ADASUVE- loxapine aerosol, powder
Galen US Incorporated
Read this Medication Guide before you start taking ADASUVE and each time it is given to you. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. You should share this information with your family members and caregivers.
What is the most important information I should know about ADASUVE?
ADASUVE is available only through the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program. The healthcare facility must be enrolled in the ADASUVE REMS Program before you can be given ADASUVE.
ADASUVE may cause serious side effects, including:
Tell your healthcare provider right away if you have any of these symptoms of bronchospasm after taking ADASUVE.
Your healthcare provider should check you for breathing problems before and after you take ADASUVE.
What is ADASUVE?
ADASUVE is a prescription medicine that is inhaled through your mouth and is used to treat acute agitation in adults with schizophrenia or bipolar I disorder.
It is not known if ADASUVE is safe and effective in children.
Who should not take ADASUVE?
Do not take ADASUVE if you:
What should I tell my healthcare provider before taking ADASUVE?
Before you take ADASUVE, tell your healthcare provider if you:
Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ADASUVE?
What should I avoid while taking ADASUVE?
What are the possible side effects of ADASUVE?
ADASUVE can cause serious side effects, including:
Tell your healthcare provider right away if you have any of these symptoms of NMS after taking ADASUVE.
The most common side effects of ADASUVE include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ADASUVE. For more information ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ADASUVE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about ADASUVE. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ADASUVE that is written for health professionals.
For more information, go to www.ADASUVE.com or call 1-800-284-0062.
What are the ingredients in ADASUVE?
Active Ingredient: loxapine
Inactive Ingredients: none
This Medication Guide has been approved by the U.S. Food and Drug Administration
Manufactured for: Galen US Inc., 25 Fretz Road, Souderton, PA 18964