"The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
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The physician should consult the package insert for clarithromycin for information concerning warnings and precautions associated with this drug.
The bismuth derived from TRITEC (ranitidine bismuth citrate) may cause a temporary and harmless darkening of the tongue and/or stool. Stool darkening should not be confused with melena (blood in the stool).
No specific clinical laboratory tests are recommended for monitoring patients prior to and/or after treatment with TRITEC (ranitidine bismuth citrate) plus clarithromycin. False-positive tests for urine protein with MULTISTIX® may occur during ranitidine therapy, and therefore, testing with sulfosalicylic acid is recommended.
Coadministration of TRITEC (ranitidine bismuth citrate) with clarithromycin resulted in increased plasma ranitidine concentrations (57%), increased plasma bismuth trough concentrations (48%), and increased 14-hydroxy-clarithromycin plasma concentrations (31%). Coadministration with aspirin results in a slight decrease in the rate of salicylate absorption that is clinically unimportant. Coadministration with a high dose of antacid (170 mEq) results in a 28% decrease in plasma concentrations of ranitidine and may decrease plasma concentrations of bismuth from TRITEC (ranitidine bismuth citrate) . These effects are clinically insignificant.
For information on drug interactions associated with ranitidine, refer to the ZANTAC ® package insert.
In a 24-month oral carcinogenicity study in B6C3F1 mice, ranitidine bismuth citrate at daily doses up to 1,000 mg/kg was not carcinogenic. For a 50-kg person of average height (1.46 m2 body surface area), this dose represents five times the recommended clinical dose of 400 mg b.i.d. (592 mg/m2 ). In a 24-month oral carcinogenicity study in Sprague-Dawley rats, ranitidine bismuth citrate at daily doses up to 500 mg/kg, five times the recommended human dose based on body surface area, was not carcinogenic.
Ranitidine bismuth citrate was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/ TK+/-) forward mutation test, the ex vivorat gastric mucosal unscheduled DNA synthesis (UDS) test, or the in vivo rat micronucleus test. It was positive in vitro human lymphocyte chromosomal aberration assay.
Ranitidine bismuth citrate at oral doses up to 1,800 mg/ kg per day (18 times the recommended human dose based on an average body surface area of 1.46 m2 ) was found to have no effect on impairment of fertility and reproductive performance of male and female rats.
Teratogenic Effects: Pregnancy Category C: TRITEC (ranitidine bismuth citrate) used in combination with clarithromycin carries a Pregnancy Category C because clarithromycin carries Pregnancy Category C. (See clarithromycin package insert Pregnancy subsection and WARNINGS section.)
Nonteratogenic Effects of Ranitidine Bismuth Citrate: Teratology studies have been performed in pregnant rats at oral doses up to 1,800 mg/kg per day (18 times the recommended human dose based body surface area) and pregnant rabbits at oral doses up to 300 mg/kg per day (6 times the recommended human dose based on body surface area) and have revealed no evidence of harm to the fetus due to ranitidine bismuth citrate.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Five patients became pregnant while they were receiving ranitidine bismuth citrate alone at varied doses. Three of these patients had normal pregnancies and newborns,; one had a voluntary abortion, and one delivered a baby with postaxial polydactyly. This Caucasian woman had a history of unexplained spontaneous abortions. She had received ranitidine bismuth citrate for 7 days prior to conception and for 20 days after conception. The investigator considered the event unrelated to TRITEC (ranitidine bismuth citrate) . Postaxial polydactyly is about 10 times more frequent in blacks than in Caucasians. In American whites, incidence figures vary from 1:3,300 to 1:630 live births, and in American blacks figures vary from 1:300 to 1:100 live births. (March of Dimes 1996.)
It is not known whether ranitidine bismuth citrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ranitidine bismuth citrate is administered to a nursing woman. It is known that both ranitidine and bismuth are excreted in rat milk.
Safety and effectiveness of ranitidine bismuth citrate plus clarithromycin in pediatric patients have not been established.
Ulcer healing and relapse rates in elderly patients (³65 years of age) were no different from those in younger age-groups. The incidence rates for adverse events and laboratory abnormalities also were not different from those seen in other age-groups. In a pharmacokinetic study, serum levels of ranitidine were increased in elderly patients, but serum bismuth levels were equivalent to those seen in the overall population.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Tritec Information
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