Hiprex contains methenamine and is used in the management of urinary tract infections, with a particular role in the prevention of recurrent episodes rather than the treatment of acute, complicated infection. The brand is registered in 12 countries, a footprint that spans an unusual mix of Nordic Europe, Central America, and the English-speaking world.
The active ingredient, methenamine, is an older urinary antiseptic whose use has persisted in specific clinical niches — notably long-term suppressive therapy in patients prone to repeat urinary tract infections, where antibiotic stewardship concerns make a non-antibiotic option useful. The structured indication block further down this page lists the registered uses recognised by national regulators in the markets where Hiprex is sold.
Geographically, Hiprex shows up in two distinct clusters: Nordic countries such as Finland, Norway, and Sweden, and a Central American group that includes Guatemala, Honduras, El Salvador, Panama, the Dominican Republic, and Costa Rica, alongside the United Kingdom, the United States, and New Zealand. Travellers and expatriates moving between these regions will often find the brand familiar; outside this set of markets, the same brand is less commonly stocked, though the active ingredient may be available under a different name.
Methenamine itself is not a frontline antibiotic, and the regulatory status, packaging, and prescribing pathway around it differ noticeably between markets — a Nordic prescription pattern is not the same as a Central American one. A local pharmacist is well placed to confirm whether methenamine is stocked in a given country and under what brand. Decisions about starting it, continuing it, or switching to another approach for urinary infection prevention should be made together with a healthcare provider who knows the patient's history.
HIPREX (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.
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 Validus Pharmaceuticals LLC at 1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
HIPREX 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 HIPREX and other antibacterial drugs, HIPREX 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-gram scored, capsule-shaped yellow tablets debossed MERRELL 277 in bottles of 100 (NDC 30698-277-01)
Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C).
Dispense in well-closed, light-resistant container with child-resistant closure.
Manufactured for and Distributed by: Validus Pharmaceuticals LLC 119 Cherry Hill Road, Suite 310 Parsippany, NJ 07054. Revised : Dec 2017
Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.
PRECAUTIONSPrescribing HIPREX 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.
Clinical studies of HIPREX 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.
HIPREX is contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see CONTRAINDICATIONS).
1 tablet (1.0 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. ½ 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 HIPREX 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.
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 Validus Pharmaceuticals LLC at 1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONSNo Information provided
Hiprex is used in the management of urinary tract infections, with a particular role in the prevention of recurrent infection rather than acute treatment. Methenamine is generally positioned as a long-term suppressive option in patients prone to repeated urinary tract infections. The structured indication list below this introduction details the registered uses recognised by national regulators in the markets where Hiprex is sold.
Hiprex contains methenamine, an older urinary antiseptic that remains in use for the prevention of recurrent urinary tract infections. Methenamine is not a conventional antibiotic, which is part of why it has retained a niche in long-term suppressive prescribing internationally. The same active ingredient circulates worldwide under different brand names depending on the regulatory market.
Hiprex is registered in 12 countries, with an unusual footprint spanning Nordic Europe, Central America, and the English-speaking world. Examples include Finland, Guatemala, the United Kingdom, New Zealand, Norway, Panama, and the United States. If your country is not on this list, a local pharmacist can confirm whether methenamine is available locally under a different brand name.
Methenamine is sold under several brand names internationally, particularly in markets where it has been on formulary for many decades. For prevention of recurrent urinary tract infection more broadly, other approaches and other molecules also exist, although they are not freely interchangeable with methenamine. To identify a local methenamine-containing product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.
Yes. Methenamine is a prescription medication in most of the markets where Hiprex is registered, and its role in urinary infection prevention is calibrated to individual patient history, urinary chemistry, and concurrent medications. Prescription pathways and stocked brands differ between Nordic Europe, Central America, and English-speaking markets, so travellers and expatriates in particular should confirm continuation arrangements with a healthcare provider familiar with their case.
