NALMEFENE HYDROCHLORIDE- nalmefene hydrochloride injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NALMEFENE HYDROCHLORIDE (UNII: K7K69QC05X) (NALMEFENE - UNII:TOV02TDP9I)

Available from:

Chengdu Shuode Pharmaceutical Co., Ltd

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose. Nalmefene Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the product. Nalmefene hydrochloride injection is an opioid antagonist with no agonist activity. It has no demonstrated abuse potential, is not addictive, and is not a controlled substance.

Product summary:

Nalmefene Hydrochloride Injection is available in the following presentations: A single-dose vial containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 1 (NDC 82432-101-01) A single-dose vial containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 1 (NDC 82432-102-02) Protect from light, store at 20°C-25°C (68°F to 77°F). [see USP Controlled Room Temperature] Discard unused portion. Manufacturer Chengdu Shuode Pharmaceutical Co., Ltd No. 9 Lekang Road, Shuangliu District Chengdu, Sichuan 610200 China (CHN) Revision date: 06/27/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALMEFENE HYDROCHLORIDE- NALMEFENE HYDROCHLORIDE INJECTION SOLUTION
CHENGDU SHUODE PHARMACEUTICAL CO., LTD
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NALMEFENE HYDROCHLORIDE INJECTION
RX ONLY
DESCRIPTION
Nalmefene Hydrochloride Injection, an opioid antagonist, is a
6-methylene analogue of
naltrexone. The chemical structure is shown below:
Molecular Formula: C
H
NO •HCl•H O
Molecular Weight: 393.91, CAS # 1228646-72-7
Chemical Name:
17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol,
hydrochloride salt, monohydrate
Nalmefene hydrochloride is a white to almost white crystalline powder
which is freely
soluble in water up to 130 mg/mL and slightly soluble in chloroform up
to 0.13 mg/mL,
with a pK of 7.6.
Nalmefene Hydrochloride Injection is available as a sterile solution
for intravenous,
intramuscular, and subcutaneous administration in two concentrations,
containing 100
µg or 1.0 mg of nalmefene free base per mL. The 100 µg/mL
concentration contains
110.8 µg of nalmefene hydrochloride and the 1.0 mg/mL concentration
contains 1.108
mg of nalmefene hydrochloride per mL. Both concentrations contain 9.0
mg of sodium
chloride per mL and the pH is adjusted in the range of 3.3-3.5 with
hydrochloric acid.
Concentrations and dosages of Nalmefene Hydrochloride Injection are
expressed as the
free base equivalent of nalmefene.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Nalmefene hydrochloride injection prevents or reverses the effects of
opioids, including
21
25
3
2
a
respiratory depression, sedation, and hypotension. Pharmacodynamic
studies have
shown that nalmefene hydrochloride injection has a longer duration of
action than
naloxone at fully reversing doses. Nalmefene hydrochloride injection
has no opioid
agonist activity.
Nalmefene hydrochloride injection is not known to produce respiratory
depression,
psychotomimetic effects, or pupillary constriction. No pharmacological
activity was
observed when nalmefene hydrochloride injection was administered in
the absence of
opioid agonists.
Nalmefene hydrochloride injection has not been shown t