"The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
Fecal incontinence is the inability to control bowel movements and is a common problem, espec"...
TO PROTECT ENTERIC COATING, MINITABLETS MUST NOT BE CRUSHED OR CHEWED. Where swallowing of capsules is difficult, they may be opened and the minitablets added to a small quantity of a soft food (e.g., applesauce, gelatin, etc.) that does not require chewing, and swallowed immediately. Contact of the minitablet with foods having a pH greater than 5.5 can dissolve the protective enteric shell.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy: Category C.
Animal reproduction studies have not been conducted with ULTRASE® MT (pancrelipase) Capsules. It is not known whether ULTRASE® MT (pancrelipase) Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ULTRASE® MT (pancrelipase) Capsules should be given to a pregnant woman only if the potential benefit outweighs the potential risk to the fetus.
It is not known whether ULTRASE® MT (pancrelipase) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ULTRASE® MT (pancrelipase) Capsules are administered to a nursing mother.
Last reviewed on RxList: 1/20/2009
This monograph has been modified to include the generic and brand name in many instances.
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