PeriostatÔ is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

THE DOSAGE OF PERIOSTAT® DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS.

Periostat® 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Periostat® should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Periostat® is taken close to meal times, allow at least one hour prior to or two hours after meals. Safety beyond 12 months and efficacy beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the tablets is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS).

Periostat® (white tablet imprinted with a PS20) containing doxycycline hyclate equivalent to 20 mg doxycycline. Bottle of 60 (NDC 64682-008-01), Bottle of 100 (NDC 64682-008-02) and Bottle of 1000 (NDC 64682-008-03).

Storage

All products are to be stored at controlled room temperatures of 59 ^oF - 86^oF (15^oC-30^oC) and dispensed in tight, light resistant containers (USP).

REFERENCES

1. Golub L.M., Sorsa T., Lee H-M., Ciancio S., Sorbi D., Ramamurthy N.S., Gruber B., Salo T., Konttinen Y.T.: Doxycycline Inhibits Neutrophil (PMN)-type Matrix Metalloproteinases in Human Adult Periodontitis Gingiva. J. Clin. Periodontol 1995; 22: 100-109.

2. Golub L.M., Ciancio S., Ramamurthy N.S., Leung M., McNamara T.F.: Low dose Doxycycline Therapy: Effect on Gingival and Crevicular Fluid Collagenase Activity in Humans. J. Periodont Res 1990; 25: 321-330.

3. Golub L.M., Lee H.M., Greenwald R.A., Ryan M.E., Salo T., Giannobile W.V.: A Matrix Metalloproteinase Inhibitor Reduces Bone-type Collagen Degradation Fragments and Specific Collegenases in Gingival Crevicular Fluid During Adult Periodontitis. Inflammation Research 1997; 46: 310-319.

4. Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline. Clin. Pharmacokinetics 1988; 15: 355-366.

5. Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man and Dog. Chemotherapy 1971; 16: 217-228.

6. Campistron G., Coulais Y., Caillard C., Mosser J., Pontagnier H., Houin G.: Pharmacokinetics and Bioavailability of Doxycycline in Humans. Arzneimittel Forschung 1986; 36: 1705-1707.

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