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Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.
Cross sensitivity and/or related problems: Patients intolerant of other belladonna alkaloids or other salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.
Pregnancy/Reproduction (FDA Pregnancy Category C): Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether PROSED®/DS tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PROSED®/DS tablets should be given to a pregnant woman only if clearly needed.
Nursing mothers: Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when PROSED®/DS tablets are administered to a nursing mother.
Prolonged use: There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenicpotential.
Pediatric: Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.
Geriatric: Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/8/2008
Additional Prosed DS Information
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