PROIN 75- phenylpropanolamine hydrochloride tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLPROPANOLAMINE HYDROCHLORIDE (UNII: 8D5I63UE1Q) (PHENYLPROPANOLAMINE - UNII:33RU150WUN)

Available from:

Pegasus Laboratories, Inc.

INN (International Name):

PHENYLPROPANOLAMINE HYDROCHLORIDE

Composition:

PHENYLPROPANOLAMINE HYDROCHLORIDE 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

PROIN (phenlypropanolamine hydrochloride) is a sympathomimetic amine closely related to ephedrine. Phenylpropanolamine hydrochloride (PPA) is the nonproprietary designtion for benzenemethanol, α - (1-aminoethyl) - hydrochloride, (R*,S*)-, (±). The empirical formula is C9 H13 NO•HCL and the molecular weight is 187.67.  It is a white cyrstalline compound having a slight aromatic odor. PPA is freely soluable in water and alcohol but is practically insoluable in ether, benzene and chloroform. The chemical structure of phenylpropanolamine is:

Product summary:

PROIN is scored and contains 25, 50 or 75 mg phenylpropanolamine hydrochloride per tablet. PROIN is packaged in bottles containing 60 or 180 tablets. Approved by FDA under NADA # 141-324. PROIN ® is a registered trademark of Pegasus Laboratories, Inc.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROIN 75- PHENYLPROPANOLAMINE HYDROCHLORIDE TABLET, CHEWABLE
PEGASUS LABORATORIES, INC.
----------
FOR ORAL USE IN DOGS ONLY
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION:
PROIN (phenlypropanolamine hydrochloride) is a sympathomimetic amine
closely related
to ephedrine.
Phenylpropanolamine hydrochloride (PPA) is the nonproprietary
designtion for
benzenemethanol, α - (1-aminoethyl) - hydrochloride, (R*,S*)-, (±).
The empirical formula is C H
NO•HCL and the molecular weight is 187.67. It is a white
cyrstalline compound having a slight aromatic odor.
PPA is freely soluable in water and alcohol but is practically
insoluable in ether, benzene
and chloroform. The chemical structure of phenylpropanolamine is:
INDICATION:
PROIN is indicated for the control of urinary incontinence due to
urethral sphincter
hypotonus in dogs.
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.
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.
Overdose has been associated with dogs chewing through closed bottles
of PROIN and
consuming multiple tablets. Therefore, it is important to store PROIN
Chewable Tablets
out of reach of dogs and other pets in a secured location.
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
9
13
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
dog