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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I—Food and Drug Administration, Department of Health and Human Services |
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SubChapter E—Animal Drugs, Feeds, and Related Products |
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Part 516 - New Animal Drugs for Minor Use and Minor Species |
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Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species |
§ 516.1760 - Phenobarbital.
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§ 516.1760 Phenobarbital.
(a) Specifications. Each tablet contains 15, 16.2, 30, 32.4, 60, 64.8, or 97.2 or 100 milligrams (mg) phenobarbital.
(b) Sponsor. See No. 064950 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient.
(2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[88 FR 84699, Dec. 6, 2023; 89 FR 85426, Oct. 28, 2024]