Methenamine Mandelate

Generic Name: methenamine mandelate

Over-the-Counter (OTC)

Brand Names:

Methenamine Mandelate

DESCRIPTION: Methenamine mandelate, USP, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate, USP is available for oral use as film-coated tablets. Active Ingredients: Methenamine Mandelate: 500 mg or 0.5 gm. Methenamine Mandelate: 1000 mg or 1.0 gm.

Overview

DESCRIPTION: Methenamine mandelate, USP, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate, USP is available for oral use as film-coated tablets. Active Ingredients: Methenamine Mandelate: 500 mg or 0.5 gm. Methenamine Mandelate: 1000 mg or 1.0 gm.

Uses

INDICATIONS AND USAGE Methenamine mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, methenamine mandelate, USP 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, USP 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.

Dosage

DOSAGE AND ADMINISTRATION The average adult dose is 4 grams daily given as 1 gram after each meal and at bedtime. Children 6 to 12 should receive half the adult dose, and children under 6 years of age should receive 250 mg per 30 lb body weight, four times daily. (See chart) Since an acid urine is essential for antibacterial activity, with maximum efficacy occurring at pH 5.5 or below, restriction of alkalinizing foods and medication is thus desirable. If testing of urine pH reveals the need, supplemental acidification should be given. Dosages Dosage Adults Pediatric Patients Tablets Tablets 1000mg 1 tablet qid - 500mg 2 tablets qid (Ages 6-12) 1 tablet qid

Side Effects

ADVERSE REACTIONS An occasional patient may experience gastrointestinal disturbance or a generalized skin rash. Microscopic and rarely gross hematuria have been described.

Interactions

DRUG INTERACTIONS Formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate, USP should not be administered concurrently with sulfamethizole.

Warnings

CONTRAINDICATIONS Contraindicated in renal insufficiency. Methenamine mandelate, USP should not be used in patients who have previously exhibited hypersensitivity to it.

Pregnancy

PREGNANCY Pregnancy Category C: Animal reproduction studies have not been conducted with methenamine mandelate, USP. It is also not known whether methenamine mandelate, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methenamine mandelate, USP should be given to a pregnant woman only if clearly needed. Since introduction, published reports on the use of methenamine mandelate, USP in pregnant women have not shown an increased risk of fetal abnormalities from use during pregnancy.

Storage

HOW SUPPLIED Methenamine Mandelate Tablets, USP 500 mg are supplied as: NDC 42799-105-01 Bottles of 100 Each tablet is blue, film coated, and bears the product code “105”. Methenamine Mandelate Tablets, USP 1000 mg are supplied as: NDC 42799-106-01 Bottles of 100 Each tablet is pink, film coated, and bears the product code “106”.

Frequently Asked Questions

What is Methenamine Mandelate used for?

INDICATIONS AND USAGE Methenamine mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, methenamine mandelate, USP 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, USP 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.

What are the side effects of Methenamine Mandelate?

ADVERSE REACTIONS An occasional patient may experience gastrointestinal disturbance or a generalized skin rash. Microscopic and rarely gross hematuria have been described.

Can I take Methenamine Mandelate during pregnancy?

PREGNANCY Pregnancy Category C: Animal reproduction studies have not been conducted with methenamine mandelate, USP. It is also not known whether methenamine mandelate, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methenamine mandelate, USP should be given to a pregnant woman only if clearly needed. Since introduction, published reports on the use of methenamine mandelate, USP in pregnant women have not shown an increased risk of fetal abnormalities from use during pregnancy.

What are the important warnings for Methenamine Mandelate?

CONTRAINDICATIONS Contraindicated in renal insufficiency. Methenamine mandelate, USP should not be used in patients who have previously exhibited hypersensitivity to it.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.