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Prosed DS

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Prosed DS

WARNINGS

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.

PRECAUTIONS

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.

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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