Uro-458
Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate
Method Pharmaceuticals, Llc
Human Prescription Drug
NDC 58657-458Uro-458 also known as Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate is a human prescription drug labeled by 'Method Pharmaceuticals, Llc'. National Drug Code (NDC) number for Uro-458 is 58657-458. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Uro-458 drug includes Hyoscyamine Sulfate - .12 mg/1 Methenamine - 81 mg/1 Methylene Blue - 10.8 mg/1 Phenyl Salicylate - 32.4 mg/1 Sodium Phosphate, Monobasic, Anhydrous - 40.8 mg/1 . The currest status of Uro-458 drug is Active.
Drug Information:
| Drug NDC: | 58657-458 |
| 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: | Uro-458 |
| 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, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Method Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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 mg/1
METHYLENE BLUE - 10.8 mg/1
PHENYL SALICYLATE - 32.4 mg/1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS - 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: | 17 Jun, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| 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, 2023 |
| 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: | Method Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1048336
|
| 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. |
| UPC: | 0358657458904
|
| UPC stands for Universal Product Code. |
| UNII: | F2R8V82B84
J50OIX95QV
T42P99266K
28A37T47QO
KH7I04HPUU
|
| 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 |
|---|
| 58657-458-90 | 90 TABLET in 1 BOTTLE (58657-458-90) | 17 Jun, 2016 | 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:
Uro-458 methenamine, sodium phosphate, monobasic, anhydrous, phenyl salicylate, methylene blue and hyoscyamine sulfate polyethylene glycol, unspecified lactose crospovidone magnesium stearate silicon dioxide fd&c blue no. 1 methenamine methenamine sodium phosphate, monobasic, anhydrous sodium cation phenyl salicylate phenyl salicylate methylene blue methylene blue cation hyoscyamine sulfate hyoscyamine blue, speckled 210 capsule shaped
Drug Interactions:
Drug interactions as a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. 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
Read more..., 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. drug abuse and dependence a dependence on the use of uro-458 tablets has not been reported and due to the nature of its ingredients, abuse of uro-458 tablets is not expected.
Indications and Usage:
Indications and usage uro-458 tablets is indicated for the treatment of symptoms of irritative voiding. indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. 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. keep this and all medications out of the reach of children. in case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Warning: keep this and all drugs out of reach of children. rx only manufactured for: method pharmaceuticals, llc fort worth, tx 76118 www.methodpharm.com rev. 05/2016
Dosage and Administration:
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.
Contraindications:
Contraindications uro-458 tablets 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 arrhythmias, congestive heart failure, coronary heart disease, and 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 - 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 method pharmaceuticals, llc at (877) 250-3427.
Drug Interactions:
Drug interactions as a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. 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
Read more..., 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. drug abuse and dependence a dependence on the use of uro-458 tablets has not been reported and due to the nature of its ingredients, abuse of uro-458 tablets is not expected.
Use in Pregnancy:
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 uro-458 tablets tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. uro-458 tablets 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 the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.
Overdosage:
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.
Description:
Description uro-458 tablets for oral administration. each tablet contains: methenamine 81 mg sodium phosphate monobasic 40.8 mg phenyl salicylate 32.4 mg methylene blue 10.8 mg hyoscyamine sulfate 0.12 mg inactive ingredients: lactose, polyethylene glycol, crospovidone, magnesium stearate, colloidal silicon dioxide, fd&c blue # 1. methenamine . [100-97-0] 1,3,5,7-tetraazatricyclo [3.3.1.-1 3,7 ] decane; hexamethylenetetramine; hmt; hmta; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; uritone; urotropin. c 6 h 12 n 4 ; mol wt 140.19; c 51.40%, h 8.63%, n 39.96%. methenamine (hexamethylenetetramine) 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. sodium phosphate monobasic. [7558-80-7] phosphoric acid sodium salt (1:1); sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; h 2 nao 4 p; mol wt 119.98, h 1.68%, na 19.16%, o 53.34%, p 25.82%. monohydrate, white, odorless slightly deliquesce crystals or granules. at 100° c loses all its water; when ignited it converts to metaphosphate. it is freely soluble in water and practically insoluble in alcohol. the aqueous solution is acid. ph of 0.1 molar aqueous solution at 25° c: 4.5. phenyl salicylate. [118-55-8] 2-hydroxybenzoic acid phenyl ester; salol. c 13 h 10 o 3 ; mol wt 214.22, c 72.89%, h 4.71%, o 22.41%. made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. phenyl salicylate exists as white crystals with a melting point of 41°-43° c. it is very slightly soluble in water and freely soluble in alcohol. methylene blue . [61-73-4] 3,7-bis(dimethylamino) phenothiazin-5-ium chloride; c.i. basic blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. c 16 h 18 cln 3 s; mol wt 319.85, c 60.08%, h 5.67%, cl 11.08%, n 13.14%, s 10.03%. methylene blue (methylthionine chloride) exists as dark green crystals. it is soluble in water and in chloroform; sparingly soluble in alcohol. hyoscyamine sulfate . [620-61-1] [3(s)-endo]-α-(hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αh,5αh-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl s-(-)-tropate; i-tropic acid ester with tropine; i-tropine tropate. c 34 h 48 n 2 o 10 s. hyoscyamine sulfate is an alkaloid of belladonna. exists as a white crystalline powder. its solutions are alkaline to litmus. affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.
Clinical Pharmacology:
Clinical pharmacology 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 a ph greater than 6.8. sodium phosphate monobasic an acidifier, helps to maintain an acid ph in the urine necessary for the degradation of methenamine. phenyl salicylate releases salicylate, a mild analgesic for pain. methylene blue possesses weak antiseptic properties. it is well absorbed by the gastrointestinal tract and is rapidly reduced to leukomethylene blue w
Read more...hich is stabilized in some combination form in the urine. 75% is excreted unchanged. hyoscyamine sulfate is a parasympatholytic drug which relaxes smooth muscles and thus produces an antispasmodic effect. it is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. most is excreted in the urine within 12 hours, 13% to 50% being unchanged. protein binding for hyoscyamine sulfate is moderate and biotransformation is hepatic.
How Supplied:
How supplied uro-458 tablets are blue to dark blue speckled, capsule-shaped tablets debossed with 210 on one side and plain on the opposite side, available in bottles of 90 tablets, (ndc:58657-458-90). for the pharmacist this product is not an orange book (ob) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable. there are no claims of bioequivalence or therapeutic equivalence.
Package Label Principal Display Panel:
Principal display panel ndc 586 57-458-90 uro -458 tablets rx only 90 tablets pdp