Tritec
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Tritec
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Tritec Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tritec in Detail - Patient Information: Side Effects
Stop taking ranitidine bismuth citrate and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take ranitidine bismuth citrate and talk to your doctor if you experience
- changes in taste;
- headache or dizziness;
- diarrhea, nausea, or constipation; or
- tremor (shaking).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Tritec (Ranitidine Bismuth Citrate) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tritec FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Placebo-controlled trials in patients with active duodenal ulcer in the United States included 1,428 patients given TRITEC (ranitidine bismuth citrate) alone or in combination with clarithromycin, 120 patients given clarithromycin alone, and 469 patients given placebo.
Incidence of Drug-Related Adverse Reactions in Placebo-Controlled Clinical Trials: The following table lists drug- related adverse reactions that occurred at a frequency of ³1% among patients treated with TRITEC (ranitidine bismuth citrate) who participated in US placebo-controlled trials.
Table 3: Drug- Related Adverse Reactions During Treatment*
| | Placebo (n=469) | TRITEC (ranitidine bismuth citrate) Tablets 800 mg (n=903) | Clarithromycin 1500 mg (n=120) | TRITEC (ranitidine bismuth citrate) Tablets 800 mg + Clarithromycin 1,000 mg (n=196) | TRITEC (ranitidine bismuth citrate) Tablets 800 mg + .Clarithromycin 1,500 mg (n=329) |
| Gastrointestinal | |||||
| Diarrhea | 1% | 2% | 5% | 4% | 58% |
| Nausea & Vomiting | 1% | <1% | 2% | 5% | 3% |
| Constipation | <1% | 1% | 0% | 2% | 2% |
| Gas | <1% | <1% | 2% | 1% | <1% |
| Neurological | |||||
| Headache | <1% | 1% | <1% | 2% | 3% |
| Dizziness | <1% | <1% | 2% | 0% | <1% |
| Miscellaneous | |||||
| Disturbance of taste | <1% | <1% | 11% | 8% | 11% |
| Sleep disorder | <1% | <1% | <1% | <1% | 2% |
| Skin | |||||
| Pruritus | 0% | <1% | 0% | <1% | 1% |
| Rashes | <1% | <1% | 0% | 2% | <1% |
| Urogenital | |||||
| Gynecological problems† | 0% (n=159) | <1% (n=267) | 6% (n=32) | 1% (n=69) | 2% (n=125) |
*Total daily doses.
† n= number of females
Although seen in US clinical trials at a frequency of <1%, the following events may be associated with the use of TRITEC (ranitidine bismuth citrate) :
Gastrointestinal: Abdominal discomfort, gastric pain.
Hepatic: Transient changes in the liver enzymes SGPT (ALT) and SGOT (AST).
Hypersensitivity: There have been rare reports of hypersensitivity reactions, including skin rash and anaphylaxis.
Central Nervous System: Tremors have been reported rarely in patients receiving TRITEC (ranitidine bismuth citrate) . The relationship to TRITEC (ranitidine bismuth citrate) has been unclear.
For information on adverse reactions associated with ranitidine, refer to the ZANTAC ® package insert. For information on adverse reactions associated with clarithromycin, refer to the clarithromycin package insert.
Read the entire FDA prescribing information for Tritec (Ranitidine Bismuth Citrate) »
Additional Tritec Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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