PRODUCT DETAILS

Once-a-day PROIN ER™
(phenylpropanolamine hydrochloride extended-release tablets)

PROIN ER is the only FDA-approved treatment of urinary incontinence (UI) due to urethral sphincter hypotonus in a convenient once-a-day tablet.

The controlled release mechanism in our patented extended-release technology maintains steady absorption throughout the day. Plus, the delicious tablets make dosing compliance easy.

Once-A-Day-Dosage | Available in 30 ct. & 90 ct. bottles

Once-a-day PROIN ER

(phenylpropanolamine hydrochloride extended-release tablets)

PROIN ER is the only FDA-approved treatment of urinary incontinence (UI) due to urethral sphincter hypotonus in a convenient once-a-day tablet.

The controlled release mechanism in our patented extended-release technology maintains steady absorption throughout the day. Plus, the delicious tablets make dosing compliance easy.

Once-A-Day-Dosage | Available in 30 ct. & 90 ct. bottles

The PROIN ER advantage

1x per day

One extended-release tablet per day can be conveniently given with food.

Accurate dosing

Available in four weight-based strengths for accurate dosage of virtually any sized dog weighing 10 pounds or more. See prescribing information for details.

Enticing flavor

Chewable, delicious tablets improve compliance and make treatment easy.

Steady absorption

Patented extended-release technology provides controlled release that ensures steady absorption.

FDA-approved

The only once-a-day, FDA-approved medication for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Convenient packaging

30 ct. & 90 ct. bottles are conveniently sized for storage and dosing.

1x per day

One extended-release tablet per day can be conveniently given with food.

Accurate dosing

Available in four weight-based strengths for accurate dosage of virtually any sized dog weighing 10 pounds or more. See prescribing information for details.

Enticing flavor

Chewable, delicious tablets improve compliance and make treatment easy.

Steady absorption

Patented extended-release technology provides controlled release that ensures steady absorption.

FDA-approved

The only once-a-day, FDA-approved medication for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Convenient packaging

30 ct. & 90 ct. bottles are conveniently sized for storage and dosing.

Weight-band dosing makes prescribing easy

PROIN ER™ comes in four strengths for accurate dosage of virtually any sized dog weighing 10 pounds or more – see prescribing information for details.

PROIN ER works by increasing urethral sphincter muscle tone to help prevent urinary leakage.

Urethral Sphincter Without PROIN ER™

Urethral Sphincter With PROIN ER™

Different absorption rates, equally effective.

Example of how extended- and immediate-release formulations release drugs for absorption*

*For concept illustration only, no actual release profiles of PROIN® or PROIN ER™

PROIN® and PROIN ER™ provide different absorption rates to ensure that effective dosages can be administered either in multiple dosages through the day (PROIN) or a single, once-a-day dosage (PROIN ER). PROIN chewable tablets release the medication into the dog’s system immediately, with levels of absorption that vary over time—multiple dosages provide the effective daily dosage prescribed.

PROIN ER, with patented extended-release technology, provides steady absorption while maintaining a safe and effective concentration of the medication in a single daily dose. Both forms are equally effective when administered as prescribed.

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.

Effectiveness, safety and oral acceptability study of PROIN ER™

(phenylpropanolamine hydrochloride extended-release tablets)

Treatment that works, in a form that pets will readily accept.

The extended-release formulation of phenylpropanolamine was evaluated in an open-label clinical field study sponsored by Pegasus Laboratories.

82.2%

of doses were voluntarily consumed when given without or with a small amount of food.1

1 Pegasus Laboratories, Inc. (2019). Freedom of Information (FOI) Summary for PROIN ER™ (phenylpropanolamine hydrochloride extended-release tablets) Dogs: US, (NADA 141-517). Center for Veterinary Medicine (CVM).

Method:

  • Multi-center clinical field study
  • 119 client-owned dogs previously diagnosed with urinary incontinence (UI) due to urethral sphincter mechanism incompetence (USMI) were administered PROIN® Chewable Tablets and considered controlled for their incontinence. Of these, 104 were evaluated for effectiveness of PROIN and PROIN ER.1
  • The pet owner recorded the number of urinary accidents during the baseline period of dosing with PROIN Chewable Tablets and during the first 28 days of dosing with PROIN ER. The ratio of average daily incidence of UI was calculated by comparing the baseline dosing period of PROIN Chewable Tablets (Day 7 to Day 1) with the Day 21 to Day 27 dosing period of PROIN ER tablets.1

1Pegasus Laboratories, Inc. (2019). Freedom of Information (FOI) Summary for PROIN ER (phenylpropanolamine hydrochloride extended-release tablets) Dogs: US, (NADA 141-517). Center for Veterinary Medicine (CVM).

Results when transitioning from PROIN to PROIN ER:

75 of 104 dogs had no change from baseline (well-controlled for signs of urinary incontinence).

19 dogs showed improvement over baseline.

Acceptability was recorded by the pet owners:
• 11.4% of doses were consumed without food
• 70.8% of doses were accepted with a small amount of food

99%
of owners in the study, when asked on Day 28, assessed their dog as “improved” or “stayed the same.”

Treatment with PROIN ER tablets administered once a day at dose range of 2–4 mg/kg orally was safe and effective for the control of urinary incontinence due to urethral sphincter hypotonus.

USES

Indicated for the control of urinary incontinence due to urethral sphincter hypotonus in dogs. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

PRODUCT INFORMATION

Active Ingredient(s): phenylpropanolamine hydrochloride

IMPORTANT SAFETY INFORMATION:

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 ER™ tablets. Contact your veterinarian immediately if the dog ingests more tablets than prescribed or if other pets ingest PROIN ER™ tablets.

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 effectiveness and safety of interchangeable use has not been evaluated.

The safe use of 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.

NADA #141-517

WARNINGS:

For oral use in dogs only. Not for human use. Keep out of the reach of children. Consult with a physician in case of accidental ingestion by humans. Keep PROIN ER™ in a secured location out of the reach of dogs, cats and other animals to prevent accidental ingestion or overdose.
PROIN ER™ may cause increased thirst; therefore provide ample fresh water. Do not split or crush tablets.
Due to the nature of the active pharmaceutical ingredient, some states may have additional legal requirements for the prescribing, sale and purchase of PROIN ER™.

Ordering information

Veterinarians

Give your patients PROIN ER™ — the only FDA-approved treatment for urinary incontinence (UI) due to urethral sphincter hypotonus in a convenient once-a-day tablet. To order, contact your local representative or authorized distributor.

Dog owners

PROIN ER™ is only available by prescription from a licensed veterinarian. Please consult with your veterinarian to see if PROIN ER™ is right for your dog.

Is PROIN ER right for your dog?

Since urinary incontinence may be new to you, here’s a helpful list of questions your veterinarian may ask to help in the diagnosis (along with performing tests like urine culture, blood tests, abdominal imaging, or ultrasound). Answering these questions before the first appointment could be the first step in managing your dog’s leaking issues.

Is PROIN ER right for your dog?

Since urinary incontinence may be new to you, here’s a helpful list of questions your veterinarian may ask to help in the diagnosis (along with performing tests like urine culture, blood tests, abdominal imaging, or ultrasound). Answering these questions before the first appointment could be the first step in managing your dog’s leaking issues.