DILAUDID- hydromorphone hydrochloride injection, solution DILAUDID HP- hydromorphone hydrochloride injection, solution DILAUDI

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

hydromorphone hydrochloride (UNII: L960UP2KRW) (hydromorphone - UNII:Q812464R06)

Διαθέσιμο από:

Purdue Pharma LP

INN (Διεθνής Όνομα):

hydromorphone hydrochloride

Σύνθεση:

hydromorphone hydrochloride 1 mg in 1 mL

Οδός χορήγησης:

INTRAMUSCULAR

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. DILAUDID-HP INJECTION 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 DILAUDID-HP. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommen

Περίληψη προϊόντος:

DILAUDID INJECTION DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each 1 mL pre-filled syringe of sterile, aqueous solution contains 1 mg, 2 mg, or 4 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 1 mg/mL pre-filled disposable syringe, NDC 76045-009-10 2mg/mL pre-filled disposable syringe, NDC 76045-010-10 4mg/mL pre-filled disposable syringe, NDC 76045-011-10 Available in a carton of twenty-four (24) syringes for each strength. DILAUDID-HP INJECTION DILAUDID-HP INJECTION (hydromorphone hydrochloride) is supplied in clear pre-filled syringes with a dark grey plunger rod. Each 1 mL pre-filled syringe of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID-HP INJECTION contains no added preservative and is supplied as follows: 10mg/mL pre-filled disposable syringe, NDC 76045-012-10 Available in a carton of twenty-four (24) syringes. 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 DILAUDID INJECTION and DILAUDID-HP INJECTION 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.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

DILAUDID- HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION
DILAUDID HP- HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION
DILAUDID HP- HYDROMORPHONE HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
PURDUE PHARMA LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DILAUDID INJECTION AND DILAUDID-
HP INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DILAUDID® INJECTION AND
DILAUDID-HP INJECTION.
DILAUDID INJECTION (HYDROMORPHONE HYDROCHLORIDE) AND DILAUDID-HP
INJECTION (HYDROMORPHONE
HYDROCHLORIDE), FOR INTRAVENOUS, INTRAMUSCULAR, OR SUBCUTANEOUS USE,
CII
INITIAL U.S. APPROVAL: JANUARY 1984
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 DILAUDID-HP INJECTION WITH STANDARD PARENTERAL
FORMULATIONS OF DILAUDID
INJECTION OR OTHER OPIOIDS, AS OVERDOSE AND DEATH COULD RESULT. (5.1)
DILAUDID INJECTION AND DILAUDID-HP INJECTION 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 DILAUDID INJECTION OR DILAUDID-HP INJECTION 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 APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUN