hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
Dosage Form: tablet
Urelle® Urinary Antiseptic
Urelle 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.
Indications and Usage for Urelle
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 obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).
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.
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.
Urelle® contains methylene blue. Methylene blue should NOT be given to patients taking serotonergic drugs.
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.
Additional Information for Healthcare Professionals
Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity.
In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity. If methylene blue must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first.
In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate. Most serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance.
Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue.
Serotonergic psychiatric medications should not be started in a patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant.
Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.
Report adverse events involving methylene blue to the FDA MedWatch program by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For more information on Urelle®, call 877 329 2256.
Urelle 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 is Urelle Supplied
Urelle® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 66663-219-01).
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.
Distributed by: AZUR PHARMA, INC. • 1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com
Manufactured by: PureTek Corporation. San Fernando, CA 91340
Urelle® is a registered trademark of Azur Pharma International II Limited.
To report a serious adverse event or obtain product information, contact (800) 890 3098.
Rx Only
URLLw-11-01
PRINCIPAL DISPLAY PANEL - BOTTLE LABEL
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
Dosage: 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.
Precaution: Contains Methylene Blue and should NOT be
taken with serotonergic psychiatric Medications. For full
product information please refer to www.azurpharma.com
To report a serious adverse event or obtain product
information, contact (800) 890 3098.
Storage: Store at controlled room temperature
20°-25°C (68°-77°F). Dispense in a tight, light
resistant container as defined in the USP.
KEEP OUT OF THE REACH OF CHILDREN.
90 TABLETS NDC 66663-219-01
Urelle®
Urinary Antiseptic
Rx Only
Dist. by: AZUR PHARMA, INC.
1818 Market Street, Suite 2350
Philadelphia, PA 19103
Mfd. by: PureTek Corporation
San Fernando, CA 91340
Urelle is a registered trademark of Azur Pharma International II Limited.
Note: Patients should be advised
that urine will be colored blue
when taking this medication.
URLLt-10-02
Bottle Label
| Urelle hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate tablet | ||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 01/01/2002 | ||
| Labeler - Azur Pharma Inc. (805611071) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| PureTek Corporation | 785961046 | MANUFACTURE | |
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