Methenamine Hippurate 1000 mg/1
Methenamine Hippurate · TABLET · AvPAK
Methenamine Hippurate is a tablet containing methenamine hippurate at 1000 mg/1, taken oral. Manufactured by AvPAK.
Key Facts
- Brand Name
- Methenamine Hippurate
- Generic Name
- Methenamine Hippurate
- NDC Code (Product)
50268-549- Manufacturer
- AvPAK
- Strength
- 1000 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212172
- Marketing Start
- 12/02/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS Methenamine hippurate tablets 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 and other antibacterial drugs, methenamine hippurate tablets 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.
Dosage & 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 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.
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.
Contraindications
CONTRAINDICATIONS 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.
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 Esjay Pharma LLC at 1-800-239-9339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Methenamine Hippurate used for?
Methenamine Hippurate contains Methenamine Hippurate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Methenamine Hippurate a controlled substance?
Methenamine Hippurate is not classified as a controlled substance by the DEA.
What is the generic name for Methenamine Hippurate?
The generic name for Methenamine Hippurate is Methenamine Hippurate. There are 4 other brand versions of Methenamine Hippurate.
What is the NDC code for Methenamine Hippurate 1000 mg/1?
The NDC (National Drug Code) for Methenamine Hippurate 1000 mg/1 is 50268-549, listed by AvPAK.