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Urelle® is used for the treatment of symptoms for a lower urinary tract infection (UTI and IC) and to reduce the symptoms of certain diagnostic procedures.
If bacteria are present in the urine the condition is known as a Urinary Tract Infection (UTI). Urinary tract infections often cause moderate-to-severe pain, the urge to urinate, and/or urinary incontinence (leakage of urine without control). Over 10 million cases of UTI are reported each year in the United States. In select cases no bacteria are found while symptoms are present and a condition called Interstitial Cystitis may exist. While much less common than UTI Interstitial Cystitis (IC) presents same symptoms as UTI, a constant urge to urinate, frequent urination, and burning pain.
Urelle® contains 32.4 mg of phenyl salicylate an analgesic to control the pain and 0.12 mg of hyoscyamine sulfate an antispasmodic to relieve the spasms that frequently accompany and aggravate the urgency, frequency, pain, and burning symptoms of urinary tract infections. Urelle® also contains 81.0 mg of methenamine and 40.80 mg of sodium biphosphate, which work in combination to control bacteria in urine. Urelle® contains 10.8 mg methylene blue that possesses weak antiseptic properties.
Description:
Urelle® are round, blue sugar-coated tablets with “P-002” imprinted on one side.
Each tablet contains:
Methenamine 81.0 mg Sodium Biphosphate 40.8 mg Phenyl Salicylate 32.4 mg Methylene Blue 10.8 mg Hyoscyamine Sulfate 0.12 mg
Indications and Usage:
Urelle® is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
Contraindications:
Hypersensitivity to any of the ingredients is possible. Risk - benefit should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstruction disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstruction uropathy (such as bladderneck obstruction due to prostatic hypertrophy).
WARNING:
Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.
Precautions:
Cross sensitivity and/or related problems - patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.
Dosage and Administration:
Adults – One tablet orally 4 times per day followed by liberal fluid intake.
Pediatric – Dosage must be individualized by a physician for older children. Urelle® is not recommended for use in children 6 years of age or younger.
How Supplied:
Urelle® are round, blue sugar-coated tablets with “P-002” imprinted on one side of the tablet in bottles of #90’s (NDC 66663-219-01).
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