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Revex
Overview
What is Revex?
REVEX (nalmefene
hydrochloride injection), an opioid antagonist, is a 6-methylene
analogue of naltrexone. The chemical structure is shown below:
Molecular Formula:
C HNO•HCl
Molecular Weight:
375.9, CAS # 58895-64-0
Chemical Name:
17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol,
hydrochloride salt.
Nalmefene
hydrochloride is a white to off-white crystalline powder which is freely
soluble in water up to 130 mg/mL and slightly soluble in chloroform up
to 0.13 mg/mL, with a pK of 7.6.
REVEX is available
as a sterile solution for intravenous, intramuscular, and subcutaneous
administration in two concentrations, containing 100 µg or 1.0
mg of nalmefene free base per mL. The 100 µg/mL concentration
contains 110.8 µg of nalmefene hydrochloride and the 1.0 mg/mL
concentration contains 1.108 mg of nalmefene hydrochloride per mL. Both
concentrations contain 9.0 mg of sodium chloride per mL and the pH is
adjusted to 3.9 with hydrochloric acid.
Concentrations and
dosages of REVEX are expressed as the free base equivalent of
nalmefene.
What does Revex look like?
What are the available doses of Revex?
Sorry No records found.
What should I talk to my health care provider before I take Revex?
Sorry No records found
How should I use Revex?
Sorry No records found
What interacts with Revex?
REVEX is contraindicated in patients with a known hypersensitivity to the product.
What are the warnings of Revex?
Use of REVEX in
Emergencies
REVEX, like
all drugs in this class, is not the primary treatment for
ventilatory failure. In most emergency settings, treatment with
REVEX should follow, not precede, the establishment of a patent
airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access.
Risk of Recurrent
Respiratory Depression
Accidental
overdose with long acting opioids [such as methadone and
levo-alpha-acetylmethadol (LAAM)] may result in prolonged
respiratory depression. Respiratory depression in both the
postoperative and overdose setting may be complex and involve
the effects of anesthetic agents, neuromuscular blockers, and
other drugs. While REVEX has a longer duration of action than
naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even
after an apparently adequate initial response to REVEX
treatment.
Patients treated with REVEX should be observed until, in the opinion of the physician, there is no
reasonable risk of recurrent respiratory
depression.
What are the precautions of Revex?
General
Pulmonary edema, cardiovascular instability,
hypotension, hypertension, ventricular tachycardia, and
ventricular fibrillation have been reported in
connection with opioid reversal in both postoperative
and emergency department settings. In many cases, these
effects appear to be the result of abrupt reversal of
opioid effects.
Although REVEX has been used safely in patients with
pre-existing cardiac disease, all drugs of this class
should be used with caution in patients at high
cardiovascular risk or who have received potentially
cardiotoxic drugs. (See .)
REVEX, like other opioid antagonists, is known to
produce acute withdrawal symptoms and, therefore, should
be used with extreme caution in patients with known
physical dependence on opioids or following surgery
involving high doses of opioids. Imprudent use or
excessive doses of opioid antagonists in the
postoperative setting has been associated with
hypertension, tachycardia, and excessive mortality in
patients at high risk for cardiovascular complications.
(See .)
Preclinical studies have shown that nalmefene at doses
up to 10 mg/kg (437 times the maximum recommended human
dose) produced incomplete reversal of
buprenorphine-induced analgesia in animal models. This
appears to be a consequence of a high affinity and slow
displacement of buprenorphine from the opioid receptors.
Hence, REVEX may not completely reverse
buprenorphine-induced respiratory
depression.
Drug Interactions
REVEX has
been administered after benzodiazepines, inhalational
anesthetics, muscle relaxants, and muscle relaxant antagonists
administered in conjunction with general anesthesia. It also has
been administered in outpatient settings, both in trials in
conscious sedation and in the emergency management of overdose
following a wide variety of agents. No deleterious interactions
have been observed.
Preclinical
studies have shown that both flumazenil and nalmefene can induce
seizures in animals. The coadministration of both flumazenil and
nalmefene produced fewer seizures than expected in a study in
rodents, based on the expected effects of each drug alone. Based
on these data, an adverse interaction from the coadministration of the two drugs is not expected, but physicians should remain
aware of the potential risk of seizures from agents in these
classes.
Carcinogenesis and
Mutagenesis and Impairment of Fertility
Nalmefene
did not have mutagenic activity in the Ames test with five
bacterial strains or the mouse lymphoma assay. Clastogenic
activity was not observed in the mouse micronucleus test or in
the cytogenic bone marrow assay in rats. However, nalmefene did
exhibit a weak but significant clastogenic activity in the human
lymphocyte metaphase assay in the absence but not in the
presence of exogenous metabolic activation. Oral administration
of nalmefene up to 1200 mg/m /day did not affect
fertility, reproductive performance, and offspring survival in
rats.
Use in Pregnancy
Reproduction studies have been performed in rats (up to
1200 mg/m /day) and rabbits (up to 2400
mg/m/day) by oral administration of
nalmefene and in rabbits by intravenous administration
up to 96 mg/m/day (114 times the human
dose). There was no evidence of impaired fertility or
harm to the fetus. There are, however, no adequate and
well-controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of
human response, this drug should be used during
pregnancy only if clearly needed.
Nursing Mothers
Nalmefene
and its metabolites were secreted into rat milk, reaching
concentrations approximately three times those in plasma at one
hour and decreasing to about half the corresponding plasma
concentrations by 24 hours following bolus administration. As no
clinical information is available, caution should be exercised
when REVEX is administered to a nursing woman.
Use in Pediatric
Patients
Safety and
effectiveness of REVEX in pediatric patients have not been
established.
Use in Neonates
The safety
and effectiveness of REVEX in neonates have not been established
in clinical studies. In a preclinical study, nalmefene was
administered by subcutaneous injection to rat pups at doses up
to 205 mg/m /day throughout maternal lactation
without producing adverse effects. A preclinical study
evaluating the irritancy of the dosage form following arterial
and venous administration in animals showed no vascular
irritancy.
REVEX
(nalmefene hydrochloride injection) should only be used in the
resuscitation of the newborn when, in the opinion of the
treating physician, the expected benefits outweigh the
risks.
Geriatric Use
Clinical
studies of REVEX (nalmefene hydrochloride injection) did not
include sufficient number of subjects aged 65 and over to
determine whether they respond differently from younger
subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger
patients. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy.
What are the side effects of Revex?
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% | |||
| Adverse Event | Nalmefene | Naloxone | Placebo |
| N=1127 | N=369 | N=77 | |
| Nausea | 18% | 18% | 6% |
| Vomiting | 9% | 7% | 4% |
| Tachycardia | 5% | 8% | - |
| Hypertension | 5% | 7% | - |
| Postoperative pain | 4% | 4% | N/A |
| Fever | 3% | 4% | - |
| Dizziness | 3% | 4% | 1% |
| Headache | 1% | 1% | 4% |
| Chills | 1% | 1% | - |
| Hypotension | 1% | 1% | - |
| Vasodilatation | 1% | 1% | - |
Incidence less than 1%
CARDIOVASCULAR: Bradycardia, arrhythmia
DIGESTIVE: Diarrhea, dry mouth
NERVOUS SYSTEM: Somnolence, depression, agitation, nervousness, tremor, confusion, withdrawal syndrome, myoclonus
RESPIRATORY: Pharyngitis
SKIN: Pruritus
UROGENITAL: Urinary retention
The incidence of adverse events was highest in patients who received more than the recommended dose of REVEX.
Laboratory findings
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.
What should I look out for while using Revex?
REVEX is
contraindicated in patients with a known hypersensitivity to the
product.
What might happen if I take too much Revex?
Intravenous doses
of up to 24 mg of nalmefene, administered to healthy volunteers in the
absence of opioid agonists, produced no serious adverse reactions,
severe signs or symptoms, or clinically significant laboratory
abnormalities. As with all opioid antagonists, use in patients
physically dependent on opioids can result in precipitated withdrawal
reactions that may result in symptoms that require medical attention.
Treatment of such cases should be symptomatic and supportive.
Administration of large amounts of opioids to patients receiving opioid
antagonists in an attempt to overcome a full blockade has resulted in
adverse respiratory and circulatory reactions.
How should I store and handle Revex?
Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006REVEX (nalmefene hydrochloride injection) is available in the following presentations:An ampul containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 10 (NDC 10019-315-21)An ampul containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 10 (NDC 10019-311-22)Store at controlled room temperature.REVEX is a registered trademark of Ivax Laboratories, Inc.Baxter is a registered trademark of Baxter International Inc.Manufactured forBaxter Healthcare CorporationDeerfield, IL 60015 USAby: Taylor PharmaceuticalsDecatur, IL 62525For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)U.S. Patent No. 4,535,157June 2006
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
REVEX
prevents or reverses the effects of opioids, including
respiratory depression, sedation, and hypotension.
Pharmacodynamic studies have shown that REVEX has a longer
duration of action than naloxone at fully reversing doses. REVEX
has no opioid agonist activity.
REVEX is
not known to produce respiratory depression, psychotomimetic
effects, or pupillary constriction. No pharmacological activity
was observed when REVEX was administered in the absence of
opioid agonists.
REVEX has
not been shown to produce tolerance, physical dependence, or
abuse potential.
REVEX can
produce acute withdrawal symptoms in individuals who are opioid dependent.
Non-Clinical Toxicology
REVEX is contraindicated in patients with a known hypersensitivity to the product.REVEX has been administered after benzodiazepines, inhalational anesthetics, muscle relaxants, and muscle relaxant antagonists administered in conjunction with general anesthesia. It also has been administered in outpatient settings, both in trials in conscious sedation and in the emergency management of overdose following a wide variety of agents. No deleterious interactions have been observed.
Preclinical studies have shown that both flumazenil and nalmefene can induce seizures in animals. The coadministration of both flumazenil and nalmefene produced fewer seizures than expected in a study in rodents, based on the expected effects of each drug alone. Based on these data, an adverse interaction from the coadministration of the two drugs is not expected, but physicians should remain aware of the potential risk of seizures from agents in these classes.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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