SUCCINYLCHOLINE CHLORIDE injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Pieejams no:

General Injectables & Vaccines, Inc.

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Succinylcholine chloride injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known.

Produktu pārskats:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution  in 10 mL multiple-dose vials. Each mL contains succinylcholine chloride, USP 20 mg. It is available as follows: Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration. Store in refrigerator at 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Biosciences LLC Bridgewater, NJ 08807 Rev. 12-2018-01

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
----------
SUCCINYLCHOLINE CHLORIDE INJECTION, USP
200 MG/10 ML (20 MG/ML)
RX ONLY
A SHORT-ACTING DEPOLARIZING SKELETAL MUSCLE RELAXANT.
BOXED WARNING
THIS DRUG SHOULD BE USED ONLY BE INDIVIDUALS FAMILIAR WITH ITS
ACTIONS, CHARACTERISTICS AND
HAZARDS .
DESCRIPTION
Succinylcholine chloride injection, USP is a sterile, nonpyrogenic
solution to be used as an ultra short-
acting, depolarizing, skeletal muscle relaxant, see HOW SUPPLIED for
summary of content and
characteristics of the solutions. The solutions are for intramuscular
or intravenous use.
Succinylcholine Chloride is chemically designated as Ethanaminium,
2,2’-[(1,4-dioxo-1,4-butanediyl)
bis(oxy)] bis [N, N, N-trimethyl-, dichloride, dihydrate, its
molecular formula is C
H Cl
N O .2H O
and its molecular weight is 397.34.
It has the following structural formula:
Succinylcholine is a diquaternary base consisting of the dichloride
salt of the dicholine ester of
succinic acid. Succinylcholine chloride, USP is a white, odorless,
crystalline powder. It is freely
soluble in water, slightly soluble in alcohol and practically
insoluble in ether. The drug is incompatible
with alkaline solutions but relatively stable in acid solutions.
Solutions of the drug lose potency unless
refrigerated.
Solution intended for multiple-dose administration contains
methylparaben, 0.18% and propylparaben,
0.02% as preservatives. Product not requiring dilution (multiple-dose
fliptop vial) contains sodium
chloride to render isotonic. May contain sodium hydroxide and/or
hydrochloric acid for pH adjustment.
pH is 3.6 (3.0 to 4.5). See table in HOW SUPPLIED section for
characteristics.
Sodium Chloride, USP, chemically designated NaCl, is a white
crystalline compound freely soluble in
water.
CLINICAL PHARMACOLOGY
Succinylcholine is a depolarizing skeletal muscle relaxant. As does
acetylcholine, it combines with the
cholinergic receptors of the motor end plate to produce
depolarizat