Urelle (hyoscyamine sulfate 0.12 MG / methenamine 81 MG / methylene blue 10.8 MG / phenyl salicylate 32.4 MG / sodium phosphate, monobasic 40.8 MG) Oral Tablet
Generic Name: HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Brand Name: URELLE
- Substance Name(s):
- HYOSCYAMINE SULFATE
- METHENAMINE
- METHYLENE BLUE
- PHENYL SALICYLATE
- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
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.
DESCRIPTION
: Urelle ® tablets for oral administration are supplied as navy blue round tablets with “A-002” debossed on one side.
Each Tablet Contains: Hyoscyamine Sulfate 0.12 mg Methenamine 81.0 mg Methylene Blue 10.8 mg Phenyl Salicylate 32.4 mg Sodium Phosphate Monobasic 40.8 mg INACTIVE INGREDIENTS: Corn Starch, Dicalcium Phosphate, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.
HOW SUPPLIED
: Urelle ® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 0037-6321-90).
Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense in a tight, light resistant container as defined in the USP.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
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.
INFORMATION FOR PATIENTS
Drug Interactions: Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A— an enzyme responsible for breaking down serotonin in the brain.
It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity.
This is referred to as Serotonin Syndrome.
Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.
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.