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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
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
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 hypoaesthesia, and post procedural discharge.
To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at 1-833-606-1421 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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
1. Data on File. Innocoll Pharmaceuticals Limited. 2. Leiman D, Niebler G, Minkowitz H. Pharmacokinetics and safety of the bupivacaine collagen-matrix implant (INL-001) compared to liquid bupivacaine infiltration after open inguinal hernia repair. Poster presented at: World Congress on Regional Anesthesia & Pain Medicine; April 19-21, 2018; New York, NY. Accessed July 30, 2020. https://epostersonline.com/ASRAWORLD18/node/1154 3. Velanovich V, Rider P, Deck K, et al. Safety and efficacy of bupivacaine HCl collagen-matrix implant (INL-001) in open inguinal hernia repair: results from two randomized controlled trials. Adv Ther. 2019;36:200-216.
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