Label: UROGESIC BLUE- methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate tablet, coated
- NDC Code(s): 0485-0151-30
- Packager: EDWARDS PHARMACEUTICALS, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 13, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Description
Each tablet contains: Methenamine, USP 81.6 mg Monobasic Sodium Phosphate, USP 40.8 mg Methylene Blue, USP 10.8 mg Hyoscyamine Sulfate, USP 0.12 mg Inactive ingredients include: microcrystalline cellulose, NF, mannitol, USP, croscarmellose sodium, NF, magnesium stearate, NF and lake blend blue.
HYOSCYAMINE SULFATE is an alkaloid of belladonna. Exists as a white crystalline powder. Affected by light. It is very soluble in water; freely soluble in alcohol; practically insoluble in ether.
METHENAMINE exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water; soluble in alcohol and in chloroform.
METHYLENE BLUE exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.
MONOBASIC SODIUM PHOSPHATE exists as a white crystalline powder. Its solutions are acidic to litmus. It is freely soluble in water and practically insoluble in alcohol.
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CLINICAL PHARMACOLOGY
HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.
METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8.
METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.
MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine.
- INDICATIONS AND USAGE
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CONTRAINDICATIONS
UROGESIC-BLUE™ is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrythmias, 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
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PRECAUTIONS
Cross sensitivity and/or related problems
patients intolerant of belladonna alkaloids may be intolerant of this medication also.
Pregnancy/Reproduction
(Pregnancy Category C)
hyoscyamine and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UROGESIC-BLUE™ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UROGESIC-BLUE™ tablets should be given to a pregnant woman only if clearly needed.
Breast-feeding
problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk.
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 usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion.
Drug Interactions
because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; 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 (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline reducing 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); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) Inhibitors (concurrent use may intensify antimuscarinic side effects, opoid (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 may become blue to blue green and the feces may be discolored as a result of the excretion of methylene blue.
- ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
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OVERDOSAGE
Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 mg to 4 mg (0.5 mg 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.
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
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PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
FORMULATION
UROGESIC-BLUE™
URINARY ANTISEPTIC ANTISPASMODIC
DESCRIPTION: Each tablet contains:
Methenamine, USP 81.6 mg
Monobasic Sodium Phosphate, USP 40.8 mg
Methylene Blue, USP 10.8 mg
Hyoscyamine Sulfate, USP 0.12 mgCONTENTS: 30 TABLETS
Rx ONLY
Manufactured for
EDWARDS PHARMACEUTICAL, INC.Berwyn, PA
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INGREDIENTS AND APPEARANCE
UROGESIC BLUE
methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0485-0151 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE 81.6 mg SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC 40.8 mg METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE 10.8 mg HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE 0.12 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MANNITOL (UNII: 3OWL53L36A) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color blue (LIGHT BLUE) Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code ED;UB Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0485-0151-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/19/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/19/2010 Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880) Establishment Name Address ID/FEI Business Operations Belcher Pharmaceuticals, LLC 965167955 manufacture(0485-0151) , analysis(0485-0151) , pack(0485-0151)