Phenobarbital

Phenobarbital

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Questions & Answers

Side Effects & Adverse Reactions

  1. Habit Forming. Phenobarbital may be habit forming. Tolerance and psychological and physical dependence may occur with continued use (see DRUG ABUSE AND DEPENDENCE and Pharmacokinetics under CLINICAL PHARMACOLOGY). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time (see DRUG ABUSE AND DEPENDENCE).
  2. Acute or Chronic Pain. Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established.
  3. Usage in Pregnancy. Barbiturates can cause fetal damage when administered to a pregnant woman. Retrospective, case-controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain. Fetal blood levels approach maternal blood levels following parenteral administration. Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy (see DRUG ABUSE AND DEPENDENCE). If phenobarbital is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
  4. Usage in Pediatric Patients. Phenobarbital has been reported to be associated with cognitive deficits in children taking it for complicated febrile seizures.
  5. Synergistic Effects. The concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

  1. Sedative
  2. Anticonvulsant – For the treatment of generalized and partial seizures.

History

There is currently no drug history available for this drug.

Other Information

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:

image description

Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital.

In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Phenobarbital Manufacturers


  • Direct Rx
    Phenobarbital Tablet [Direct Rx]
  • Eci Pharmaceuticals, Llc
    Phenobarbital Tablet [Eci Pharmaceuticals, Llc]
  • Cardinal Health
    Phenobarbital Tablet [Cardinal Health]
  • Pack Pharmaceuticals, Llc
    Phenobarbital Liquid [Pack Pharmaceuticals, Llc]
  • Contract Pharmacy Services-pa
    Phenobarbital Tablet [Contract Pharmacy Services-pa]
  • Pd-rx Pharmaceuticals, Inc.
    Phenobarbital Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Mckesson Contract Packaging
    Phenobarbital Tablet [Mckesson Contract Packaging]
  • Bryant Ranch Prepack
    Phenobarbital Tablet [Bryant Ranch Prepack]
  • C.o. Truxton, Inc.
    Phenobarbital Tablet [C.o. Truxton, Inc.]
  • West-ward Pharmaceutical Corp
    Phenobarbital Tablet [West-ward Pharmaceutical Corp]
  • Aphena Pharma Solutions – Tennessee, Inc.
    Phenobarbital Tablet [Aphena Pharma Solutions – Tennessee, Inc.]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Phenobarbital Tablet [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Bryant Ranch Prepack
    Phenobarbital Tablet [Bryant Ranch Prepack]
  • Qualitest Pharmaceuticals
    Phenobarbital Tablet [Qualitest Pharmaceuticals]
  • American Health Packaging
    Phenobarbital Tablet [American Health Packaging]

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