Hiprex
Methenamine Hippurate
Validus Pharmaceuticals Llc
Human Prescription Drug
NDC 30698-477Hiprex also known as Methenamine Hippurate is a human prescription drug labeled by 'Validus Pharmaceuticals Llc'. National Drug Code (NDC) number for Hiprex is 30698-477. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Hiprex drug includes Methenamine Hippurate - 1 g/1 . The currest status of Hiprex drug is Active.
Drug Information:
| Drug NDC: | 30698-477 |
| 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: | Hiprex |
| 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 Hippurate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Validus 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: | METHENAMINE HIPPURATE - 1 g/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: | NDA |
| 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: | 09 Sep, 1976 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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. |
| Application Number: | NDA017681 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Validus Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 992150
992152
|
| 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: | M329791L57
|
| 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 |
|---|
| 30698-477-01 | 100 TABLET in 1 BOTTLE (30698-477-01) | 09 Sep, 1976 | 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:
Hiprex methenamine hippurate methenamine hippurate methenamine fd&c yellow no. 5 magnesium stearate povidone saccharin sodium w;1037
Indications and Usage:
Indications hiprex is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. to reduce the development of drug-resistant bacteria and maintain the effectiveness of hiprex and other antibacterial drugs, hiprex should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Warnings:
Warning large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.
Dosage and Administration:
Dosage and administration 1 tablet (1.0 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1.0 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. since the antibacterial activity of hiprex is greater in acid urine, restriction of alkalinizing foods and medications is desirable. if necessary, as indicated by urinary ph and clinical response, supplemental acidification of the urine should be instituted. the efficacy of therapy should be monitored by repeated urine cultures.
Contraindications:
Contraindications hiprex (methenamine hippurate tablets usp) is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.
Adverse Reactions:
Adverse reactions minor adverse reactions have been reported in less than 3.5% of patients treated. these reactions have included nausea, upset stomach, dysuria, and rash. to report suspected adverse reactions, contact validus pharmaceuticals llc at 1-866-982-5438 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Geriatric Use:
Geriatric use clinical studies of hiprex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. hiprex is contraindicated in patients with renal insufficiency and severe hepatic insufficiency ( see contraindications ).
Description:
Description each yellow capsule-shaped tablet contains 1 g methenamine hippurate which is the hippuric acid salt of methenamine (hexamethylene tetramine). the tablet also contains inactive ingredients. fd&c yellow no. 5 ( tartrazine, see precautions ) , magnesium stearate, povidone, and saccharin sodium.
Mechanism of Action:
Actions microbiology: hiprex (methenamine hippurate tablets usp) has antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. the drug is generally active against e. coli, enterococci and staphylococci. enterobacter aerogenes is generally resistant. the urine must be kept sufficiently acid for urea-splitting organisms such as proteus and pseudomonas to be inhibited. human pharmacology: within 1/2 hour after ingestion of a single 1-gram dose of hiprex, antibacterial activity is demonstrable in the urine. urine has continuous antibacterial activity when hiprex is administered at the recommended dosage schedule of 1 gram twice daily. over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1-gram dose. similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. this action may be important in older patients or in those with some degree of renal impairment.
How Supplied:
How supplied 1-gram scored, capsule-shaped yellow tablets debossed w 1037 in bottles of 100 (ndc 30698-477-01). store at 68° to 77°f (20° to 25°c); excursions permitted to 59° to 86°f (15° to 30°c) [see usp controlled room temperature]. dispense in well-closed, light-resistant container with child-resistant closure. manufactured for and distributed by: validus pharmaceuticals llc parsippany, nj 07054 info@validuspharma.com www.validuspharma.com 1-866-982-5438 product of india © 2021 validus pharmaceuticals llc 60029-03july 2021
Information for Patients:
Information for patients patients should be counseled that antibacterial drugs including hiprex should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when hiprex is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by hiprex or other antibacterial drugs in the future.
Package Label Principal Display Panel:
Principal display panel ndc 30698-477-01 hiprex ® (methenamine hippurate tablets usp) 1 gram 100 tablets rx only principal display panel ndc 30698-477-01 hiprex® (methenamine hippurate tablets usp) 1 gram 100 tablets rx only