NALMEFENE HYDROCHLORIDE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Purdue Pharma L.P.

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Nalmefene hydrochloride injection is available in the following presentation: A single-dose vial containing 2 mg/2 mL (1 mg/mL) of nalmefene base. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in original carton. Protect from light. Discard unused portion. For additional information, contact Purdue Pharma's Medical Services Department @ 1-888-726-7535.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NALMEFENE HYDROCHLORIDE- NALMEFENE HYDROCHLORIDE INJECTION, SOLUTION
PURDUE PHARMA L.P.
----------
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
Molecular Weight: 375.9, CAS # 58895-64-0
Chemical Name:
17-(Cyclopropylmethyl)-4,5_a_-epoxy-6-methylenemorphinan-3,14-diol,
hydrochloride salt.
Nalmefene hydrochloride is a white to off-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 concentration of 1
mg of nalmefene
free base per mL. The 1 mg/mL concentration contains 1.108 mg of
nalmefene
hydrochloride per mL, 9.0 mg of sodium chloride per mL, and the pH is
adjusted to 3.9
with hydrochloric acid.
Concentration and dosage 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
respiratory depression, sedation, and hypotension. Pharmacodynamic
studies have
shown that Nalmefene hydrochloride injection has a longer duration of
action than
21
25
3
a
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 to produce
tolerance, physical
dependence, or abuse potential.
Nalmefene hydrochloride injection can produce acute withdrawal
symptoms in individuals
who are opioid dependent.
PHARMACOKINETICS
Nalmef