PROIN ER- phenylpropanolamine hydrochloride tablet, extended release

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.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Description: PROIN ER (phenylpropanolamine hydrochloride extended-release tablets) is a sympathomimetic amine closely related to ephedrine. Phenylpropanolamine hydrochloride (PPA) is the nonproprietary designation for benzenemethanol, a-(1-aminoethyl)-hydrochloride, (R*, S*)-, (±). The empirical formula is C9H13NO•HCl and the molecular weight is 187.67. It is a white crystalline compound having a slight aromatic odor. PPA is freely soluble in water and alcohol but is practically insoluble in ether, benzene and chloroform. The chemical structure of phenylpropanolamine hydrochloride is:   

Product summary:

PROIN ER tablets contain 18, 38, 74 or 145 mg phenylpropanolamine hydrochloride per tablet. PROIN ER is packaged in bottles containing 30 or 90 tablets.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROIN ER- PHENYLPROPANOLAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE
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:
Description: PROIN ER (phenylpropanolamine hydrochloride
extended-release tablets) is
a sympathomimetic amine closely related to ephedrine.
Phenylpropanolamine
hydrochloride (PPA) is the nonproprietary designation for
benzenemethanol, a-(1-
aminoethyl)-hydrochloride, (R*, S*)-, (±). The empirical formula is
C9H13NO•HCl and the
molecular weight is 187.67. It is a white crystalline compound having
a slight aromatic
odor. PPA is freely soluble in water and alcohol but is practically
insoluble in ether,
benzene and chloroform. The chemical structure of phenylpropanolamine
hydrochloride
is:
INDICATION:
For the control of urinary incontinence due to urethral sphincter
hypotonus in dogs.
DOSAGE AND ADMINISTRATION:
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.
Dogs weighing less than 10 pounds cannot be safely dosed because
tablet
administration would result in a dose over 4 mg/kg.
TABLE 1. DOSE ADMINISTRATION BODY WEIGHT IN POUNDS PROIN ER
10-20
18 mg
21-40
38 mg
41-80
74 mg
81-125
145 mg
A
b
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.
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 accident