Drugplain

Methenamine Mandelate 500 mg/1

Methenamine Mandelate · TABLET, FILM COATED · Bryant Ranch Prepack

No Recall History
Plain English

Methenamine Mandelate is a tablet, film coated containing methenamine mandelate at 500 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Methenamine Mandelate
Generic Name
Methenamine Mandelate
NDC Code (Product)
72162-2654
Manufacturer
Bryant Ranch Prepack
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Marketing Start
03/19/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

urinary tract infection28 reports
fatigue20 reports
asthenia18 reports
drug ineffective18 reports
fall18 reports
diarrhoea17 reports
product dose omission issue14 reports
malaise13 reports
nausea12 reports
dizziness11 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growthsupporting to a growth-inhibiting medium. There is a growing body of evidence that long-term administration of methenamine mandelate can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. Therapeutic Use Rationale Methe…

Dosage & Administration

DOSAGE AND ADMINISTRATION The average adult dose is 4 g a day given as one 1000 mg tablet or two 500 mg tablets after each meal and at bedtime. Children 6 to 12 years of age should receive half the adult dose; one 500 mg tablet, 4 times a day.

Warnings

WARNINGS Methenamine mandelate should be avoided in patients with gout because it may precipitate urate crystals in their urine. A similar situation may arise in patients with a predisposition to the formation of uric acid stones. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.

Contraindications

CONTRAINDICATIONS Methenamine mandelate tablets are contraindicated in patients with renal insufficiency, severe hepatic disease, severe dehydration, and in patients who have exhibited hypersensitivity to any components of this product.

Drug Interactions

Drug Interactions Formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate should not be administered concurrently with sulfamethizole or other sulfonamides. Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine.

Adverse Reactions

ADVERSE REACTIONS Gastrointestinal disturbances (nausea, stomach upset), generalized skin rash, dysuria, painful or difficult urination may occur occasionally with the use of methenamine preparations. Microscopic and rarely, gross hematuria have been described.

Frequently Asked Questions

What is Methenamine Mandelate used for?

Methenamine Mandelate contains Methenamine Mandelate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Methenamine Mandelate a controlled substance?

Methenamine Mandelate is not classified as a controlled substance by the DEA.

What is the generic name for Methenamine Mandelate?

The generic name for Methenamine Mandelate is Methenamine Mandelate. There are no other listed brand versions of Methenamine Mandelate.

What is the NDC code for Methenamine Mandelate 500 mg/1?

The NDC (National Drug Code) for Methenamine Mandelate 500 mg/1 is 72162-2654, listed by Bryant Ranch Prepack.

Product NDC

72162-2654

Package NDC

72162-2654-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)