PHENOBARBITAL SODIUM injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

PHENOBARBITAL SODIUM (UNII: SW9M9BB5K3) (PHENOBARBITAL - UNII:YQE403BP4D)

Доступна з:

BPI Labs LLC

Адміністрація маршрут:

INTRAMUSCULAR

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

- Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. - Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY ). -  Preanesthetic. - Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the t

Огляд продуктів:

Phenobarbital Sodium Injection, USP is available in the following:     65 mg/mL, 1 mL vials packaged in 10s (NDC 54288-136-10) and 25s (NDC 54288-136-25)     130 mg/mL, 1 mL vials packaged in 10s (NDC 54288-137-10) and 25s (NDC 54288-137-25) Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Do not use if solution is discolored or contains a precipitate. Contains no preservatives. To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at 727-471-0850, or the FDA at 1-800-FDA-1088 or  www.fda.gov/medwatch. For Product Inquiry call 727-471-0850. Manufactured by: BPI Labs, LLC 12393 Belcher Rd S, Ste 450, Largo, FL USA 33773                  R-2302 LI28I-29I

Статус Авторизація:

unapproved drug other

Характеристики продукта

PHENOBARBITAL SODIUM- PHENOBARBITAL SODIUM INJECTION
BPI LABS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
PHENOBARBITAL SODIUM INJECTION, USP
CIV
FOR IM OR SLOW IV ADMINISTRATION ONLY
DO NOT USE IF SOLUTION IS DISCOLORED OR CONTAINS A PRECIPITATE
RX ONLY
DESCRIPTION
The barbiturates are nonselective central nervous system (CNS)
depressants which are
primarily used as sedative hypnotics and also anticonvulsants in
subhypnotic doses. The
barbiturates and their sodium salts are subject to control under the
Federal Controlled
Substances Act (CIV).
Barbiturates are substituted pyrimidine derivatives in which the basic
structure common
to these drugs is barbituric acid, a substance which has no central
nervous system
activity. CNS activity is obtained by substituting alkyl, alkenyl or
aryl groups on the
pyrimidine ring.
Phenobarbital Sodium Injection, USP is a sterile solution for
intramuscular or slow
intravenous administration as a long-acting barbiturate. Each mL
contains phenobarbital
sodium either 65 mg or 130 mg, alcohol 0.1 mL, and propylene glycol
0.678 mL in Water
for Injection; hydrochloric acid added, if needed, for pH adjustment.
The pH range is 9.2-
10.2. Contains no preservative.
Chemically, phenobarbital sodium is 2,4,6(1 _H_,3 _H_,5
_H_)-Pyrimidinetrione,5-ethyl-5-phenyl-
, monosodium salt and has the following structural formula:
C
H
N
NaO
MW 254.22
The sodium salt of phenobarbital occurs as a white, slightly bitter
powder, crystalline
granules or flaky crystals; it is soluble in alcohol and practically
insoluble in ether or
chloroform.
CLINICAL PHARMACOLOGY
Barbiturates are capable of producing all levels of CNS mood
alteration from excitation
to mild sedation, to hypnosis and deep coma. Overdosage can produce
death. In high
enough therapeutic doses, barbiturates induce anesthesia.
Barbiturates depress the sensory cortex, decrease motor activity