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Minocycline Hydrochloride eent

Pronunciation

Class: Antibacterials
ATC Class: J01AA08
VA Class: OR900
Brands: Arestin

Introduction

Antibacterial; semisynthetic tetracycline antibiotic.a

Uses for Minocycline Hydrochloride

Periodontitis

Reduction of pocket depth in the treatment of adult periodontitis; used as an adjunct to scaling and root planing procedures.1

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Minocycline Hydrochloride Dosage and Administration

Administration

Subgingival Administration

Administered subgingivally (as extended-release powder) into periodontal pockets by an oral health-care professional.1

Administration does not require local anesthesia.1

Preparation is bioresorbable and does not have to be manually removed.1

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

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.1

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

Dosage

Available as minocycline hydrochloride; dosage expressed in terms 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 3 treatments were administered at intervals of 3 months.1

Cautions for Minocycline Hydrochloride

Contraindications

  • Known hypersensitivity to minocycline or other tetracyclines.1

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.1

Sensitivity Reactions

Photosensitivity Reactions

Possible photosensitivity reactions (e.g., exaggerated sunburn reaction).1 Discontinue therapy at the first sign of skin erythema.1

General Precautions

Dental Precautions

Use in acutely abscessed periodontal pockets has not been studied and is not recommended.1

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.1

Oral Candidiasis

Possible overgrowth of nonsusceptible organisms, including fungi.1 Use with caution in patients with a history of or predisposition to oral candidiasis.1 Safety and efficacy not established in patients with concomitant oral candidiasis.1

Immunocompromised Patients

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

Specific Populations

Pregnancy

Category D.1

Lactation

Distributed into milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2 Possible permanent tooth discoloration (see Dental Effects in Cautions).1

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 Minocycline Hydrochloride

No formal drug interaction studies have been performed.1

Minocycline Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Following subgingival administration, mean AUC and peak concentration in saliva were 125 and 1000 times higher, respectively, than values in serum.1 2

Stability

Storage

Subgingival

Powder, extended-release

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

Actions and Spectrum

  • Bacteriostatic.1

  • Inhibits protein synthesis in susceptible organisms.1

  • Active in vitro at concentrations of ≤8 mcg/mL against Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Eikenella corrodens, and Actinobacillus actinomycetemcomitans.1

Advice to Patients

  • Not meant for self-administration; only qualified oral health-care professionals familiar with the administration of minocycline hydrochloride extended-release powder should administer the drug.1

  • Importance of not eating hard, crunchy, or sticky foods for 1 week following administration.1

  • Importance of not brushing teeth for 12 hours following administration, as well as of not touching treated areas.1

  • Importance of not using interproximal cleaning devices for 10 days following administration.1

  • Importance of notifying clinician promptly if pain, swelling, or other problems occur.1 Mild to moderate sensitivity may be expected during the first week following scaling and root planing and administration of minocycline hydrochloride extended-release powder.1

  • Importance of avoiding exposure to direct sunlight or UV light; importance of notifying clinician and of discontinuing therapy at the first sign of skin erythema.1

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

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, 2004-2014, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. OraPharma, Inc. Arestin (minocycline hydrochloride) microspheres prescribing information. Warminster, PA; 2001 Apr.

2. Reviewers’ comments (personal observations).

a. AHFS drug information 2003. McEvoy GK, ed. Minocycline Hydrochloride. Bethesda, MD: American Society of Hospital Pharmacists; 2003:2600-1.

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