This site is intended for US healthcare professionals only.
This site is intended for US healthcare professionals only.

NOW APPROVED for Postsurgical Pain Management for up to 24 hours in Adults Following Open Inguinal Hernia Repair

Xaracoll
The FIRST and
ONLY implant to deliver local, long-lasting, postsurgical pain relief

View Full Important Safety Information

INDICATIONS AND USAGE

XARACOLL is indicated in adults for placement into the surgical site to produce postsurgical local analgesia for up to 24 hours following open inguinal hernia repair

Limitations of Use: Safety and effectiveness have not been established in other surgical procedures, including orthopedic and boney procedures.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of XARACOLL
  • Obstetrical paracervical block anesthesia. The use of bupivacaine in this technique has resulted in fetal bradycardia and death

WARNINGS AND PRECAUTIONS

  • Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after placement of XARACOLL
  • Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full Prescribing Information for more detail on managing these risks

ADVERSE REACTIONS

Most common adverse reactions in clinical trials (incidence ≥2% and higher than placebo) included incision site swelling, dysgeusia, headache, tremor, blurred vision, seroma, scrotal swelling, pyrexia, oral hypoesthesia, and post procedural discharge.

To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at 1-833-606-1421 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Local Anesthetics: 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, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Based on animal data, may cause fetal harm
  • Moderate to Severe Hepatic Impairment: Consider increased monitoring for bupivacaine systemic toxicity
View Full Important Safety Information

INDICATIONS AND USAGE

XARACOLL is indicated for placement into the surgical site in adults to produce postsurgical local analgesia following open inguinal hernia repair.

IMPORTANT SAFETY INFORMATION

  • Monitoring of cardiovascular, neurological, and respiratory status, as well as vital signs, should be performed during and after placement of XARACOLL, as with other local anesthetic products