periostat bottle
Therapeutic Class: Tetracycline antibiotic
Form: Capsule
Formats: Doxycycline Hyclate Capsules USP 20 mg
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Adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Tetracycline antibiotic
DIN: 02247104

What is PERIOSTAT used for?

PERIOSTAT is used in adults with gum disease (periodontitis) after a certain dental procedure (scaling and root planing). It helps to improve tooth attachment and reduce gum pockets.

PERIOSTAT contains an antibacterial ingredient called doxycycline that is also used to treat bacterial infections.

How does PERIOSTAT work?

PERIOSTAT belongs to the class of antibiotics known as tetracyclines. It may help to prevent the breakdown of gum tissue. PERIOSTAT® capsule contains doxycycline hyclate which is a semi-synthetic tetracycline. Doxycycline is an inhibitor of collagenase activity. Studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with chronic adult periodontitis, in an action unrelated to its antibacterial mode of action.

What are the ingredients in PERIOSTAT?

Medicinal ingredients: Doxycycline hyclate
Non-medicinal ingredients: hard gelatin capsules, magnesium stearate, microcrystalline cellulose and titanium dioxide.

PERIOSTAT comes in the following dosage forms:

Capsules; 20 mg

Do not use PERIOSTAT if you:

  • Are allergic or hypersensitive to doxycycline or any other tetracycline antibiotic.
  • Have the autoimmune disease myasthenia gravis, which causes severe weakness in the muscles used for breathing and moving parts of the body.
  • Are pregnant or planning to become pregnant. Using PERIOSTAT during pregnancy can cause birth defects. It can also cause damage and discolouration to your unborn babies developing teeth.
  • Are breastfeeding or planning to breastfeed. PERIOSTAT can pass into breastmilk and cause damage and discolouration to your babies developing teeth.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PERIOSTAT. Talk about any health conditions or problems you may have, including if you:
  • Are taking medicines to thin the blood, used to prevent blood clots.
  • You are taking other antibiotics, such as penicillin.
  • Have a history of oral thrush (yeast infection in your mouth and/or throat) or are at risk for this type of infection.

Other warnings you should know about:

Sun Sensitivity

PERIOSTAT can cause your skin to become sensitive to the sun. While taking PERIOSTAT, use sunscreen and protective clothing if you are going to be in direct sunlight and avoid tanning beds and other sources of UV light. If you notice any skin redness after being in the sun while taking PERIOSTAT contact your healthcare professional immediately.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with PERIOSTAT:
  • Antacids, used to treat heartburn and indigestion that contain aluminum, calcium, magnesium or bismuth subsalicylate
  • Iron-containing preparations, such as iron supplements
  • Medicines to thin the blood, used to prevent blood clots
  • Antibiotics, used to treat bacterial infections, such as penicillin, tetracycline and methoxyfluorane
  • Barbiturates used to treat insomnia and anxiety, such as phenobarbital
  • Anti-seizure medicines, such as carbamazepine and phenytoin
  • Oral birth control pills

How to take PERIOSTAT:

  • Take PERIOSTAT twice a day, at least one hour before your morning and evening meals.
  • PERIOSTAT capsules should be swallowed with a full glass of water.
  • Although you may feel better early in treatment, PERIOSTAT should be used exactly as directed by your healthcare professional.
  • Overuse of PERIOSTAT could lead to the growth of bacteria that will not be killed by doxycycline (resistance). This means that doxycycline will not work for you in the future.
  • Do not share your medicine.
Usual Adult Dose:
  • 20 mg twice a day for up to 9 months PERIOSTAT® Prescribing Information Page 16 of 17
What are possible side effects from using PERIOSTAT? These are not all the possible side effects you may feel when taking PERIOSTAT. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:
  • Headache
  • Common cold (runny nose, sneezing, cough, sore throat)
  • Flu symptoms (fever, body aches, headache, cough, sore throat)
  • Sinus infection (sinusitis), sinus congestion, sinus headache
  • Tooth ache or other tooth problem
  • Gum pain
  • Nausea, indigestion
  • Diarrhea
  • Joint pain, back pain/ache, muscle pain
  • Rash
  • Menstrual cramps
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Storage:
  • Stored at room temperatures of 15°C - 30°C in a tight, light-resistant container.
  • Protected from excessive humidity.
  • Keep out of reach and sight or children.

ADVERSE REACTIONS

In clinical trials of adult patients with periodontal disease 213 patients received PERIOSTAT® _20 mg BID over a 9 - 12-month period. The most frequent adverse reactions occurring in studies involving treatment with PERIOSTAT® or placebo are listed below.

If you want more information about PERIOSTAT:


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Adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Collagenase inhibitor drug
DIN: 02247104

Indications

Adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

DESCRIPTION

PERIOSTAT® capsule contains doxycycline hyclate which is a semi-synthetic tetracycline. Doxycycline is an inhibitor of collagenase activity. Studies have shown that low-dose doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with chronic adult periodontitis, in an action unrelated to its antibacterial mode of action.

PRESCRIBING INFORMATION

  • 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.

Format

Periostat® is available as a 20 mg tablet formulation of doxycycline for oral administration.

Ingredients

Medicinal Ingredient: 20 mg doxycycline

Non-Medicinal Ingredients: Hard Gelatin Capsules, Magnesium Stearate, Microcrystalline Cellulose and Titanium Dioxide.

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Clinical study

In a randomized, multi-centered, double-blind, 9-month Phase 3 study involving 190 adult patients with periodontal disease [at least two probing sites per quadrant of between 5 and 9 mm pocket depth (PD) and attachment level (ALv)], the effects of oral administration of 20 mg twice a day of doxycycline hyclate (using a bioequivalent capsule formulation) plus scaling and root planing (SRP) were compared to placebo control plus SRP. Both treatment groups were administered a course of scaling and root planing in 2 quadrants at Baseline. Measurements of ALv, PD and bleeding-on-probing (BOP) were obtained at Baseline, 3, 6, and 9 months from each site about each tooth in the two quadrants that received SRP using the UNC-15 manual probe. Each tooth site was categorized into one of three strata based on Baseline PD: 0-3 mm (no disease), 4-6 mm (mild/moderate disease), ≥ 7 mm (severe disease). For each stratum and treatment group, the following were calculated at month 3, 6, and 9: mean change in ALv from baseline, mean change in PD from baseline, mean percentage of tooth sites per patient exhibiting attachment loss of ≥ 2 mm from baseline, and percentage of tooth sites with bleeding on probing. The results are summarized in the following table.

ADVERSE REACTIONS

In clinical trials of adult patients with periodontal disease 213 patients received PERIOSTAT® _20 mg BID over a 9 - 12-month period. The most frequent adverse reactions occurring in studies involving treatment with PERIOSTAT® or placebo are listed below.

Monograph

Consult the full monograph here

References

  1. Comprehensive Summary (Part III - Vol 4, pg. 7 / Part IV - Vol 11, pg. 1-2).
  2. Comprehensive Summary (Part III - Vol 4, pg. 92 / Part IV - Vol 11-17).
  3. 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.
  4. Minocycline reduces gingival collagenolytic activity during diabetis: Preliminary observations and a proposed new mechanism of action. (Part III - Vol 4, pg. 21 / Part IV - Vol 5, pg. 10).
  5. Inhibition of purified collagenase from alkali-burned rabbit corneas. (Part III - Vol 4, pg. 27 / Part IV - Vol 5, pg. 13).
  6. Regulation of cytoplasmic calcium concentration in tetracycline-treated osteoclasts. (Part III - Vol 4, pg. 33 / Part IV - Vol 5, pg. 17).
  7. 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. (Part III - Vol 4, pg. 130 / Part IV - Vol 21, pg. 203).
  8. 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.
  9. The clinical dose response of doxycycline in reducing excessive collagenase levels associated with periodontal disease. (Part III- Vol 4, pg. 113 / Part IV - Vol 108, pg. 1).
  10. Single dose of placebo or doxycycline 10, 20 or 100 mg. (Part III - Vol 4, pg. 116 / Part IV - Vol 109, pg. 91).
  11. Twice daily (BID) doses of doxycycline 20 mg or tetracycline 100 mg or no treatment for 4 weeks. (Part III - Vol 4, pg. 124 / Part IV - Vol 108, pg. 53).
  12. A bioavailability and dose proportionality study of three dosing levels of doxycycline capsules in normal healthy male volunteers. (Part III - Vol 4, pg. 93 / Part IV - Vol 11, pg. 18 & Vol 13, pg. 1).
  13. A double blind, single dose , 2-period crossover pharmacokinetic study in healthy volunteers. (Part III - Vol 4, pg. 94 / Part IV - Vol 11, pg. 26 & Vol 14-16).
  14. An open-label, multiple dose, three period crossover study in healthy volunteers. (Part III - Vol 4, pg. 95 / Part IV - Vol 11, pg. 14 & Vol 12, pg. 1).
  15. Comprehensive Summary (Part III - Vol 4, pg. 43-44 / Part IV - Vol 7, pg. 1 & Vol 8, pg. 1, 197, 21).
  16. Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline. Clin. Pharmacokinetics. 1988; 15; 355-366. (Part III - Vol 4, pg. 19 / Part IV - Vol 11, pg. 87-98).
  17. 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. (Part III - Vol 4, pg. 19 / Part IV - Vol 11, pg. 60-62).
  18. Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man and Dog. Chemotherapy. 1971; 16: 217-228. (Part III - Vol 4, pg. 88 / Part IV - Vol 5, pg. 205-221).
  19. A 9-Month, Multicentre, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Periostat (20 mg doxycycline hyclate capsules) BID in Conjunction with Scaling and Root Planing Versus Placebo BID in Conjunction with Scaling and Root Planing on Attachment Level, and Pocket Depth in Patients with Adult Periodontitis. (Part III - Vol 4, pg. 100-106 / Part IV - Vol 111-124).
  20. Comprehensive Summary (Part III - Vol 4, pg. 7-8 / Part IV - Vol 11, pg. 1-2).
  21. Comprehensive Summary (Part III - Vol 4, pg. 77-80 / Part IV - Vol 5, pg. 192).
  22. Comprehensive Summary (Part III - Vol 4, pg. 136 / Part IV - Vol 20, pg. 488).
  23. Mouse Micronucleous test (Part III - Vol 4, pg. 74 / Part IV - Vol 10, pg. 276).
  24. In vitro mammalian cell cytogenetic test - CHO cells (Part III - Vol 4, pg. 72 / Part IV - Vol 10, pg. 251).
  25. Comprehensive Summary (Part III - Vol 4, pg. 79 / Part IV - Vol 5, pg. 192).

FOR MORE INFORMATIONS

For more informations on Periostat, contact Oral Science at 1 888-442-7070 or service@oralscience.com