The use of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to age of 8 years) may cause permanent discoloration of the teeth. Tetracycline drugs should not be used in this age group unless other treatment is not likely to be effective or if alternative therapy is contraindicated.

Tetracyclines as a class are associated with photosensitivity. Treatment should be discontinued at the first sign of cutaneous erythema.

Accumulations of tetracycline associated with renal failure can lead to liver toxicity. These effects have not been studied in the plasma concentration range associated with Actisite®.

General

Actisite fibers must be removed after 10 days. Packing fibers tightly into a draining abscess without allowance for drainage might result in the formation of a lateral fistula. Fibers should not be used in an acutely abscessed periodontal pocket. Their use in chronic abscesses has not been evaluated.

As with other antibiotic preparations, Actisite (tetracycline hydrochloride) periodontal fiber therapy may result in overgrowth of nonsusceptible organisms, including fungi. Actisite should be used with caution in patients with a history of or predisposition to oral candidiasis.

The safety and effectiveness of Actisite fiber have not been established for the treatment of periodontitis in patients with coexistent oral candidiasis.

Use of antibiotic preparations may result in the development of resistant bacteria. Resistance has not been observed during 10 days of Actisite fiber therapy. The effects of prolonged treatment have not been studied.

Management of patients with periodontal disease should include a consideration of potentially contributing medical disorders.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies with Actisite fiber have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Category C

Administration of tetracycline during pregnancy may cause permanent discoloration of teeth of offspring. Animal studies indicate that tetracyclines can cause retardation of fetal skeletal development. Actisite fiber should be administered to a pregnant woman only if clearly needed. Animal reproduction studies have not been conducted with Actisite fiber. It is also not known whether Actisite fiber can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Nursing Mothers

Tetracycline appears in breast milk following oral administration. It is not known whether tetracycline is excreted in human milk following use of Actisite® (tetracycline hydrochloride) periodontal fiber. Because of the potential for serious adverse reactions from tetracycline HCl in nursing infants, Actisite fiber should be used in a nursing woman only if clearly needed.

Pediatrics

The safety and effectiveness of Actisite fiber in children have not been established. Oral doses of tetracycline in children up to 8 years of age have caused permanent discoloration of teeth.

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