Me Naphos Mb Hyo 1
Urinary Antiseptic Antispasmodic
Method Pharmaceuticals
Human Prescription Drug
NDC 58657-454Me Naphos Mb Hyo 1 also known as Urinary Antiseptic Antispasmodic is a human prescription drug labeled by 'Method Pharmaceuticals'. National Drug Code (NDC) number for Me Naphos Mb Hyo 1 is 58657-454. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Me Naphos Mb Hyo 1 drug includes Hyoscyamine Sulfate Anhydrous - .12 mg/1 Methenamine - 81.6 mg/1 Methylene Blue Anhydrous - 10.8 mg/1 Sodium Phosphate, Monobasic, Monohydrate - 40.8 mg/1 . The currest status of Me Naphos Mb Hyo 1 drug is Active.
Drug Information:
| Drug NDC: | 58657-454 |
| 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: | Me Naphos Mb Hyo 1 |
| 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: | Urinary Antiseptic Antispasmodic |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Method Pharmaceuticals |
| 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 ANHYDROUS - .12 mg/1
METHENAMINE - 81.6 mg/1
METHYLENE BLUE ANHYDROUS - 10.8 mg/1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - 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: | 01 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jan, 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
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1050325
|
| 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: | 0358657454012
|
| UPC stands for Universal Product Code. |
| UNII: | OB570Z127K
J50OIX95QV
8NAP7826UB
593YOG76RN
|
| 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: | 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 |
|---|
| 58657-454-01 | 100 TABLET in 1 BOTTLE (58657-454-01) | 01 Dec, 2015 | 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:
Me naphos mb hyo 1 urinary antiseptic antispasmodic cellulose, microcrystalline croscarmellose sodium magnesium stearate fd&c blue no. 1 methenamine methenamine sodium phosphate, monobasic, monohydrate phosphate ion methylene blue anhydrous methylene blue cation methylene blue cation hyoscyamine sulfate anhydrous hyoscyamine light blue to blue m455
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, 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 may become blue to blue green and the feces may be discolored as a result of the excretion of methylene blue.
Indications and Usage:
Indication and usage me/naphos/mb/hyo 1 tablets 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.
General Precautions:
Directions: 1 tablet 4 times daily followed by liberal fluid intake, or as directed by a physician. for full product information see attached booklet. store at 25° c (77° f); excursions permitted to 15° c to 30° c (59° f to 86° f) [see usp controlled room temperature]. protect from moisture or direct sunlight. note : patient should be advised that urine will be colored blue while taking this medication. pharmacist : preserve and dispense in tight-light resistant container as defined in the usp. keep this and all medicines out of the reach of children. tamper evident by heat seal under cap. do not use if there is evidence of tampering. to report an adverse event, please contact method pharmaceuticals, llc at (877) 250-3427.
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.
Adverse Reactions:
Adverse reactions cardiovascula r 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, 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 may become blue to blue green and the feces may be discolored as a result of the excretion of methylene blue.
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 ....................................... 10.8 mg hyoscyamine sulfate ............................... 0.12 mg
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 blu e 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 me/naphos/mb/hyo 1 tablets are light blue to blue, oval, biconvex tablets debossed with "m455" with scoreline on one side and plain on the other side. supplied in bottles of 100 tablets (ndc 58657-454-01).
Package Label Principal Display Panel:
Distributed by: method pharmaceuticals, llc arlington, tx 76006 rev. date: 01/2016 pinciple display panel booklet principle display booklet