Video: Latest Treatment for Hep C.

Tetracycline Periodontal Fibers (Mucosal-Local)


VA CLASSIFICATION
Primary: OR900
Secondary: DE101

Commonly used brand name(s): Actisite.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Antibacterial (dental)—

Indications

General considerations
Periodontal disease is primarily caused by facultative and obligate anaerobic bacteria. {06} Probable pathogens include Fusobacterium nucleatum , Porphyromonas gingivalis , Prevotella intermedia , Eikenella corrodens , Campylobacter rectus (Wolinella recta) , and Actinobacillus actinomycetemcomitans . {01} These organisms were found to be sensitive to tetracycline in vitro at the same local concentration as that achieved by tetracycline periodontal fibers in the periodontal pocket. {01}

Tetracycline periodontal fibers have been found to decrease the incidence of inflammation and edema {05}, pocket depth, and the amount of bleeding upon pocket probing. {06} This may occur because the high local concentration of tetracycline suppresses bacteria for an extended period of time and serves as a barrier to entry of the bacteria. {05} After being released locally, tetracycline may be adsorbed by tooth cementum, forming a reservoir from which the medication continues to be released after the fiber has been removed. {06} In addition, tetracycline inhibits collagenolytic enzymes and acts on root surfaces or fibroblasts. {06}

Accepted

Periodontitis (treatment adjunct)—Tetracycline periodontal fibers are indicated as an adjunct to scaling and root planing for the reduction of pocket depth and bleeding on probing in selected patients with adult periodontitis. {01} {07}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Tetracycline hydrochloride: 480.9 {02}

Mechanism of action/Effect:

Bacteriostatic {01} {03}; thought to act by inhibiting protein synthesis. {01} {03} Tetracycline binds primarily to the 30S subunits of the bacterial ribosomes, and appears to prevent access of aminoacyl tRNA to the acceptor site on the mRNA-ribosome complex. {03}


Rate of release:

The fiber releases tetracycline in vitro at a rate of approximately 2 mcg per centimeter per hour (mcg/cm/hr). {01}



Concentration:


Mean values—

Gingival fluid: Approximately 1590 mcg per mL (mcg/mL) of tetracycline per site throughout the 10 day period. {01} Concentrations of 4 to 8 mcg/mL are inhibitory for most pathogenic periodontal organisms. {06}

Saliva: Approximately 50.7 mcg/mL of tetracycline immediately after fiber treatment of 9 teeth; concentration values decline to 7.6 mcg/mL at the end of ten days. {01}

Plasma: During fiber treatment of up to 11 teeth (average total tetracycline dose of 105 mg), the mean tetracycline concentration in the plasma remains below the lower limit of assay detection (< 0.1 mcg/mL). {01} {06} In comparison, a 500-mg oral dose of tetracycline produces peak serum concentrations of about 3 to 4 mcg/mL. {04}




Precautions to Consider

Carcinogenicity

Animal studies have not been done. {01}

Mutagenicity

Animal studies have not been done. {01}

Pregnancy/Reproduction
Fertility—
Animal studies have not been done. {01}

Pregnancy—
No adequate and well-controlled studies have been done in pregnant women. {01} Use of systemic tetracyclines is not recommended during pregnancy because of interference with fetal bone and dental development. {04}

Animal studies have not been done to determine whether tetracycline periodontal fibers can cause fetal harm. Use of systemic tetracyclines in animals has been shown to cause retardation of fetal skeletal development. {01}

FDA Pregnancy Category C.

Breast-feeding

It is not known whether tetracycline from tetracycline periodontal fibers is distributed into human breast milk. Tetracycline periodontal fibers produce plasma concentrations of less than 0.1 mcg/mL. {01} However, systemically administered tetracycline is distributed into breast milk. {01}

Pediatrics

Safety and efficacy have not been established in children. {01} Tetracycline periodontal fibers produce plasma concentrations of less than 0.1 mcg/mL. {01} However, systemic use of tetracyclines in children up to 8 years of age has caused permanent discoloration of teeth. {01} {04}


Geriatrics


No information is available on the relationship of age to the effects of tetracycline periodontal fibers in geriatric patients.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
» Hypersensitivity to tetracyclines


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare (less than 1%) {01}
    
Gingival inflammation and pain (redness and swelling of gums)
    
glossitis (tongue pain and redness)
Note: Gingival inflammation and pain may occur following fiber placement in an abscessed area.





Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent (10 to 11%) {01}
    
Discomfort on fiber placement
    
local erythema following removal

Incidence rare (less than 1%) {01}
    
Oral candidiasis (white patches on tongue or in mouth)
    
sore throat{07}
    
staining of tongue





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Tetracycline Periodontal Fibers (Dental) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Hypersensitivity to tetracyclines

Proper use of this medication
»
When tetracycline periodontal fiber is in place, avoiding actions that may dislodge the fibers, such as
Chewing hard, crusty, or sticky foods, or chewing gum

Brushing or flossing near any treated areas

Engaging in any other hygienic practices that might dislodge the fibers

Probing the treated area with tongue, toothpicks, or fingers

Precautions while using this medication
Checking with dentist promptly if the fiber is dislodged or falls out before the next scheduled visit

Checking with dentist promptly if pain or swelling or other problems occur

Not missing any appointments with dentist; all fibers must be removed after 10 days


Side/adverse effects
Signs of potential side effects, especially gingival inflammation and pain, and glossitis


General Dosing Information
Each 23-cm (9-inch) tetracycline periodontal fiber contains 12.7 mg of tetracycline hydrochloride evenly dispersed throughout the fiber. It provides a continuous release of tetracycline for 10 days. {01}

The length of fiber used will vary with the periodontal pocket depth and contour, and the number of teeth being treated. {01} {06} The fibers should be in contact with the base of the pocket and should be filled in to closely approximate the anatomy of the pocket. {01}

An appropriate cyanoacrylate adhesive should be used to secure the fiber in the pocket. {01}

Fibers should be replaced if they are lost before 7 days following their insertion into the periodontal pocket. {01}

Repeated applications of tetracycline periodontal fibers have not been studied. {01}


Dental Dosage Forms

TETRACYCLINE PERIODONTAL FIBERS

Usual adult dose
Antibacterial
Topical, insert a sufficient number of fibers to fill the periodontal pocket. Secure fibers with cyanoacrylate adhesive and leave for ten days. {01} {07}


Usual pediatric dose
Safety and efficacy have not been established. {01}

Strength(s) usually available
U.S.—


12.7 mg of tetracycline hydrochloride per fiber (Rx) [Actisite{07}]

Canada—
Not commercially available.

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F).



Revised: 06/11/1999



References
  1. Actisite package insert (Alza Pharmaceuticals—US), New 3/94, Rec 6/94.
  1. Fleeger CA, editor. USAN 1995. USP dictionary of USAN and international drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1994: 664.
  1. Gilman AG, Rall TW, Nies AS, Taylor P, editors. Goodman and Gilman's the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press, 1990: 1117-21.
  1. Gorbach SL, Bartlett JG, Blacklow NR, editors. Infectious diseases. Philadelphia: W.B. Saunders Company, 1992: 212.
  1. Ciancio SG, Cobb CM, Leung M. Tissue concentration and localization of tetracycline folowing site-specific tetracycline fiber therapy. J Periodontol 1992; 63: 849-53.
  1. Rapley JW, Cobb CM, Killoy WJ, Williams DR. Serum levels of tetracycline during treatment with tetracycline-containing fibers. J Periodontol 1992; 63: 817-20.
  1. Actisite package insert (Alza—US), Rev 12/96, Rec 4/99.
Hide
(web4)