Perforomist inhalation

You should not use formoterol if you are allergic to it. Do not use formoterol inhalation to treat asthma without using another long-term asthma control medicine (such as an inhaled steroid).

Formoterol may increase the risk of death or hospitalization in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risk.

To make sure formoterol inhalation 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;

• diabetes;

• a thyroid disorder;

• pheochromocytoma (tumor of the adrenal gland); or

• a history of aneurysm (swelling of an artery).

Foradil capsules may contain lactose and milk protein. Talk to your doctor before using this form of formoterol if you have allergies or severe problems with lactose (milk sugar).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using formoterol.

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

Foradil should not be given to a child younger than 5 years old. Perforomist is is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Use only the prescribed dose of this medicine, and do not use it for longer than your doctor recommends.

If you use formoterol for asthma, you must use it together with another long-term asthma control medication. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice.

For asthma or COPD, formoterol is usually given 2 times a day, about 12 hours apart. To prevent exercise-induced asthma, use the medicine 15 minutes before exercising and allow 12 hours to pass before using the medicine again. Follow your doctor's dosing instructions very carefully.

Formoterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Use only a fast acting inhalation medicine for an attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your asthma or COPD.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Any child using formoterol inhalation should be supervised by an adult while using this medicine.

Formoterol capsules are for use only in the Foradil Aerolizer device provided. Do not take the capsule by mouth. Use only one capsule at a time. Use dry hands when handling the capsule. Never place a capsule in the mouthpiece of the inhaler.

The Foradil Aerolizer inhalation device is not to be used with a spacer.

Perforomist solution is for use only with a standard jet nebulizer machine connected to an air compressor. Do not mix formoterol with other medicines in the nebulizer. Do not take this medicine by mouth or swallow it while inhaling.

To use the Perforomist solution with a nebulizer:

• Open the foil pouch and single-use vial. Squeeze all of the medicine out into the chamber of the nebulizer. Attach the mouthpiece or face mask to the drug chamber. Then, attach the chamber to the compressor.

• Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.

• Breathe in slowly and evenly until you have inhaled all of the medicine (usually 5 to 10 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.

• Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Use formoterol inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Store this medicine at room temperature away from moisture and heat. Keep all capsules and vials in their original packaging until you are ready to use a dose. Throw away any Perforomist solution vials that have not been used within 3 months.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

Do not use a second form of formoterol (Bevespi, Dulera, Symbicort) or other long-acting inhaled bronchodilator (arformoterol, salmeterol, Advair, Brovana, Serevent) without your doctor's advice.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• theophylline;

• a diuretic or "water pill";

• a beta-blocker--atenolol, carvedilol, metoprolol, propranolol, sotalol, and others; or

• an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete. Other drugs may interact with formoterol inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Before using formoterol, tell your doctor or pharmacist if you are allergic to it; or to arformoterol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (e.g., irregular heartbeat, angina), high blood pressure, liver problems, overactive thyroid (hyperthyroidism), seizures, swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).

Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using formoterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using formoterol safely.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Applies to formoterol: inhalation aerosol powder, inhalation capsule, inhalation solution

Along with its needed effects, formoterol (the active ingredient contained in Perforomist) 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 formoterol:

• Body aches or pain
• chills
• cold or flu-like symptoms
• cough or hoarseness
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Chest pain or discomfort
• cough-producing mucous
• dry throat
• labored breathing
• pain or tenderness around the eyes and cheekbones
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trauma
• trouble with swallowing
• voice changes

• Convulsions
• decreased urine
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• noisy breathing

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• sweating

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

• Arm, back, or jaw pain
• chest tightness or heaviness
• general feeling or discomfort or illness
• increased hunger
• increased urination
• muscle pain
• muscle spasm or jerking of all extremities
• nausea
• no blood pressure or pulse
• numbness or tingling in the hands, feet, or lips
• palpitations or pounding in the ears
• pounding or racing heartbeat or pulse
• sleeplessness
• slow heartbeat
• stopping of heart
• sudden loss of consciousness
• unconsciousness
• vomiting

Some side effects of formoterol 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:

• Agitation
• back pain
• increased mucous in the throat and lungs
• leg cramps
• muscle cramps
• redness of the skin
• restlessness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet
• trouble sleeping

Applies to formoterol: inhalation capsule, inhalation solution

General

Common adverse reaction to Long-acting beta2-adrenergic agonists (LABA) drugs include: Angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis, and insomnia.[Ref]

Other

Very common (10% or more): Viral infection (17.2%)
Common (1% to 10%): Fever (2.2%), fatigue
Very rare (less than 0.01%): Peripheral edema[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (7.4%)
Common (1% to 10%): Serious asthma exacerbations (up to 6.4%), bronchitis (4.6%), pharyngitis (3.5%), chest infection (2.7%), sinusitis (2.7%), dyspnea (2.1%), increased sputum (1.5%) tonsillitis (1.2%), dysphonia (1%), chest pain, cough
Uncommon (0.1% to 1%): Bronchospasm, throat irritation (including paradoxical bronchospasm)[Ref]

Serious asthma exacerbations (acute worsening of asthma resulting in hospitalization) occurred more commonly in patients receiving higher than the recommended dose of this drug than in patients who received placebo.
While most of cases of asthma exacerbation have been in patients with severe or acutely deteriorating asthma, a few have occurred in patients with less severe asthma. It is not possible to determine from these individual case reports whether this drug contributed to the events.[Ref]

Dermatologic

Common (1% to 10%): Rash (1.1%)
Uncommon (0.1% to 1%): Hyperhidrosis[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea (4.9%), vomiting (2.4%), dry mouth, nausea[Ref]

Musculoskeletal

Common (1% to 10%): Back pain (4.2%), leg cramps (1.7%), muscle cramps
Uncommon (0.1% to 1%): Myalgia[Ref]

Nervous system

Central nervous system stimulating effects have been sporadically reported following inhalation of beta2-sympathomimetics, manifesting as hyperexcitability. These effects were mainly observed in children up to 12 years of age.[Ref]

Common (1% to 10%): Headache, tremor, dizziness
Uncommon (0.1% to 1%): Taste disturbances, nervousness
Very rare (less than 0.01%): Central nervous system stimulation[Ref]

Psychiatric

Common (1% to 10%): Anxiety (1.5%). insomnia (1.5%)
Uncommon (0.1% to 1%): Sleep disturbances
Rare (less than 0.1%): Agitation, restlessness
Very rare (less than 0.01%): Abnormal behavior, hallucination[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, palpitations, cardiac arrhythmias (e.g. atrial fibrillation), supraventricular tachycardia, extrasystoles, angina pectoris
Very rare (less than 0.01%): Prolongation of QTc interval, variations in blood pressure
Postmarketing reports: Tachyarrhythmia, blood pressure increased (including hypertension)[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (e.g. bronchospasm, exanthema, urticaria, pruritus)
Very rare (less than 0.01%): Angioneurotic edema, edema (including conjunctival irritation and eyelid edema)
Postmarketing reports: Anaphylactic reactions, including severe hypotension and angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema).[Ref]

Metabolic

Treatment with beta2-agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.[Ref]

Uncommon (0.1% to 1%): Hypokalemia, hyperglycemia[Ref]

Renal

Rare (less than 0.1%): Nephritis[Ref]

Hematologic

Very rare (less than 0.01%): Thrombopenia[Ref]

Some side effects of Perforomist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.