PROTOPAM CHLORIDE- pralidoxime chloride injection, powder, lyophilized, for solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

PRALIDOXIME CHLORIDE (UNII: 38X7XS076H) (PRALIDOXIME - UNII:P7MU9UTP52)

MAH:

Baxter Healthcare Corporation

INN:

PRALIDOXIME CHLORIDE

composition:

PRALIDOXIME CHLORIDE 1 g in 20 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

PROTOPAM Chloride is indicated as an antidote: The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness. There are no known absolute contraindications for the use of PROTOPAM Chloride (see PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION). Relative contraindications include known hypersensitivity to the drug and other situations in which the risk of its use clearly outweighs possible benefit. PROTOPAM Chloride is not subject to abuse and possesses no known potential for dependence.

leaflet_short:

NDC 60977-141-01—Hospital Package: This contains six 20 mL vials of 1 g each of sterile PROTOPAM Chloride (pralidoxime chloride) for Injection white to off-white porous cake*, without diluent or syringe. *When necessary, sodium hydroxide is added during processing to adjust the pH. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

authorization_status:

New Drug Application

SPC

PROTOPAM CHLORIDE- PRALIDOXIME CHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
PROTOPAM (PRALIDOXIME CHLORIDE) FOR INJECTION
DESCRIPTION
Chemical name: 2-formyl-1-methylpyridinium chloride oxime. Available
in the United States as
PROTOPAM Chloride for Injection (PROTOPAM Chloride), pralidoxime
chloride is frequently
referred to as 2-PAM Chloride.
Structural formula:
C7H9CIN2O M.W. 172.61
Pralidoxime chloride occurs as an odorless, white, nonhygroscopic,
crystalline powder which is
soluble in water. Stable in air, it melts between 215º and 225º C,
with decomposition.
The specific activity of the drug resides in the
2-formyl-1-methylpyridinium ion and is independent of
the particular salt employed. The chloride is preferred because of
physiologic compatibility, excellent
water solubility at all temperatures, and high potency per gram, due
to its low molecular weight.
Pralidoxime chloride is a cholinesterase reactivator.
PROTOPAM Chloride for intravenous injection or infusion is prepared by
cryo-desiccation. Each vial
contains 1000 mg of sterile pralidoxime chloride, and sodium hydroxide
to adjust pH, to be
reconstituted with 20 mL of Sterile Water for Injection, USP. The pH
of the reconstituted solution is 3.5
to 4.5. Intramuscular or subcutaneous injection may be used when
intravenous injection is not feasible.
CLINICAL PHARMACOLOGY
The principal action of pralidoxime chloride is to reactivate
cholinesterase (mainly outside of the
central nervous system) which has been inactivated by phosphorylation
due to an organophosphate
pesticide or related compound. The destruction of accumulated
acetylcholine can then proceed, and
neuromuscular junctions will again function normally. Pralidoxime
chloride also slows the process of
“aging” of phosphorylated cholinesterase to a nonreactivatable
form, and detoxifies certain
organophosphates by direct chemical reaction. The drug has its most
critical effect in relieving
paralysis of the muscles of respiration. Because pralidox