Aerobid

Aerobid is used to help control the symptoms of asthma and improve lung function. This medication will not relieve an asthma attack that has already started.

Flunisolide belongs to the family known as Corticosteroids (cortisone-like medications). It works by preventing swelling (inflammation) in the lungs that causes an asthma attack.

This medication is only available through your doctor’s prescription.

This product is available in the following forms:

• Aerosol Powder

As with all medicines, the risks of using Aerobid must be compared to how much it will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

• Allergies: Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals. 
• Pediatric Usage: Up-to-date pediatric appropriate studies have not indicated that the use of this medication causes any problems that would limit the use of Flunisolide in children. However, safety and efficacy have not been established in children younger than 4 years of age.
• Geriatric Usage: No up-to-date studies have been performed in the elderly population. However, no problems specific to the elderly have been documented. However, elderly patients are more likely to have age-related liver, kidney or heart problems. This may require caution in patients taking inhaled Flunisolide.
• Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
• Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases,your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

• • Bupropion
  • Pixantrone
• Other Medical Problems: The presence of pre-existing medical problems may affect your use of this medication. Inform your doctor if you have any other medical problems, especially:

• • Acute asthma attacks
  • Acute bronchospasm (difficulty breathing) - Should not be used in patients with these conditions.
  • Bone problems (ex. Osteoporosis)
  • Current or history of cataracts
  • Current or history of glaucoma - Use with caution. May make these conditions worse.
  • Chickenpox
  • Herpes simplex infection of the eye
  • Untreated infections (virus, bacteria, fungus, parasite)
  • Measles
  • Current or history of tuberculosis - Use with caution. This medication can reduce the body’s ability to fight off these infections.
  • Infection
  • Stress
  • Surgery
  • Trauma - Oral Corticosteroids may be needed during these periods.

Aerobid is used with a specific inhaler and comes with a patient information pamphlet. Read the directions carefully before using this medication. Ask your doctor about any questions you have.

Only take this medication as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

How to use this medication

• This inhaler comes with a built-in spacer device. Do not separate the purple actuator with the gray spacer. Do not use another spacer or holding chamber device with this inhaler.
• Open and position the inhaler by pulling the purple actuator from the gray spacer and snap it into an “L” shape.
• When using this inhaler for the first time, or you have not used it for more than 2 weeks, it may not deliver the right amount of medication. Before using, you will need to prime the inhaler by pressing down on the metal canister twice into the air, away from your face.
• Exhale fully and place the mouthpiece in front of your mouth in the upright position. Do not block the mouthpiece with you teeth or tongue.
• Press down on the gray top and inhale until you have taken a full, deep breath.
• Hold your breath as long as you can, then exhale slowly and resume normal breathing. This gives the medication time to settle in your lungs.
• If your doctor has prescribed more than one dose, wait for 20-30 seconds and repeat the instructions.
• Snap the purple actuator back into a straight position and push it back into the gray spacer.
• After each dose, gargle and rinse your mouth with water.

Each inhaler comes with a “Check-Off” chart. This helps you to track the number of doses you have taken. Mark off all of your doses. Before you reach the last number of doses, call your doctor to see if you need a refill. The inhaler, actuator and spacer must be discarded after 60 doses, even if the canister is not empty.

If you are taking oral corticosteroids with this medication, your doctor may want to adjust your dose of oral corticosteroids. Ask your doctor before changing your dose.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For aerosol inhalation:

• Adults and children 12 years of age or older - One dose is 80mcg. Start with 2 doses twice a day. Your doctor may increase your dose as needed. The dose is not usually more than 4 doses twice a day.
• Children 6-11 years of age - Start with one dose twice a day. Your doctor may increase your dose as needed. The dose is not usually more than 2 doses twice a day.
• Children younger than 6 years of age - Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medication, take is as soon as possible. If it is almost time for your next dose, skip the next dose and resume your normal dosing schedule. Do not double dose.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not expose the canister to extreme cold or heat. Do not puncture the canister or throw into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

It is very important that your doctor checks in with you often while you are receiving Aerobid to make sure that it is working properly.

If your symptoms do not improve within 2-4 weeks, or if they worsen, call your doctor.

You should not use this medication if your asthma attack has already started or if you experience a severe asthma attack. Your doctor may prescribe another medication for you to use in case of an acute asthma attack.

This medication may cause fungal infections in the mouth or throat (thrush). Inform your doctor immediately if you have white patches in the mouth or throat, or experience pain when eating or swallowing. Do not change your dose or stop this medication without asking your doctor.

It is recommended that you carry a medical ID card stating your condition and the medication you are using, as well as directions in case of an emergency.

Using too much of this medication or using it for an extended period of time may increase your risk of adrenal gland problems.

Talk to your doctor if you experience one or more of these symptoms while using this medication:

• Darkening of the skin
• Diarrhea
• Dizziness
• Fainting (syncope)
• Loss of appetite
• Depression
• Nausea
• Skin rash
• Unusual fatigue or weakness
• Vomiting

This medication may decrease bone mineral density when used for an extended period of time. A low bone mineral density may cause weak bones or osteoporosis. This medication may cause a delay in the growth of a child.

Call your doctor immediately if you experience blurred vision or another change in vision while using this medication. This medication may cause paradoxical bronchospasm, which can be life-threatening.

Inform your doctor immediately if you experience cough, breathing difficulty, shortness of breath or wheezing.

Do not take other prescription or over-the-counter medications unless they have been discussed with your doctor.

Aerobid may produce unwanted affects along with the intended 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 you experience any of the following side-effects:

More Common

• Body aches or pain
• Congestion
• Cough
• Dry or Sore throat
• Fever
• Headache
• Hoarseness
• Pain or Tenderness around the eyes and cheekbones
• Shortness of breath or difficulty breathing
• Sneezing
• Stuffy or Runny nose
• Tender, Swollen glands in the neck
• Chest tightness or wheezing
• Difficulty swallowing
• Voice changes

Less Common

• Bladder pain
• Blistering, Peeling, or Loosening of the skin
• Bloating or Swelling of the face, arms, hands, lower legs, or feet
• Bloody nose
• Bloody or Cloudy urine
• Blurred vision
• Chest pain
• Chills
• Cough producing mucus
• Diarrhea
• Difficult, Burning, or Painful urination
• Dizziness
• Excessive sweating
• Fast, Irregular, Pounding, or Racing heartbeat (palpitations, tachycardia)
• Frequent urge to urinate (polyuria)
• General feeling of discomfort or illness (malaise)
• Hives
• Itching
• Joint or Muscle pain
• Lower back or side pain
• Nervousness
• Pounding in the ears (pulsatile tinnitus)
• Puffiness or Swelling of the eyelids or around the eyes, face, lips, or tongue
• Red, Irritated eyes
• Skin rash
• Slow heartbeat (bradycardia)
• Sore mouth or tongue
• Sores, Ulcers, or White spots in the mouth or on the lips
• Swelling
• Tingling of the hands or feet
• Unusual fatigue or weakness
• Unusual weight gain or loss

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to the treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less Common

• Abdominal or Stomach fullness
• Acid or Sour stomach
• Changes in appetite
• Bad, Unusual, or Unpleasant (after) taste
• Belching
• Skin blemishes
• Burning, Dry or Itchy eyes
• Change in taste
• Constipation
• Cramps
• Difficulty with moving
• Discharge or Excessive tearing
• Dizziness or lightheadedness
• Dar pain
• Fear or Anxiety
• Feeling of constant movement of self or surroundings (veritgo)
• Gas
• Headache
• Heartburn
• Heavy bleeding
• Indigestion
• Irritability
• Itching of the genital area
• Loss of smell or taste
• Muscle aching or cramping
• Muscle stiffness
• Pain during sexual intercourse
• Neck pain
• Acne
• Redness, Pain, or Swelling of the eye, eyelid, or inner lining of the eyelid
• Restlessness
• Sensation of spinning (vertigo)
• Tremors
• Skin rash, encrusted, scaly, and oozing
• Stomach discomfort, upset, or pain
• Swollen joints
• Thick, white vaginal discharge with no odor or with a mild odor
• Trouble sleeping (insomnia)

Other side effects may occur in some patients that are not listed. Ask your doctor if you experience any other side effects. Call your doctor for advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.