PROIN ER (phenylpropanolamine hydrochloride extended-release tablets) for Dogs, 74-mg, 60 tablets

PROIN ER IMPORTANT SAFETY INFORMATION: For oral use in dogs only. Not for human use. Keep out of reach of children. If accidentally ingested by humans, contact a physician immediately.

The most commonly reported side effects were vomiting, loss of appetite, diarrhea, excessive salivation, agitation, tiredness, vocalization, confusion, increased water consumption, weight loss, weakness, fever, panting, and reversible changes in skin color (flushing or bright pink). Abnormal gait, seizures or tremors, as well as liver enzyme elevations, kidney failure, blood in urine and urine retention have been reported. In some cases death, including euthanasia has been reported. Sudden death was sometimes preceded by vocalization or collapse.

Instances of dogs chewing through closed vials of PROIN and eating the vial contents have been reported, in some cases resulting in overdose. Keep the product in a secured storage area out of the reach of pets in order to prevent accidental ingestion or overdose, as dogs may willingly consume more than the recommended dosage of PROIN Chewable Tablets or PROIN ER tablets. Contact your veterinarian immediately if the dog ingests more tablets than prescribed or if other pets ingest PROIN Chewable tablets or PROIN ER tablets.

PROIN and PROIN ER may cause elevated blood pressure and should be used with caution in dogs with pre-existing heart disease, high blood pressure, liver disease, kidney insufficiency, diabetes, glaucoma, and other conditions associated with high blood pressure. Dogs may transition from PROIN Chewable Tablets to PROIN ER without a break in administration. However, do not alternate PROIN ER with PROIN Chewable Tablets because the effectiveness and safety of interchangeable use have not been evaluated.

The safe use of PROIN and PROIN ER in dogs used for breeding purposes, during pregnancy or in lactating bitches, has not been evaluated. Contact your veterinarian if you notice restlessness or irritability, loss of appetite, the incontinence persists or worsens, or any other unusual signs. See prescribing information for complete details regarding adverse events, warning and precautions or visit prnpharmacal.com.