Uses
Periodontitis
Reduction of pocket depth in the treatment of adult periodontitis; used as an adjunct to scaling and root planing procedures.
Dosage and Administration
Administration
Subgingival Administration
Administered subgingivally (as extended-release powder) into periodontal pockets by an oral health-care professional.
Administration does not require local anesthesia.
Preparation is bioresorbable and does not have to be manually removed.
A unit-dose cartridge containing minocycline hydrochloride dry powder must be inserted into a cartridge handle prior to administration. The handle mechanism should be sterilized prior to reuse on another patient.
Subgingival Administration Technique
Administer by inserting the unit-dose cartridge to the base of the periodontal pocket and then pressing the thumb ring in the handle mechanism to expel the powder while gradually withdrawing the tip from the base of the pocket.
No dental adhesive or periodontal dressing is required following subgingival administration.
Dosage
Available as minocycline hydrochloride; dosage expressed in terms of minocycline.
Adults
Periodontitis
Subgingival
Dosage varies depending on the size, shape, and number of periodontal pockets treated. In clinical trials, up to 3 treatments were administered at intervals of 3 months.
Cautions
Contraindications
Warnings/Precautions
Warnings
Dental Effects
Avoid use during tooth development (e.g., the last half of pregnancy, infancy, childhood to the age of 8 years); potential for permanent tooth discoloration (yellow-gray brown) or enamel hypoplasia.
Sensitivity Reactions
Photosensitivity Reactions
Possible photosensitivity reactions (e.g., exaggerated sunburn reaction). Discontinue therapy at the first sign of skin erythema.
General Precautions
Dental Precautions
Use in acutely abscessed periodontal pockets has not been studied and is not recommended.
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.
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.
Immunocompromised Patients
Not studied in immunocompromised patients (e.g., those with diabetes or HIV infection, those receiving chemotherapy or radiation therapy).
Specific Populations
Pregnancy
Category D.
Lactation
Distributed into milk. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children <18 years of age. Possible permanent tooth discoloration (see Dental Effects in Cautions).
Common Adverse Effects
Periodontitis, tooth disorder, tooth caries, dental pain, gingivitis, headache, infection, stomatitis, mouth ulceration, flu syndrome, pharyngitis, pain, dyspepsia, dental infection, mucous membrane disorder.
Drug Interactions
No formal drug interaction studies have been performed.
Pharmacokinetics
Absorption
Bioavailability
Following subgingival administration, mean AUC and peak concentration in saliva were 125 and 1000 times higher, respectively, than values in serum.
Stability
Storage
Subgingival
Powder, extended-release
20–25°C (may be exposed to temperatures ranging from 15–30°C). Avoid exposure to excessive heat.
Actions
- Bacteriostatic.
- Inhibits protein synthesis in susceptible organisms.
- Active in vitro at concentrations of ≤8 mcg/mL against Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Eikenella corrodens, and Actinobacillus actinomycetemcomitans.
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