BREVITAL SODIUM- methohexital sodium injection, powder, lyophilized, for solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

METHOHEXITAL SODIUM (UNII: 60200PNZ7Q) (METHOHEXITAL - UNII:E5B8ND5IPE)

Disponible desde:

Par Pharmaceutical, Inc.

Designación común internacional (DCI):

METHOHEXITAL SODIUM

Composición:

METHOHEXITAL SODIUM 500 mg

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

BREVITAL can be used in adults as follows: - 1.For intravenous induction of anesthesia prior to the use of other general anesthetic agents. - 2.For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. - 3.For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures. - 4.As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS ). - 5.As an agent for inducing a hypnotic state. BREVITAL can be used in pediatric patients older than 1 month as follows: - 1.For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents. - 2.For rectal or intramuscular induction of anesthesia and as an adjun

Resumen del producto:

Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) BREVITAL® Vials*: The 500 mg vials (with 30 mg anhydrous sodium carbonate) are available as follows: *In crystalline form.

Estado de Autorización:

New Drug Application

Ficha técnica

BREVITAL SODIUM- METHOHEXITAL SODIUM INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
PAR PHARMACEUTICAL, INC.
----------
BREVITAL
(METHOHEXITAL SODIUM) FOR INJECTION, USP
CIV
For Intravenous Use in Adults
For Rectal and Intramuscular Use Only in Pediatric Patients
WARNING
BREVITAL SHOULD BE USED ONLY IN HOSPITAL OR AMBULATORY CARE SETTINGS
THAT PROVIDE FOR
CONTINUOUS MONITORING OF RESPIRATORY (E.G. PULSE OXIMETRY) AND CARDIAC
FUNCTION. IMMEDIATE
AVAILABILITY OF RESUSCITATIVE DRUGS AND AGE- AND SIZE-APPROPRIATE
EQUIPMENT FOR
BAG/VALVE/MASK VENTILATION AND INTUBATION AND PERSONNEL TRAINED IN
THEIR USE AND SKILLED IN
AIRWAY MANAGEMENT SHOULD BE ASSURED. FOR DEEPLY SEDATED PATIENTS, A
DESIGNATED INDIVIDUAL
OTHER THAN THE PRACTITIONER PERFORMING THE PROCEDURE SHOULD BE PRESENT
TO CONTINUOUSLY
MONITOR THE PATIENT. (SEE WARNINGS.)
DESCRIPTION
BREVITAL® (methohexital sodium, USP) for injection, is 2,4,6 (1_H_,
3_H_, 5_H_)-Pyrimidinetrione, 1-
methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt
and has the empirical formula
C
H N NaO . Its molecular weight is 284.29.
The structural formula is as follows:
Methohexital sodium is a rapid, ultrashort-acting barbiturate
anesthetic. Methohexital sodium for
injection is a freeze-dried, sterile, nonpyrogenic mixture of
methohexital sodium with 6% anhydrous
sodium carbonate added as a buffer. It contains not less than 90% and
not more than 110% of the labeled
amount of methohexital sodium. It occurs as a white, freeze-dried plug
that is freely soluble in water.
This product is oxygen sensitive. The pH of the 1% solution is between
10 and 11; the pH of the 0.2%
solution in 5% dextrose is between 9.5 and 10.5.
Methohexital sodium may be administered by direct intravenous
injection or continuous intravenous
drip, intramuscular or rectal routes (see PRECAUTIONS/PEDIATRIC USE).
Reconstituting instructions
vary depending on the route of administration (see DOSAGE AND
ADMINISTRATION).
®
14
17
2
3
CLINICAL PHARMACOLOGY
Compared with thiamylal and thiopental, methohexital