NALOXONE HYDROCHLORIDE injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Доступна с:

General Injectables & Vaccines, Inc

ИНН (Международная Имя):

NALOXONE HYDROCHLORIDE

состав:

NALOXONE HYDROCHLORIDE 1 mg in 1 mL

Администрация маршрут:

PARENTERAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including, propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine and butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock. (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock). Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to it or to any of the other ingredients in naloxone hydrochloride. Naloxone hydrochloride is an opioid antagonist. Physical dependence associated with the use of naloxone hydrochloride has not been reported. Tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur.

Обзор продуктов:

1 mg/mL naloxone hydrochloride injection USP, for intravenous, intramuscular and subcutaneous administration. Available as follows: 1 mg/mL 2 mL single dose disposable prefilled syringes, in the MIN-I-JET® system with 21 G. x 11/2” needle. Shrink Wrapped Packages of 10. NDC 76329-1469-1 Stock No. 1469 (contains no preservative) 2 mL single dose disposable Luer-JetTM Luer-Lock Prefilled Syringe. Shrink Wrapped Packages of 10. NDC 76329-3369-1 Stock No. 3369 (contains no preservative) Syringe Assembly Directions: The MIN-I-JET® syringe with needle, illustrated below, is the basic unit upon which all the other syringe systems are built; slight adaptations and/ or additional auxiliary parts create the other syringe systems. Assembly directions remain essentially the same. USE ASEPTIC TECHNIQUE Do not assemble until ready to use.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION
GENERAL INJECTABLES & VACCINES, INC
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NALOXONE HYDROCHLORIDE INJECTION, USP
OPIOID ANTAGONIST
RX ONLY
DESCRIPTION
NALOXONE HYDROCHLORIDE
INJECTION, USP
Opioid Antagonist
Rx Only
Naloxone hydrochloride, an opioid antagonist, is a synthetic congener
of oxymorphone.
In structure it differs from oxymorphone in that the methyl group on
the nitrogen atom
is replaced by an allyl group.
NALOXONE HYDROCHLORIDE
(-)-17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
Naloxone hydrochloride occurs as a white to slightly off-white powder,
and is soluble in
water, in dilute acids, and in strong alkali; slightly soluble in
alcohol; practically insoluble in
ether and in chloroform.
Naloxone Hydrochloride Injection is available as a sterile solution
for intravenous,
intramuscular and subcutaneous administration in 1 mg/mL
concentration. pH is
adjusted to 3.5 ± 0.5 with hydrochloric acid. Each mL also contains
8.35 mg of sodium
chloride. Naloxone Hydrochloride Injection is preservative-free.
CLINICAL PHARMACOLOGY
Complete or Partial Reversal of Opioid Depression
Naloxone hydrochloride prevents or reverses the effects of opioids
including respiratory
depression, sedation, and hypotension. Also, it can reverse the
psychotomimetic and
dysphoric effects of agonist-antagonist such as pentazocine.
Naloxone hydrochloride is an essentially pure opioid antagonist, i.e.,
it does not possess
the “agonistic” or morphine-like properties characteristic of
other opioid antagonists.
When administered in usual doses and in the absence of opioids or
agonistic effects of
other opioid antagonists, it exhibits essentially no pharmacologic
activity.
Naloxone hydrochloride has not been shown to produce tolerance or
cause physical or
psychological dependence. In the presence of physical dependence on
opioids, naloxone
hydrochloride will produce withdrawal symptoms. However, in the
presence of opioid
dependence, opiate withdrawal symptoms may appear within minutes of
nalox