Important Risk Information
Download and read the EXALGO Important Risk Information, including boxed warning.
Scroll down for Important Risk Information including boxed warning
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Scroll down for Important Risk Information including boxed warning
INDICATION
EXALGO® is a strong opioid pain medicine. EXALGO is used in people who are opioid tolerant. EXALGO is used to manage moderate to severe pain that is continuous and is expected to last for a long time.
IMPORTANT RISK INFORMATION
IMPORTANT WARNINGS
Abuse Potential
EXALGO contains hydromorphone, a strong pain medication and a Schedule II controlled substance with the potential for abuse like other strong pain medications, legal or illegal. Medication prescribers should assess each patient for the potential to abuse strong pain medications or become addicted to them before they give EXALGO. The risk for strong pain medication abuse is higher in patients who have abused strong pain medications before or who have family members that have (this includes both strong pain medication or alcohol) or mental illness (like depression). Medication prescribers should regularly monitor all patients they give EXALGO for signs they are not using the medication correctly.
Life-threatening Respiratory Depression
Slowed breathing may occur with EXALGO and could cause death. Death could occur even if used exactly as the medication prescriber said. EXALGO should only be used if patients have been taking strong pain medicines for a long time. The right dose is important and EXALGO should only be prescribed by healthcare professionals who have experience with strong pain medications for treating pain that will last for a long time. Watch for slowed breathing especially when first started or if the dose is increased. Swallow the tablet whole. Do not crush or chew as this can cause death.
Do not use EXALGO if you are NOT opioid tolerant. Use of EXALGO by people who are not opioid tolerant can cause life-threatening breathing problems that can cause death.
Accidental Exposure
Accidentally taking EXALGO, especially in children, can cause death.
- Do not take EXALGO if:
- - You have not been taking strong pain medications for a long period of time. Slowed breathing could occur and cause death.
- - You have bad slowed breathing
- - You have bad asthma, unless you are in the hospital and being observed by a medical professional
- - You have any type of block in your intestines
- - You have had surgery on your intestines
- - You are allergic to hydromorphone or sulfites
- EXALGO should not be used if:
- - The pain is only occurring occasionally
- - The pain is mild or not going to last for a long time
- - The pain just started
- - The pain is after surgery
- Patients considered to have taken strong pain medications for a long period of time are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.
- Do not drive or operate heavy machinery or other dangerous activities until you know how EXALGO affects you. EXALGO can make you sleepy and cause you to feel dizzy or lightheaded. This may affect your ability to think and react.
- Do not drink alcohol or use prescription or non-prescription medicines that contain alcohol while taking EXALGO. Using alcohol while taking EXALGO may cause overdose and death.
- Do not take EXALGO if you already take a monoamine oxidase inhibitor medicine (MAOI). Do not take EXALGO within 14 days after you stop taking an MAOI medicine.
- Tell your healthcare provider about all your medicines. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with EXALGO.
- Breathing problems, which occur more often in older people or weakened patients, is the chief hazard with EXALGO. Call your doctor or get emergency medical help if you have any symptoms listed below. It can mean that you have taken too much (overdose) EXALGO. You have trouble breathing. You have extreme drowsiness with slowed breathing. You have shallow breathing (little chest movement with breathing). You feel faint, dizzy, or confused. You have other unusual symptoms.
- Common side effects of EXALGO include constipation, nausea, vomiting, drowsiness or sleepiness, headache and dizziness. Serious events can include drop in blood pressure, symptoms of stomach or intestinal blockage, allergic reactions, and physical dependence symptoms from stopping EXALGO all at once.
Please see Medication Guide for Important Risk Information and Full Prescribing Information.
