DOSAGE AND ADMINISTRATION
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.
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,
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.”
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.
Additional Arestin Information
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