A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Revia Indications, Dosage, Storage, Stability - Naltrexone
Revia Indications, Dosage, Storage, Stability - Naltrexone
INDICATIONS
AND USES
REVIA is indicated:
In the treatment of alcohol dependence and for the blockade of the effects
of exogenously administered opioids.
REVIA has not been shown to provide any therapeutic benefit except as part
of an appropriate plan of management for the addictions.
DOSAGE AND ADMINISTRATION
IF THERE IS ANY QUESTION OF OCCULT OPIOID DEPENDENCE, PERFORM A NALOXONE CHALLENGE
TEST AND DO NOT INITIATE REVIA THERAPY UNTIL THE NALOXONE CHALLENGE IS NEGATIVE.
Treatment of Alcoholism:
A dose of 50 mg once daily is recommended for most patients (see Individualization
of Dosage ). The placebo-controlled studies that demonstrated the efficacy
of REVIA as an adjunctive treatment of alcoholism used a dose regimen of REVIA
50 mg once daily for up to 12 weeks. Other dose regimens or durations of therapy
were not evaluated in these trials.
A patient is a candidate for treatment with REVIA if:
- The patient is willing to take a medicine to help with alcohol dependence
- The patient is opioid free for 7-10 days
- The patient does not have severe or active liver or kidney problems (Typical
guidelines suggest liver function tests no greater than 3 times the upper
limits of normal, and bilirubin normal.)
- The patient is not allergic to REVIA , and no other contraindications are
present
Refer to CONTRAINDICATIONS
, WARNINGS, and PRECAUTIONS Sections
for additional information.
REVIA should be considered as only one of many factors determining the success
of treatment of alcoholism. Factors associated with a good outcome in the clinical
trials with REVIA were the type, intensity, and duration of treatment; appropriate
management of comorbid conditions; use of community-based support groups; and
good medication compliance. To achieve the best possible treatment outcome,
appropriate compliance-enhancing techniques should be implemented for all components
of the treatment program, especially medication compliance.
Treatment of Opioid Dependence:
Initiate treatment with REVIA using the following guidelines:
- Treatment should not be attempted unless the patient has remained opioid-free
for at least 7-10 days. Self-reporting of abstinence from opioids in opioid
addicts should be verified by analysis of the patient's urine for absence
of opioids. The patient should not be manifesting withdrawal signs or reporting
withdrawal symptoms.
- If there is any question of occult opioid dependence, perform a naloxone
challenge test. If signs of opioid withdrawal are still observed following
naloxone challenge, treatment with REVIA should not be attempted. The naloxone
challenge can be repeated in 24 hours.
- Treatment should be initiated carefully, with an initial dose of 25 mg of
REVIA. If no withdrawal signs occur, the patient may be started on 50 mg a
day thereafter.
Naloxone Challenge Test: The naloxone challenge test should not be performed
in a patient showing clinical signs or symptoms of opioid withdrawal, or in
a patient whose urine contains opioids. The naloxone challenge test may be administered
by either the intravenous or subcutaneous routes.
Intravenous:
Inject 0.2 mg naloxone.
Observe for 30 seconds for signs or symptoms of withdrawal.
If no evidence of withdrawal, inject 0.6 mg of naloxone.
Observe for an additional 20 minutes.
Subcutaneous:
Administer 0.8 mg naloxone.
Observe for 20 minutes for signs or symptoms of withdrawal.
Note: Individual patients, especially those with opioid dependence, may respond
to lower doses of naloxone. In some cases, 0.1 mg IV naloxone has produced a
diagnostic response.
Interpretation of the Challenge: Monitor vital signs and observe the
patient for signs and symptoms of opioid withdrawal. These may include, but
are not limited to: nausea, vomiting, dysphoria, yawning, sweating, tearing,
rhinorrhea, stuffy nose, craving for opioids, poor appetite, abdominal cramps,
sense of fear, skin erythema, disrupted sleep patterns, fidgeting, uneasiness,
poor ability to focus, mental lapses, muscle aches or cramps, pupillary dilation,
piloerection, fever, changes in blood pressure, pulse or temperature, anxiety,
depression, irritability, back ache, bone or joint pains, tremors, sensations
of skin crawling or fasciculations. If signs or symptoms of withdrawal appear,
the test is positive and no additional naloxone should be administered.
Warning: If the test is positive, do NOT initiate REVIA therapy. Repeat the
challenge in 24 hours. If the test is negative, REVIA therapy may be started
if no other contraindictions are present. If there is any doubt about the result
of the test, hold REVIA and repeat the challenge in 24 hours.
Alternative Dosing Schedules:
Once the patient has been started on REVIA, 50 mg every 24 hours will produce
adequate clinical blockade of the actions of parenterally administered opioids
(i.e., this dose will block the effects of a 25 mg intravenous heroin challenge).
A flexible approach to a dosing regimen may need to be employed in cases of
supervised administration. Thus, patients may receive 50 mg of REVIA every weekday
with a 100 mg dose on Saturday, 100 mg every other day, or 150 mg every third
day. The degree of blockade produced by REVIA may be reduced by these extended
dosing intervals.
There may be a higher risk of hepatocellular injury with single doses above
50 mg, and use of higher doses and extended dosing intervals should balance
the possible risks against the probable benefits (see WARNINGSand Individualization
of Dosage ).
Patient Compliance: REVIA should be considered as only one
of many factors determining the success of treatment. To achieve the best possible
treatment outcome, appropriate compliance-enhancing techniques should be implemented
for all components of the treatment program, including medication compliance.
HOW SUPPLIED
REVIA (naltrexone hydrochloride) tablets are available in pale yellow 50 mg
capsule-shaped film-coated tablets, scored and imprinted with "DuPont" on one
side and "11" on the other, as follows:
Bottles of 30 Tablets NDC
0056-0011-30
Bottles of 100 Tablets NDC
0056-0011-70
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP
Controlled Room Temperature].
DuPont Pharma
Wilmington, Delaware 19880
REVIAź is a Registered U.S. Trademark of DuPont Pharmaceuticals Co.
Copyright © DuPont Pharma 1999.
Made and Printed in U.S.A.
May 1999.
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