| Function: | Antibiotic and Antimicrobial Agents |
|---|---|
| Certification: | GMP, FDA |
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | Identification | ||
| Name | Rifaximin | |
| Synonyms | 2S-Acetyloxy-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11, 16,20,22,24,26-octamethyl-2,7-(epoxypentoeleca(1,11,13)trienimino)benzofuro[4,5-e]pyride[1,2-a]benzimidazole-1,15(2H)-dione | |
| Molecular Structure | ||
| Molecular Formula | C43H51N3O11 | |
| Molecular Weight | 785.88 | |
| CAS Registry Number | 80621-81-4 | |
| Appearance | Red-orange, hygroscopic, crystalline powder. |
Solubility |
practically insoluble in water, soluble in acetone and in methanol. |
Related substances |
1)Sum of the impurities D and H: not more than 2.5 times the area of the principal peak in the chromatogram obtained with reference solution(a) ( ≤0.5%) |
| 2)Unspecified impurities:for each impurty,not more than 0.5times the area of the principal peak in the chromatogram obtained with Reference solution(a) ( ≤0.1%) | |
| 3)Total:not more than 5times the area of the principal peak in the chromatogram obtained with reference solution(a)( ≤ 1.0%) | |
| Sulfated ash | ≤ 0.1% |
| Moisture,wt,% | ≤ 4.5% |
| Heavy metal | ≤ 20 ppm |
| Assay, wt,% | 97.0% ~ 102.0% |
Rifaximin may be used to treat and prevent traveler's diarrhea.
Rifaximin is approved in the United States for the treatment of irritable bowel syndrome. It possesses anti-inflammatory and antibacterial properties and additionally, it is a nonabsorbable antibiotic that acts locally in the gut. These properties make it efficacious in relieving chronic functional symptoms of non-constipation type irritable bowel syndrome (IBS). It appears to retain its therapeutic properties for this indication, even after repeated courses. Rifaximin is particularly indicated where small intestine bacterial overgrowth is suspected of involvement in a person's IBS. Symptom relief or improvement can be obtained for global IBS symptoms including: abdominal pain, flatulence, bloating, and stool consistency. A drawback is that repeated courses may be necessary for relapse of symptoms. There is evidence that rifaximin can be curative in some people with IBS.
Rifaximin may also be a useful addition to vancomycin when treating patients with relapsing C. difficile infection. However the quality of evidence of these studies was judged to be low.Although exposure to rifamycins in the past may increase risk for resistance, so rifaximin should be avoided in such cases.
In the United States, rifaximin has orphan drug status for the treatment of hepatic encephalopathy.Although high-quality evidence is still lacking, rifaximin appears to be as effective as or more effective than other available treatments for hepatic encephalopathy (such as lactulose), is better tolerated, and may work faster.Rifaximin is taken by mouth. It has minimal side effects, prevents reoccurring encephalopathy, and is associated with high patient satisfaction. People are more compliant and satisfied to take this medication than any other due to minimal side effects, prolonged remission, and overall cost. It reduces the levels of intestinal ammonia-producing bacteria thus alleviating the symptoms of hepatic encephalopathy and reducing mortality.The drawbacks to rifaximin are increased cost and lack of robust clinical trials for HE without combination lactulose therapy.
Other uses include treatment of: infectious diarrhea, small intestinal bacterial overgrowth, inflammatory bowel disease, and diverticular disease. Rifaximin is effective in treating small intestinal bacterial overgrowth regardless of whether it is associated with irritable bowel syndrome or not.
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