"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
No serious adverse reactions or potential safety hazards have been reported with the use of ACI-JEL (vaginal jelly) .
General: No special care is required for the safe and effective use of ACI-JEL (vaginal jelly) . Drug Interactions: No incidence of drug interactions have been reported with concomitant use of ACI-JEL (vaginal jelly) and any other medications. Laboratory Tests: The monitoring of vaginal acidity (pH) may be helpful in following the patient's response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0.) Carcinogenesis: No long-term studies in animals have been performed to evaluate carcinogenic potential. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with ACI-JEL (vaginal jelly) . It is also not known whether ACI-JEL (vaginal jelly) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ACI-JEL (vaginal jelly) should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACI-JEL (vaginal jelly) is administered to a nursing woman.
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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