"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(hydromorphone HCl) Extended Release Tablets
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME
Addiction, Abuse, and Misuse
EXALGO exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing EXALGO, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of EXALGO. Monitor for respiratory depression, especially during initiation of EXALGO or following a dose increase. Instruct patients to swallow EXALGO tablets whole; crushing, chewing, or dissolving EXALGO tablets can cause rapid release and absorption of a potentially fatal dose of hydromorphone [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of EXALGO, especially by children, can result in a fatal overdose of hydromorphone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of EXALGO during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS].
EXALGO extended-release 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 a serious side effect such as:
- weak or shallow breathing;
- pounding heartbeats or fluttering in your chest;
- wheezing, chest tightness, trouble breathing;
- seizure (convulsions);
- confusion, severe weakness or drowsiness; or
- feeling like you might pass out.
Less serious side effects are more likely to...
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: 4/30/2014
This monograph has been modified to include the generic and brand name in many instances.
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