K-BroVet 250 description, usages, side effects, indications, overdosage, supplying and lots more!

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K-BroVet 250

Pegasus Laboratories, Inc.
Pegasus Laboratories, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


How Supplied:


Storage Conditions:



Indication:


Contraindications:


Dosage and Administration:


(R-21)



(R-3)

Warnings:




Caution:






Possible Side Effects:

Dog may experience drowsiness when taking K-BroVet but this will generally go away after approximately 3 weeks. Increased hunger, thirst, urination, vomiting, constipation, anorexia, and uncoordinated movements may occur with K-BroVet. During the load in dose increased nausea may be experienced.

There is no information on the relative frequency of pancreatitis in dogs associated with bromide therapy alone. However, pancreatitis has been reported to be more frequent in dogs on concurrent phenobarbital and bromide therapy than dogs on phenobarbital alone. (R-12)

Personality changes have been occasionally reported in dogs on bromide, including attention seeking, irritability or aggression, and aimless pacing.

Reproduction/Pregnancy/Lactation:

The effects of bromide on canine reproduction have not been studied.

Young Dogs:

Safety of administering bromide to neonates and young animals has not been evaluated. (R-16-17)

Drug Interaction and/or Related Effects:

Drug interaction and/or related effects have been selected on the basis of their critical significance (possible mechanism in parenthesis where appropriate) - not necessarily inclusive (* = major clinical significance):

Note: Any of the following medications taken in combinations, depending on the amount taken could also interact with K-BroVet.

Medications and foods containing bromide and chloride for reabsorption by the kidneys; increased amounts of chloride can promote loss of bromide in the urine, leading to a lowering of serum bromide concentrations: Decreased chloride consumption will promote increased renal reabsorption of bromide. (R-1;2;4;5-7,15)

Halothane anesthesia (when inhaled a percentage of halothane is metabolized by dogs to produce bromide, along with other compounds; peak serum concentration occurs within about a day and, in one group of dogs, ranged from 0.04 to 0.088 mg/mL and persisted, with some diminishment for at lease ten days.(R-10;11) Consideration should be given to animals that must have repeated anesthesia or that already require high serum bromide concentration for seizure control. Increased bromide levels due to metabolism of halothane are unlikely to be a significant risk for bromide toxicity in most dogs.

Pharmacology:


(R-2; 15)


(R-4)
(R-20)
(R-2)


(R-7)
(R-4; 5; 7)(R-14;15)


(R-5;6)(R-4)

Overdose:



(R-3;18)(R-3)

(R-18)(R-8)

(R-9)

(R-3;18)

(R-13)



  • For dogs on concurrent phenobarbital  and bromide therapy with mild sedation, ataxia or hind leg weakness, a 10 to 25% reduction in phenobarbital may resolve the signs within 5 to seven days. (R-19)
  • For dogs receiving bromide as the only anticonvulsant, K-BroVet may be discontinued for a few days while monitoring serum concentration, to see if mild signs of toxicity will resolve.
  • If necessary renal excretion of bromide may be accelerated by increasing sodium chloride consumption or administering 0.9% sodium chloride intravenously over twelve hours, depending on the severity of the toxicity. (R-7;8;13)
  • Supportive treatment
  • Continue to monitor

References:

1. Podell M, Fenner WR. Bromide therapy in refractory canine idiopathic epilepsy. J Vet Intern Med (1993) Sep-Oct. 7(5):318-27.

2. Trepanier, L.A. Use of bromide as an anticonvulsant for dogs with epilepsy. J Am Vet Med Assoc. 1995 Jul 15, 207(2) 163-6.

3. March PA, Podell M, Sams RA.Pharmacokinetics and toxicity of bromide following high-dose oral potassium bromide administration in healthy beagles. J Vet Pharmacol Ther 2002, 25:425-32.

4. Trepanier LA, Babish JG. Pharmacokinetic properties of bromide in dogs after intravenous and oral administration of single doses. Res Vet Sci 1995, 58 248-51.

5. Wolf RL., Eadie GS. Reabsorption of bromide by the kidney. AM S Physiol 1950. 163(2) 436-41.

6. USP Committee comment. Rec 9/9/04.

7. Palmer JW, Clarke HT. The elimination of bromides from the blood stream. J Biol Chem 1933; 99:435.

8. Yohn SE, Morrison WB, Sharp PE. Bromide toxicosis (bromism) in a dog treated with potassium bromide for refractory seizures. J AM Vet Med Assoc 1992 Aug 1, 201(13) 468-70.

9. Knight HD, Costner GC. Bromide intoxication of horses, goats and cattle. J Am Vet Med Assoc 1977 Sept 1; 171(5):446-8.

10. Pedersoli WM. Serum bromide concentrations during and after halothane anesthesia in dogs. Am J Vet Res 1980 Jan; 41(1) 77-80.

11. De Moor A, Van Den Hende C, Moens Y et al. Increased plasma bromide concentrations in the horse after halothane anesthesia. Am J Vet Res 1978 Oct. 39(10): 1624-6.

12. Gaskill CL, Cribb AE. Pancreatitis associated with potassium bromide/phenobarbital combination therapy in epileptic dogs. Can Vet L 2000 Jul, 4: 555-8.

13. Nichols ES, Trepanier LA, Linn K. Bromide toxicosis secondary to renal insufficiency in an epileptic dog. J Am Vet Med Assoc 1996 Jan 15, 208(2) 231-3.

14. Shaw N, Trepanier LA, Garland S. High dietary chloride content associated with loss of therapeutic serum bromide concentrations in an epileptic dog. J Am Vet Med Assoc 1996 Jan15.208 (2) 234-6.

15. Trepanier LA, Babish JG, Effect of dietary chloride content on the elimination of bromide by dogs. res vet Sci 1995; 58: 252-5.

16. Okuda K, Yasuhhara A, Kamei A, et al. Successful control with bromide of two patients with malignant migrating partial seizures in infancy. Brain Dev 2000 Jan; 22(1): 56-9

17. Ernst JP, Doose H, Baier WK. Bromides were effective in intractable epilepsy with generalized tonic-clonic seizures and onset in early childhood. Brain Dev 1988;10(6) 385-8.

18. Sisson A. Current experiences with anticonvulsants in dogs and cats. In: Proceedings of the fifteenth annual veterinary medical forum. Lakewood, Colorado: American College of Veterinary Internal Medicine 1997. p. 596-8.

19. Trepanier LA. Optimal bromide therapy and monitoring. In:Proceedings of the fifteenth annual veterinary medical forum. Lakewood, Colorado: American College of Veterinary Internal Medicine 1997. p. 100-101.

20. USP Committee comment, Rec 11/01/04.

21 Plumbs veterinary Handbook 6th Edition.

Principle Display Panel:





A liver flavored
chewable tablet
for dogs containing
Potassium Bromide

For additional product information
see supplemental fold-out booklet
on top of container.

NET CONTENTS 60 TABLETS

K-BroVet 250
K-BroVet 250

K-BroVet 250

Potassium Bromide TABLET, CHEWABLE

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:49427-322
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM BROMIDE POTASSIUM CATION 250 mg

Product Characteristics

Color Size Imprint Code Shape
brown (tan with brown speckles) 11 mm 250 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:49427-322-48 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-02-23


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