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 121 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 in unit doses of 12 cartridges in one tray (NDC 65976-100-24) packaged with desiccant in a heat-sealed foil-laminated resealable pouch. 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: Cord Logistics, Inc.
15 Ingram Boulevard
La Vergne, TN 37086