Methenamine Mandelate Tablets: Package Insert / Prescribing Info

Methenamine Mandelate Tablets Description

Methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate is available for oral use as film-coated tablets.

Methenamine mandelate tablets contain 500 mg and 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide.

Methenamine Mandelate Tablets - Clinical Pharmacology

Methenamine mandelate is readily absorbed but remains essentially inactive until it is excreted by the kidneys and concentrated in the urine. An acid urine is essential for antibacterial action, with maximum efficacy occurring at pH 5.5 or less. In an acid urine, mandelic acid exerts its antibacterial action and also contributes to the acidification of the urine. Mandelic acid is excreted both by glomerular filtration and tubular excretion. The methenamine component is hydrolyzed in acid urine to ammonia and to the bactericidal agent formaldehyde.

Proportionally less formaldehyde is released as urinary pH approaches 6.0 and insufficient quantities are released above this level for therapeutic response. There is equally effective antibacterial activity against both gram-positive and gram-negative organisms, since the antibacterial action of mandelic acid and formaldehyde is nonspecific. There are reports that methenamine mandelate is ineffective in some infections with Proteus vulgaris and urea-splitting strains of Pseudomonas aeruginosa and A. aerogenes. Since urea-splitting strains may raise the pH of the urine, particular attention to supplementary acidification with agents such as ascorbic acid, and urinary pH monitoring is required. However, results in any single case will depend to a large extent on the underlying pathology and the overall management.

Indications and Usage for Methenamine Mandelate Tablets

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 growth-supporting 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: Methenamine mandelate helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. Methenamine mandelate should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. A thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate.

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.

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.

Precautions

Adverse Reactions/Side Effects

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.

OVERDOSAGE

Minimize absorption by inducing vomiting or by gastric lavage followed by administration of activated charcoal. Administer orally fluids and alkalinize with sodium bicarbonate.

Methenamine Mandelate Tablets 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.

How is Methenamine Mandelate Tablets supplied

Methenamine Mandelate Tablets, USP 500 mg are blue, unscored, oval, film-coated, debossed with "CE 34" on one side and plain on the other side.

Supplied in bottles of 60 (NDC 62135-200-60)
Supplied in bottles of 100 (NDC 62135-200-01)
Supplied in bottles of 120 (NDC 62135-200-12)

Methenamine Mandelate Tablets, USP 1000 mg (1 g) are blue, unscored, oval, film-coated, debossed with "CE 35" on one side and plain on the other side.

Supplied in bottles of 60 (NDC 62135-201-60)
Supplied in bottles of 100 (NDC 62135-201-01)
Supplied in bottles of 120 (NDC 62135-201-12)

Preserve in well-closed containers

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for:
Chartwell RX LLC.
Congers, NY 10920
Made in USA
L70516 Rev. 09/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Methenamine Mandelate Tablets, USP 500 mg - NDC 62135-200-60 - 60 Tablets Label

Methenamine Mandelate Tablets, USP 500 mg - NDC 62135-200-01 - 100 Tablets Label

Methenamine Mandelate Tablets, USP 500 mg - NDC 62135-200-12 - 120 Tablets Label

Methenamine Mandelate Tablets, USP 1000 mg - NDC 62135-201-60 - 60 Tablets Label

Methenamine Mandelate Tablets, USP 1000 mg - NDC 62135-201-01 - 100 Tablets Label

Methenamine Mandelate Tablets, USP 1000 mg - NDC 62135-201-12 - 120 Tablets Label