PERIOSTAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PERIOSTAT (PERIOSTAT).
Inhibits matrix metalloproteinases (MMPs), particularly collagenase, thereby reducing connective tissue breakdown; also has anti-inflammatory and antibacterial properties.
| Metabolism | Not extensively metabolized; excreted primarily unchanged in urine. |
| Excretion | Renal: 60% unchanged drug; fecal: 40% as unchanged and metabolites |
| Half-life | Terminal elimination half-life is 16-18 hours; clinically allows twice-daily dosing for sustained therapeutic levels |
| Protein binding | 20-30% bound to plasma proteins (primarily albumin) |
| Volume of Distribution | 1.0-1.5 L/kg; suggests moderate tissue distribution including gingival crevicular fluid |
| Bioavailability | Oral: 55-70% (with food reduces absorption); subgingival: 100% locally |
| Onset of Action | Oral: 2-3 days for reduction of gingival bleeding; subgingival controlled-release: immediate upon placement |
| Duration of Action | Oral: 24 hours with twice-daily dosing; subgingival: up to 21 days after a single application |
20 mg orally twice daily
| Dosage form | CAPSULE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment; not studied in severe renal impairment (CrCl <30 mL/min) or dialysis. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B); not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Safety and efficacy not established in pediatric patients under 18 years. |
| Geriatric use | No specific dose adjustment recommended; use with caution due to potential for age-related renal and hepatic function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PERIOSTAT (PERIOSTAT).
| Breastfeeding | Doxycycline is excreted into breast milk in low concentrations; M/P ratio approximately 0.3–0.4. Not recommended during breastfeeding due to potential for tooth discoloration and bone growth inhibition in the nursing infant. If alternative antibiotics are not suitable, use with caution and monitor infant for gastrointestinal disturbances and rash. |
| Teratogenic Risk | Periostat (doxycycline) is a tetracycline antibiotic. First trimester: Avoid due to possible teratogenic effects (animal studies show skeletal abnormalities; human data limited but risk cannot be excluded). Second and third trimesters: Contraindicated due to permanent tooth discoloration and enamel hypoplasia in the fetus, as well as reversible inhibition of bone growth. Tetracyclines form calcium complexes in bone and teeth. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to tetracyclines","Pregnancy","Lactation","Children under 9 years of age"]
| Precautions | ["Photosensitivity","Superinfection due to overgrowth of nonsusceptible organisms","Use in pregnancy (Category D) may cause fetal harm","Avoid in children under 9 years of age (may cause permanent tooth discoloration and enamel hypoplasia)","Hepatic or renal impairment requires dose adjustment"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal liver function, renal function, and signs of hepatotoxicity (rare). No specific fetal monitoring required if exposure occurs during pregnancy, but if inadvertent use in second/third trimester, consider ultrasound for fetal bone growth and dental development assessment. In neonates exposed in utero, monitor for tooth discoloration and bone growth. |
| Fertility Effects | Doxycycline has no known clinically significant effects on human fertility. In animal studies, high doses caused reduced spermatogenesis and impaired fertility, but relevance to humans at therapeutic doses is low. |