NDC 0485-0151 Urogesic Blue

Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate

NDC Product Code 0485-0151

NDC CODE: 0485-0151

Proprietary Name: Urogesic Blue What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
ED;UB
Score: 2

NDC Code Structure

NDC 0485-0151-01

Package Description: 100 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC 0485-0151-30

Package Description: 30 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Urogesic Blue with NDC 0485-0151 is a a human prescription drug product labeled by Edwards Pharmaceuticals, Inc.. The generic name of Urogesic Blue is methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Edwards Pharmaceuticals, Inc.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Urogesic Blue Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • METHENAMINE 81.6 mg/1
  • SODIUM PHOSPHATE, MONOBASIC 40.8 mg/1
  • METHYLENE BLUE 10.8 mg/1
  • HYOSCYAMINE SULFATE .12 mg/1
  • METHENAMINE 81.6 mg/1
  • SODIUM PHOSPHATE, MONOBASIC 40.8 mg/1
  • METHYLENE BLUE 10.8 mg/1
  • HYOSCYAMINE SULFATE .12 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MANNITOL (UNII: 3OWL53L36A)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Agent - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Agent - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Edwards Pharmaceuticals, Inc.
Labeler Code: 0485
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-19-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Urogesic Blue Product Label Images

Urogesic Blue Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

Manufactured for:


Edwards Pharmaceutical, Inc.


111 W. Mulberry St. Ripley, Mississippi 38663


Manufactured by:


Belcher Pharmaceuticals, LLC


Largo, FL 33777


May 2011                    R-0110B

Description

Each tablet contains:Methenamine, USP81.6 mgMonobasic Sodium Phosphate, USP40.8 mgMethylene Blue, USP10.8 mgHyoscyamine Sulfate, USP0.12 mgInactive 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.

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

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.

Patients intolerant of belladonna alkaloids may be intolerant of this medication also.

(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

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.

Adults

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

Older Children

Dosage must be individualized by physician. Not recommended for use in children up to 6 years of age.

How 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 100 tablets (NDC 0485-0151-01).

Caution

RX ONLY

Storage

Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) (See USP Controlled Room Temperature). Keep container tightly closed.

* Please review the disclaimer below.