- (a) Specifications. Each tablet contains 15, 16.2, 30, 32.4, 60, 64.8, 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]