Methenamine Hippurate

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Overview

What is Methenamine Hippurate?

Each white to off-white colored capsule shaped tablet contains 1 g Methenamine Hippurate USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients. Magnesium stearate, povidone, and saccharin sodium.

What does Methenamine Hippurate look like?

What are the available doses of Methenamine Hippurate?

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What should I talk to my health care provider before I take Methenamine Hippurate?

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How should I use Methenamine Hippurate?

Methenamine hippurate tablets USP are 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 tablets USP and other antibacterial drugs, methenamine hippurate tablets USP 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.

1 tablet (1 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 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of methenamine hippurate tablets 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.

What interacts with Methenamine Hippurate?

Methenamine hippurate tablets are 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.

What are the warnings of Methenamine Hippurate?

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What are the precautions of Methenamine Hippurate?

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 and strains of . 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.

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 tablets are contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see ).

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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.

What are the side effects of Methenamine Hippurate?

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876

or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I look out for while using Methenamine Hippurate?

Methenamine hippurate tablets are 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.

Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

What might happen if I take too much Methenamine Hippurate?

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How should I store and handle Methenamine Hippurate?

Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018Methenamine Hippurate Tablets USP, 1 gStore atDispense in well-closed, light-resistant container with child-resistant closure.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 038, IndiaRevised: 01/2018

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Microbiology

E. coli

Enterobacter aerogenes

Proteus

Pseudomonas

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Non-Clinical Toxicology

Methenamine hippurate tablets are 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.

Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see ).

Concomitant use of isosorbide dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).

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 and strains of . 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.

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876

or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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