Concomitant Therapy

Patients who have been taking inhaled, short-acting beta2-agonists (e.g., albuterol) on a regular basis should be instructed to discontinue the regular use of these products and use them only for symptomatic relief of acute symptoms. PERFOROMIST Inhalation Solution should not be used in conjunction with other inhaled medications containing long-acting beta2-agonists. Patients should be warned not to stop or change the dose of other concomitant COPD therapy without medical advice, even if symptoms improve after initiating treatment with PERFOROMIST Inhalation Solution.

Common Adverse Reactions with Beta2-agonists

Patients should be informed that treatment with beta2-agonists may lead to adverse reactions that include palpitations, chest pain, rapid heart rate, increased or decreased blood pressure, headache, tremor, nervousness, dry mouth, muscle cramps, nausea, dizziness, fatigue, malaise, low blood potassium, high blood sugar, high blood acid, or trouble sleeping [see ADVERSE REACTIONS (6.1)].

Instructions for Administration

It is important that patients understand how to use PERFOROMIST Inhalation Solution with a nebulizer appropriately [see the accompanying Medication Guide]. Patients should be instructed not to mix other medications with PERFOROMIST Inhalation Solution or ingest PERFOROMIST Inhalation Solution. Patients should throw the plastic dispensing container away immediately after use. Due to their small size, the container and top pose a danger of choking to young children.

FDA-Approved Medication Guide

See the accompanying Medication Guide.

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203

U.S. Pat. No. 6,667,344
U.S. Pat. No. 6,814,953

A3-031-00

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MEDICATION GUIDE

PERFOROMIST®(Per-FOR-o-mist)
(formoterol fumarate) Inhalation Solution

PERFOROMIST Inhalation Solution is only for use with a nebulizer.

Read the Medication Guide that comes with PERFOROMIST Inhalation Solution before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution can cause serious side effects including:

•
People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems.
•
It is not known if LABA medicines, such as PERFOROMIST Inhalation Solution, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).
•
  Get emergency medical care if:
•
breathing problems worsen quickly
•
you use your rescue inhaler medicine, but it does not relieve your breathing problems
What is PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution is used long term, 2 times a day (morning and evening), in controll