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Actisite

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Actisite

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Actisite

Actisite Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Actisite (tetracycline hydrochloride) Periodontal Fiber is an antibiotic used as an adjunct to scaling and root planing for reduction of pocket depth and bleeding on probing in patients with adult periodontitis. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include discomfort on fiber placement and local redness following removal.

Actisite fiber provides continuous release dosing of tetracycline for 10 days. At the end of 10 days of treatment, all fibers must be removed. Actisite may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Actisite should be used only if prescribed. This drug passes into breast milk when taken in other forms. It is unknown if it passes into breast milk when used as periodontal fiber. Consult your doctor before breastfeeding.

Our Actisite (tetracycline hydrochloride) Periodontal Fiber Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Actisite FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Actisite (Tetracycline Periodontal) »

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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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