Urogesic Blue Description

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.

Urogesic Blue - 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 for Urogesic Blue

UROGESIC-BLUE™ is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

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

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.

Precautions

Adverse Reactions/Side Effects

Cardiovascular – rapid pulse, flushing

Central Nervous System – blurred vision, dizziness

Respiratory – shortness of breath or troubled breathing

Genitourinary – difficulty micturition, acute urinary retention

Gastrointestinal – dry mouth, nausea/vomiting

Drug Abuse and Dependence

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

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.

Urogesic Blue Dosage and Administration

How is Urogesic Blue supplied

UROGESIC-BLUE™ are light blue to blue, oval, biconvex tablets debossed with "ED UB" with scoreline on one side and plain on the other side. Supplied in bottles of 30 tablets (NDC 0485-0151-30).

Manufactured for:
Edwards Pharmaceutical, Inc.
111 W. Mulberry St. Ripley, Mississippi 38663

Manufactured by:
Belcher Pharmaceuticals, LLC.
Largo, FL 33777

November 2014
R-1410

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 mg

CONTENTS: 30 TABLETS

Rx ONLY

Manufactured for

EDWARDS PHARMACEUTICAL, INC.

Berwyn, PA