HYDROMORPHONE (NEXJECT) Drug Abuse and Dependence

(hydromorphone hydrochloride injection, USP)

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Hydromorphone Hydrochloride Injection contains hydromorphone, a Schedule II controlled substance.

9.2 Abuse

Hydromorphone Hydrochloride Injection contains hydromorphone, a substance with high potential for misuse and abuse, which can lead to the development of ‎substance use disorder, including addiction [see Warnings and Precautions (5.1)].

Misuse is the intentional use, for therapeutic purposes, of a drug by an ‎individual in a way other than ‎‎prescribed by a healthcare provider or for ‎whom it was not prescribed.‎

Abuse is the intentional non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug, use despite harmful consequences, giving a higher priority to drug use than to other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of Hydromorphone Hydrochloride Injection increases ‎risk of overdose, which may lead to ‎central nervous system and ‎respiratory depression, hypotension, seizures, and death. The risk is ‎increased with ‎concurrent abuse of Hydromorphone Hydrochloride ‎Injection with alcohol and/or other CNS ‎depressants.‎ Abuse of and addiction to opioids in some individuals may not be ‎accompanied by concurrent ‎tolerance and symptoms of physical ‎dependence. In addition, abuse of opioids can occur in the absence of ‎‎addiction.‎

All patients treated with opioids require careful and frequent reevaluation ‎for signs of misuse, abuse, and ‎addiction, because use of opioid analgesic ‎products carries the risk of addiction even under appropriate ‎medical use. ‎Patients at high risk of Hydromorphone Hydrochloride Injection abuse ‎include those with a ‎history of prolonged use of any opioid, including products containing ‎hydromorphone, those with a history of drug or alcohol abuse, ‎or those ‎who use Hydromorphone Hydrochloride Injection in combination with ‎other abused drugs.‎

"Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control.

Hydromorphone Hydrochloride Injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of Hydromorphone Hydrochloride Injection

Abuse of Hydromorphone Hydrochloride Injection poses a risk of overdose and death. The risk is increased with concurrent use of Hydromorphone Hydrochloride Injection with alcohol and/or other CNS depressants.

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

9.3 Dependence

Both tolerance and physical dependence can develop during use of opioid therapy.

Tolerance is a physiological state characterized by a reduced response to ‎a drug after repeated administration (i.e., a ‎higher ‎dose of a drug is ‎required to produce the same effect that was once obtained at a lower ‎dose).‎

Physical dependence is a state that develops as a result of a physiological ‎adaptation in response to repeated drug use, ‎manifested ‎by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid use.

Hydromorphone Hydrochloride Injection should not be abruptly discontinued in a physically-dependent patient [see Dosage and Administration (2.6)]. If Hydromorphone Hydrochloride Injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically ‎characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically-dependent on opioids will also be physically-dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)].

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Drug Abuse and Dependence

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Hydromorphone Hydrochloride Injection contains hydromorphone, a Schedule II controlled substance.

9.2 Abuse

Hydromorphone Hydrochloride Injection contains hydromorphone, a substance with high potential for misuse and abuse, which can lead to the development of ‎substance use disorder, including addiction [see Warnings and Precautions (5.1)].

Misuse is the intentional use, for therapeutic purposes, of a drug by an ‎individual in a way other than ‎‎prescribed by a healthcare provider or for ‎whom it was not prescribed.‎

Abuse is the intentional non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug, use despite harmful consequences, giving a higher priority to drug use than to other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of Hydromorphone Hydrochloride Injection increases ‎risk of overdose, which may lead to ‎central nervous system and ‎respiratory depression, hypotension, seizures, and death. The risk is ‎increased with ‎concurrent abuse of Hydromorphone Hydrochloride ‎Injection with alcohol and/or other CNS ‎depressants.‎ Abuse of and addiction to opioids in some individuals may not be ‎accompanied by concurrent ‎tolerance and symptoms of physical ‎dependence. In addition, abuse of opioids can occur in the absence of ‎‎addiction.‎

All patients treated with opioids require careful and frequent reevaluation ‎for signs of misuse, abuse, and ‎addiction, because use of opioid analgesic ‎products carries the risk of addiction even under appropriate ‎medical use. ‎Patients at high risk of Hydromorphone Hydrochloride Injection abuse ‎include those with a ‎history of prolonged use of any opioid, including products containing ‎hydromorphone, those with a history of drug or alcohol abuse, ‎or those ‎who use Hydromorphone Hydrochloride Injection in combination with ‎other abused drugs.‎

"Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control.

Hydromorphone Hydrochloride Injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of Hydromorphone Hydrochloride Injection

Abuse of Hydromorphone Hydrochloride Injection poses a risk of overdose and death. The risk is increased with concurrent use of Hydromorphone Hydrochloride Injection with alcohol and/or other CNS depressants.

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

9.3 Dependence

Both tolerance and physical dependence can develop during use of opioid therapy.

Tolerance is a physiological state characterized by a reduced response to ‎a drug after repeated administration (i.e., a ‎higher ‎dose of a drug is ‎required to produce the same effect that was once obtained at a lower ‎dose).‎

Physical dependence is a state that develops as a result of a physiological ‎adaptation in response to repeated drug use, ‎manifested ‎by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid use.

Hydromorphone Hydrochloride Injection should not be abruptly discontinued in a physically-dependent patient [see Dosage and Administration (2.6)]. If Hydromorphone Hydrochloride Injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically ‎characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically-dependent on opioids will also be physically-dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)].

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