Exalgo (Hydromorphone Hydrochloride Extended Release Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Exalgo

Pain Management »

Introduction to pain management

Pain management can be simple or complex, depending on the cause of the pain. An example of pain that is typically less complex would be nerve root irritation from a herniated disc with pain radiating down the leg. This condition can often be alleviated with an epidural steroid injection and physical therapy. Sometimes, however, the pain does not go away. This can require a wide variety of skills and techniques to treat the pain. These skills and techniques include:

Interventional procedures
Medication management
Physical therapy or chiropractic therapy
Psychological counseling and support
Acupuncture and other alternative therapies; and
Referral to other medical specialists

All of these skills and services are necessary because pain can involve many aspects of a person's daily life.

How is pain tre...

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EXALGO
(hydromorphone hydrochloride) Extended Release Tablets

WARNING

POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse

EXALGO (hydromorphone hydrochloride extended release tablets) contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO (hydromorphone hydrochloride extended release tablets) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO (hydromorphone hydrochloride extended release tablets) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Proper Patient Selection

EXALGO is an extended release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg of oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.

EXALGO (hydromorphone hydrochloride extended release tablets) is for use in opioid tolerant patients only.

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO (hydromorphone hydrochloride extended release tablets) , especially in children, can result in a fatal overdose of hydromorphone.

Limitations of Use

EXALGO (hydromorphone hydrochloride extended release tablets) is not indicated for the management of acute or postoperative pain.

EXALGO (hydromorphone hydrochloride extended release tablets) is not intended for use as an as needed analgesic.

EXALGO (hydromorphone hydrochloride extended release tablets) tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO (hydromorphone hydrochloride extended release tablets) or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.

DRUG DESCRIPTION

EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist.

Hydromorphone hydrochloride, USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6one 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 (hydromorphone hydrochloride) Structural Formula Illustration

EXALGO (hydromorphone hydrochloride extended release tablets) also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin.

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...

Read All Potential Precautions of Exalgo »

Last reviewed on RxList: 3/24/2010
This monograph has been modified to include the generic and brand name in many instances.