Country: United States
Language: English
Source: NLM (National Library of Medicine)
PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D)
Sterling-Knight Pharmaceuticals, LLC
PHENOBARBITAL
PHENOBARBITAL 97.2 mg
ORAL
PRESCRIPTION DRUG
A. Sedative B. Anticonvulsant – For the treatment of generalized and partial seizures. Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident. Controlled Substance – Phenobarbital is a Schedule IV drug. Dependence – Barbiturates may be habit forming. Tolerance, psychological dependence, and physical dependence may occur, especially following prolonged use of high doses of barbiturates. Daily administration in excess of 400 mg of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree of physical dependence. A dosage of 600 to 800 mg taken for at least 35 days is sufficient to produce withdrawal seizures. The average daily dose for the barbiturate addict is usually about 1.5 g. As tolerance to barbiturates develops, the amount needed to maintain the sam
Phenobarbital Tablets, USP 16.2 mg are white, round biconvex tablets; with “BP” scoreline “16.2” debossed on one side and plain on the other side, and supplied as follows: • Bottles of 100 tablets NDC 69336-115-10 • Bottles of 1000 tablets NDC 69336-115-11 Phenobarbital Tablets, USP 32.4 mg are white, round biconvex tablets; with “BP” scoreline “32.4” debossed on one side and plain on the other side, and supplied as follows: • Bottles of 100 tablets NDC 69336-116-10 • Bottles of 1000 tablets NDC 69336-116-11 Phenobarbital Tablets, USP 64.8 mg are white, round biconvex tablets; with “BP” scoreline “64.8” debossed on one side and plain on the other side, and supplied as follows: • Bottles of 100 tablets NDC 69336-117-10 • Bottles of 1000 tablets NDC 69336-117-11 Phenobarbital Tablets, USP 97.2 mg are white, round biconvex tablets; with “BP” scoreline “97.2” debossed on one side and plain on the other side, and supplied as follows: • Bottles of 100 tablets NDC 69336-118-10 • Bottles of 1000 tablets NDC 69336-118-11 Manufactured for: Sterling Knight Pharmaceuticals, LLC Ripley, Mississippi (MS) 38663, United States (USA) Revised August 2018 L66I-SKP R-1808
unapproved drug other
PHENOBARBITAL- PHENOBARBITAL TABLET STERLING-KNIGHT PHARMACEUTICALS, 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 TABLETS, USP CIV RX ONLY WARNING: MAY BE HABIT-FORMING DESCRIPTION The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula: Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital. In addition each tablet contains: Microcrystalline Cellulose, Anhydrous Lactose, Sodium Starch Glycolate, Pregelatinized Starch, Sodium Lauryl sulfate, Magnesium Stearate. CLINICAL PHARMACOLOGY Barbiturates are capable of producing all levels of CNS mood alteration, from excitation to mild sedation, hypnosis, and deep coma. Overdosage can produce death. In high enough therapeutic doses, barbiturates induce anesthesia. Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, and hypnosis. Barbiturate-induced sleep differs from physiologic sleep. Sleep laboratory studies have demonstrated that barbiturates reduce the amount of time sp Read the complete document