A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, in people who are already regularly using opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Not for use to treat pain that is not around-the-clock.
DOSAGE AND ADMINISTRATION
Initiate the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. Overestimating the EXALGO dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with EXALGO.
Consider the following factors when selecting an initial dose of EXALGO:
Total daily dose and potency of the opioid the patient has been taking previously;
Reliability of the relative potency estimate used to calculate the equivalent dose of hydromorphone needed (Note: potency estimates may vary with the route of administration);
Patient’s degree of opioid experience and opioid tolerance;
General condition and medical status of the patient;
Type and severity of the patient’s pain.
EXALGO is administered at a frequency of once daily (every 24 hours), approximately the same time
every day, with or without food.
Important information about EXALGO:
Get emergency help right away if you take too much EXALGO (overdose). When you first start taking EXALGO, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur. Never give anyone else your EXALGO. They could die from taking it. Store EXALGO away from children and in a safe place to prevent stealing or abuse. Selling or giving away EXALGO is against the law.
Do not take EXALGO if you have:
– Severe asthma, trouble breathing, or other lung problems.
– A bowel blockage or have narrowing of the stomach or intestines.
Before taking EXALGO, tell your healthcare provider if you have a history of:
head injury, seizures liver, kidney, thyroid problems allergy to sulfites
Problems urinating pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
Pregnant or planning to become pregnant. Prolonged use of EXALGO during pregnancy can cause withdrawal
Symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Breastfeeding. EXALGO passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking EXALGO with certain other medicines can cause serious side effects.
While taking EXALGO, DO NOT:
Drive or operate heavy machinery, until you know how EXALGO affects you. EXALGO can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with EXALGO may cause you to overdose and die.
The possible side effects of EXALGO are:
Abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.
WARNINGS AND PRECAUTIONS
EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance.
Hydromorphone can be abused in a manner similar to other opioid agonists, legal or illicit. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing EXALGO in situations where there is concern about increased risks of misuse, abuse, or diversion. Concerns about abuse, addiction, and diversion should not, however, prevent the proper management of pain.
Assess each patient’s risk for opioid abuse or addiction prior to prescribing EXALGO. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Routinely monitor all patients receiving
opioids for signs of misuse, abuse, and addiction because these drugs carry a risk for addiction even under appropriate medical use.