Buy Revia Online

Revia (naltrexone hydrochloride)

THERAPEUTIC CLASS

Opioid antagonist

DEA CLASS

RX

INDICATIONS

Treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.

ADULT DOSAGE

Alcohol Dependence

Usual: 50mg qd up to 12 weeks

Prior to initiating therapy, an opioid-free interval of a minimum of 7-10 days is recommended for patients previously dependent on short-acting opioids

Alternative Dosing Schedules:
May receive 50mg every weekday w/ a 100mg dose on Saturday, 100mg qod, or 150mg every 3rd day; may reduce the degree of blockade produced by therapy by these extended dosing intervals

Opioid Dependence

For Blockade of Effects of Exogenously Administered Opioids:
Initial: 25mg; if no withdrawal signs occur, may start on 50mg qd thereafter

Prior to initiating therapy, an opioid-free interval of a minimum of 7-10 days is recommended for patients previously dependent on short-acting opioids

Alternative Dosing Schedules:
May receive 50mg every weekday w/ a 100mg dose on Saturday, 100mg qod, or 150mg every 3rd day; may reduce the degree of blockade produced by therapy by these extended dosing intervals

Conversions

Switching from Buprenorphine, Buprenorphine/Naloxone, or Methadone:
Be prepared to manage withdrawal symptomatically w/ nonopioid medications

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 50mg* *scored

CONTRAINDICATIONS

Patient receiving opioid analgesics; currently dependent on opioids, including those currently maintained on opiate agonists (eg, methadone) or partial agonists (eg, buprenorphine); in acute opioid withdrawal; and who has failed the naloxone challenge test or who has a positive urine screen for opioids.

WARNINGS/PRECAUTIONS

Patients may have reduced tolerance to opioids after opioid detoxification; may result in potentially life-threatening opioid intoxication with use of previously tolerated opioid doses. Potential risk of patients attempting to overcome antagonism by taking opioids; may lead to life-threatening opioid intoxication or fatal overdose. Withdrawal syndrome, severe enough to require hospitalization, may occur when withdrawal is precipitated abruptly by the administration of an opioid antagonist to an opioid-dependent patient. Opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free before starting treatment to reduce risk of either precipitated withdrawal in patients dependent on opioids or exacerbation of a preexisting subclinical withdrawal syndrome; an opioid-free interval of a minimum of 7-10 days is recommended for patients previously dependent on short-acting opioids. May experience severe manifestations of precipitated withdrawal when being switched from opioid agonist to opioid antagonist therapy; patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as 2 weeks. A naloxone challenge test may be helpful to determine if patient is opioid-free; however, precipitated withdrawal may occur despite having negative urine toxicology screen or tolerating a naloxone challenge test. Cases of hepatitis, clinically significant liver dysfunction, and transient, asymptomatic hepatic transaminase elevations reported; d/c in the event of symptoms and/or signs of acute hepatitis. Depression, suicide, attempted suicide, and suicidal ideation reported. In emergency situations, suggested plan for pain management is regional analgesia, conscious sedation with benzodiazepine, use of nonopioid analgesics, or general anesthesia. In a situation requiring opioid analgesia, amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged. Rapidly acting opioid analgesic is preferred. Caution with renal or hepatic impairment. Appropriate compliance-enhancing techniques should be implemented for all components of the treatment program.

ADVERSE REACTIONS

N/V, headache, dizziness, nervousness, fatigue, low energy, insomnia, anxiety, difficulty sleeping, abdominal pain/cramps, joint/muscle pain.

DRUG INTERACTIONS

See Contraindications. Concomitant use with other hepatotoxic medications (eg, disulfiram) is not ordinarily recommended unless the probable benefits outweigh the known risks. Lethargy and somnolence reported with thioridazine. Patients may not benefit from opioid-containing medications (eg, cough and cold preparations, antidiarrheal preparations, opioid analgesics).

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Opioid antagonist; markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered opioids.

PHARMACOKINETICS

Absorption: Rapid and nearly complete. Bioavailability (5-40%); Tmax=1 hr (naltrexone and 6-β-naltrexol). Distribution: (IV) Vd=1350L; plasma protein binding (21%). Metabolism: Liver; 6-β-naltrexol (major metabolite). Elimination: Urine (53-79%; <2% unchanged, 43% unchanged/conjugated 6-β-naltrexol), feces; T1/2=4 hrs, 13 hrs (6-β-naltrexol).

ASSESSMENT

Assess for renal/hepatic impairment, any other conditions where treatment is contraindicated or cautioned, pregnancy/nursing status, and possible drug interactions. Assess patients, including patients treated for alcohol dependence, for underlying opioid dependence and for any recent use of opioids.

MONITORING

Monitor for opioid intoxication/overdose, withdrawal syndrome, liver impairment, depression, suicidality, and other adverse reactions.

PATIENT COUNSELING

Instruct to take ud. Advise patient that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose if they use opioids after treatment is discontinued or temporarily interrupted. Advise that patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on therapy. Inform that administration of large doses of heroin or any other opioid to try to bypass the blockade may lead to serious injury, coma, or death. Inform that patient may not experience the expected effects from opioid-containing analgesic, antidiarrheal, or antitussive medications. Instruct to be off all opioids for a minimum of 7-10 days before starting therapy in order to avoid precipitation of opioid withdrawal. Advise not to take therapy if they have any symptoms of opioid withdrawal. Advise all patients, including those with alcohol dependence, to notify physician of any recent use of opioids or any history of opioid dependence before starting therapy. Inform that drug may cause liver injury; instruct to immediately notify physician if symptoms and/or signs of liver disease develop. Inform that depression may be experienced while taking therapy; instruct to contact physician if they become depressed or symptoms of depression are experienced. Advise that therapy has been shown to be effective only when used as part of a treatment program that includes counseling and support. Advise that dizziness may occur; instruct to avoid driving or operating heavy machinery. Advise to notify physician if pregnant or intending to become pregnant during treatment, breastfeeding, or experiencing other unusual or significant side effects while on therapy.

STORAGE

20-25°C (68-77°F). Protect from light.

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