may require special caution when receiving fluticasone and salmeterol combination.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Fluconazole
• Posaconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amprenavir
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bemiparin
• Boceprevir
• Bupropion
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clozapine
• Cobicistat
• Conivaptan
• Darunavir
• Dasabuvir
• Dasatinib
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Droperidol
• Fingolimod
• Flecainide
• Fosamprenavir
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Halofantrine
• Haloperidol
• Ibutilide
• Idelalisib
• Iloperidone
• Indinavir
• Itraconazole
• Ketoconazole
• Lapatinib
• Lopinavir
• Lumacaftor
• Lumefantrine
• Mefloquine
• Mifepristone
• Nadroparin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Ombitasvir
• Ondansetron
• Paliperidone
• Paritaprevir
• Pixantrone
• Posaconazole
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Quinidine
• Quinine
• Ranolazine
• Ritonavir
• Saquinavir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sunitinib
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Toremifene
• Trazodone
• Trifluoperazine
• Vardenafil
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• COPD flare-up or
• Milk protein allergy, severe—Should not be used in patients with these conditions.

• Blood vessel disease (eg, Churg-Strauss syndrome) or
• Bone problems (eg, osteoporosis) or
• Cataracts or
• Diabetes or
• Glaucoma or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Measles or
• Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.

• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• blindness
• blurred vision
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• chills
• cough
• decreased vision
• difficulty with breathing or swallowing
• eye pain
• fast heartbeat
• fever
• headache
• hives or welts, skin itching, rash, or redness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea or vomiting
• noisy breathing
• painful or difficult urination
• sensation of pins and needles
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stabbing pain in the arms or legs
• swelling of the face, throat, or tongue
• swollen glands
• tearing
• unusual bleeding or bruising

• Abdominal or stomach pain
• backache
• bruising
• darkening of the skin
• decrease in height
• diarrhea
• difficulty with moving
• dizziness
• facial hair growth in females
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heavy bleeding
• increased hunger
• increased thirst or urination
• irritability
• large, flat, blue, or purplish patches in the skin
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle pain or stiffness
• muscle wasting
• pain in the back, ribs, arms, or legs
• pain in the joints
• sweating
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

• Chest pain or tightness
• confusion
• convulsions (seizures)
• decreased urine output
• dry mouth
• faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• general feeling of discomfort or illness
• high blood pressure
• loss of appetite
• mood changes
• nervousness
• numbness or tingling in the hands, feet, or lips
• sudden sweating
• tremors
• trouble with sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• choking
• congestion
• dryness of the throat
• high-pitched noise when breathing
• hoarseness
• runny nose
• sneezing
• trouble with swallowing
• voice changes

• Cough-producing mucus
• flu-like symptoms
• irritation or inflammation of the eye
• muscle pain
• pain or tenderness around the eyes and cheekbones
• sleep disorders
• stuffy nose
• white patches in the mouth or throat or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation. Salmeterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Fluticasone and salmeterol inhalation is used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.

Fluticasone and salmeterol may also be used for purposes not listed in this medication guide.

US BOXED WARNING:
Asthma Related Death:
Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in this drug, increase the risk of asthma related death. Data from a large placebo-controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe this drug for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue this drug) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use this drug for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Inhalation Powder: Safety and efficacy have not been established in patients younger than 4 years.

Inhalation Aerosol: Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Data not available