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(hydromorphone HCl) Extended Release Tablets
ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE
Abuse Potential EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see WARNINGS AND PRECAUTIONS]. 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 depressive disorder). Routinely monitor all patients receiving EXALGO for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence].
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of EXALGO, even when the drug has been used as recommended and not misused or abused [see WARNINGS AND PRECAUTIONS]. EXALGO is for use in opioid tolerant patients only. Proper dosing and titration are essential and EXALGO should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of EXALGO or following a dose increase. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of hydromorphone.
Accidental ingestion of EXALGO, especially in children, can result in a fatal overdose of hydromorphone [see WARNINGS AND PRECAUTIONS].
EXALGO tablets are for oral use and contain hydromorphone hydrochloride, a mu-opioid agonist.
Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3•HCl. The compound has the following structural formula:
EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg, 16 mg, and 32 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin.
What are the possible side effects of hydromorphone (Dilaudid, Dilaudid-5, Exalgo)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- seizure (convulsions);
- cold, clammy skin;
- severe weakness or dizziness; or
- feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
- nausea, vomiting, constipation, loss of...
What are the precautions when taking hydromorphone hydrochloride extended release tablets (Exalgo)?
Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to hydromorphone; or to other narcotic pain medications (such as morphine); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as...
Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Exalgo Information
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