Proin Rx

Dosage and Administration:

The total recommended dosage for oral administration is 2 mg/kg (0.91 mg/lb) of body weight twice daily. Proin^® is scored and dosage should be calculated in half-tablet increments.

Storage:

Store at controlled room temperature 20-25^°C (68-77^°F), excursions permitted between 15-40^°C (59-104^°F)

Always follow the dosage instructions for Proin^® provided by your veterinarian. Monitor your dog after giving Proin^® to be sure all of it was consumed. If you have difficulty giving Proin^®, contact your veterinarian. It may take several days of treatment with Proin^® before urinary incontinence improves. If you miss a dose, give it as soon as you remember. If it is close to the time for the next dose, skip the dose you missed and go back to the regular dosing schedule. Do not give two doses at once. Proin^® should only be given to the dog for which it was prescribed. Because Proin is flavored, store in a secure area. Contact your veterinarian if you notice restlessness or irritability, loss of appetite, the incontinence persists or worsens, or any other unusual signs. Consult your veterinarian before using Proin^® with any other medications

Active Ingredients:

Phenylpropanolamine hydrochloride

Proin® is scored and contain 25, 50 or 75 mg phenylpropanolamine (as hydrochloride) per tablet. Twenty-five and 50 mg tablets are packaged in bottles containing 60 or 180 tablets, and 75 mg tablets are packaged in bottles containing 60 tablets.

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Warnings:

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

Precautions:

Proin^® may cause increased thirst; therefore, provide ample fresh water. Proin^® should be stored out of reach of dogs in a secured area. Use in dogs with incontinence due to a urinary tract infection will mask symptoms. Proin^® is not effective in dogs with incontinence due to neurologic disease or malformations. Proin^® may cause hypertension; therefore, use with caution in dogs with pre-existing heart disease, hypertension, liver disease, kidney insufficiency, diabetes, glaucoma, and conditions with a predilection for hypertension. Use with caution in dogs receiving sympathomimetic drugs, tricyclic antidepressants, or monoamine oxidase inhibitors as increased toxicity may result. Use with caution in dogs administered halogenated gaseous anesthetics as this may increase the risk of cardiac arrhythmias. A laboratory study on human blood revealed that PPA used in conjunction with aspirin may potentiate decreased platelet aggregation.

The safe use of Proin^® in dogs used for breeding purposes, during pregnancy or in lactating bitches, has not been evaluated.

In an FDA approved 28 day clinical trial PROIN^® reduced mean urinary accidents per week in female dogs by 82%.1 In the second part of the clinical field study (180 days), Proin^® achieved 98.1% owner satisifaction for the control of urinary incontinence.

A 28-day placebo-controlled clinical study was conducted in 21 study sites across the U.S. The study included 184 dogs with urinary incontinence due to sphincter hypotonus of which 127 dogs (100 female, 27 male) were evaluated for effectiveness. Dogs were randomly assigned either to receive 2 mg/kg Proin^® (123 dogs) or a placebo (61 dogs) administered orally twice daily for 28 days. Proinhtml^® administered at 2 mg/kg orally twice a day was effective for the control of urinary incontinence based on a decrease in urinary accidents per week as compared to the placebo. Changes to hematology and serum chemistry were not considered clinically significant or related to treatment. The most commonly reported side effects were: emesis, hypertension, anorexia, weight loss, proteinuria, and behavioral changes.

In a margin of safety study, phenylpropanolamine hydrochloride (PPA) was administered to dogs twice daily at 1X, 3X or 5X the recommended dose (2 mg/kg) for 182 days. This study demonstrated the safety of phenylpropanolamine administered to dogs at 2, 6 and 10 mg/kg twice daily for 6 months. The most pronounced effects of treatment were a dose-dependent increase in blood pressure, and a dose dependent decrease in heart rate. There were no findings in ophthalmic examinations or histologic evaluation of tissues collected at necropsy to indicate target organ damage that would be caused by chronic hypertension. A decline in body weight and condition was noted in both treated and untreated females. Temporary elevations of platelet count and serum ALT were observed in treated dogs.

Prescription
This item requires a valid prescription from a licensed veterinarian.

Restrictions
This product is not shippable to the following states: Illinois and West Virginia.