Urogesic Blue
Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate
Edwards Pharmaceuticals, Inc.
Human Prescription Drug
NDC 0485-0151Urogesic Blue also known as Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate is a human prescription drug labeled by 'Edwards Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Urogesic Blue is 0485-0151. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Urogesic Blue drug includes Hyoscyamine Sulfate - .12 mg/1 Methenamine - 81.6 mg/1 Methylene Blue - 10.8 mg/1 Sodium Phosphate, Monobasic - 40.8 mg/1 . The currest status of Urogesic Blue drug is Active.
Drug Information:
| Drug NDC: | 0485-0151 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Urogesic Blue |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Edwards Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYOSCYAMINE SULFATE - .12 mg/1
METHENAMINE - 81.6 mg/1
METHYLENE BLUE - 10.8 mg/1
SODIUM PHOSPHATE, MONOBASIC - 40.8 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 19 Nov, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | EDWARDS PHARMACEUTICALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1050325
1251290
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | F2R8V82B84
J50OIX95QV
T42P99266K
3980JIH2SW
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Oxidation-Reduction Activity [MoA]
Oxidation-Reduction Agent [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0485-0151-30 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0151-30) | 19 Nov, 2010 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Urogesic blue methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate cellulose, microcrystalline mannitol croscarmellose sodium magnesium stearate methenamine methenamine sodium phosphate, monobasic sodium cation methylene blue methylene blue cation hyoscyamine sulfate hyoscyamine light blue ed;ub
Drug Interactions:
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);
Read more... 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.
Indications and Usage:
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.
Warnings:
Warnings do not exceed recommended dosage. if rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.
Dosage and Administration:
Dosage and administration 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.
Contraindications:
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).
Adverse Reactions:
Adverse reactions cardiovascular â rapid pulse, flushing central nervous system â blurred vision, dizziness respiratory â shortness of breath or troubled breathing genitourinary â difficulty micturition, acute urinary retention gastrointestinal â dry mouth, nausea/vomiting
Drug Interactions:
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);
Read more... 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.
Use in Pregnancy:
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.
Pediatric Use:
Pediatric infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.
Geriatric Use:
Geriatric use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion.
Overdosage:
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.
Description:
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.
Clinical Pharmacology:
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
Read more... 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.
How Supplied:
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 30 tablets (ndc 0485-0151-30). 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.
Package Label Principal Display Panel:
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 label