METHENAMINE HIPPURATE tablet

Methenamine Hippurate by

Drug Labeling and Warnings

Methenamine Hippurate by is a Prescription medication manufactured, distributed, or labeled by Leading Pharma, LLC, PATHEON PHARMACEUTICALS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets USP and other anti bacterial 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 Methena mine (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 hydolyzed 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, anti bacterial activity is demonstrable in the urine. Urine has continuous anti bacterial activity when methenamine hippurate is ad min istered 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 longterm 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 sulfona mides 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 maintainan 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 (tartra zine), which may cause allergictype reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartra zine) 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

REPORTING ADVERSE REACTION STATEMENT AND PHONE NUMBERS CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA- 1088 OR LEADING PHARMA,LLC AT 844-740-7500

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 acid ifica tion of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.

HOW SUPPLIED

1-gram scored, capsuleshaped yellow tablets debossed W 1037 in bottles of 100 (NDC: 69315-210-01) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Prescribing information as of January 2016

Distributed by:

Leading Pharma, LLC
Fairfield, NJ 07004

Manufactured by:
Patheon Pharmaceuticals, Inc.
Cincinnati, OH 45237

70032118


Rev. 01/16 .

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

METHENAMINE HIPPURATE 
methenamine hippurate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69315-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHENAMINE HIPPURATE (UNII: M329791L57) (METHENAMINE - UNII:J50OIX95QV)	METHENAMINE HIPPURATE	1 g

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	CAPSULE	Size	5mm
Flavor		Imprint Code	W;1037
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69315-210-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA017681	06/03/2016

Labeler - Leading Pharma, LLC (079575060)

Registrant - Leading Pharma, LLC (079575060)

Establishment
Name	Address	ID/FEI	Business Operations
PATHEON PHARMACEUTICALS INC.		005286822	MANUFACTURE(69315-210)