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Drug overview for NALTREXONE HCL (naltrexone hcl):
Generic name: NALTREXONE HCL (nal-TREX-one)
Drug class: Opioid Antagonists
Therapeutic class: Chemical Dependency, Agents to Treat
Naltrexone is essentially a pure opiate antagonist.
No enhanced Uses information available for this drug.
Generic name: NALTREXONE HCL (nal-TREX-one)
Drug class: Opioid Antagonists
Therapeutic class: Chemical Dependency, Agents to Treat
Naltrexone is essentially a pure opiate antagonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
NALTREXONE 50 MG TABLET
The following indications for NALTREXONE HCL (naltrexone hcl) have been approved by the FDA:
Indications:
Alcohol use disorder
Prevention of relapse to opioid dependence
Professional Synonyms:
Alcohol addiction
Alcohol dependence
Alcoholism
Indications:
Alcohol use disorder
Prevention of relapse to opioid dependence
Professional Synonyms:
Alcohol addiction
Alcohol dependence
Alcoholism
The following dosing information is available for NALTREXONE HCL (naltrexone hcl):
Prior to initiation of naltrexone therapy in patients physically dependent on opiates, detoxification should be completed. Because of the risk of precipitating opiate withdrawal (see Cautions: Opiate Withdrawal), the manufacturers recommend that a period of at least 7-10 days elapse between discontinuance of opiates and initiation of naltrexone therapy. This period varies depending on the dose and duration of the opiate used, and some clinicians recommend at least 7 days in patients using relatively short-acting opiates (e.g., heroin, hydromorphone, meperidine, morphine) and at least 10-14 days in those using longer-acting opiates (e.g., methadone).
Because of the risk of relapse to drug abuse during this period, shorter periods of opiate abstinence (e.g., 2-5 days) prior to initiation of naltrexone therapy have been used in some patients. Alternatively, clonidine has been used concomitantly with naltrexone during initiation of therapy to minimize symptoms of opiate withdrawal. Some clinicians have cautiously precipitated withdrawal using repeated naloxone injections and then rapidly initiated naltrexone therapy with incremental doses of the drug; this procedure can reduce the transition period from opiate dependence to naltrexone maintenance and generally is well accepted by patients.
Detoxification from opiates may be accomplished in an outpatient or supervised (e.g., hospital) setting. Detoxification in a supervised setting permits closer monitoring of patients during withdrawal, control over access to illicit drugs, and the opportunity to initiate naltrexone therapy during the period when the tendency to relapse to drug abuse may be greatest. Regardless of the setting for detoxification, it generally is preferable to detoxify the patient from all drugs on which they are dependent before initiating naltrexone therapy.
In addition to patient verification of abstinence from opiates, urinalysis should be performed after the minimum 7- to 10-day waiting period, but prior to administration of naltrexone, to confirm the absence of opiates. If urinary determination is negative, a naloxone challenge test should be performed prior to administering naltrexone if the clinician believes there is a risk of precipitating a withdrawal reaction following administration of naltrexone.
Because of the risk of relapse to drug abuse during this period, shorter periods of opiate abstinence (e.g., 2-5 days) prior to initiation of naltrexone therapy have been used in some patients. Alternatively, clonidine has been used concomitantly with naltrexone during initiation of therapy to minimize symptoms of opiate withdrawal. Some clinicians have cautiously precipitated withdrawal using repeated naloxone injections and then rapidly initiated naltrexone therapy with incremental doses of the drug; this procedure can reduce the transition period from opiate dependence to naltrexone maintenance and generally is well accepted by patients.
Detoxification from opiates may be accomplished in an outpatient or supervised (e.g., hospital) setting. Detoxification in a supervised setting permits closer monitoring of patients during withdrawal, control over access to illicit drugs, and the opportunity to initiate naltrexone therapy during the period when the tendency to relapse to drug abuse may be greatest. Regardless of the setting for detoxification, it generally is preferable to detoxify the patient from all drugs on which they are dependent before initiating naltrexone therapy.
In addition to patient verification of abstinence from opiates, urinalysis should be performed after the minimum 7- to 10-day waiting period, but prior to administration of naltrexone, to confirm the absence of opiates. If urinary determination is negative, a naloxone challenge test should be performed prior to administering naltrexone if the clinician believes there is a risk of precipitating a withdrawal reaction following administration of naltrexone.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NALTREXONE 50 MG TABLET | Maintenance | Adults take 1 tablet (50 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NALTREXONE 50 MG TABLET | Maintenance | Adults take 1 tablet (50 mg) by oral route once daily |
The following drug interaction information is available for NALTREXONE HCL (naltrexone hcl):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Opioid Antagonists/Opioid Analgesics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Naltrexone, nalmefene, and samidorphan are opioid antagonists and thus inhibit the effects of opioid analgesics.(1-3) CLINICAL EFFECTS: Concurrent administration or the administration of naltrexone within 7-10 days of opioids may induce acute abstinence syndrome or exacerbate a pre-existing subclinical abstinence syndrome.(1,4) Patients taking naltrexone may not experience beneficial effects of opioid-containing medications.(4) Samidorphan can precipitate opioid withdrawal in patients who are dependent on opioids. In patients who use opioids, delay initiation of samidorphan for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids.(3) Concurrent use of nalmefene tablets with opioid agonists may prevent the beneficial effects of the opioid.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of naltrexone states that the administration of naltrexone concurrently with opioids or to patients dependent on opioids is contraindicated.(1,4) Patients previously dependent on short-acting opioids should be opioid-free for a minimum of seven to ten days before beginning naltrexone therapy. Patients previously on buprenorphine or methadone may be vulnerable to withdrawal symptoms for as long as 2 weeks.(1,4) The manufacturer of naltrexone states that the naloxone challenge test, described in the naltrexone prescribing information, can be administered to determine if patients are opioid free.(1) The manufacturer of samidorphan states the concurrent use of samidorphan in patients using opioids or undergoing acute opioid withdrawal is contraindicated. Prior to initiating samidorphan, there should be at least a 7-day opioid free interval from the last use of short-acting opioids, and at least a 14-day opioid free interval from the last use of long-acting opioids.(3) The UK manufacturer of nalmefene tablets (for reduction of alcohol consumption) states the concurrent use of opioid analgesics is contraindicated.(2) Suspend the use of nalmefene tablets for 7 days prior to the anticipated use of opioids (e.g., elective surgery).(2) DISCUSSION: A double-blind, randomized, placebo-control study evaluated pain relief and side effects of 35 opioid-naive patients undergoing cesarean section. All patients received spinal anesthesia (bupivacaine and morphine) and were randomized to also receive placebo, naltrexone 3 mg, or naltrexone 6 mg. Patients treated with naltrexone experienced shorter duration of pain relief (not statistically significant), however incidence of opioid-induced side effects was reduced. Patients in the naltrexone 6 mg group had lower rates of pruritus, vomiting, and somnolence (all statistically significant) compared to the placebo group.(5) In a double-blind, randomized, placebo-control trial ten recreational opioid users were studied to determine the effects of hydromorphone (4 mg and 16 mg), tramadol (87.5 mg, 175 mg, and 350 mg), and placebo after pretreatment with naltrexone (50 mg) or placebo. Results show that lower doses of hydromorphone and tramadol acted similar to placebo. Hydromorphone 16 mg alone caused euphoria and miosis which were blocked by naltrexone. Tramadol 350 mg produced a lower magnitude of euphoria and miosis compared to hydromorphone. Naltrexone partially diminished the euphoria caused by tramadol, while it enhanced some of the unpleasant monoaminergic effects (flushing, malaise, vomiting).(6) A case report describes a 28 year-old ex-heroin addict who was stable on methadone 100 mg daily and simultaneously stopped using heroin and began drinking alcohol. He was admitted to the hospital for alcohol detoxification and, by mistake, was given naltrexone 100 mg instead of methadone 100 mg. The patient experienced withdrawal symptoms including chills, agitation, muscle and abdominal pain, generalized piloerection, and dilated pupils. Treatment of withdrawal was titrated to treat symptoms and required administration 78 mg of parenteral hydromorphone, after which the patient experienced relief for the following six hours.(8) Intentional administration of an opioid antagonist, naloxone, with opioid analgesics has been performed with close monitoring to lower required opioid dose by inducing withdrawal. Three case reports describe patients who had improved pain relief on significantly reduced doses of opioid analgesics.(8) In a double-blind controlled trial, 267 trauma patients were randomized to receive 0.05 mg/kg intravenous morphine either alone or in combination with 5 mg naltrexone oral suspension. Evaluated endpoints include reduction of pain and incidence of side effects. Results indicate that ultra-low dose naltrexone does not alter opioid requirements for pain control, but does lower incidence of nausea [2 (1.16%) vs 16 (11.6%), p<0.001].(9) |
ACETAMIN-CAFF-DIHYDROCODEINE, ACETAMINOPHEN-CODEINE, APADAZ, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BELBUCA, BELLADONNA-OPIUM, BENZHYDROCODONE-ACETAMINOPHEN, BRIXADI, BUPRENORPHINE, BUPRENORPHINE HCL, BUPRENORPHINE-NALOXONE, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTORPHANOL TARTRATE, BUTRANS, CARISOPRODOL-ASPIRIN-CODEINE, CODEINE PHOSPHATE, CODEINE SULFATE, CONZIP, DEMEROL, DIHYDROCODEINE BITARTRATE, DILAUDID, DIPHENOXYLATE-ATROPINE, DISKETS, DSUVIA, DURAMORPH, ENDOCET, FENTANYL, FENTANYL CITRATE, FENTANYL CITRATE-0.9% NACL, FENTANYL CITRATE-D5W, FENTANYL CITRATE-STERILE WATER, FENTANYL CITRATE-WATER, FENTANYL-BUPIVACAINE-0.9% NACL, FENTANYL-BUPIVACAINE-NACL, FENTANYL-ROPIVACAINE-0.9% NACL, FENTANYL-ROPIVACAINE-NACL, FIORICET WITH CODEINE, HYCODAN, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE ER, HYDROCODONE-ACETAMINOPHEN, HYDROCODONE-CHLORPHENIRAMNE ER, HYDROCODONE-HOMATROPINE MBR, HYDROCODONE-IBUPROFEN, HYDROMET, HYDROMORPHONE ER, HYDROMORPHONE HCL, HYDROMORPHONE HCL-0.9% NACL, HYDROMORPHONE HCL-D5W, HYDROMORPHONE HCL-NACL, HYDROMORPHONE HCL-WATER, HYSINGLA ER, INFUMORPH, LEVORPHANOL TARTRATE, LOMOTIL, MEPERIDINE HCL, MEPERIDINE HCL-0.9% NACL, METHADONE HCL, METHADONE HCL-0.9% NACL, METHADONE HCL-NACL, METHADONE INTENSOL, METHADOSE, MITIGO, MORPHINE SULFATE, MORPHINE SULFATE ER, MORPHINE SULFATE-0.9% NACL, MORPHINE SULFATE-NACL, MOTOFEN, MS CONTIN, NALBUPHINE HCL, NALOCET, NUCYNTA, NUCYNTA ER, OLINVYK, OPIUM TINCTURE, OXYCODONE HCL, OXYCODONE HCL ER, OXYCODONE HYDROCHLORIDE, OXYCODONE-ACETAMINOPHEN, OXYCONTIN, OXYMORPHONE HCL, OXYMORPHONE HCL ER, PENTAZOCINE-NALOXONE HCL, PERCOCET, PRIMLEV, PROLATE, PROMETHAZINE-CODEINE, QDOLO, REMIFENTANIL HCL, ROXICODONE, ROXYBOND, SUBLOCADE, SUBOXONE, SUFENTANIL CITRATE, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN, TREZIX, TUXARIN ER, ULTIVA, XTAMPZA ER, ZUBSOLV |
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for NALTREXONE HCL (naltrexone hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Acute hepatic failure |
| Opioid use last 4 hours in narcotic-dependent patient |
| Opioid withdrawal symptoms |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute hepatitis |
| Depression |
| Eosinophilic pneumonia |
| Suicidal ideation |
There are 0 moderate contraindications.
The following adverse reaction information is available for NALTREXONE HCL (naltrexone hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 30 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Allergic dermatitis Angioedema Skin rash |
None. |
| Rare/Very Rare |
|---|
|
Abnormal ECG Abnormal hepatic function tests Acute cognitive impairment Altered mental status Blurred vision Depression Drug-induced hepatitis Dyspnea Dysuria Earache Epistaxis Fever Gastrointestinal ulcer Hallucinations Hypertension Idiopathic thrombocytopenic purpura Increased urinary frequency Lymphadenopathy Mood changes Ocular inflammation Ocular irritation Ocular pain Phlebitis Pruritus of skin Sleep apnea Suicidal ideation Tinnitus |
There are 31 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal pain with cramps Arthralgia Fatigue Headache disorder Insomnia Myalgia Nausea Symptoms of anxiety Vomiting |
Anorexia Chills Constipation Cough Diarrhea Dizziness Hoarseness Irritability Nasal congestion Nervousness Polydipsia Rhinorrhea Sinusitis Sneezing Sore throat Tachycardia |
| Rare/Very Rare |
|---|
|
Drowsy Edema Erectile dysfunction Muscle fasciculation Palpitations Tremor |
The following precautions are available for NALTREXONE HCL (naltrexone hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
In reproduction studies in rats and rabbits, oral naltrexone was shown to increase the incidence of early fetal loss. There are no adequate and controlled studies to date using naltrexone in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. It is not known whether naltrexone affects the duration of labor and delivery.
Naltrexone and its major metabolite, 6-beta-naltrexol, are distributed into human milk. Because of the potential for serious adverse effects in nursing infants, a decision should be make whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for NALTREXONE HCL (naltrexone hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NALTREXONE HCL (naltrexone hcl)'s list of indications:
| Alcohol use disorder | |
| F10.1 | Alcohol abuse |
| F10.10 | Alcohol abuse, uncomplicated |
| F10.12 | Alcohol abuse with intoxication |
| F10.120 | Alcohol abuse with intoxication, uncomplicated |
| F10.121 | Alcohol abuse with intoxication delirium |
| F10.129 | Alcohol abuse with intoxication, unspecified |
| F10.13 | Alcohol abuse, with withdrawal |
| F10.130 | Alcohol abuse with withdrawal, uncomplicated |
| F10.131 | Alcohol abuse with withdrawal delirium |
| F10.132 | Alcohol abuse with withdrawal with perceptual disturbance |
| F10.139 | Alcohol abuse with withdrawal, unspecified |
| F10.14 | Alcohol abuse with alcohol-induced mood disorder |
| F10.15 | Alcohol abuse with alcohol-induced psychotic disorder |
| F10.150 | Alcohol abuse with alcohol-induced psychotic disorder with delusions |
| F10.151 | Alcohol abuse with alcohol-induced psychotic disorder with hallucinations |
| F10.159 | Alcohol abuse with alcohol-induced psychotic disorder, unspecified |
| F10.18 | Alcohol abuse with other alcohol-induced disorders |
| F10.180 | Alcohol abuse with alcohol-induced anxiety disorder |
| F10.181 | Alcohol abuse with alcohol-induced sexual dysfunction |
| F10.182 | Alcohol abuse with alcohol-induced sleep disorder |
| F10.188 | Alcohol abuse with other alcohol-induced disorder |
| F10.19 | Alcohol abuse with unspecified alcohol-induced disorder |
| F10.2 | Alcohol dependence |
| F10.20 | Alcohol dependence, uncomplicated |
| F10.22 | Alcohol dependence with intoxication |
| F10.220 | Alcohol dependence with intoxication, uncomplicated |
| F10.221 | Alcohol dependence with intoxication delirium |
| F10.229 | Alcohol dependence with intoxication, unspecified |
| F10.23 | Alcohol dependence with withdrawal |
| F10.230 | Alcohol dependence with withdrawal, uncomplicated |
| F10.231 | Alcohol dependence with withdrawal delirium |
| F10.232 | Alcohol dependence with withdrawal with perceptual disturbance |
| F10.239 | Alcohol dependence with withdrawal, unspecified |
| F10.24 | Alcohol dependence with alcohol-induced mood disorder |
| F10.25 | Alcohol dependence with alcohol-induced psychotic disorder |
| F10.250 | Alcohol dependence with alcohol-induced psychotic disorder with delusions |
| F10.251 | Alcohol dependence with alcohol-induced psychotic disorder with hallucinations |
| F10.259 | Alcohol dependence with alcohol-induced psychotic disorder, unspecified |
| F10.26 | Alcohol dependence with alcohol-induced persisting amnestic disorder |
| F10.27 | Alcohol dependence with alcohol-induced persisting dementia |
| F10.28 | Alcohol dependence with other alcohol-induced disorders |
| F10.280 | Alcohol dependence with alcohol-induced anxiety disorder |
| F10.281 | Alcohol dependence with alcohol-induced sexual dysfunction |
| F10.282 | Alcohol dependence with alcohol-induced sleep disorder |
| F10.288 | Alcohol dependence with other alcohol-induced disorder |
| F10.29 | Alcohol dependence with unspecified alcohol-induced disorder |
| Prevention of relapse to opioid dependence | |
| F11.11 | Opioid abuse, in remission |
| F11.21 | Opioid dependence, in remission |
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