REVIA Tablet (2020)

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Περιεχόμενα

Name of the medicinal product

REVIATM (naltrexone hydrochloride).

Indications and clinical use

REVIA (naltrexone hydrochloride) is indicated to provide blockade of the pharmacologic effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified, ...

Contraindications

REVIA (naltrexone hydrochloride) is contraindicated in: Patients receiving opioid analgesics. Patients currently dependent on opioids, including those currently maintained on opiate agonists [eg. Methadone ...

Warnings and precautions

WARNINGS Unintended Precipitation of Withdrawal To prevent occurrence of an acute withdrawalsyndrome,or exacerbation of a preexisting sub-clinical withdrawalsyndrome,patients should remain opioid-free ...

Adverse reactions

While extensive clinical studies evaluating the use of REVIA (naltrexone hydrochloride) in detoxified, formerly opioid dependent individuals failed to identify any single, serious untoward risk of REVIA ...

Dosage and administration

Initiation of REVIA (naltrexone HCI) Therapy DO NOT ATTEMPT TREATMENT WITH REVIA UNLESS, IN THE MEDICAL JUDGEMENT OF THE PRESCRIBING PHYSICIAN, THERE IS NO REASONABLE POSSIBILITY OF OPIOID USE WITHIN THE ...

Overdosage

Symptoms There is limited clinical experience with REVIA (naltrexone hydrochloride) overdosage in humans. In one study, subjects who received 800 mg daily REVIA for up to one week showed no evidence of ...

Action and clinical pharmacology

Pharmacodynamic actions REVIA (naltrexone hydrochloride) is a pure opioid antagonist. It markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered opioids. ...

Storage and stability

Store at controlled room temperature (15°-30°C). Dispense in a tight container as defined in the USP.

Dosage forms, composition and packaging

REVIA (naltrexone hydrochloride) tablets are available as 50 mg, light yellow, capsule-shaped, biconvex, film coated tablet. Debossed with REVIA on one side and 177 on the scored side. Bottles of 50. ...

Pharmaceutical information

Drug Substance Proper Name:Naltrexone Hydrochloride Chemical Names: Morphinan-6-one,17-(cyclopropylmethyl)-4,5-epoxy-3,14- dihydroxy,(5α)- 17-(Cyclopropylmethyl)-4,5a-epoxy-3,14-dihydroxymorphinan-6-one ...

Detailed pharmacology

REVIA (naltrexone hydrochloride), an opioid antagonist is a synthetic congener of oxymorphone, and differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl ...

Clinical trials

Treatment of Opioid Addiction REVIA has been shown to produce complete blockade of the euphoric effects of opioids in both volunteer and addict populations. When administered by means that enforce compliance, ...

Toxicology

Test parameters and drug-related findings of toxicology studies carried out with naltrexone are summarized in the following table: Acute Toxicity Dose (mg/kg) Drug-Related Findings<br>LD<sub>50</sub> ...

Marketing authorization holder

Teva Canada Limited, 30 Novopharm Court, Toronto, ON M1B 2K9, Canada, www.tevacanada.com

Submission control number

234458

Date of revision

July 16, 2020

References

Altshuler HL, Phillips PE, Feinhandler DA. Alterations of ethanol self-administration by naltrexone. Life Sci. 1980; 26: 679-688. 2. Armeanu M, Berkhout GMJ, Schoemaker J. Pulsatile luteinizing hormone ...

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