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Xaracoll Generic Name & Formulations
Legal Class
Rx
General Description
Bupivacaine HCl 100mg (equivalent to 88.8mg bupivacaine) and purified Type I collagen 75mg; per implant.
Pharmacological Class
Local anesthetic (amide-type).
How Supplied
Pouches (3×100mg implants)—4, 10
Manufacturer
Generic Availability
NO
Xaracoll Indications
Indications
For placement into the surgical site to produce postsurgical analgesia for up to 24hrs following open inguinal hernia repair.
Limitations of Use
Safety and efficacy not established in other surgical procedures, including orthopedic and boney procedures.
Xaracoll Dosage and Administration
Adult
See full labeling. For single-dose administration only. Each implant should be cut in half prior to placement into the surgical site. Place 300mg (3×100mg implants) into the surgical site dry (3 halves below the site of mesh placement and 3 halves just below the skin closure). Maximum dose: 300mg/patient.
Children
Not established.
Xaracoll Contraindications
Contraindications
Obstetrical paracervical block anesthesia.
Xaracoll Boxed Warnings
Not Applicable
Xaracoll Warnings/Precautions
Warnings/Precautions
To be administered under the supervision of experienced clinicians. Have resuscitative equipment and medical personnel readily available. Monitor cardiovascular and respiratory vital signs, and patient's state of consciousness after administration. Risk of methemoglobinemia (esp. in G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6 months of age, concurrent exposure to oxidizing agents or metabolites); monitor closely; consider removal of implants and discontinue any oxidizing agents if occurs. Cardiovascular dysfunction (eg, hypotension, heart block); monitor closely for BP, HR, and ECG changes. Risk of delayed bone healing with unapproved use. Renal or moderate to severe hepatic impairment: monitor for toxicity. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
Xaracoll Pharmacokinetics
See Literature
Xaracoll Interactions
Interactions
Avoid additional local anesthetics within 96hrs following implantation; if unavoidable, monitor for neurologic and cardiovascular effects. Increased risk of methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, others (eg, acetaminophen, metoclopramide, quinine, sulfasalazine).
Xaracoll Adverse Reactions
Adverse Reactions
Incision site swelling, dysgeusia, headache, tremor, vision blurred, seroma, scrotal swelling, pyrexia, hypoesthesia oral, post procedural discharge; CNS toxicity (eg, excitation, depression, restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth/lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, drowsiness), cardiac disorders, neurologic effects, allergic-type reactions.
Xaracoll Clinical Trials
See Literature
Xaracoll Note
Not Applicable
Xaracoll Patient Counseling
See Literature
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