Astero Gel

Astero® is indicated for associated pain, painful wounds and wound healing in either open and closed injuries or conditions. Conditions of pain include topical pain, postsurgical pain and pain associated w/various types of closed or open wounds. Conditions of closed wounds include soft tissue and bony injuries caused by contusions, hematomas, crush injuries and sprains/strains due to torsion, traction, compression and/or blunt trauma.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Astero® should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact Poison Control Center right away.

Serious interactions:

Antiarrhythmic Drugs: Astero® should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Bupivacaine liposome: Lidocaine Hydrochloride USP increases toxicity of Bupivacaine by increasing the free (unencapsulated) bupivacaine. Dofetilide: Lidocaine Hydrochloride USP increases effects of dofetilide through pharmacodynamic synergism. Lomitapide: Lidocaine Hydrochloride USP increases levels of lomitapide by affecting hepatic/intestinal enzymes CYP3A4 metabolism.

General interactions:

Drugs metabolized via CYP3A4 enzyme: (ex. Antipsychotics, SSRIs, TCAs, many chemotherapeutics, calcium channel blockers, benzodiazepines) Lidocaine Hydrochloride USP may increase serum levels of many drugs metabolized by hepatic / intestinal CYP3A4 enzymes. Drugs that affect hepatic CYP1A2 enzyme: (ex. Quinolone antibiotics, cimetidine, barbiturates, benzodiazepines, erythromycin) May increase serum Lidocaine Hydrochloride USP levels by decreasing Lidocaine Hydrochloride USP metabolism by CYP1A2 enzyme.

Studies of Lidocaine Hydrochloride USP in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

STORE AND DISPOSE OF THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN AND PETS. All prescriptions using this product shall be pursuant to state statutes as applicable. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86º F). See USP Controlled Room Temperature. Protect from freezing.

Manufactured for: Gensco Laboratories, 8550 NW 33rd Street, Suite 200, Doral, FL 33122