METHENAMINE HIPPURATE

Main information

  • Trade name:
  • METHENAMINE HIPPURATE- methenamine hippurate tablet
  • Composition:
  • Methenamine Hippurate 1 g
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METHENAMINE HIPPURATE- methenamine hippurate tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Methenamine hippurate 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 methenamine hippurate and other antibacterial drugs, methenamine hippurate 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. Methenamine hippurate tablets USP is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to
  • Product summary:
  • 1-gram scored, capsule-shaped yellow tablets debossed W 1037 in bottles of 100 (NDC 0955-1037-10). Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • New Drug Application
  • Authorization number:
  • 0955-1037-10
  • Last update:
  • 27-05-2019

Summary of Product characteristics: dosage, interactions, side effects

METHENAMINE HIPPURATE- methenamine hippurate tablet

Winthrop U.S.

----------

METHENAMINE HIPPURATE TABLETS, USP

To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine

hippurate tablets USP and other antibacterial drugs, methenamine hippurate should be used only to treat

or prevent infections that are proven or strongly suspected to be caused by bacteria.

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.

ACTIONS

Microbiology

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 methenamine hippurate, antibacterial activity

is demonstrable in the urine. Urine has continuous antibacterial activity when methenamine hippurate 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.

INDICATIONS

Methenamine hippurate 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 methenamine

hippurate and other antibacterial drugs, methenamine hippurate 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.

CONTRAINDICATIONS

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.

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.

PRECAUTIONS

Prescribing methenamine hippurate in the absence of a proven or strongly suspected bacterial infection

or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the

development of drug-resistant bacteria.

1. Care should be taken to maintain an acid pH of the urine, especially when treating infections due to

urea-splitting organisms such as Proteus and strains of Pseudomonas.

2. In a few instances in one study, the serum transaminase levels were slightly elevated during treatment

but returned to normal while the patients were still taking methenamine hippurate. Because of this

report, it is recommended that liver function studies be performed periodically on patients taking the

drug, especially those with liver dysfunction.

3. Use in Pregnancy: In early pregnancy the safe use of methenamine hippurate is not established. In the

last trimester, safety is suggested, but not definitely proved. No adverse effects on the fetus were

seen in studies in pregnant rats and rabbits.

Methenamine hippurate taken during pregnancy can interfere with laboratory tests of urine estriol

(resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure.

This interference is due to the presence in the urine of methenamine and/or formaldehyde. Enzymatic

hydrolysis, in place of acid hydrolysis, will circumvent this problem.

4. This product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions

(including bronchial asthma) in certain susceptible individuals. Although the overall incidence of

FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in

patients who also have aspirin hypersensitivity.

Information for Patients

Patients should be counseled that antibacterial drugs including methenamine hippurate should only be

used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When

methenamine hippurate 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 methenamine hippurate or other antibacterial drugs in the future.

Geriatric Use

Clinical studies of methenamine hippurate 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.

Methenamine hippurate is contraindicated in patients with renal insufficiency and severe hepatic

insufficiency (see CONTRAINDICATIONS).

ADVERSE REACTIONS

Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have

Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have

included nausea, upset stomach, dysuria, and rash.

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 methenamine hippurate 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.

HOW SUPPLIED

1-gram scored, capsule-shaped yellow tablets debossed W 1037 in bottles of 100 (NDC 0955-1037-

10).

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room

Temperature].

Prescribing information as of August 2011a

Manufactured for:

Winthrop U.S.,

A business of sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

©2011 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 1 gram Bottle Label

NDC 0955-1037-10

W

Winthrop

Methenamine

Hippurate tablets USP

1 gram

Rx only

100 Tablets

sanofi aventis

METHENAMINE HIPPURATE

methenamine hippurate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 9 55-10 37

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Methena mine Hippura te (UNII: M329 79 1L57) (Methenamine - UNII:J50 OIX9 5QV)

Methenamine Hippurate

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C Yello w No . 5 (UNII: I753WB2F1M)

Ma g nesium Stea ra te (UNII: 70 0 9 7M6 I30 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Product Characteristics

Color

YELLOW

S core

2 pieces

S hap e

OVAL (capsule-shaped)

S iz e

19 mm

Flavor

Imprint Code

W;10 37

Contains

Packag ing

Winthrop U.S.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 55-10 37-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/23/20 12

0 5/30 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 176 8 1

0 1/23/20 12

0 5/30 /20 19

Labeler -

Winthrop U.S. (824676584)

Revised: 9/2018