PHENOBARBITAL SODIUM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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 treatmen

Product summary:

Phenobarbital Sodium Injection, USP is available in the following: 65 mg/mL, 1 mL vials packaged in 25s (NDC: 63629-1998-1) Storage Store at 20°-25°C (68°-77°), 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. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL SODIUM- PHENOBARBITAL SODIUM INJECTION
BRYANT RANCH PREPACK
_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._
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PHENOBARBITAL SODIUM INJECTION, USP
CIV
FOR IM OR SLOW IV ADMINISTRATION
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, propylene glycol 0.678
mL and benzyl
alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if
needed, for pH
adjustment. The pH range is 9.2-10.2.
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: C12 H 11 N 2 NAO 3 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 ac