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URELLE

RxNorm 1048336· HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE· ORAL

Viatris Specialty LLC

Indications and usage

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.

Dosage and administration

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.

Warnings

WARNINGS: If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately. Patients should be advised that urine will be colored blue when taking this medication. Do not exceed recommended dosage.

Contraindications

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 obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • off label use13
  • fatigue9
  • vision blurred9
  • cystitis interstitial8
  • tremor7
  • dizziness6
  • pain6
  • product use issue6
  • vomiting6
  • amnesia5
  • asthenia5
  • heart rate increased5
  • maculopathy5
  • nausea5
  • staphylococcal infection5
  • anxiety4

Adverse reactions (label)

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KR · 한국Products in Korea (12)

View more: Full FDA label on DailyMed →Label effective 20150113