What is REVIA and how is it used?
Revia (naltrexone) is a special drug that blocks the effects of other narcotic drugs and alcohol used to treat drug or alcohol dependence and is taken orally in tablet form.
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What are the side effects of Revia?
Side effects of Revia include:
weakness,
Tired
sleep problems (insomnia),
increased thirst,
anxiety,
nervous
Insomnia,
irritability,
Vertigo ,
fainting,
muscle or joint pain,
decreased sex drive,
impotence, or
Difficulty having an orgasm.
00Sudden opiate withdrawal symptoms can occur within minutes after taking REVIA. Tell your doctor if you have withdrawal symptoms of Revia, including:
colic,
nausea or vomiting,
Diarrhea,
joint/bone/muscle pain,
mental/mood changes (eg, anxiety, confusion, extreme drowsiness, visual hallucinations), or
Runny nose .
Description
Revia (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic homolog of oxymorphone without opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropyl methyl group. REVIA is also related to a powerful opioid antagonist, naloxone, or n-allylnoroxymorphone.
naltrexone hydrochloride
Rivia is a white crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. REVIA is available as film-coated tablets containing 50 mg of naltrexone hydrochloride.
REVIA tablets also contain: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, synthetic iron red oxide, synthetic yellow iron oxide and titanium dioxide. Indications and dosage
Indications for use
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 addiction management plan.
Dosage and method of use
To reduce the risk of precipitated withdrawal in opioid-dependent patients, or exacerbation of a pre-existing subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol). Before starting REVIA treatment. An opioid-free period of at least 7 to 10 days is recommended for patients who were previously dependent on short-acting opioids.
Switching from buprenorphine or buprenorphine/naloxone or methadone
There are no systematically collected data specifically addressing the switch from buprenorphine or methadone to REVIA; However, a review of post-marketing case reports has indicated that some patients may experience severe manifestations of precipitated withdrawal when switching from opioid agonist therapy to opioid antagonist therapy. Patients switching off buprenorphine or methadone may be prone to precipitation of withdrawal symptoms for up to two weeks. Healthcare providers should be prepared to manage symptomatic withdrawal with non-opioid medications.
alcohol addiction treatment
A dose of 50 mg once daily is recommended for most patients. Placebo-controlled studies demonstrating the efficacy of REVIA as an adjunct to alcoholism have used a dose regimen of REVIA 50 mg once daily for up to 12 weeks. Other dosage regimens or treatment durations were not evaluated in these trials.
REVIA should be considered as only one of many factors that determine the success of alcohol dependence treatment. Factors associated with a good outcome in clinical trials with REVIA were the type, intensity, and duration of treatment; appropriate management of co-morbid conditions; use of community support groups; And good compliance with medication. To achieve the best possible therapeutic outcome, appropriate techniques must be implemented to enhance compliance with all components of the treatment programme, especially compliance with medications.
Treatment of opioid dependence
Treatment should begin with an initial dose of 25 mg of REVIA. If there are no signs of withdrawal, the patient can be started on a dose of 50 mg per day thereafter.
A dose of 50 mg once a day will produce an adequate clinical blockade of the actions of parenteral opioids. As with many non-addictive agonist therapies, REVIA has proven value only when given as part of a comprehensive management plan that includes some measures to ensure the patient is taking the drug.
Naloxone Challenge Test
Doctors are reminded that there is no completely reliable way to determine if a patient has gone through an opioid-free period. A naloxone challenge test may be useful if there is any question of occult opiate dependence. If signs of opioid withdrawal continue to be observed after naloxone challenge, treatment with REVIA should not be attempted. The naloxone challenge can be repeated within 24 hours.
The naloxone challenge test should not be performed in a patient with clinical signs or symptoms of opioid withdrawal, or in a patient whose urine contains opioids. The naloxone challenge test can be done either intravenously or under the skin.
intravenous
Inject 0.2 mg naloxone.
Watch for 30 seconds for signs or symptoms of withdrawal.
In the absence of evidence of withdrawal, inject 0.6 mg of naloxone.
Pay attention for an additional 20 minutes.
under the skin
Administer 0.8 mg naloxone.
Pay attention for 20 minutes for signs or symptoms of withdrawal.
Note: Individual patients, especially those dependent on opioids, may respond to lower doses of naloxone. In some cases, 0.1 mg of intravenous naloxone results in a diagnostic response.
Interpretation of the challenge
Monitor vital signs and monitor the patient for signs and symptoms of opioid withdrawal. These may include, but are not limited to: nausea, vomiting, dysphonia, yawning, sweating, tearing, runny nose, stuffy nose, craving for opioids, poor appetite, abdominal cramps, feeling afraid, skin redness, and disturbed sleep patterns restlessness, restlessness, impaired ability to concentrate, mental lapses, muscle aches or cramps, dilated pupils, distension, fever, changes in blood pressure, pulse or temperature, anxiety, depression, irritability, back pain, bone or joint pain, Tremors, a feeling of crawling skin or fasciculations. If signs or symptoms of withdrawal occur, the test is positive and additional naloxone should not be given.
Warning: If the test is positive, do not start REVIA treatment. Repeat the challenge within 24 hours. If the test is negative, REVIA therapy may be started in the absence of other contraindications. If there is any doubt about the test result, press REVIA and repeat the challenge within 24 hours.
Alternative Dosing Tables
A flexible approach to the dosing regimen may be required in cases of supervised administration. Thus, patients may receive 50 mg of REVIA every weekday at a dose of 100 mg on Saturday, 100 mg every other day, or 150 mg every third day. The degree of REVIA-induced blockade can be reduced by these extended dosing intervals.
There may be a greater risk of hepatocyte injury with single doses greater than 50 mg, and use of higher doses and extended dosing intervals must balance potential risks with potential benefits.
Patient adherence to treatment
REVIA should be considered as only one of many factors that determine the success of treatment. To achieve the best possible therapeutic outcome, appropriate techniques must be implemented to promote compliance with all components of the treatment programme, including drug compliance
Side Effects
During two 12-week randomized, double-blind, placebo-controlled trials evaluating the efficacy of REVIA as an adjunct treatment for alcoholism, most patients tolerated REVIA well. In these studies, a total of 93 patients received REVIA at a dose of 50 mg once daily. Five of these patients discontinued REVIA because of nausea. No serious adverse events were reported during these two trials.
While extensive clinical studies evaluating the use of REVIA in detoxification of previously opioid-dependent individuals have failed to identify any individual serious undesirable risk of REVIA use, placebo-controlled studies use up to five times the doses of REVIA (up to to 300 mg per day) of that recommended for use in opioid receptor blockades has been shown that REVIA causes hepatocellular injury in a significant proportion of patients exposed to higher doses (see WARNINGS AND PRECAUTIONS, Laboratory Tests).
Follow side effects
Aside from this finding, and the risk of precipitated withdrawal from opioids, the available evidence does not incriminate REVIA, used at any dose, as the cause of any other serious adverse reaction in an “opioid-free” patient. It is important to realize that REVIA can precipitate or exacerbate the signs and symptoms of abstinence in any individual who is not completely free of exogenous opioids.
Patients with addiction disorders. Especially opioid addicts, are at risk for many adverse events and abnormal laboratory findings, including liver function abnormalities. Data from both controlled and observational studies suggest that these abnormalities, other than the dose-related hepatotoxicity described above, are not related to REVIA use.
Among opioid-free individuals, administration of REVIA at the recommended dose was not associated with a predictable profile of serious or unwanted adverse events. However, as mentioned above, among individuals who use opioids, REVIA may cause serious withdrawal reactions (see CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION).
Adverse events reported
REVIA has not been shown to cause significant increases in complaints in placebo-controlled trials in patients known to have been opioid-free for more than 7 to 10 days. Studies in alcoholic populations and volunteers in clinical pharmacology have indicated that a small percentage of patients may experience compound opiate-like withdrawal symptoms consisting of crying, mild nausea, abdominal cramps, insomnia, bone or joint pain, myalgia, and nasal symptoms. This may represent detection of occult opioid use, or it may represent symptoms attributable to naltrexone. A number of alternative dosing patterns have been recommended to try to reduce the frequency of these complaints.
Alcohol addiction
In an open-label safety study with approximately 570 people with alcohol dependence receiving Revia, the following new adverse reactions occurred in 2% or more of patients: nausea (10%), headache (7%), dizziness (4%), nervousness (4 %), fatigue (4%), insomnia (3%), vomiting (3%), anxiety (2%), drowsiness (2%).
Depression, suicidal ideation, and suicide attempts were reported in all groups when comparing naltrexone, placebo, or controls undergoing treatment for alcoholism.
Although a causal relationship with REVIA is not suspected, clinicians should be aware that treatment with REVIA does not reduce the risk of suicide in these patients (see PRECAUTIONS).
opioid addiction
The following adverse reactions have been reported both at baseline and during clinical trials of REVIA in opioid addiction with an incidence rate of more than 10%:
Difficulty sleeping, anxiety, nervousness, abdominal pain/cramps, nausea and/or vomiting, low energy, joint and muscle pain, headache.
The incidence was less than 10% for:
Loss of appetite, diarrhea, constipation, increased thirst, increased energy, feeling down, irritability, dizziness, rash, delayed ejaculation, decreased potency, and chills.
The following events occurred in less than 1% of the subjects:
my breath
Nasal congestion, itching, runny nose, sneezing, sore throat, increased mucus or phlegm, sinus problems, difficulty breathing, hoarseness, cough, shortness of breath.
Cardiovascular
Nosebleeds, phlebitis, edema, hypertension, nonspecific changes in the electrocardiogram, heart palpitations, tachycardia.
Digestive system
Increased gas, hemorrhoids, diarrhea, ulcers.
musculoskeletal system
Pain in the shoulders, legs or knees. tremors, twitching
Genitourinary system
increased frequency of urination or discomfort during it; Increased or decreased sexual interest.
Dermatology
Oily skin, itching, acne, athlete’s foot, cold sores, hair loss.
psychological
Depression, paranoia, fatigue, anxiety, confusion, disorientation, hallucinations, nightmares, bad dreams.
Distinctive senses
Eyes: blurry, burning, photosensitive, swollen, painful, tired eyes. Ears – “plug,” painful, tinnitus.
years
Increased appetite, weight loss, weight gain, yawning, drowsiness, fever, dry mouth, “head pounding,” groin pain, swollen glands, “side” pain, cold feet, “hot fits.”
Post-marketing experience
Data collected from REVIA post-marketing use show that most events usually occur early in the course of drug therapy and are transient. It is not always possible to distinguish these events from the signs and symptoms that may result from withdrawal syndrome. Reported events include anorexia, asthenia, chest pain, fatigue, headache, hot flashes, malaise, changes in blood pressure, agitation, dizziness, hyperkinesia, nausea, vomiting, tremor, abdominal pain, diarrhea, palpitations, and aching. Muscles, anxiety, confusion, euphoria, hallucinations, insomnia, nervousness, drowsiness, abnormal thinking, shortness of breath, rash, increased sweating, vision abnormalities, idiopathic thrombocytopenic purpura.
In some individuals, the use of opioid antagonists has been associated with a change in baseline levels of certain hypothalamic, pituitary, adrenal, or gonadotropic hormones. The clinical significance of such changes is not fully understood.
Adverse events, including withdrawal symptoms and death, have been reported with REVIA use in ultra-rapid opioid detoxification programmes. The cause of death in these cases is unknown.
Lab Tests
In a placebo-controlled study in which REVIA was administered to obese subjects at a dose approximately five times the recommended dose for opioid receptor blockade (300 mg per day), 19% (5/26) of REVIA recipients and 0% (0)/24) of Patients treated with placebo developed elevations in serum transaminases (ie, peak ALT values ranging from 121 to 532; or 3 to 19 times the baseline values) after three to eight weeks of treatment. The participating patients were generally clinically asymptomatic, and the transaminase levels of all patients for whom follow-up was obtained returned to (or about) baseline values within weeks.
Transaminase elevations have also been observed in other placebo-controlled studies, in which exposure to REVIA at doses higher than the amount recommended for the treatment of alcohol dependence or opioid blockade produced more numerous and significant elevations of serum transaminases than did placebo. Elevations in transaminase occurred in 3 of 9 patients with Alzheimer’s disease who received REVIA (at doses up to 300 mg/day) for 5 to 8 weeks in an open clinical trial.
drug abuse and dependence
Revia is a pure opiate antagonist. It does not lead to physical or psychological dependence. Tolerance to the antagonist effect of opioids is not known. Drug interaction
drug interaction
Studies have not been performed to evaluate potential interactions between REVIA and medications other than opioids. Thus, caution is advised if concomitant administration of REVIA and other drugs is required.
The concomitant safety and efficacy of Revia and Disulfiram is unknown, and the concomitant use of the two potentially hepatotoxic drugs is not recommended as the potential benefits outweigh the known risks.
Drowsiness and drowsiness have been reported following doses of REVIA and thioridazine.
Patients taking REVIA may not benefit from opioid-containing medicines, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. In an emergency situation when opioid analgesics must be administered to a patient receiving REVIA, the amount of opioids required may be greater than normal, and the resulting respiratory depression may be deeper and prolonged.
Warnings
Exposure to opioid overdose
After opioid detoxification, patients’ tolerance to opioids will likely decrease. As the blockade of the exogenous opioids provided by REVIA eventually wears off and completely dissipates, patients treated with REVIA may respond to lower doses of opioids than previously used, just as they would soon after completion of detoxification.
This can lead to potentially life-threatening opioid intoxication (respiratory impairment or cessation, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids. Cases of opioid overdose with fatal outcomes have been reported in patients after discontinuation of treatment.
Patients should be cautioned that they may be more sensitive to opioids, even at lower doses, after discontinuation of REVIA therapy. It is important for patients to inform family members and those closest to the patient of this increased sensitivity. Toward opioids and risk of overdose (see PATIENT INFORMATION).
There is also the possibility that a patient being treated with REVIA will overcome the effect of REVIA’s opiate blockade. Although REVIA is a powerful opponent, the blockade produced by REVIA can be overcome. Plasma concentration may be from exogenous opioids. obtained immediately after its acute intake is sufficient to overcome the blockade of the competitive future.
This poses a potential risk to individuals trying on their own to overcome the blockade. By administering large amounts of exogenous opioids. Any attempt by a patient to overcome hostility by taking opioids is particularly dangerous and may result in life-threatening opioid poisoning or fatal overdose. Patients should be informed of the serious consequences of attempting to overcome opioid blockade.
Accelerating opioid withdrawal
Symptoms of spontaneous withdrawal of opioids. (associated with discontinuation of opioids in a dependent individual) is uncomfortable, but is not generally thought to be severe or to warrant hospitalization. However, when withdrawal is abruptly precipitated by the administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe enough to require hospitalization. Withdrawal symptoms usually appear within five minutes of taking REVIA and persist for up to 48 hours. Mental status changes including confusion, drowsiness, and visual hallucinations. Significant fluid losses from vomiting and diarrhea required administration of intravenous fluids. A post-marketing review of accelerated opioid withdrawal in combination with naltrexone treatment identified cases with withdrawal symptoms severe enough to require hospitalization and, in some cases, management in an intensive care unit.
To prevent precipitated withdrawal in patients dependent on opioids. or exacerbation of pre-existing subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before initiating REVIA therapy. An opioid-free period of at least 7 to 10 days is recommended. For patients previously dependent on short-acting opioids. Patients switching off buprenorphine or methadone may be prone to precipitation of withdrawal symptoms for up to two weeks.
Continue to accelerate opioid withdrawal
If the health care provider considers that a rapid transition from agonist to agonist therapy is necessary and appropriate. Monitor the patient closely in an appropriate medical setting where rapid withdrawal can be managed.
In each case, health care providers should always be prepared to manage withdrawal symptoms with non-opioid medications because there is no completely reliable way to determine whether a patient has experienced an opioid-free period. A naloxone challenge test may be helpful. However, some case reports have indicated that patients may experience precipitated withdrawal despite having a negative urine toxicology test or tolerating a naloxone challenge test (usually in preparation for transition from buprenorphine therapy).
Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to provide an accurate account of their last opioid use. Patients who have been treated for alcohol dependence with REVIA should also be evaluated for baseline dependence on opioids and any recent use of opioids prior to initiating treatment with REVIA. Accelerated withdrawal of opioids has been observed in alcohol-dependent patients in circumstances in which the prescriber was not aware of additional opioid use or co-dependence on opioids.
Hepatotoxicity
Cases of hepatitis and clinically significant hepatic dysfunction have been observed concurrently with exposure to REVIA during the clinical development program and in the post-marketing period. Transient elevations of hepatic transaminases have also been observed in clinical and post-marketing trials. When patients have elevated transaminases, there is often some possibility of etiological or etiological contributions being specific.
Including existing pre-alcoholic liver disease, hepatitis B and/or C infection, and concomitant use of other potentially hepatotoxic drugs. Although clinically significant hepatic dysfunction is not usually recognized as a manifestation of opiate withdrawal, abruptly precipitated opioid withdrawal may result in systemic consequences, including acute liver injury.
Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they develop symptoms of acute hepatitis. Revia should be discontinued if symptoms and/or signs of acute hepatitis occur.
Depression and suicide
Depression, suicide, suicide attempts, and suicidal ideation were reported in post-marketing experience with REVIA (naltrexone hydrochloride) used in the treatment of opioid dependence. No causal relationship has been proven. In the literature, endogenous opioids have been theorized to contribute to a variety of conditions.
Patients dependent on alcohol and opioids, including those taking REVIA, should be monitored for the development of depression or suicidal ideation. Families and caregivers of patients being treated with REVIA should be alerted to the need to monitor patients for symptoms of depression or suicidality, and to report such symptoms to the patient’s health care provider.
Ultra-rapid withdrawal of opioids
Safe use of REVIA in ultra-fast opiate detoxification programs have not been established (see ADVERSE REACTIONS).
