UROPHEN MB (Page 2 of 2)

Urinary alkalizers and thiazide diuretics:

May cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde.

Antimuscarinics:

Concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications.

Antacids/antidiarrheals:

Concurrent use may reduce absorption of hyoscyamine resulting in decreased therapeutic effectiveness. Concurrent use with antacids may cause urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine.

Antimyasthenics:

Concurrent use with hyoscyamine may further reduce intestinal motility, therefore, caution is recommended.

Ketoconazole and hyoscyamine may cause increased gastrointestinal pH. Concurrent administration with hyoscyamine may result in marked reduction in the absorption of ketoconazole. Patients should be advised to take this combination at least 2 hours after ketoconazole.

Monoamine oxidase (MAO) inhibitors:

Concurrent use with hyoscyamine may intensify antimuscarinic side effects.

Opioid (narcotic) analgesics may result in increased risk of severe constipation.

Sulfonamides:

These drugs may precipitate with formaldehyde in the urine increasing the danger of crystalluria.

Patients should be advised that the urine and/or stools may become blue to blue-green as a result of the excretion of methylene blue.

Pregnancy/Reproduction (FDA Pregnancy Category C):

Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether UROPHEN MB™ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UROPHEN MB™ should be given to a pregnant woman only if clearly needed.

Nursing mothers:

Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when UROPHEN MB™ is administered to a nursing mother.

Prolonged use:

There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric:

Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric :

Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.

ADVERSE REACTIONS

Cardiovascular — rapid pulse, flushing
Central Nervous System — blurred vision, dizziness, drowsiness
Respiratory — shortness of breath or troubled breathing
Genitourinary — difficult micturition, acute urinary retention
Gastrointestinal — dry mouth, nausea and vomiting

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Burel Pharmaceuticals, Inc at 1-601-706-9819 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug Abuse And Dependence

A dependence on the use of UROPHEN MB™ has not been reported and due to the nature of its ingredients, abuse of UROPHEN MB™ is not expected.

OVERDOSAGE

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children) repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.

Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration.
Symptomatic treatment as necessary.

If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately

UROPHEN MB™ DOSAGE AND ADMINISTRATION

Adults: One tablet orally 4 times per day followed by liberal fluid intake.

Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.

HOW IS UROPHEN MB™ SUPPLIED

UROPHEN MB™ are blue tablets, oval, biconvex, debossed with “BL 07” with scoreline on one side and plain on the other side, available in bottles of 100 tablets, NDC 35573-307-10.

STORAGE

Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed. Protect from moisture and direct sunlight.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

KEEP OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Note: Patients should be advised that urine will be colored blue when taking this medication.

Rx Only

Manufactured for:
Burel Pharmaceuticals, Inc
Richland, MS 39218

Rev. 7/2015

NDC 35573-307-10

UROPHEN MB ®

URINARY ANTISEPTIC

Each Tablet Contains:

Methenamine81.6 mg
Benzoic Acid9.0 mg
Phenyl Salicylate36.2
Methylene Blue10.8 mg
Hyoscyamine Sulfate0.12 mg

Rx ONLY

Buruel Pharmaceuticals

100 Tablets

UROPHEN MB™ is a trademark of Burel Pharmaceuticals, Inc
Manufactured for:
Burel Pharmaceuticals, Inc
Richland, MS 39218

Principal Display Panel -- Bottle Label
(click image for full-size original)
UROPHEN MB
hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and benzoic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-307
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg
METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg
METHYLENE BLUE (METHYLENE BLUE CATION) METHYLENE BLUE 10.8 mg
PHENYL SALICYLATE (PHENYL SALICYLATE) PHENYL SALICYLATE 36.2 mg
BENZOIC ACID (BENZOIC ACID) BENZOIC ACID 9 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A CORN
MAGNESIUM STEARATE
CARBOMER 934
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (biconvex) Size 13mm
Flavor Imprint Code BL;07
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35573-307-10 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/28/2015
Labeler — Burel Pharmaceuticals, Inc (002152814)

Revised: 04/2016 Burel Pharmaceuticals, Inc

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