INSTRUCTIONS FOR USE

About Hikma’s Generic Equivalent to ADVAIR DISKUS®

The active ingredients in ADVAIR DISKUS® and Hikma’s generic Fluticasone Propionate and Salmeterol Inhalation Powder, USP are the same. These ingredients have been demonstrated in clinical studies to help improve lung function all day for appropriate asthma or COPD patients. As an FDA-approved generic equivalent to ADVAIR DISKUS®, you can expect Hikma’s generic to be a therapeutically equivalent substitute.

Fluticasone propionate and salmeterol inhalation powder, USP 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. Read more.
  • At the 250 mcg/50 mcg strength, treat chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema or both. Read more.

Hikma Pharmaceuticals USA Inc. generic Fluticasone Propionate and Salmeterol Inhaler, USP contains a combination of fluticasone propionate (100 or 250 mcg) and salmeterol (50 mcg) as a powder formulation for oral inhalation.

Inhaler for Hikma’s Generic Equivalent to ADVAIR DISKUS®
Inhaler Instructions

See our Instructions for use.
Follow these steps every time you use fluticasone propionate and salmeterol inhalation powder, USP.

Fluticasone propionate and salmeterol inhalation powder, USP is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for:

  • Twice-daily treatment of asthma in patients aged 4 years and older.
  • At the 250 mcg/50 mcg strength, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
  • Important Limitation of Use: Not indicated for relief of acute bronchospasm.

For the Treatment of Asthma

Fluticasone propionate and salmeterol inhalation powder, USP 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. Fluticasone propionate and salmeterol inhalation powder, USP 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 (ICS). Fluticasone propionate and salmeterol inhalation powder, USP is for adults and children with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

Important Limitation of Use: Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.

For the Maintenance Treatment of COPD

Fluticasone propionate and salmeterol inhalation powder, USP 250 mcg/50 mcg is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema or both. Fluticasone propionate and salmeterol inhalation powder, USP 250 mcg/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 COPD symptoms for several days).

Important Limitation of Use: Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.

Download Prescribing Information

Fluticasone propionate and salmeterol inhalation powder, USP, for oral inhalation

Contraindications

The use of fluticasone propionate and salmeterol inhalation powder, USP is contraindicated in the following conditions:

  • Primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) where intensive measures are required.
  • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol or any of the excipients.

Warnings and Precautions

Warnings While Using This Medicine:

Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, cataracts, diabetes, glaucoma, heart disease, high blood pressure, heart rhythm problems, thyroid problems, seizures, or osteoporosis. Tell your doctor about any immune system problems or infections, including herpes simplex in your eye, tuberculosis, or parasites. Tell your doctor if you have been exposed to chickenpox or measles.

This medicine may cause the following problems:

  • Increased risk of asthma-related hospital stays, intubations, and death
  • Increased trouble breathing right after use (paradoxical bronchospasm)
  • Increased risk of pneumonia in people who have COPD
  • Increased risk of infection, including fungus infection in the mouth (thrush)
  • Low bone mineral density, which may lead to osteoporosis
  • Cataracts, glaucoma, or other vision problems
  • Slow growth in children
  • Adrenal gland problems

This medicine will not stop an asthma attack that has already started. You should have another medicine to use in case of an acute asthma attack or COPD flare-up. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.

If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.

Tell any doctor or dentist who treats you that you are using this medicine.

Call your doctor if your symptoms do not improve or if they get worse.

Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Changes in skin color, dark freckles, easy bruising, muscle weakness, round or puffy face
  • Chest pain, trouble breathing
  • Dry mouth, increased thirst, muscle cramps, nausea, vomiting
  • Eye pain or trouble seeing
  • Fast, pounding, or uneven heartbeat
  • Fever, chills, cough, runny or stuffy nose, sore throat, body aches
  • Tremors, nervousness, or shaking
  • Unusual tiredness or weakness
  • Worsening of breathing problems

If you notice these less serious side effects, talk with your doctor:

  • Headache
  • Hoarseness, voice changes
  • White patches inside the mouth or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor.

Fluticasone propionate and salmeterol inhalation powder, USP contains salmeterol. Long-acting beta2-adrenergic agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. Fluticasone propionate and salmeterol inhalation powder, USP contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

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 use fluticasone propionate and salmeterol inhalation powder, USP to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use fluticasone propionate and salmeterol inhalation powder, USP if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.

Do not use fluticasone propionate and salmeterol inhalation powder, USP if you are allergic to fluticasone propionate, salmeterol or any of the ingredients in fluticasone propionate and salmeterol inhalation powder, USP. Ask your healthcare provider if you are not sure.

Do not use fluticasone propionate and salmeterol inhalation powder, USP more often or at a higher dose than prescribed.

Rinse your mouth with water without swallowing after each dose of fluticasone propionate and salmeterol inhalation powder, USP.

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, your peak flow meter results decrease or you have asthma and your symptoms do not improve after using fluticasone propionate and salmeterol inhalation powder, USP regularly for 1 week.

Fluticasone propionate and salmeterol inhalation powder, USP can cause serious side effects, including:

  • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after each dose of fluticasone propionate and salmeterol inhalation powder, USP.
  • Pneumonia. People with COPD have a greater chance of getting pneumonia. Fluticasone propionate and salmeterol inhalation powder, USP may increase this risk. Call your healthcare provider right away if you have an increase in mucus (sputum) production, change in mucus color, fever, chills, increased cough or increased breathing problems.
  • Weakened immune system and greater chance of getting infections (immunosuppression). Fluticasone propionate and salmeterol inhalation powder, USP may make you more prone to infection. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adult using corticosteroid.
  • Reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroid medicines (like prednisone) and start taking a medicine containing an inhaled steroid (like fluticasone propionate and salmeterol inhalation powder, USP). During this transition period, when your body is under stress such as fever, trauma, infection, surgery or more severe COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include feeling tired, lack of energy, weakness, nausea and vomiting and low blood pressure.
  • Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using fluticasone propionate and salmeterol inhalation powder, USP and call your healthcare provider right away.
  • Serious allergic reactions. Call your healthcare provider or get emergency medical care right away if you have any of the following symptoms of a serious allergic reaction: rash; hives; swelling of the mouth, face and/or tongue; breathing problems.
  • Effects on the heart. Call your healthcare provider if you have an increase in blood pressure, fast or irregular heartbeat or chest pain.
  • Effects on the nervous system. Call your healthcare provider if you have tremor or nervousness.
  • Bone thinning or weakness (osteoporosis). Get regular bone density screenings if you have or are at risk for osteoporosis.
  • Slowed growth in children. Have your child’s growth checked regularly by a healthcare provider while using fluticasone propionate and salmeterol inhalation powder, USP.
  • Eye problems. Tell your healthcare provider if you have glaucoma, increased pressure in your eye, cataracts or other changes in vision. Get regular eye exams while using fluticasone propionate and salmeterol inhalation powder, USP.
  • Changes in laboratory blood levels (sugar, potassium, certain types of white blood cells). Get blood tests at your healthcare provider’s recommendation.

Common Side Effects

Common side effects of fluticasone propionate and salmeterol inhalation powder, USP in patients with asthma include upper respiratory tract infection, throat irritation, hoarseness and voice changes, thrush in the mouth or throat, bronchitis, cough, headache and nausea and vomiting. In children with asthma, infections in the ear, nose and throat are common.

Common side effects of fluticasone propionate and salmeterol inhalation powder, USP in patients with COPD include thrush in the mouth or throat, throat irritation, hoarseness and voice changes, viral respiratory infections, headache and muscle and bone pain.

These are not all the possible side effects of fluticasone propionate and salmeterol inhalation powder, USP. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Interactions

Tell your healthcare provider about all of your medical conditions and about all the medicines you take, as fluticasone propionate and salmeterol inhalation powder, USP can interact with other medicines and may cause side effects, in some cases severe.

Pregnancy and Breastfeeding

Tell your healthcare provider if you are pregnant, plan to become pregnant or are breastfeeding

Dosage and Administration

Fluticasone propionate and salmeterol inhalation powder 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 use or taking more than 1 inhalation twice daily of the prescribed strength of fluticasone propionate and salmeterol inhalation powder is not recommended.

Do not use additional LABA for any reason.

Indications and Usage

Treatment of Asthma

Fluticasone propionate and salmeterol inhalation powder, USP is indicated for the twice-daily treatment of asthma in patients aged 4 years and older.

Important Limitation of Use:

Fluticasone propionate and salmeterol inhalation powder, USP is NOT indicated for the relief of acute bronchospasm.

Maintenance Treatment of COPD

Fluticasone propionate and salmeterol inhalation powder, USP 250 mcg/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Fluticasone propionate and salmeterol inhalation powder, USP 250 mcg/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Important Limitation of Use:

Fluticasone propionate and salmeterol inhalation powder, USP is NOT indicated for the relief of acute bronchospasm.

For more information about fluticasone propionate and salmeterol inhalation powder, USP, please see the full Prescribing Information and Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922