KBroVet-CA1 500: Product Information

KBROVET-CA1 500- potassium bromide tablet, chewable
Pegasus Laboratories, Inc.

KBroVet®-CA1 (potassium bromide chewable tablets)

Anti-epileptic for use in dogs only.

Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-544

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal Law to use this product other than as directed in the labeling.

CONTRAINDICATIONS:

KBroVet-CA1 should not be used in animals with a history of hypersensitivity to bromide.

DESCRIPTION:

KBroVet-CA1 are liver-flavored chewable tablets that contain potassium bromide (KBr). KBr is an odorless, colorless crystal or white crystalline powder or white granular solid with a pungent bitter saline taste. The molar mass of KBr is 119.002 g/mol, with a high soluability in water, glycerol and ethanol.

INDICATION:

KBroVet-CA1 (potassium bromide chewable tablets) are indicated for the control of seizures associated with idiopathic epilepsy in dogs.

DOSAGE AND ADMINISTRATION:

The total recommended daily dosage range for oral administration is 25 — 68 mg/kg (11-31 mg/lb) of body weight. See pacakge insert for complete dosing instructions. The dosage of KBroVet-CA1 should be adjusted based on monitoring of clinical response of the individual patient. KBroVet-CA1 may be dosed with or without food. Use of an initial loading dosage regimen may be considered on an individual patient basis, balancing the time required to achieve a therapeutic response while minimizing side effects.

WARNINGS: User Safety Warnings

Not for human use. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans.

Animal Safety Warnings

Not for use in cats.

Keep KBroVet-CA1 in a secured location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

PRECAUTIONS:

Dogs receiving KBr should be carefully monitored when changing diets, administering chloride-containing IV fluids, and administering concurrent medications. Careful monitoring is important in dogs that have a condition that may cause difficulty maintaining electrolyte balance.

Animals with decreased renal function may be predisposed to bromide toxicosis.

Some dogs may experience epileptic episodes that are unresponsive or refractory to KBr monotherapy and KBr alone may not be adequate treatment for every dog with idiopathic epilepsy.

The safe use of KBroVet-CA1 has not been evaluated in dogs that are intended for breeding, or that are pregnant or lactating. The safe use of KBr in neonates and young animals has not been established. Reproductive effects of KBr have been reported in other species. In dogs, ataxia, diarrhea, hematochezia, excessive salivation, shivering, skin lesions, stupor progressing to coma and death have been reported with a dose of 200 to 500 mg/kg a day for 4 to 26 weeks.

ADVERSE REACTIONS:

In a retrospective field study of 51 dogs diagnosed with idio- pathic epilepsy and receiving only KBr to control seizures associated with idiopathic epilepsy, adverse reactions were documented for the initial 60 days of treatment. Increased appetite, weight gain, vomiting/regurgitation and sedation were the most common clinical abnormalities documented in the 60 day period after start of KBr therapy (Table 1).

Table 1. Adverse Reactions Reported During Initial Dosing Phase (60 Day Period After Start of KBr Therapy)

Adverse Reaction

Number of Dogs with the

Adverse Reaction

Increased Appetite 11
Weight Gain 8
Vomiting 5
Regurgitation 4
Sedation 3
Polydipsia 2
Ataxia 2
Polyuria 2
Weakness 2
Decreased Activity 1
Diarrhea 1
Disorientation 1
Lethargy 1
Partial Lack of Efficacy 1
Petit Mal Epilepsy 1
Seizure 1
Tiredness 1
Tremors 1


Adverse reactions were also documented during the 30 days prior to KBr sample submission. Weight gain, weakness, ataxia, and increased appetite were the most common adverse reactions documented during this time period (Table 2).

Table 2. Adverse Reactions Reported During Dosing Phase (30 Day Period Before KBr Sample Submission)

Adverse Reaction

Number of Dogs with the

Adverse Reaction

Weight Gain 7
Weakness 5
Ataxia 4
Increased Appetite 4
Polydipsia 3
Sedation 3
Diarrhea 2
Polyuria 2
Regurgitation 2
Vomiting 2
Decreased Appetite 1
Disorientation 1
Loose Stool 1
Panting 1
Tremors 1

Adverse events associated with concurrent use of KBr with other antiepileptic drugs such as phenobarbital have been reported. Neurologic signs were the most common adverse event and included sedation, irritability, restlessness, depres- sion, behavioral changes, ataxia, hind limb paresis, mydriasis, stupor, and coma. The neurologic signs were reported to be reversible.

CONTACT INFORMATION:

For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact Pegasus Laboratories at 1-800-874-9764. For additional information reporting adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY

Mechanism of action: KBr is a halide salt that is thought to exert its antiepileptic activity by passing through neuronal chloride ion channels, thereby hyperpolarizing neuronal membranes, raising the seizure threshold, and stabilizing neurons against excitatory input from epileptic foci.

Pharmacokinetics: The pharmacokinetics of a multi-dose regimen of administration in normal dogs have been evaluated as described in a comprehensive literature review. In one study, KBr was administered at 30 mg/kg orally every 12 hrs for a period of 115 days. Serum, urine, and cerebrospinal fluid (CSF) bromide concentrations were measured at the onset of dosing, during the accumulation phase, at steady-state, and after a subsequent dose adjustment. Median elimination half-life and steady-state serum concen- tration were 15.2 days and 245 mg/dL, respectively. Apparent total body clearance was 16.4 mL/day/kg and volume of distribution was 0.40 L/kg. The CSF:serum bromide ratio at steady-state was 0.77.

Distribution, Metabolism, and Elimination: Bromide distributes into the CSF and interstitial tissues of the brain and is actively transported out of the CNS via the choroid plexus. At pharmacological doses, the active transport mechanism is overwhelmed and bromide accumulates in the brain and CSF. Bromide is not metabolized by the liver and is eliminated unchanged, primarily by renal clearance. Increased dietary consumption 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, causing an increase in bromide elimination half-life in dogs.

Page 1 of 2 1 2

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2022. All Rights Reserved.