Methenamine mandelate warnings and precautions
| Methenamine mandelate |
|---|
| METHENAMINE MANDELATE® FDA Package Insert |
| Description |
| Clinical Pharmacology |
| Indications and Usage |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Dosage and Administration |
| How Supplied |
| Labels and Packages |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]
Warnings and Precautions
General: Dysuria may occur (usually at higher than recommended dosage). This can be controlled by reducing the dosage and the acidification. When urine acidification is contraindicated or unattainable (as with some urea-splitting bacteria), the drug is not recommended.
Drug Interactions: Formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate, USP should not be administered concurrently with sulfamethizole.
Drug/Laboratory Test Interactions: Formaldehyde interferes with fluorometric procedures for determination of urinary catecholamines and vanillylmandelic acid (VMA), causing erroneously high results. Formaldehyde also causes falsely decreased urine estriol levels by reacting with estriol when acid hydrolysis techniques are used; estriol determinations which use enzymatic hydrolysis are unaffected by formaldehyde. Formaldehyde causes falsely elevated 17-hydroxycorticosteroid levels when the Porter-Silber method is used and falsely decreased 5-hydroxyindoleacetic acid (5HIAA) levels by inhibiting color development when nitrosonaphthol methods are used.
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.[1]
References
- ↑ "METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]". Text " accessdate" ignored (help)
Adapted from the FDA Package Insert.