"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"...
(Generic versions may still be available.)
There has been limited experience with overdosage. Adverse events related to overdosage with ranitidine are usually reversible, nonspecific, and non- life threatening and result in no adverse sequelae. Although not seen in clinical trials with TRITEC (ranitidine bismuth citrate) , bismuth intoxication from prolonged overdosage or deliberate self- poisoning can result in neurotoxicity and nephrotoxicity and possibly other symptoms seen with the use of soluble bismuth compounds. In the event of an overdose or suspected bismuth toxicity, measures should be employed to remove unabsorbed material from the gastrointestinal tract, and symptom monitoring and other supportive therapy should be employed, if indicated.
Single oral doses of ranitidine bismuth citrate at 3,000 and 4,000 mg/ kg in male and female mice, respectively (approximately 15 to 20 times the recommended human dose based on body surface area), and at 2,000 and 3,000 mg/ kg in male and female rats, respectively, (approximately 20 to 30 times the recommended human dose based on body surface area) were lethal. Symptoms of acute toxicity were piloerection, tremors, hunched posture, rapid respiration, and decreased activity.
TRITEC (ranitidine bismuth citrate) is contraindicated in patients known to have hypersensitivity to ranitidine bismuth citrate or any of its ingredients.
For information on clarithromycin contraindications, see clarithromycin package insert.
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
Report Problems to the Food and Drug Administration
Get the latest treatment options.