DOSAGE AND ADMINISTRATION
ARESTIN® is provided as a dry powder, packaged in a unit-dose cartridge with a deformable tip (see Figure 1), which is inserted into a spring-loaded cartridge handle mechanism (see Figure 2) 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 3-4). 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 and 2
Figure 3 and 4
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, foil-laminated pouch (NDC 65976-100-01).
12 unit-dose cartridges in 1 tray with desiccant in a heat-sealed, foil-laminated, resealable pouch (NDC 65976-100-24). 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., 5 Walnut Grove Drive, Horsham, PA 19044This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/13/2016
Additional Arestin Information
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