June 11, 2024
The U.S. Food and Drug Administration has approved the first generic phenylpropanolamine hydrochloride chewable tablets for dogs, aimed at controlling urinary incontinence caused by weakened muscles responsible for urination (urethral sphincter hypotonus).
Urinary incontinence in dogs occurs when they lose control over their urination. This condition, often due to urethral sphincter hypotonus, can develop as dogs age, weakening the muscle in the urethra (the passage from the bladder to the outside of the body).
These chewable tablets contain the same active ingredient (phenylpropanolamine hydrochloride) in the same concentration and dosage form as the brand name Proin chewable tablets, which were first approved on August 4, 2011. The FDA has confirmed that the generic tablets do not contain any inactive ingredients that would significantly affect the bioavailability of the active ingredient.
Available by prescription only, these tablets require a licensed veterinarian's expertise to diagnose urinary incontinence and determine the appropriateness of this treatment.
The tablets come in 25, 50, and 75 mg strengths, available in 60 and 180 count bottles. They are scored for dosage calculation in half-tablet increments. The recommended dosage is 2 mg/kg (0.91 mg/lb) of body weight, administered orally twice daily, using a suitable combination of half-tablet increments.
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