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:

Cameron Pharmaceuticals

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria, marked impairment of liver functions or with severe respiratory distress where dyspnea or obstruction is evident. Large doses are contraindicated in nephritic subjects. Barbiturates should not be administered to persons with known previous addiction to the sedative-hypnotic group since ordinary doses may be ineffectual and may contribute to further addiction. Intraarterial administration is contraindicated. Its consequences vary from transient pain to gangrene. Subcutaneous administration produces tissue irritation, ranging from tenderness and redness to necrosis and is not recommended. (See DOSAGE AND ADMINISTRATION, Treatment of Adverse Effects Due to Inadvertent Error in Administration .) Phenobarbital Sodium Injection contains the preservative benzyl alcohol and is not recommended for use in neonates. There have been reports of f

Product summary:

Phenobarbital Sodium Injection, USP is available in the following: 65 mg/mL, 1 mL vials packaged in 25s (NDC 42494-441-25) 130 mg/mL, 1 mL vials packaged in 25s (NDC 42494-442-25) 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. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL SODIUM- PHENOBARBITAL SODIUM INJECTION
CAMERON PHARMACEUTICALS
_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