Advair HFA 115 / 21

Name: Advair HFA 115 / 21

Descriptions

Fluticasone and salmeterol is a combination of two medicines that are used to help control the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

Inhaled salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It relieves cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine must be used with a short-acting medicine (e.g. albuterol) for an asthma attack or asthma symptoms that need attention right away.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Aerosol Liquid
  • Disk
  • Aerosol Powder

Advair HFA 115/21 Side Effects

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:

More common
  • 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
Incidence not known
  • 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:

Symptoms of overdose
  • 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:

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

Pregnancy

Information about this fluticasone-and-salmeterol-inhalation-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Other Interactions

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 (e.g., Churg-Strauss syndrome) or
  • Bone problems (e.g., osteoporosis) or
  • Cataracts or
  • Diabetes or
  • Glaucoma or
  • Heart disease or
  • Heart rhythm problems (e.g., 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.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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