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Minocycline hydrochloride periodontal microspheres: Drug information

Minocycline hydrochloride periodontal microspheres: Drug information
(For additional information see "Minocycline hydrochloride periodontal microspheres: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Arestin
Brand Names: Canada
  • Arestin Microspheres
Pharmacologic Category
  • Antibiotic, Tetracycline Derivative
Dosing: Adult
Periodontitis, non-severe, plaque-associated

Periodontitis, non-severe, plaque-associated (adjunctive agent): Subgingival: Variable-dose product; dose depends on size, shape, and number of pockets being treated; in clinical trials, up to 122 unit-dose cartridges were used in a single visit, with administration of one treatment every 3 months (up to 3 total treatments) in pockets with depth ≥5 mm (Ref). Use in addition to periodontal debridement (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Dental disease (12%)

1% to 10%:

Central nervous system: Headache (9%), pain (4%)

Gastrointestinal: Dental caries (10%), toothache (10%), gingivitis (9%), oral mucosa ulcer (5%), dyspepsia (4%), mucous membrane disease (3%)

Infection: Infection (8%)

Respiratory: Flu-like symptoms (5%), pharyngitis (4%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, erythema multiforme (oral minocycline), facial swelling, pruritus, skin rash, Stevens-Johnson syndrome (oral minocycline), urticaria

Contraindications

Hypersensitivity to minocycline, other tetracyclines, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune syndromes: Lupus-like, hepatitis, and vasculitis autoimmune syndromes (including serum sickness [eg, fever, rash, arthralgia, lymphadenopathy, malaise]) have been reported with oral minocycline use; discontinue use if symptoms occur and assess liver function, antinuclear antibodies, and CBC.

• Hypersensitivity reactions: Anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, swelling of the face, fever, lymphadenopathy, and pruritus have been reported.

• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; do not use tanning equipment.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Special populations:

• Pediatric: May cause tissue hyperpigmentation, enamel hypoplasia, or permanent tooth discoloration; use of tetracyclines should be avoided during tooth development (children <8 years of age) unless other drugs are not likely to be effective or are contraindicated.

Other warnings/precautions:

• Appropriate use: Use in an acutely abscessed periodontal pocket has not been studied and is not recommended. The effects of treatment for >6 months have not been studied. Should be used with caution in patients having a history of predisposition to oral candidiasis. Safety and effectiveness have not been established for the treatment of periodontitis in patients with coexistent oral candidiasis. Not clinically tested in immunocompromised patients (such as those immunocompromised by diabetes, chemotherapy, radiation therapy, or infection with HIV). Not clinically tested for use in the regeneration of alveolar bone, either in preparation for or in conjunction with the placement of endosseous (dental) implants or in the treatment of failing implants.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Miscellaneous, Dental [strength expressed as base]:

Arestin: 1 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Misc (Arestin Dental)

1 mg (per each): $121.39

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Miscellaneous, Dental [strength expressed as base]:

Arestin Microspheres: 1 mg (1 ea)

Administration: Adult

Administration of minocycline periodontal microspheres does not require local anesthesia. Professional subgingival administration is accomplished 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. The handle mechanism should be sterilized between patients. Minocycline periodontal microspheres do not have to be removed (they are bioresorbable), nor is an adhesive or dressing required.

Use: Labeled Indications

Periodontitis, non-severe, plaque-associated: Adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. May be used as part of a periodontal maintenance program that includes good oral hygiene, scaling, and root planing.

Pregnancy Considerations

Tetracycline-class antibiotics may cause fetal harm following maternal use in pregnancy. Tetracyclines accumulate in developing teeth and long tubular bones (Mylonas 2011). Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure.

As a class, tetracyclines are generally considered second-line antibiotics in pregnant women and their use should be avoided (Mylonas 2011).

Refer to the Minocycline (Systemic) monograph for additional information.

Breastfeeding Considerations

Tetracyclines are present in breast milk.

Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother. Refer to the Minocycline (Systemic) monograph for additional information.

Monitoring Parameters

If symptomatic for autoimmune disorder, evaluate liver function tests, antinuclear antibodies, and CBC

Mechanism of Action

Minocycline is bacteriostatic and exerts its antimicrobial activity by inhibiting protein synthesis.

  1. Arestin (minocycline) [prescribing information]. Bridgewater, NJ: Orapharma Inc; June 2020.
  2. Goodson JM, Gunsolley JC, Grossi SG, et al. Minocycline HCl microspheres reduce red-complex bacteria in periodontal disease therapy. J Periodontol. 2007;78(8):1568-1579. doi:10.1902/jop.2007.060488 [PubMed 17668977]
  3. Mylonas I. Antibiotic chemotherapy during pregnancy and lactation period: aspects for consideration. Arch Gynecol Obstet. 2011;283(1):7‐18. doi:10.1007/s00404-010-1646-3 [PubMed 20814687]
  4. Refers to manufacturer's labeling.
  5. Smiley CJ, Tracy SL, Abt E, et al. Evidence-based clinical practice guideline on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015;146(7):525-535. doi:10.1016/j.adaj.2015.01.026 [PubMed 26113100]
  6. Williams RC, Paquette DW, Offenbacher S, et al. Treatment of periodontitis by local administration of minocycline microspheres: a controlled trial. J Periodontol. 2001;72(11):1535-1544. doi:10.1902/jop.2001.72.11.1535 [PubMed 11759865]
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