"Dec. 3, 2012 -- A major revision to the diagnostic "bible" -- which defines what is and what is not a mental illness -- has the final approval of the American Psychiatric Association (APA).
The approval means the final draft of the fi"...
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Revex Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Revex in Detail - Patient Information: Side Effects
If you are addicted to narcotics or have been using an opioid medicine for a long time, you may have unpleasant withdrawal symptoms when you receive nalmefene to reverse the effects of a narcotic overdose.
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.
Tell your caregivers right away if you have any of these symptoms, some of which may be signs that you need to receive additional doses of nalmefene:
- extreme drowsiness;
- weak or shallow breathing;
- chest pain or fluttering in your chest; or
- feeling like you might pass out.
Less serious side effects may include:
- nausea, vomiting, stomach pain;
- muscle or joint pain;
- chills; or
- feeling anxious or depressed.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Read the entire detailed patient monograph for Revex (Nalmefene Hydrochloride) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Revex FDA Prescribing Information: Side Effects
Adverse event information was obtained following administration of REVEX to 152 normal volunteers and in controlled clinical trials to 1127 patients for the treatment of opioid overdose or for postoperative opioid reversal.
Nalmefene was well tolerated and showed no serious toxicity during experimental administration to healthy individuals, even when given at 15 times the highest recommended dose. In a small number of subjects, at doses exceeding the recommended REVEX dose, nalmefene produced symptoms suggestive of reversal of endogenous opioids, such as have been reported for other narcotic antagonist drugs. These symptoms (nausea, chills, myalgia, dysphoria, abdominal cramps, and joint pain) were usually transient and occurred at very low frequency.
Such symptoms of precipitated opioid withdrawal at the recommended clinical doses were seen in both postoperative and overdose patients who were later found to have had histories of covert opioid use. Symptoms of precipitated withdrawal were similar to those seen with other opioid antagonists, were transient following the lower doses used in the postoperative setting, and more prolonged following the administration of the larger doses used in the treatment of overdose.
Tachycardia and nausea following the use of nalmefene in the postoperative setting were reported at the same frequencies as for naloxone at equivalent doses. The risk of both these adverse events was low at doses giving partial opioid reversal and increased with increases in dose. Thus, total doses larger than 1.0 µg/kg in the postoperative setting and 1.5 mg/70 kg in the treatment of overdose are not recommended.
Relative Frequencies of Common Adverse Reactions With an
Incidence Greater than 1% (all patients, all clinical settings)
Incidence less than 1%
DIGESTIVE: Diarrhea, dry mouth
UROGENITAL: Urinary retention
The incidence of adverse events was highest in patients who received more than the recommended dose of REVEX.
Transient increases in CPK were reported as adverse events in 0.5% of the postoperative patients studied. These increases were believed to be related to surgery and not believed to be related to the administration of REVEX. Increases in AST were reported as adverse events in 0.3% of the patients receiving either nalmefene or naloxone. The clinical significance of this finding is unknown. No cases of hepatitis or hepatic injury due to either nalmefene or naloxone were observed in the clinical trials.
Drug Abuse And Dependence
REVEX is an opioid antagonist with no agonist activity. It has no demonstrated abuse potential, is not addictive, and is not a controlled substance.
Read the entire FDA prescribing information for Revex (Nalmefene Hydrochloride) »
Additional Revex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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