Drug: Arestin

ARESTIN® (minocycline hydrochloride) Microspheres is a subgingival sustained- release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer, Poly (glycolide-co-dl-lactide) or PGLA, for professional subgingival administration into periodontal pockets. Each unit-dose cartridge delivers minocycline hydrochloride equivalent to 1 mg of minocycline free base, The molecular formula of minocycline hydrochloride is C23H27N3O7•HCI, and the molecular weight is 493.94. The structural formula of minocycline hydrochloride is Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

The most frequently reported nondental treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain. Table 5: Adverse Events (AEs) Reported in ≥ 3% of the Combined Clinical
  SRP Alone
N=250 SRP + Vehicle
N=249 SRP + ARESTIN®
N=423 Number (%) of Patients
Treatment-emergent AEs 62.4% 71,9% 68.1% Total Number of AEs 543 589 987   Periodontitis 25.6% 28.1% 16.3%   Tooth Disorder 12.0% 13.7% 12.3%   Tooth Caries 9.2% 11.2% 9.9%   Dental Pain 8.8% 8.8% 9.9%   Gingivitis 7.2% 8.8% 9.2%   Headache 7.2% 11,6% 9.0%   Infection 8.0% 9.6% 7.6%   Stomatitis 8.4% 6.8% 6.4%   Mouth Ulceration 1.6% 3.2% 5.0%   Flu Syndrome 3.2% 6.4% 5.0%   Pharyngitis 3.2% 1.6% 4.3%   Pain 4.0% 1.2% 4.3%   Dyspepsia 2.0% 0 4.0%   Infection Dental 4.0% 3.6% 3.8%   Mucous Membrane Disorder 2.4% 0.8% 3.3% Trial Population of 3 Multicenter US Trials by Treatment Group The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN® compromise clinical attachment. Read the Arestin (minocycline hydrochloride microspheres) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

ARESTIN® is provided as a dry powder, packaged in a unit-dose cartridge, which is Inserted Into a cartridge handle to administer the product. The oral health care professional removes the disposable cartridge from its pouch and connects the cartridge to the handle mechanism (see Figures 1 -3). ARESTIN® Is a variable dose product, dependent on the size, shape, and number of pockets being treated. In US clinical trials, up to 122 unit-dose cartridges were used In a single visit and up to 3 treatments, at 3-month intervals, were administered in pockets with pocket depth of 5 mm or greater. Figure 1
Figure 2
Figure 3
The administration of ARESTIN® 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. ARESTIN® does not have to be removed, as it is bioresorbable, nor is an adhesive or dressing required,

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

ARESTIN® is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis, ARESTIN® may be used as part of a periodontal maintenance program which includes good oral hygiene, and scaling and root planing.

Source: http://www.rxlist.com

ARESTIN® should not be used in any patient who has a known sensitivity to minocycline or tetracyclines.Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg is supplied as follows:
  • 1 unit-dose cartridge with desiccant In a heat-sealed, foll-lamlnated pouch (NDC 65976-100-01).
  • 12 unit-dose cartridges in 1 tray with desiccant in a heat-sealed, foil-laminated, resealable pouch (NDC 65976-100-12). There is 1 pouch in each box.
  • 12 unit-dose cartridges in 1 tray with desiccant in a heat-sealed, foil-laminated, resealable pouch (NDC 65976-100-24). There are 2 pouches in each box,
Each unit-dose cartridge contains the product identifier “OP-1.” Storage Conditions Store at 20° to 25°C (68° to 77°F)/60% RH: excursions permitted to 15° to 30°C (59° to 86°F). Avoid exposure to excessive heat. Manufactured for OraPharma, Inc. Distributed by: Henry Schein Midwest 5315W. 74th St #138 Indianapolis, IN 46268 317-876-7800. Henry Schein North 41 Weaver Rd Denver, PA 17517 717-335-7230. Henry Schein Southeast 8691 Jessie B Smith Ct. Jacksonville, FL 32219 904-380-3230. Henry Schein West 225 Vista Blvd #101 Sparks, NV 89434 775-352-3700. Henry Schein Southwest 1001 Nolen Drive #400 Grapevine, TX 7605' 817-416-9770. Cardinal Health- CH-SPS 15 Ingram Blvd Suite 100 La Vergne, TN 37086. CVS #6570 2800 Enterprise Street Indianapolis, IN 46219. Revised 09/2011 Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Hypersensitivity Reactions Hypersensitivity reactions that included, but were not limited to anaphylaxis, angioneurotic edema, urticaria, rash, swelling of the face and pruritus have been reported with the use of ARESTIN® . Some of these reactions were serious. Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens- Johnson syndrome and erythema multiforme have been reported with oral minocycline. Autoimmune Syndromes Tetracyclines, Including oral minocycline, have been associated with the development of autoimmune syndromes including a Lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. No further treatment with ARESTIN® should be administered to the patient. The use of ARESTIN® in an acutely abscessed periodontal pocket has not been studied and is not recommended. While no overgrowth by opportunistic microorganisms, such as yeast, were noted during clinical studies, as with other antimicrobials, the use of ARESTIN® may result in overgrowth of nonsusceptible microorganisms including fungi. The effects of treatment for greater than 6 months has not been studied. ARESTIN® should be used with caution in patients having a history of predisposition to oral candidiasis. The safety and effectiveness of ARESTIN® has not been established for the treatment of periodontitis in patients with coexistent oral candidiasis. ARESTIN® has not been clinically tested in immunocompromised patients (such as those immunocompromised by diabetes, chemotherapy, radiation therapy, or infection with HIV). If superinfection is suspected, appropriate measures should be taken, ARESTIN® has not been clinically tested in pregnant women. ARESTIN® has not been 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. Carcinogenicity, Mutagenicity, Impairment of Fertility Dietary administration of minocycline In long-term tumorlgenldty studies In rate resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia In rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Minocycline demonstrated no potential to cause genetic toxicity in a battery of assays which included a bacterial reverse mutation assay (Ames test), an in vitro mammalian cell gene mutation test (L5178Y/TK+- mouse lymphoma assay), an in vitro mammalian chromosome aberration test, and an in vivo micronucleus assay conducted in ICR mice. Fertility and general reproduction studies have provided evidence that minocycline impairs fertility in male rats. Teratogenic Effects Pregnancy Category D. (See WARNINGS.) Labor and Delivery The effects of tetracyclines on labor and delivery are unknown. Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions In nursing Infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the Importance of the drug to the mother. (See WARNINGS.) Pediatric Use Since adult periodontitis does not affect children, the safety and effectiveness of ARESTIN® in pediatric patients cannot be established. Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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