Important Safety Information
What is OXAYDO®?
OXAYDO® (oxycodone HCl, USP) is an immediate-release oral formulation of oxycodone HCl for the treatment of acute and chronic moderate to severe pain where the use of an opioid pain medication is appropriate.
Risk of Abuse
OXAYDO® is a Schedule II controlled substance with a risk for abuse similar to other opioid pain medications. OXAYDO® may be abused by crushing, chewing, snorting or injecting the product and these practices pose a significant risk to the abuser that could result in overdose and death.
Do not use OXAYDO® if you have:
- Slowed breathing
- Very slow movement of your intestines or blocked intestines
- Acute or severe asthma
- Known allergy to oxycodone or any components of the product
- Inflamed pancreas
Serious side effects of OXAYDO® may include:
- Slowed or stopped breathing, especially if you are:
- elderly or weakened
- suffering from conditions with low oxygen or air passageway blockage
- taking large doses of opioids for the first time
- taking other drugs that slow breathing
- suffering from chronic obstructive pulmonary disease (COPD) or heart problems associated with lung disease
- Cardiac arrest
- Low blood pressure
- Circulatory collapse or shock
- Worsening symptoms if taken with a head injury
- Greater effects such as slowed breathing, low blood pressure, significant sleepiness, or coma if OXAYDO® is taken with medications that affect the central nervous system
- Severe low blood pressure if you have a problem maintaining your blood pressure
The most common side effects of OXAYDO® are:
- Inability to sleep
Tell your doctor if you have:
- Severe kidney or liver disease
- Addison's disease
- Underactive thyroid function
- Enlarged prostate
- Difficulty urinating
- A seizure disorder
Some medications can interact with OXAYDO®. Tell your doctor about all the medications that you take, especially if you take:
- Muscle relaxants
- Other pain medications
- Monoamine Oxidase Inhibitors (MAOIs)
Do not use alcoholic beverages, or any medications containing alcohol while taking OXAYDO®.
Keep OXAYDO® out of the reach of children.
OXAYDO® may impair mental and/or physical abilities; use with caution with potentially hazardous activities.
To report SUSPECTED ADVERSE REACTIONS, contact Egalet US Inc. at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.