Proin ER Tablets

How to Order Prescriptions

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Description

PROIN ER™ (phenylpropanolamine hydrochloride extended-release tablets) provides the same proven efficacy as PROIN®  in extendedrelease tablets for once-a-day dosing. Our patented extended-release technology provides a controlled release mechanism that provides steady absorption.

Benefits

An FDA approved treatment for urinary incontinence due to urethral sphincter hypotonus in dogs.

Scored tablets, available in three strengths, make accurate dosing easy.

The tablets are a chewable liver-flavored form that dogs love.

• 18 mg: 10-20 lbs.
• 38 mg: 21-40 lbs.
• 74 mg: 41-80 lbs.
• 145 mg: 81-125 lbs.

How it works

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

Indications

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Directions

The recommended dosage is 2 to 4 mg/kg (0.9 to 1.8 mg/lb) of body weight once daily according to Table 1 below. Administer PROIN ER with food (see Clinical Pharmacology). Do not split or crush tablets.

Body weight in pounds	PROIN ER
10-20	18 mg
21-40	38 mg
41-80	74 mg
81-125	145 mg
*Body weight should be rounded to the nearest pound
**Dogs exceeding 125 lbs should receive the appropriate combination of tablets to achieve the recommended dosage.

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

Caution

Federal (USA) 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.

Keep PROIN ER in a secured location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

Proin ER may mask signs of incontinence due to urinary tract infection. PROIN ER is not effective in dogs with incontinence due to neurologic disease or malformations.

PROIN ER 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 phenylpropanolamine (PPA) used in conjunction with aspirin may potentiate decreased platelet aggregation.

PROIN ER may cause increased thirst; therefore, provide dogs with ample fresh water.

The safe use of PROIN ER has not been evaluated in dogs that are intended for breeding, or that are pregnant or lactating.

Information For Dog Owners

Always follow the dosage instructions for PROIN ER provided by your veterinarian. Give PROIN ER with food and do not split or crush the tablet. Monitor your dog after giving PROIN ER to be sure all of it was consumed. If you have difficulty giving PROIN ER, contact your veterinarian.

PROIN ER may cause increased thirst; therefore, provide dogs with ample fresh water.

If you forget to give your dog a dose, then resume dosing at the next scheduled dose. Keep PROIN ER in a secured location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Contact your veterinarian immediately if the dog ingests more tablets than prescribed or if other pets ingest PROIN ER. In the case of accidental ingestion by humans, contact a physician immediately.

Contact your veterinarian if you notice restlessness, irritability, loss of appetite, the incontinence persists or worsens, or any other unusual signs.

Consult your veterinarian before administering PROIN ER with any other medications.

Animal Safety

The safety of PROIN ER was established based on the safety data from PROIN Chewable Tablets (see below) and a comparative analysis of pharmacokinetic (PK) data for PROIN ER and PROIN Chewable Tablets. The statistical analysis of observed and simulated post-prandial pharmacokinetic data resulted in confidence limits consistent with equal or lower oral bioavailability for PROIN ER when administered once daily versus PROIN Chewable Tablets when administered twice daily. Therefore, the safety data from PROIN Chewable Tablets could be applied to PROIN ER. Emesis and hyperemia of the ventral abdomen were observed during the PK studies.

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.

Storage

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