Xaracoll Dosage

Important Dosage and Administration Information

• XARACOLL is to be administered by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from bupivacaine exposure.
• The toxic effects of local anesthetics are additive. Avoid additional local anesthetic administration within 96 hours following XARACOLL implantation. If additional local anesthetic administration with XARACOLL cannot be avoided based on clinical need, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Warnings and Precautions (5.1), Drug Interactions (7), Overdosage (10)].
• Use XARACOLL only if the following are immediately available: oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.1), Adverse Reactions (6), Overdosage (10)].
• XARACOLL is supplied as a sterile product that should be handled using aseptic technique. XARACOLL is designed as a ready-to-use product and requires no preparation other than cutting the individual implants as needed to accommodate the surgical space.
• Each single-dose package (pouch) of XARACOLL contains three implants comprising the total dose of 300 mg bupivacaine HCl. Inspect the outer pouch and inner blister packaging prior to use. Do not use XARACOLL if the packaging has been compromised.
• XARACOLL is white to off-white in color, has uniform thickness, and is approximately 5 cm × 5 cm × 0.5 cm in size. Do not use XARACOLL if it appears discolored, contains foreign particulates, or is collapsed, compressed, or misshapen.
• Avoid excessive handling and compression of XARACOLL.
• Avoid contact of XARACOLL with liquids prior to placement. Place the XARACOLL implant into the surgical site dry. Pre-moistening may result in premature release of bupivacaine from XARACOLL.

Recommended Dose

• XARACOLL is intended for single-dose administration. The recommended dose of XARACOLL is 300 mg (3 x 100 mg implants).
• Doses of XARACOLL above 300 mg (3 x 100 mg implants) per patient have not been studied in clinical trials.

Placement Instructions

• Both the outer pouch and the inner blister packaging containing the individual implants are designed to be peeled open. Aseptically peel open the outer pouch, then remove and aseptically peel open the three inner blister packages containing XARACOLL. To avoid cutting the implants prior to placement, do not open the blister packaging using scissors or a scalpel.
• Carefully remove XARACOLL from the inner blister packages and inspect each implant prior to use.
• Using aseptic technique, cut each XARACOLL implant in half prior to placement into the surgical site. Place three halves below the site of mesh placement and three halves just below the skin closure.
• XARACOLL may become difficult to move once placed in the surgical site and moistened. Use care when moving XARACOLL after placement.

Compatibility Considerations

Administration of additional local anesthetics, including bupivacaine HCl, into the surgical site with XARACOLL has not been studied.

Studies conducted with XARACOLL demonstrated that commonly used surgical materials (nonabsorbable surgical suture, delayed absorbable surgical suture, and surgical mesh) are not affected by the presence of XARACOLL.

When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, allow the surgical site to dry before XARACOLL is administered.