Hydromorphone Hydrochloride

HYDROMORPHONE HYDROCHLORIDE — hydromorphone hydrochloride tablet
Elite Laboratories, Inc.

hydromorphone-100 count

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Hydromorphone Hydrochloride Tablets, USP expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Hydromorphone Hydrochloride Tablets, USP, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addition, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.2) ]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Hydrochloride Tablets, USP. Monitor for respiratory depression, especially during initiation of Hydromorphone Hydrochloride Tablets, USP or following a dose increase [see Warnings and Precautions (5.3)].

Accidental Ingestion

Accidental ingestion of even one dose of Hydromorphone Hydrochloride Tablets, USP, especially by children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.3)]

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Hydromorphone Hydrochloride Tablets, USP during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4)]

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.5), Drug Interactions (7) ].

• Reserve concomitant prescribing of Hydromorphone Hydrochloride Tablets, USP and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

• Limit dosages and durations to the minimum required.

• Follow patients for signs and symptoms of respiratory depression and sedation.

1 INDICATIONS & USAGE& USAGE

Hydromorphone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve Hydromorphone Hydrochloride Tablets, USP for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

• Have not been tolerated, or are not expected to be tolerated,

• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

2 DOSAGE & ADMINISTRATION& ADMINISTRATION

2.1 Important Dosage and Administration Instructions

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

• Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].

• Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Hydromorphone Hydrochloride Tablets, USP and adjust the dosage accordingly [see Warnings and Precautions (5.3)].

2.2 Initial Dosage

Initiating Treatment with Hydromorphone Hydrochloride Tablets

Hydromorphone Hydrochloride Tablets

Initiate treatment with Hydromorphone Hydrochloride Tablets 8 mg, orally, every 12 hours.

Conversion from Other Opioids to Hydromorphone Hydrochloride Tablets, USP

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydromorphone Hydrochloride Tablets, USP. It is safer to underestimate a patient’s 24-hour Hydromorphone Hydrochloride dosage than to overestimate the 24-hour dosage and manage an adverse reaction due to overdose.

In general, it is safest to start Hydromorphone Hydrochloride therapy by administering half of the usual starting dose every 4-6 hours for Hydromorphone Hydrochloride Tablets, USP. The dose of Hydromorphone Hydrochloride can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved [See Dosage and Administration (2.4)].

Conversion from Hydromorphone Hydrochloride Tablets, USP to Extended-Release Hydromorphone Hydrochloride

The relative bioavailability of Hydromorphone Hydrochloride Tablets, USP compared to extended-release hydromorphone hydrochloride is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.

2.3 Dosage Modifications in Patients with Hepatic Impairment

Initiate treatment with one-fourth to one-half the usual Hydromorphone Hydrochloride starting dose depending on the degree of impairment [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

2.4 Dosage Modifications in Patients with Renal Impairment

Initiate treatment with one-fourth to one-half the usual Hydromorphone Hydrochloride starting dose depending on the degree of impairment [see Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

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