KBroVet-CA1 is conditionally approved pending a full demonstration of effectiveness.
Additional information for Conditional Approvals can be found by searching www.fda.gov for “animal conditional approval”.
Two retrospective studies were used to determine the dose and demonstrate a reasonable expectation of effectiveness for KBroVet-CA1 for the control of seizures associated with idiopathic epilepsy in dogs.
In a dose determination retrospective study, the total daily oral dose of KBr given for greater than or equal to 45 days (approaching steady- state conditions) was described. To be included in this study, cases were required to meet the following eligibility require- ments: samples submitted for serum bromide concentration evaluation within the required date range (January 1, 2003 to August 31, 2010), and dogs were between greater than or equal to 0.5 and less than or equal to 5.0 years of age, receiving only KBr to control seizures associated with idiopathic epilepsy, administered KBr once or twice daily for greater than or equal to 45 days at the dose noted on the submission form, and the serum bromide concentration was greater than or equal to 0.8 and less than or equal to 3.5 mg/mL.
A total of 284 case records (58.5% male and 41.6% female), with a mean age of 3.6 years (0.7-5.0 years) and a mean body weight of 20.5 kg (1.3-88.2 kg), were evaluated between January 1, 2003 to August 31, 2010. The mean total daily oral dose was 46.6 (±21.9) mg/kg with a range of 24.5-68.3 mg/kg. These results describe the total daily oral dose range to achieve serum bromide concentrations within 10% of the published therapeutic range (greater than or equal to 0.8 and less than or equal to 3.5 mg/mL)1,2 for dogs with idiopathic epilepsy.
A pilot retrospective study involving review of case records of 51 client-owned dogs was conducted to evaluate the effec- tiveness of KBr in dogs. This retrospective study evaluated case records of dogs previously receiving only KBr to control seizures associated with idiopathic epilepsy and for which blood samples had been analyzed to quantify serum bromide concentrations for the purpose of therapeutic drug monitoring.
Seizure counts, seizure count changes, seizure event days per month and seizure severity scores were tabulated for eligible cases, comparing the 30 day period before initial treatment with KBr and the 30 day period of steady state KBr dosing. Seizure count within an individual case was required to decrease by 50% or greater in order for the case to be classified as a seizure count success. Similarly, reduction in the number of seizure event days per month by greater than or equal to 50% was required for the case to be classified as a seizure event day count success. No increase in severity score denoted an individual case treatment success for this variable. Of the 51 evaluable cases, 27 were determined as valid for safety and effectiveness data and 24 were determined to be valid for only safety data.
Of the 27 cases, 19 (70%) were defined as “success” and 8 (30%) were defined as “failures” based on seizure count results. Eighteen (67%) were defined as “success” and 9 (33%) were defined as “failures” based on seizure event day results. Seizure severity score decreased or did not change in 25 of the 27 cases evaluated for effectiveness. Overall, of the 27 dogs included in the effectiveness analysis, 18 (67%) were considered treatment successes and 9 (33%) were considered treatment failures.
Safety was assessed in a systematic review of literature and a retrospective field study. Reversible neurologic signs were the most consistently reported adverse effect and were generally associated with adjunctive KBr treatment or high serum bromide concentrations. Adverse effects were also seen in some dogs with low serum bromide concentration. Dermatologic and respiratory abnormalities were rare in dogs. Evidence suggested that administration of KBr with food may alleviate gastrointestinal irritation and that monitoring for polyphagia, thyroid hormone abnormalities, and high serum bromide concentrations may be beneficial.
KBroVet-CA1 are liver-flavored, non-scored tablets containing
250 mg or 500 mg of potassium bromide per tablet. KBroVet-CA1 is packaged in bottles containing 60 or 180 tablets.
500 mg Tablet (60 ct) bottle NDC 49427-324-48
250 mg Tablet (60 ct) bottle NDC 49427-323-48
500 mg Tablet (180 ct) bottle NDC 49427-324-50
250 mg Tablet (180 ct) bottle NDC 49427-323-50
Store at controlled room temperature 20-25°C (68-77°F).
1 Boothe DM. Anticonvulsant and other neurologic therapies. In: Boothe DM, Ed. SmallAnimal clinical pharmacology and therapeutics. Philadelphia: WB Saunders Co.,2001; 431-456
2 Dewey CW. Anticonvulsant therapy in dogs and cats. Vet Clin North Am Small Anim Pract 2006; 36:1107-1127.
NDC #: 49427-324-48 or 49427-324-50
(potassium bromide chewable tablets)
Anti-epileptic for use in dogs only
Conditionally approved by FDA pending a full demonstartion of effectiveness under application number 141-544.
CAUTION: 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.
Net Contents: 60 or 180 TABLETS
Manufactured by Pegasus Laboratories, Inc.
Employee-Owned, Pensacola, FL 32514.
Manufactured in the USA.
PRN® and KBroVet® are registered trademarks of Pegasus Laboratories, Inc.
| KBROVET-CA1 500
potassium bromide tablet, chewable
|Labeler — Pegasus Laboratories, Inc. (108454760)|
|Registrant — Pegasus Laboratories, Inc. (108454760)|
|Pegasus Laboratories, Inc.||108454760||analysis, manufacture, label|
Revised: 01/2022 Pegasus Laboratories, Inc.
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