HYDROMORPHONE HYDROCHLORIDE- hydromorphone hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

HYDROMORPHONE HYDROCHLORIDE

Composition:

HYDROMORPHONE HYDROCHLORIDE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering Hydromorphone Hydrochloride Injection (HPF). Lim

Product summary:

Hydromorphone Hydrochloride Injection Hydromorphone Hydrochloride Injection is supplied in single dose colorless vials. Each mL of sterile, aqueous solution contains 1 mg, 2 mg, or 4 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. Hydromorphone Hydrochloride Injection is preservative free and is supplied as follows: Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] Hydromorphone Hydrochloride Injection (HPF) is supplied in single dose amber vials. Each single dose vial of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. Hydromorphone Hydrochloride Injection (HPF) is preservative free and is supplied as follows: PROTECT FROM LIGHT. Protect from light until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Safety and Handling Instructions Access to drugs with a potential for abuse such as Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.

Authorization status:

New Drug Application

Summary of Product characteristics

HYDROMORPHONE HYDROCHLORIDE - HYDROMORPHONE HYDROCHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE HYDROCHLORIDE
INJECTION AND HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF) SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR HYDROMORPHONE HYDROCHLORIDE INJECTION AND
HYDROMORPHONE
HYDROCHLORIDE INJECTION (HPF).
HYDROMORPHONE HYDROCHLORIDE INJECTION AND
HYDROMORPHONE HYDROCHLORIDE INJECTION [HIGH POTENCY FORMULATION
(HPF)],
FOR INTRAVENOUS, INTRAMUSCULAR, OR SUBCUTANEOUS USE, CII
INITIAL U.S. APPROVAL: JANUARY 1984
RX ONLY
WARNING: RISK OF MEDICATION ERRORS, ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING
RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS
FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT CONFUSE HYDROMORPHONE HYDROCHLORIDE INJECTION [HIGH POTENCY
FORMULATION (HPF)] WITH
STANDARD PARENTERAL FORMULATIONS OF HYDROMORPHONE HYDROCHLORIDE
INJECTION OR OTHER OPIOIDS, AS
OVERDOSE AND DEATH COULD RESULT. (5.1)
HYDROMORPHONE HYDROCHLORIDE INJECTION AND HYDROMORPHONE HYDROCHLORIDE
INJECTION [HIGH
POTENCY FORMULATION (HPF)] EXPOSES USERS TO RISKS OF ADDICTIONS,
ABUSE, AND MISUSE, WHICH CAN LEAD TO
OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND
MONITOR REGULARLY FOR THESE
BEHAVIORS AND CONDITIONS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
PROLONGED USE OF HYDROMORPHONE HYDROCHLORIDE INJECTION OR
HYDROMORPHONE HYDROCHLORIDE
INJECTION [HIGH POTENCY FORMULATION (HPF)] DURING PREGNANCY CAN RESULT
IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED
AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPR