NALBUPHINE HCI injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NALBUPHINE HYDROCHLORIDE (UNII: ZU4275277R) (NALBUPHINE - UNII:L2T84IQI2K)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia Nalbuphine Hydrochloride Injection is contraindicated in patients with: Significant respiratory depression [see WARNINGS] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see

Product summary:

NALBUPHINE HCI INJECTION is supplied in the following dosage forms. NDC 51662-1418-1 NALBUPHINE HCI INJECTION 20mg/mL 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Nalbuphine Hydrochloride Injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALBUPHINE HCI- NALBUPHINE HCI INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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NALBUPHINE HCI INJECTION 20MG/ML 10ML VIAL
SPL UNCLASSIFIED
Injection
Ampul
Fliptop Vial
Protect from light.
Rx only
BOXED WARNING
Life-Threatening Respiratory Depression - Serious, life-threatening,
or fatal respiratory
depression may occur with use of Nalbuphine Hydrochloride Injection,
particularly when used
concomitantly ...
DESCRIPTION
Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist
analgesic of the phenanthrene series.
It is chemically related to both the widely used opioid antagonist,
naloxone, and the potent opioid
analgesic, oxymorphone. Chemically nalbuphine hydrochloride is
17-(cyclobutylmethyl)-4,5α-
epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride
molecular weight is 393.91
and is soluble in H2O (35.5 mg/mL at 25°C) and ethanol (0.8%);
insoluble in CHCl3 and ether.
Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The
molecular formula is C21H27NO4 ·
HCl. The structural formula is:
Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution
of nalbuphine hydrochloride in
water for injection. This product may be administered by subcutaneous,
intramuscular or intravenous
injection.
Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg;
sodium citrate, dihydrate 0.47
mg and citric acid, anhydrous 0.63 mg added as buffers and may contain
sodium hydroxide and/or
hydrochloric acid for pH adjustment; pH 3.7 (3.0 to 4.5). Contains
sodium chloride for tonicity
adjustment.
Multiple-dose vials contain 1.8 mg/mL methylparaben and 0.2 mg/mL
propylparaben added as
preservatives. Single-dose products contain no bacteriostat or
antimicrobial agent and unused portions
must be discarded.
CLINICAL PHARMACOLOGY
Effects on the Endocrine System
Chronic use of opioids may influence the
hypothalamic-pituitary-gonadal axis, leading to androgen
deficiency that may manifest as low libido, impotence, erectile
dysfunction, amenorrhea, or infertility.
The