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Arestin eent

Generic Name: Minocycline Hydrochloride eent
Class: Antibacterials
ATC Class: J01AA08
VA Class: OR900

Medically reviewed on May 14, 2018

Introduction

Antibacterial; tetracycline antibiotic.1

Uses for Arestin

Periodontitis

Used subgingivally for treatment of adult periodontitis as an adjunct to scaling and root planing procedures to reduce pocket depth.1

Arestin Dosage and Administration

Administration

Subgingival Administration

Administered subgingivally as extended-release powder into periodontal pockets by a dental health-care professional.1

Administration does not require local anesthesia.1

Extended-release preparation is bioresorbable and does not need to be manually removed.1

Subgingival Administration Technique

A unit-dose cartridge containing minocycline extended-release dry powder must be inserted into a spring-loaded cartridge handle prior to administration.1 The handle mechanism should be sterilized prior to reuse on another patient.1

Administer by inserting the unit-dose cartridge into 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.1

No dental adhesive or periodontal dressing is required following subgingival administration.1

Consult manufacturer's information for additional information regarding subgingival administration of minocycline extended-release powder.1

Dosage

Available as minocycline hydrochloride; dosage expressed in terms of minocycline.1

Each commercially available unit-dose cartridge delivers 1 mg of minocycline.1

Adults

Periodontitis
Subgingival

Dosage varies depending on the size, shape, and number of periodontal pockets treated.1

In clinical trials, up to 122 unit-dose cartridges were used during a single visit to treat all pocket sites with probing depth ≥5 mm and up to 3 treatments were administered at intervals of 3 months.1

Cautions for Arestin

Contraindications

  • Known hypersensitivity to minocycline or other tetracyclines.1

Warnings/Precautions

Warnings

Dental and Bone Effects

Do not use tetracyclines during tooth development (e.g., pregnancy, infancy, childhood to the age of 8 years); potential for permanent tooth discoloration (yellow-gray-brown) or enamel hypoplasia.1 More common during long-term tetracycline use, but also reported following repeated short-term use of the drugs.1

Tetracyclines form a stable calcium complex in any bone-forming tissue.3 Reversible decrease in fibula growth rate has occurred in premature infants receiving oral tetracycline.3

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions and hypersensitivity syndrome reported in patients receiving oral tetracyclines.1 These reactions have included, but are not limited to, anaphylaxis, anaphylactoid reactions, angioedema, urticaria, rash, and eosinophilia;1 hepatitis, pneumonitis, nephritis, myocarditis, and/or pericarditis may also be present.1 Serious skin reactions, including Stevens-Johnson syndrome and erythema multiforme, reported with oral minocycline.1

Swelling of the face, pruritus, fever, and lymphadenopathy reported in patients receiving minocycline extended-release powder for subgingival administration.1 Some of these reactions were serious.1

Photosensitivity Reactions

Photosensitivity, manifested as exaggerated sunburn reaction on areas of body exposed to direct sunlight or ultraviolet (UV) light, reported in some patients receiving tetracyclines.1

Discontinue subgingival minocycline at first sign of skin erythema.1

Other Warnings/Precautions

Autoimmune Syndrome

Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndromes, including a lupus-like syndrome manifested as arthralgia, myalgia, rash, and swelling.1

Sporadic cases of serum sickness-like reactions have presented shortly after oral minocycline use;1 manifested as fever, rash, arthralgia, lymphadenopathy, and malaise.1

Permanently discontinue subgingival minocycline if symptoms of autoimmune syndrome develop.1 Evaluate the patient using appropriate tests, including liver function tests, antinuclear antibody (ANA) tests, and CBCs.1

Acute Periodontitis

Use of subgingival minocycline in acutely abscessed periodontal pockets not studied and not recommended.1

Superinfection/Candidiasis

Possible overgrowth of nonsusceptible organisms, including fungi.1 Effects of subgingival minocycline administered for >6 months not studied.1 If superinfection is suspected, take appropriate measures.1

Use with caution in patients with a history of or predisposition to oral candidiasis.1 Safety and efficacy for treatment of periodontitis not established in patients with concomitant oral candidiasis.1

Immunocompromised Patients

Not studied in immunocompromised patients (e.g., those with diabetes mellitus or HIV infection, those receiving chemotherapy or radiation therapy).1

Dental Implants

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 dental implants.1

Specific Populations

Pregnancy

Do not use tetracyclines during pregnancy.1 If a tetracycline used during pregnancy, apprise patient of potential hazards to the fetus.1

Subgingival minocycline not evaluated in pregnant women;1 effects of tetracyclines on labor and delivery unknown.1

Lactation

Distributed into milk.1

Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.1 2 (See Dental and Bone Effects under Cautions.)

Common Adverse Effects

Periodontitis,1 tooth disorder,1 tooth caries,1 dental pain,1 gingivitis,1 headache,1 infection,1 stomatitis,1 mouth ulceration,1 flu syndrome,1 pharyngitis,1 pain,1 dyspepsia,1 dental infection,1 mucous membrane disorder.1

Interactions for Arestin

No formal drug interaction studies performed with subgingival minocycline.1

Arestin Pharmacokinetics

Absorption

Bioavailability

Adults with moderate to advanced chronic periodontitis: Subgingival administration of 1 mg (1 unit dose) of minocycline extended-release powder into each periodontal pocket site with probing depth ≥5 mm resulted in mean dose-normalized AUC and peak concentration in saliva 125 and 1000 times higher, respectively, than values in serum.1 2 Minimum of 30 affected sites on at least 8 teeth were treated; mean total dose of subgingival minocycline was 46.2 mg (range of 25–112 unit doses per patient).1

Stability

Storage

Subgingival

Powder, extended-release

20–25°C (may be exposed to 15–30°C).1 Avoid exposure to excessive heat.1

Actions and Spectrum

  • Mechanism of action of extended-release subgingival minocycline as adjunct to scaling and root planing procedures for reduction of pocket depth in patients with periodontitis unknown.1

  • Minocycline has antibacterial activity against some organisms associated with periodontal disease, but qualitative and quantitative changes in plaque microorganisms not demonstrated following subgingival administration in patients with periodontitis.1

  • Bacteriostatic.1 Inhibits protein synthesis in susceptible organisms.1

  • Active in vitro against some organisms associated with periodontal disease.1

  • Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Eikenella corrodens, and Actinobacillus actinomycetemcomitans are inhibited in vitro by minocycline concentrations ≤8 mcg/mL.1

Advice to Patients

  • Advise patients to not eat hard, crunchy, or sticky foods (e.g., carrots, taffy, gum) and not touch treated areas for 1 week after receiving subgingival minocycline.1

  • Importance of not using interproximal cleaning devices around treated sites for 10 days after receiving subgingival minocycline.1

  • Advise patients that mild to moderate sensitivity is expected during first week following scaling and root planing and administration of subgingival minocycline.1 Importance of notifying dental health-care professional promptly if pain, swelling, or other problems occur.1

  • Importance of contacting a dental health-care professional if itching, swelling, rash, papules, reddening, difficulty breathing, or any other signs or symptoms of possible hypersensitivity occur.1

  • Advise patients that photosensitivity reactions reported with tetracyclines; importance of avoiding exposure to direct sunlight or UV light and importance of notifying clinician and discontinuing therapy at first sign of skin erythema.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Minocycline Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Subgingival

Powder, extended-release (containing microspheres)

1 mg (of minocycline) per cartridge

Arestin

OraPharma

AHFS DI Essentials. © Copyright 2018, Selected Revisions May 14, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. OraPharma, Inc. Arestin (minocycline hydrochloride) microspheres prescribing information. Bridgewater, NJ; 2017 May.

2. Reviewers’ comments (personal observations).

3. Alvogen, Inc. Minocycline hydrochloride capsules, USP prescribing information. Pine Brook, NJ; 2016 Dec.

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