Frequently Asked Questions

What does conditionally approved mean?

KBroVet®-CA1 is conditionally approved by the FDA. This means that the product has been proven safe and has a reasonable expectation of effectiveness. The sponsor will continue to collect the evidence of effectiveness needed for the product to receive full approval. Conditionally approved animal drugs are limited to a specific use, which can be found on the package insert. Learn more about conditional approval at FDA.gov.

How does conditional approval differ from traditional/formal approval?
The FDA grants drug approvals following successful demonstration of efficacy, safety and manufacturing protocols. A conditional approval is granted for only certain types of treatments for serious or life-threatening conditions where demonstrating effectiveness requires complex or difficult studies.

Once safety and manufacturing protocols have been proven, the FDA will consider an approval when there is a reasonable expectation of effectiveness for use. The conditional approval is valid for one year, after which it must be renewed annually (for up to four additional years) by demonstrating progress toward full approval.

Can I transition my dog from the previous bottle of KBroVet tablets directly to the new KBroVet®-CA1 tablets without a washout or transition period?
Yes.
Are there any special diet implications to keep in mind when my dog is prescribed KBroVet®-CA1?
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.
If my dog’s seizure frequency increases, can I increase the dose of KBroVet®-CA1?
Please consult your veterinarian if seizure frequency increases. The total recommended daily dosage range for oral administration is 25–68 mg/kg (11–31 mg/lb) of body weight. The dosage of KBroVet-CA1 should be adjusted based on monitoring of clinical response of the individual dog.
Are KBroVet®-CA1 tablets flavored?
Yes, the tablets contain a proprietary flavoring to increase acceptance by dogs.
Are the new KBroVet®-CA1 tablets scored? Can I split KBroVet®-CA1 tablets?
Tablets are not scored, nor can tablet uniformity across the tablet be guaranteed. It is not recommended that the tablets be split.
How should KBroVet®-CA1 tablets be stored?
Store at controlled room temperature 20–25°C (68–77°F). Keep out of reach of children and animals. Additionally, clients should be advised to keep KBroVet-CA1 in a secured location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
What are the differences between KBroVet®-CA1 (potassium bromide chewable tablets) and the former KBroVet tablets?
The two products are labeled differently due the FDA’s conditional approval of KBroVet-CA1. Please see the full product label and package insert for details. Additionally, the tablets are no longer scored, nor contain cyanocobalamin (vitamin B-12). All other ingredients remain the same.
How do KBroVet®-CA1 tablets work to control seizures?
The active ingredient, potassium bromide, is thought to exert its antiepileptic activity by passing through neuronal chloride ion channels, thereby hyperpolarizing neuronal membranes. With the neuronal membranes more negatively charged, this decreases the action potential across the synapse, thus raising the seizure threshold and stabilizing neurons against excitatory input from epileptic foci.
What are side effects of KBroVet®-CA1?

The most commonly reported side effects were increased appetite and thirst, increased urination, weight gain, sedation, and ataxia. For full prescribing information see the package insert by clicking here.

Are there contraindications for other medications in which KBroVet®-CA1 should not be used?

KBroVet-CA1 should not be used in animals with a history of hypersensitivity to bromide. Please see full product label and package insert for all labeled contraindications, warning and precautions.

I’ve been using KBroVet for years and I thought it was already approved. Was it not? Is this a step backward for the product?
This is a step forward for the product in the eyes of the FDA. Thanks to a close partnership with the FDA and due to a recognized marketplace need, PRN® Pharmacal has manufactured KBroVet for nearly a decade as an unapproved drug while working toward completion of a formal approval. Recently, the FDA granted conditional approval based on reasonable expectation of efficacy, demonstrated safety, and approval of manufacturing controls.

Talk to your veterinarian about KBroVet®-CA1

Talk to your veterinarian about KBroVet®-CA1

Is the cloud of idiopathic epilepsy casting a shadow on day-to-day life with your dog? Be prepared to discuss treatment options and why KBroVet-CA1 might be the right choice for your dog.

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