KBroVet-CA1 500: Product Information (Page 2 of 2)

REASONABLE EXPECTATION OF EFFECTIVENESS:

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.

ANIMAL SAFETY:

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.

HOW SUPPLIED:

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

STORAGE CONDITIONS:

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.

Principal Display Panel:

NDC #: 49427-324-48 or 49427-324-50

KBroVet-CA1

(potassium bromide chewable tablets)

Anti-epileptic for use in dogs only

500 mg

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.

PRN Pharmacal

Net Contents: 60 or 180 TABLETS

Expiry Date

Lot Number

Manufactured by Pegasus Laboratories, Inc.

Employee-Owned, Pensacola, FL 32514.

Manufactured in the USA.

10-2020

PRN® and KBroVet® are registered trademarks of Pegasus Laboratories, Inc.

KBroVet-CA1 500 mg 60 count Bottle Label
(click image for full-size original)
KBroVet-CA1 500 mg 60 count Bottle Label
(click image for full-size original)

KBroVet-CA1 500 mg 180 count Bottle Label
(click image for full-size original)
KBroVet-CA1 500 mg 180 count Bottle Label
(click image for full-size original)

KBROVET-CA1 500
potassium bromide tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:49427-324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM BROMIDE (BROMIDE ION) POTASSIUM BROMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE 385.7 mg
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 266 mg
CYANOCOBALAMIN 0.013 mg
STEARIC ACID 121 mg
Product Characteristics
Color brown (tan;with;brown;speckles) Score no score
Shape ROUND Size 16mm
Flavor LIVER Imprint Code 500;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49427-324-48 60 TABLET, CHEWABLE in 1 PACKAGE None
2 NDC:49427-324-50 180 TABLET, CHEWABLE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
conditional NADA NADA141544 04/29/2021
Labeler — Pegasus Laboratories, Inc. (108454760)
Registrant — Pegasus Laboratories, Inc. (108454760)
Establishment
Name Address ID/FEI Operations
Pegasus Laboratories, Inc. 108454760 analysis, manufacture, label
Establishment
Name Address ID/FEI Operations
Biospectra 042724830 api manufacture

Revised: 01/2022 Pegasus Laboratories, Inc.

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