Perforomist

>10%

Viral infection (17.2%)

1-10%

Bronchitis (4.6%)

Chest infection (2.7%)

Dyspnea (2.1%)

Chest pain (1.9%)

Tremor (1.9%)

Dizziness (1.6%)

Frequency Not Defined

Angina

Arrhythmias

Hypo/hypertension

Tachycardia

Hypokalemia

Hyperglycemia

Metabolic acidosis

Headache

Insomnia

Paradoxical bronchospasm

Severe asthma exacerbation

Postmarketing Reports

Immune system disorders: Rare reports of anaphylactic reactions, including severe hypotension and angioedema

Metabolism and nutrition disorders: Hypokalemia, hyperglycemia

Respiratory, thoracic and mediastinal disorders: Cough

Skin and subcutaneous tissue disorders: Rash

Cardiac disorders: Angina pectoris, cardiac arrhythmias (eg, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia)

Investigations: Electrocardiogram QT prolonged, blood pressure increased (including hypertension)

Perforomist may cause serious side effects. See "Perforomist Precautions."

Common side effects with Perforomist include:

• diarrhea
• nausea
• nasopharyngitis
• dry mouth
• vomiting
• dizziness
• insomnia (difficulty falling or staying asleep)

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with Perforomist. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aminophylline 
• antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), and sotalol (Betapace, Betapace AF)
• diuretics ('water pills') such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Esidrix, Hydrodiuril, Microzide, Oretic), metolazone (Zaroxolyn), torsemide (Demadex).
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); pimozide (Orap)
• procainamide (Procanbid, Pronestyl)
• quinidine (Quinidex)
• salmeterol (Serevent) or salmeterol and fluticasone (Advair)
• sparfloxacin (Zagam)
• theophylline (Theo-Chron, Theolair)
• thioridazine (Mellaril)

This is not a complete list of Perforomist drug interactions. Ask your doctor or pharmacist for more information.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of formoterol inhalation powder in children 5 years of age and older. Safety and efficacy have not been established for children younger than 5 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of formoterol inhalation solution in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Buserelin
• Clozapine
• Dabrafenib
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Domperidone
• Donepezil
• Efavirenz
• Escitalopram
• Fluconazole
• Fluoxetine
• Foscarnet
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ivabradine
• Ketoconazole
• Leuprolide
• Levofloxacin
• Methadone
• Metronidazole
• Nafarelin
• Panobinostat
• Pasireotide
• Pimavanserin
• Pitolisant
• Posaconazole
• Quetiapine
• Ribociclib
• Sotalol
• Sulpiride
• Tacrolimus
• Triptorelin
• Vemurafenib
• Vinflunine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Acute asthma attack or
• COPD attack, severe—Should not be used if you are having an acute asthma attack, severe COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma or COPD attack.

• Angina (severe chest pain) or
• Diabetes or
• Heart or blood vessel disease (e.g., aneurysm) or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (acids in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures—Use with caution. May make these conditions worse.

• Lactose intolerance—Use with caution. The capsule form of this medicine contains lactose.

• It is used to treat asthma.
• It is used to treat COPD (chronic obstructive pulmonary disease).
• It is used to prevent exercise-induced breathing problems.
• This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

• Tell all of your health care providers that you take Perforomist. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), this medicine may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• Do not take more of Perforomist or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Perforomist while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Keep using Perforomist as you have been told by your doctor or other health care provider, even if you feel well.
• Do not use this medicine more than 2 times in a day. Space doses by about 12 hours.
• For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
• Do not mix other drugs in nebulizer.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Perforomist (formoterol inhalation solution) is taken on an as needed basis for asthma caused by working out. Do not take more often than every 12 hours unless told to do so by your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Perforomist, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Perforomist. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Perforomist.

Review Date: October 4, 2017

All LABA, including Perforomist, are contraindicated in patients with asthma without use of a long-term asthma control medication. [see WARNINGS and PRECAUTIONS (5.1)].

The expected signs and symptoms with overdosage of Perforomist Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS. Signs and symptoms may include angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, and metabolic acidosis. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Perforomist Inhalation Solution.

Treatment of overdosage consists of discontinuation of Perforomist Inhalation Solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Perforomist Inhalation Solution. Cardiac monitoring is recommended in cases of overdosage.

The minimum lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 32,000 times the maximum recommended daily inhalation dose in humans on a mg/m2 basis). The median lethal oral doses in Chinese hamsters, rats, and mice provide even higher multiples of the maximum recommended daily inhalation dose in humans.

  For additional information about overdose treatment, call a poison control center (1-800-222-1222).