(potassium bromide chewable tablets)
Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-544.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
|Item #||Product Name||Supplied|
|30032348||KBroVet®-CA1 250 mg Chewable Tablets||60 ct. bottle|
|30032350||KBroVet®-CA1 250 mg Chewable Tablets||180 ct. bottle|
|30032448||KBroVet®-CA1 500 mg Chewable Tablets||60 ct. bottle|
|30032450||KBroVet®-CA1 500 mg Chewable Tablets||180 ct. bottle|
KBroVet®-CA1 is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-544. See prescribing information for complete details regarding adverse events, warnings, and precautions. It is a violation of Federal Law to use this product other than as directed in the labeling. Contraindicated in dogs with a history of hypersensitivity to bromide. Not for use in cats. Not for human use. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans. The most commonly reported side effects were increased appetite and thirst, increased urination, weight gain, sedation, and ataxia. Reversible neurologic signs (sedation, ataxia, weakness) were generally associated with adjunctive potassium bromide treatment or high serum bromide concentrations. Animals with kidney disease may be predisposed to bromide toxicities. The safe use of KBroVet®-CA1 has not been evaluated in dogs that are intended for breeding, are pregnant or lactating, or less than 6 months of age. Use caution 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.
Not for use in humans. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans. Not for use in cats. Keep KBroVet-CA1 in a secured location out of reach of dogs, cats, and other animal to prevent accidental ingestion or overdose.