The prescribing information for naltrexone hydrochloride tablets, USP 50 mg, says the 50 mg tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. For the 50 mg tablet, its dosage section for alcoholism recommends 50 mg once daily for most patients. It also says opioid-dependent patients should be opioid-free before starting the 50 mg tablet. This guide is about the 50 mg tablet only. It is not about low-dose naltrexone.
What the 50 mg tablet is for
The label for the 50 mg tablet describes naltrexone as an opioid antagonist that is a synthetic congener of oxymorphone with no opioid agonist properties. Its clinical pharmacology section says naltrexone hydrochloride is a pure opioid antagonist that markedly attenuates or completely blocks, reversibly, the subjective effects of opioids. It says the 50 mg tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. It also says the safe use of naltrexone hydrochloride in pediatric patients younger than 18 years old has not been established.
For the approval record, Drugs@FDA lists 11/20/1984 as the date of the original approval action for NDA 018932 (Revia, naltrexone hydrochloride 50 mg tablets). That date belongs to the 50 mg tablet application record. It is not a date for any low-dose use.
How the label doses the 50 mg tablet
| Question | What the 50 mg tablet label says |
|---|---|
| Strength | The label says the product is available as film-coated tablets containing 50 mg of naltrexone hydrochloride. |
| Dose for alcoholism | The dosage section for treatment of alcoholism says a dose of 50 mg once daily is recommended for most patients. |
| What its studies tested | The label says its placebo-controlled alcoholism studies used 50 mg once daily for up to 12 weeks, and that other dose regimens or durations of therapy were not evaluated in those trials. |
The opioid-free requirement before starting
For the 50 mg tablet, the label says opioid-dependent patients should be opioid-free (including tramadol) before starting treatment. It says an opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids.
The label also reminds clinicians that there is no completely reliable method for determining whether a patient has had an adequate opioid-free period. It says a naloxone challenge test may be helpful if there is any question of occult opioid dependence. These statements are about the 50 mg tablet.
What the label tells prescribers to say to patients
The information for patients section of the label for the 50 mg tablet says to advise patients that naltrexone hydrochloride has been shown to be effective only when used as part of a treatment program that includes counseling and support. It also says to advise all patients, including those with alcohol dependence, that it is imperative to notify healthcare providers of any recent use of opioids or any history of opioid dependence before starting naltrexone hydrochloride to avoid precipitation of opioid withdrawal.
The same section says to advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids after naltrexone hydrochloride treatment is discontinued or temporarily interrupted. These statements are for the 50 mg tablet. They are not about low-dose naltrexone.
What this does not tell you
These are statements from one label for the 50 mg tablet. They do not tell you what applies to low-dose naltrexone. The passages used here do not address low-dose use, and this guide does not say whether the rest of the label does. The label's dose, warnings and adverse reaction rates are for the 50 mg tablet and should not be read as figures for any other dose.
The 50 mg tablet label describes an FDA-approved tablet. An FDA questions-and-answers page states that compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. A licensed provider decides what is appropriate for a person, and the label tells prescribers to advise patients to notify healthcare providers of any recent use of opioids.