Drug Catalog - Product Detail
METHENAMINE HIPPURATE 1GM TAB 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0577-01 | ALVOGEN | 100 | 1GM | TABLET |
PACKAGE FILES
Generic Name
METHENAMINE HIPPURATE
Substance Name
METHENAMINE HIPPURATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA016151
Description
DESCRIPTION Methenamine Hippurate Tablets are a urinary tract antiseptic drug. Each white, scored tablet contains methenamine hippurate 1g (see HOW SUPPLIED). Methenamine Hippurate Tablets also contain: magnesium stearate, povidone and saccharin sodium. Chemically, methenamine hippurate is the hippuric acid salt of methenamine (hexamethylenetetramine). Structural formula: C 15 H 21 N 5 O 3 Molecular Weight 319.37 Methenamine structural formula
How Supplied
HOW SUPPLIED Methenamine Hippurate Tablets are capsule-shaped, scored, white, debossed “CL 20” on one side. Each tablet contains methenamine hippurate 1 g. Bottles of 100 tablets (NDC 47781-577-01). Store at controlled room temperature 15°-30°C (59°-86°F).
Indications & Usage
INDICATIONS AND USAGE 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. 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION One tablet (1 g) twice daily for adults and children over 12 years of age. One-half tablet or one tablet (0.5 or 1 g) twice daily for children 6 to 12 years of age. The antibacterial activity of Methenamine Hippurate Tablets is greater in acid urine. Therefore, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine may be instituted. The efficacy of therapy should be monitored by repeated urine cultures.