• Clinical Info

Cautions

Contraindications

• Known hypersensitivity to doxycycline or other tetracyclines.

Warnings/Precautions

Warnings

Dental and Bone Effects

Avoid use during tooth development (e.g., the last half of pregnancy, infancy, childhood up to 8 years of age); potential for permanent tooth discoloration or enamel hypoplasia.

Tetracyclines form a stable calcium complex in any bone-forming tissue. Reversible decrease in fibula growth rate has occurred in premature infants receiving oral tetracycline.

Sensitivity Reactions

Photosensitivity Reactions

Possible photosensitivity reactions (e.g., exaggerated sunburn reaction). Discontinue oral or subgingival therapy at the first sign of skin erythema.

General Precautions

Precautions Related to Subgingival Doxycycline

Not studied for use in the regeneration of alveolar bone, either in preparation for or in conjunction with placement of endosseous (dental) implants or in the treatment of failing implants.

Not studied in patients with extremely severe periodontal defects with little remaining periodontium.

Not studied in immunocompromised patients (e.g., those with diabetes or HIV infection, those receiving chemotherapy or radiation therapy).

Oral Candidiasis

Possible overgrowth of nonsusceptible organisms, including fungi. Use with caution in patients with a history of or predisposition to oral candidiasis. Safety and efficacy not established in patients with concomitant oral candidiasis.

Specific Populations

Pregnancy

Category D.

Lactation

Distributed into milk. Discontinue nursing or the drug.

Pediatric Use

Do not use oral doxycycline in children <8 years of age.

Safety and efficacy of subgingival doxycycline not established in children <18 years of age.

Possible permanent tooth discoloration (see Dental and Bone Effects under Cautions).

Common Adverse Effects

Oral: Headache, common cold, flu symptoms, toothache, GI symptoms (diarrhea, nausea, dyspepsia), joint pain.

Subgingival: Headache; common cold; gum discomfort, pain or soreness, loss of attachment, or increased pocket depth; toothache or pressure sensitivity; periodontal abscess, exudate, infection, drainage, extreme mobility, or suppuration; thermal tooth sensitivity.

Drug Interactions

Drug interactions reported involve oral doxycycline. No formal drug interaction studies have been performed with doxycycline hyclate polymer for subgingival administration.

Specific Drugs

Pharmacokinetics

Absorption

Bioavailability

Oral: Doxycycline hyclate rapidly and almost completely absorbed from GI tract. In adults receiving 20-mg tablets of doxycycline hyclate, peak serum doxycycline concentrations attained within 1.4 hours after a single dose or within 2 hours of a dose at steady-state.

Subgingival: Concentrations in gingival crevicular fluid (GCF) peaked 2 hours following administration and remained >1000 mcg/mL through 18 hours. GCF concentrations then declined gradually but remained >MIC for periodontal pathogens (≤6 mcg/mL) through 7 days; serum concentrations remained ≤0.1 mcg/mL.

Stability

Storage

Oral

Tablets

15–30°C in tight, light-resistant container.

Subgingival

For liquid, extended-release polymer

2–8°C.

Actions

• Usually is bacteriostatic.
• Inhibits protein synthesis in susceptible organisms.
• Active in vitro at concentrations of ≤6 mcg/mL against Porphyromonas gingivalis, Prevotella intermedia, Campylobacter rectus, and Fusobacterium nucleatum.
• No evidence of doxycycline or multidrug resistance in subgingival plaque or saliva in a clinical study of 6 months’ duration of subgingival doxycycline hyclate.