Actisite Generic Name: tetracycline periodontal Brand Name: Actisite Drug Class: Tetracyclines side effects drug center actisite (tetracycline periodontal) drug Related Drugs Dynacin PROFESSIONAL CONSUMER SIDE EFFECTS Contents Drug Description Indications Dosage Side Effects & Drug Interactions Warnings Precautions Overdosage & Contraindications Clinical Pharmacology Medication Guide Drug Description What is Actisite and how is it used? Actisite is a prescription medicine used to treat the symptoms of bacterial infection of the skin, intestines, respiratory tract, urinary tract, genitals, lymph nodes, and other body systems. Actisite may be used alone or with other medications. Actisite belongs to a class of drugs called Tetracyclines. It is not known if Actisite is safe and effective in children younger than 8 years of age. What are the possible side effects of Actisite? Actisite may cause serious side effects including: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe blistering and peeling, red skin rash, fever, chills, body aches, flu symptoms, pale or yellowed skin, easy bruising, unusual bleeding, and any signs of a new infection Get medical help right away, if you have any of the symptoms listed above. The most common side effects of Actisite include: nausea, vomiting, diarrhea, upset stomach, loss of appetite, white patches or sores inside your mouth or on your lips, swollen tongue, black or “hairy” tongue, trouble swallowing, sores or swelling in your rectal or genital area, and vaginal itching or discharge Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Actisite. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Actisite is a prescription medicine used to treat the symptoms of bacterial infection of the skin, intestines, respiratory tract, urinary tract, genitals, lymph nodes, and other body systems. Actisite may be used alone or with other medications. Actisite belongs to a class of drugs called Tetracyclines. It is not known if Actisite is safe and effective in children younger than 8 years of age. What are the possible side effects of Actisite? Actisite may cause serious side effects including: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe blistering and peeling, red skin rash, fever, chills, body aches, flu symptoms, pale or yellowed skin, easy bruising, unusual bleeding, and any signs of a new infection Get medical help right away, if you have any of the symptoms listed above. The most common side effects of Actisite include: nausea, vomiting, diarrhea, upset stomach, loss of appetite, white patches or sores inside your mouth or on your lips, swollen tongue, black or “hairy” tongue, trouble swallowing, sores or swelling in your rectal or genital area, and vaginal itching or discharge Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Actisite. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. DESCRIPTION Actisite® (tetracycline periodontal) periodontal fiber for periodontal pocket placement consists of a 23 cm (9 inch) monofilament of ethylene/vinyl acetate copolymer, 0.5 mm in diameter, containing 12.7 mg of evenly dispersed tetracycline hydrochloride, USP.Actisite® (tetracycline periodontal) fiber provides continuous release of tetracycline for 10 days. Actisite (tetracycline periodontal) is an antibiotic originally isolated from Streptomyces aureofaciens. Chemically it is the monohydrochloride of [4S-(4 α,4a α,5a α, 6 ß, 12a α)] -4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12, 12a-pentahydroxy-6-methyl-1,11-dioxo-2- naphthacenecarboxamide. Empirical Formula: C22H24N2O8.HCl. The chemical structure of tetracycline hydrochloride: Indications INDICATIONS Actisite® (tetracycline periodontal) periodontal fiber is indicated as an adjunct to scaling and root planing for reduction of pocket depth and bleeding on probing in patients with adult periodontitis. Treatment with Actisite (tetracycline periodontal) is a component of an intervention program which includes good oral hygiene and scaling and root planing. Effectiveness of repeated fiber applications in a site has not been studied. The effects of Actisite (tetracycline periodontal) on bone loss, tooth mobility, or tooth loss from periodontal disease has not been established. Dosage DOSAGE AND ADMINISTRATION Actisite (tetracycline periodontal) periodontal fiber for 10 days is indicated as an adjunct to scaling and root planing. Repeated fiber applications have not been studied. Actisite (tetracycline periodontal) fiber should be inserted into the periodontal pocket until the pocket is filled. The length of fiber used will vary with pocket depth and contour. The fiber should be placed to closely approximate the pocket anatomy and should be in contact with the base of the pocket. An appropriate cyanoacrylate adhesive should be used to help secure the fiber in the pocket. When placed within a periodontal pocket, Actisite (tetracycline periodontal) fiber provides continuous release of tetracycline for 10 days. At the end of 10 days of treatment, all fibers must be removed. Fibers lost before 7 days should be replaced. HOW SUPPLIED Actisite (tetracycline periodontal) periodontal fiber is available in cartons containing 4 fibers and 10 fibers. Each individually packaged, yellow fiber is 23 cm (9 inches) long and contains 12.7 mg of Actisite (tetracycline periodontal) . NDC 17314-4800-4 (4 Fiber carton) NDC 17314-4800-1 (10 Fiber carton) Store at controlled room temperature 15o-30oC (59o-86oF). Caution: Federal law prohibits dispensing without prescription. Manufactured by ALZA Corporation, Palo Alto, CA 94304 USA For: P&L/ALZA For product information call: 1-800-ACTISITE (tetracycline periodontal) To place an order call: 1-800-543-2577 &Copy; Procter & Gamble and ALZA Corporation 4/94 All rights reserved Side Effects & Drug Interactions 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. DRUG INTERACTIONS Warnings WARNINGS 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® (tetracycline periodontal) . Precautions PRECAUTIONS General Actisite (tetracycline periodontal) 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 (tetracycline periodontal) should be used with caution in patients with a history of or predisposition to oral candidiasis. The safety and effectiveness of Actisite (tetracycline periodontal) 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 (tetracycline periodontal) 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 (tetracycline periodontal) 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 (tetracycline periodontal) fiber should be administered to a pregnant woman only if clearly needed. Animal reproduction studies have not been conducted with Actisite (tetracycline periodontal) fiber. It is also not known whether Actisite (tetracycline periodontal) 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 (tetracycline periodontal) fiber should be used in a nursing woman only if clearly needed. Pediatrics The safety and effectiveness of Actisite (tetracycline periodontal) 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. Overdosage & Contraindications OVERDOSE See DOSAGE AND ADMINISTRATION. CONTRAINDICATIONS Actisite (tetracycline periodontal) fiber should not be used in patients who are hypersensitive to any tetracycline. Clinical Pharmacology CLINICAL PHARMACOLOGY Microbiology The clinical significance of the microbiological findings with Actisite (tetracycline periodontal) is not known. The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by inhibiting protein synthesis. In vitro testing has shown that probable periodontal pathogens, including Fusobacterium nucleatum, Porphyromonas (Bacteroides) gingivalis, Prevotella intermedia (Bacteroides intermedius), Eikenella corrodens, Campylobacter rectus (Wolinella recta), and Actinobacillus actinomycetemcomitans, are susceptible to local 32 µg/mL tetracycline concentrations achieved in the periodontal pocket with the use of Actisite® (tetracycline hydrochloride) periodontal fiber. Pharmacokinetics Actisite (tetracycline periodontal) fiber releases tetracycline in vitro at a rate of approximately 2 µg/cm-h. In the periodontal pocket, the system provides for a per site mean gingival fluid concentration of 1590 µg/mL tetracycline throughout the 10-day treatment period. Concentration in saliva immediately after fiber placement (9 teeth) was 50.7 µg/mL and declined to 7.6 µg/mL at the end of 10 days. During fiber treatment of up to 11 teeth per patient (average tetracycline dose of 105 mg) mean tetracycline concentrations in plasma were below the lower limit of assay detection (<0.1 µg/mL). This lower assay limit is 20- to 25-fold lower than that expected during a regimen of 250 mg by oral capsule every 6 hours. Clinical Studies In a controlled 60-day clinical trial, 113 adult patients with periodontitis (56 men and 57 women; age range 25-88; 95 Caucasian, 11 Black, 3 Hispanic and 4 Asian) entered with a mean pocket depth of 7.2 mm (98% of pocket depths were within the range of 4 mm to 11 mm). Subjects received supragingival cleaning followed by one of four treatments, randomized to a single tooth per quadrant. These treatments were: 1) Actisite (tetracycline periodontal) fiber for 10 ± 2 days, 2) control fiber for 10 ± 2 days, 3) scaling and root planing under local anesthesia, or 4) no treatment. Teeth treated with Actisite (tetracycline periodontal) fiber were later found to have significantly reduced probing depth and bleeding on controlled force probing. Probing depth reductions were greater in deep (> or equal to 7 mm) than in moderate (< or equal to 6 mm) sites. In a randomized, single-blind 6-month study of 113 adult periodontal maintenance patients (57 men and 56 women; age range 32-75; 111 Caucasian, 2 Black), the effects of scaling and root planing alone, and scaling and root planing followed by Actisite (tetracycline periodontal) fiber treatment, were compared. Subjects entered with a baseline pocket depth mean of 6.4mm (97% of the pockets were within a range of 4 mm to 11 mm). Two non-adjacent sites with pockets with bleeding on probing were selected for treatment and follow-up at 1, 3, and 6 months. A longitudinal multi-variate analysis showed that adjunctive fiber therapy with scaling and root planing provided significantly greater reductions in probing depth and bleeding on probing than scaling and root planing alone at follow-up visits. The results are summarized in the following table: Time (mo.) Probing Depth Reduction (mm) Bleeding on Probing (%) S/RPa S/RP + Fiber S/RP S/RP + Fiber 0 0.00 0.00 90 87 1 0.82 1.20 48 30** 3 0.98 1.27 48 34 6 1.05 1.72 51 38* * Significant difference between treatment groups (p<0.05) ** Significant difference between treatment groups (p<0.01) aS/RP = scaling and root planing Microbiology - In the 60-day study, immediately following therapy, both Actisite (tetracycline periodontal) fiber and scaling and root planing produced significant reductions in the number of sites infected with probable periodontal pathogens compared to untreated controls. The clinical significance of these findings is not known. Medication Guide PATIENT INFORMATION When Actisite® (tetracycline periodontal) fiber is in place, patients should avoid actions that may dislodge the fiber. Patients should receive the following instructions: Do not chew hard, crusty, or sticky foods. Do not brush or floss near any treated areas. (Continue to clean other teeth.) Do not engage in any other hygienic practices that could potentially dislodge the fibers. Do not probe at the treated area with tongue or fingers. Notify the dentist promptly if the fiber is dislodged or falls out before the scheduled recall visit, or if pain or swelling or other problems occur.
