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Periostat

Clinical Pharmacology
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Clinical Pharmacology

Periostat

Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half life of doxycycline.

Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is variously reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours.5,6 Half life averaged 18 hours in subjects receiving a single 20 mg doxycycline dose.

Special Populations

Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients.

Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients (See WARNINGS).

Gender: A study was conducted in 42 subjects where doxycycline pharmacokinetics were compared in men and women. It was observed that Cmax was approximately 1.7-fold higher in women than in men. There were no apparent max differences in other pharmacokinetic parameters.

Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated.

Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the half-life of doxycycline.

Hepatic Insufficiency Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency.

Drug Interactions: (See DRUG INTERACTIONS)

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.

Clinical Results at Nine Months as an Adjunct to SRP
Parameter

Baseline Pocket Depth

0-3 mm

4-6 mm

>/=7 mm
Number of Patients (Periostat® 20mg BID)

90

90

79
Number of Patients (Placebo)
Brand Name: Periostat
Generic Name: Doxycycline Hyclate

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