Actisite
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Actisite
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
SIDE EFFECTS
Actisite (tetracycline periodontal) fiber has been studied in 1437 patients distributed as follows over pivotal, controlled, and open- label studies.
| Study Type | ||||
| Demographics | Pivotal | Controlled | Uncontrolled | TOTAL |
| Gender: | ||||
| Male | 113 | 70 | 455 | 638 |
| Female | 113 | 55 | 631 | 799 |
| Age Range | 25-88 | 25-73 | 13-87 | 13-88 |
| Race: | ||||
| Black | 13 | 12 | 41 | 66 |
| Asian | 4 | 1 | 10 | 15 |
| Hispanic | 3 | 3 | 11 | 17 |
| Caucasian | 206 | 105 | 964 | 1275 |
| Native American | 0 | 2 | 56 | 58 |
| Other | 0 | 2 | 5 | 7 |
The most frequently reported adverse reactions in the 226 patients in the pivotal clinical trials were discomfort on fiber placement (10%) and local erythema following removal (11%).
In controlled and open-label trials patients, the following adverse reactions have been reported in less than 1% of patients: oral candidiasis, glossitis, possible allergic response, staining of the tongue, severe gingival inflammation, throbbing pain, pain following placement in an abscessed area, and minor throat irritation.
Read the Actisite (tetracycline periodontal) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Actisite 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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