Methenamine Mandelate

Chartwell Rx, Llc
Human Prescription Drug
NDC 62135-201

Methenamine Mandelate is a human prescription drug labeled by 'Chartwell Rx, Llc'. National Drug Code (NDC) number for Methenamine Mandelate is 62135-201. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Methenamine Mandelate drug includes Methenamine Mandelate - 1000 mg/1 . The currest status of Methenamine Mandelate drug is Active.

Drug Information:

Drug NDC:	62135-201
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:	Methenamine Mandelate
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 Mandelate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Chartwell Rx, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Film 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:	METHENAMINE MANDELATE - 1000 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 Oct, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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, 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:	Chartwell RX, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	992153 992184
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:	0362135201128 0362135201609 0362135200121 0362135200015 0362135201012 0362135200602
UPC stands for Universal Product Code.
UNII:	695N30CINR
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
62135-201-01	100 TABLET, FILM COATED in 1 BOTTLE (62135-201-01)	01 Oct, 2021	N/A	No
62135-201-12	120 TABLET, FILM COATED in 1 BOTTLE (62135-201-12)	01 Oct, 2021	N/A	No
62135-201-60	60 TABLET, FILM COATED in 1 BOTTLE (62135-201-60)	01 Oct, 2021	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.

Other medicines with the same generic name

Product Elements:

Methenamine mandelate methenamine mandelate croscarmellose sodium fd&c blue no. 2--aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide talc titanium dioxide methenamine mandelate methenamine ce;34 methenamine mandelate methenamine mandelate croscarmellose sodium fd&c blue no. 2--aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide talc titanium dioxide methenamine mandelate methenamine ce;35

Drug Interactions:

Drug interactions formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate should not be administered concurrently with sulfamethizole or other sulfonamides. concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine.

Indications and Usage:

Indications and usage methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. when used as recommended, methenamine mandelate is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. pathogens resistant to other antibacterial agents may respond to methenamine mandelate because of the nonspecific effect of formaldehyde formed in an acid urine. prophylactic use rationale: urine is a good culture medium for many urinary pathogens. inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. the Read more...

re is a growing body of evidence that long-term administration of methenamine mandelate can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. therapeutic use rationale : methenamine mandelate helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. methenamine mandelate should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. a thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate.

Warnings:

Warnings methenamine mandelate should be avoided in patients with gout because it may precipitate urate crystals in their urine. a similar situation may arise in patients with a predisposition to the formation of uric acid stones. methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.

General Precautions:

General dysuria may occur (usually at higher than recommended dosage). this can be controlled by reducing the dosage and the acidification. when urine acidification is contraindicated or unattainable (as with some urea-splitting bacteria), the drug is not recommended. large doses of methenamine (8 g daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

Dosage and Administration:

Dosage and administration the average adult dose is 4 g a day given as one 1000 mg tablet or two 500 mg tablets after each meal and at bedtime. children 6 to 12 years of age should receive half the adult dose; one 500 mg tablet, 4 times a day.

Contraindications:

Contraindications methenamine mandelate tablets are contraindicated in patients with renal insufficiency, severe hepatic disease, severe dehydration, and in patients who have exhibited hypersensitivity to any components of this product.

Adverse Reactions:

Adverse reactions gastrointestinal disturbances (nausea, stomach upset), generalized skin rash, dysuria, painful or difficult urination may occur occasionally with the use of methenamine preparations. microscopic and rarely, gross hematuria have been described.

Drug Interactions:

Use in Pregnancy:

Pregnancy teratogenic effects. pregnancy category c. animal reproduction studies have not been conducted with methenamine mandelate. it is also not known whether methenamine mandelate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. since methenamine is known to cross the placental barrier, methenamine mandelate should be given to a pregnant woman only if the potential benefit outweighs the risk.

Description:

Description methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. methenamine mandelate is available for oral use as film-coated tablets. methenamine mandelate tablets contain 500 mg and 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, fd&c blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide.

Clinical Pharmacology:

Clinical pharmacology methenamine mandelate is readily absorbed but remains essentially inactive until it is excreted by the kidneys and concentrated in the urine. an acid urine is essential for antibacterial action, with maximum efficacy occurring at ph 5.5 or less. in an acid urine, mandelic acid exerts its antibacterial action and also contributes to the acidification of the urine. mandelic acid is excreted both by glomerular filtration and tubular excretion. the methenamine component is hydrolyzed in acid urine to ammonia and to the bactericidal agent formaldehyde. proportionally less formaldehyde is released as urinary ph approaches 6.0 and insufficient quantities are released above this level for therapeutic response. there is equally effective antibacterial activity against both gram-positive and gram-negative organisms, since the antibacterial action of mandelic acid and formaldehyde is nonspecific. there are reports that methenamine mandelate is ineffective in some infections Read more...

with proteus vulgaris and urea-splitting strains of pseudomonas aeruginosa and a. aerogenes . since urea-splitting strains may raise the ph of the urine, particular attention to supplementary acidification with agents such as ascorbic acid, and urinary ph monitoring is required. however, results in any single case will depend to a large extent on the underlying pathology and the overall management.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis and mutagenesis methenamine mandelate has not been evaluated for carcinogenicity or mutagenicity. methenamine was evaluated for mutagenicity in the ames salmonella/mammalian microsome test. five strains of salmonella typhimurium (ta98, ta100, ta1535, ta1537 and ta1538) and a strain of escherichia coli (wp2uvra) were used. at a dose of 10,000 Î¼g/plate methenamine showed mutagenic activity in salmonella typhimurium ta98 and ta100 by metabolic activation and also showed mutagenic activity in ta98 without microsomal activation. in one large study, no evidence of carcinogenicity was found following long-term oral administration of methenamine 1.25 g/kg/day to rats (104 weeks) and mice (60 weeks).

How Supplied:

How supplied methenamine mandelate tablets, usp 500 mg are blue, unscored, oval, film-coated, debossed with "ce 34" on one side and plain on the other side. supplied in bottles of 60 (ndc 62135-200-60) supplied in bottles of 100 (ndc 62135-200-01) supplied in bottles of 120 (ndc 62135-200-12) methenamine mandelate tablets, usp 1000 mg (1 g) are blue, unscored, oval, film-coated, debossed with "ce 35" on one side and plain on the other side. supplied in bottles of 60 (ndc 62135-201-60) supplied in bottles of 100 (ndc 62135-201-01) supplied in bottles of 120 (ndc 62135-201-12) preserve in well-closed containers store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted to 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. manufactured for: chartwell rx llc. congers, ny 10920 made in usa l70516 rev. 09/2021

Information for Patients:

Information for patients to assure an acidic ph, patients should be instructed to restrict or avoid milk products and antacids containing sodium carbonate or bicarbonate.

Package Label Principal Display Panel:

Package label-principal display panel methenamine mandelate tablets, usp 500 mg - ndc 62135-200-60 - 60 tablets label methenamine mandelate tablets, usp 500 mg - ndc 62135-200-01 - 100 tablets label methenamine mandelate tablets, usp 500 mg - ndc 62135-200-12 - 120 tablets label methenamine mandelate tablets, usp 1000 mg - ndc 62135-201-60 - 60 tablets label methenamine mandelate tablets, usp 1000 mg - ndc 62135-201-01 - 100 tablets label methenamine mandelate tablets, usp 1000 mg - ndc 62135-201-12 - 120 tablets label methenamine mandelate tablets, usp 500 mg - ndc 62135-200-60 - 60 tablets label methenamine mandelate tablets, usp 500 mg - ndc 62135-200-01 - 100 tablets label methenamine mandelate tablets, usp 500 mg - ndc 62135-200-12 - 120 tablets label methenamine mandelate tablets, usp 1000 mg - ndc 62135-201-60 - 60 tablets label methenamine mandelate tablets, usp 1000 mg - ndc 62135-201-01 - 100 tablets label methenamine mandelate tablets, usp 1000 mg - ndc 62135-201-12 - 120 tablets label

Comments/ Reviews:

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