Description
ARESTIN (minocycline hydrochloride) microspheres, 1 mg, Rx only
DESCRIPTION
ARESTIN (minocycline hydrochloride) microspheres, 1 mg 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.
INDICATION
ARESTIN® (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN® may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.
IMPORTANT SAFETY INFORMATION
Do not take ARESTIN if you are allergic to minocycline or tetracyclines. Ask your dentist or pharmacist for a list of these drugs if you are not sure. Swelling of the face, itching of the skin, fever and enlarged lymph nodes have been reported with the use of ARESTIN. Some of these reactions were serious. Tell your dentist right away if you have any signs of allergic reaction, such as skin reactions or trouble breathing, or if you have an exaggerated sunburn reaction.
- THE USE OF TETRACYCLINE CLASS DRUGS, INCLUDING ARESTIN, DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
- ARESTIN has not been studied in patients with weakened immune systems (such as patients with HIV infections or diabetes, or those receiving chemotherapy or radiation). Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndrome with symptoms such as joint pain, muscle pain, rash, swelling, fever, enlarged lymph nodes, and general body weakness. Tell your doctor about any health problems you have, including whether you have had oral candidiasis (“thrush”) in the past, and about all medications you are taking.
- In clinical studies, the most frequently reported non-dental side effects were headache, infection, flu symptoms, and pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
