Aerobid-M

Applies to flunisolide: inhalation aerosol liquid, inhalation aerosol powder

Along with its needed effects, flunisolide (the active ingredient contained in Aerobid-M) 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 while taking flunisolide:

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• pain or tenderness around the eyes and cheekbones
• shortness of breath or troubled breathing
• sneezing
• stuffy or runny nose
• tender, swollen glands in the neck
• tightness of the chest or wheezing
• trouble with swallowing
• voice changes

• 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
• fast, irregular, pounding, or racing heartbeat or pulse
• frequent urge to urinate
• general feeling of discomfort or illness
• hives
• itching
• joint or muscle pain
• lower back or side pain
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red, irritated eyes
• skin rash
• slow heartbeat
• sore mouth or tongue
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

• Creamy white, curd-like patches in the mouth or throat
• darkening of the skin
• discouragement
• fainting
• feeling sad or empty
• irritability
• loss of appetite
• loss of interest or pleasure
• loss of strength or energy
• muscle weakness
• nausea
• pain when eating or swallowing
• trouble concentrating
• trouble sleeping
• vomiting

Some side effects of flunisolide 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:

• Abdominal or stomach fullness
• acid or sour stomach
• appetite changes
• bad, unusual, or unpleasant (after) taste
• belching
• blemishes on the skin
• burning, dry, or itching eyes
• change in taste
• constipation
• cramps
• difficulty with moving
• discharge or excessive tearing
• dizziness or lightheadedness
• ear pain
• fear
• feeling of constant movement of self or surroundings
• gas
• headache, severe and throbbing
• heartburn
• heavy bleeding
• indigestion
• irritability
• itching of the vagina or genital area
• loss of smell or taste
• muscle aching or cramping
• muscle stiffness
• pain during sexual intercourse
• pain in the neck
• pimples
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• restlessness
• sensation of spinning
• shakiness
• 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 sitting still
• trouble sleeping
• upset stomach

Initial dose: 160 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day

Comments:
-Not indicated for the relief of acute bronchospasm.
-Contains a built-in spacer; do not use with any external spacer or holding chamber.
-Onset and degree of symptom relief varies with individual; if adequate response is not realized after 3 to 4 weeks of therapy, higher doses may provide additional benefit.
-Once asthma stability has been achieved, patients should be titrated to the lowest effective dose.
-For patients receiving oral corticosteroids, gradually taper oral corticosteroids on a weekly basis beginning after the first week of inhaled therapy (e.g., no more than prednisone 2.5 mg/day once a week); patients should be carefully monitored for asthma instability during transition; once oral corticosteroid taper is complete, inhalation dose should be reduced to the lowest effective dose.

Uses: For the maintenance treatment of asthma as prophylactic therapy; may also be used for patients with asthma requiring oral corticosteroids when use may reduce or eliminate the need for oral corticosteroids.