Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
PHENOBARBITAL SODIUM (UNII: SW9M9BB5K3) (PHENOBARBITAL - UNII:YQE403BP4D)
BPI Labs LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
- 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
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
unapproved drug other
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 Soma hati kamili