• In order to address ongoing shortages of Bupivacaine Hydrochloride Injection, Areva Pharmaceuticals (Areva), is coordinating with the U.S. Food and Drug Administration (FDA) to make available 5 mL and 10 mL Bupivacaine Hydrochloride Injection 0.25% and 0.5% Single-Dose ampules manufactured by Areva's supplier, Fisiopharma, in Italy. (nih.gov)
  • At this time, no other entity except Areva is authorized by the FDA to import or distribute Bupivacaine Hydrochloride Injection, 2.5 mg/mL and 5 mg/mL (equivalent to 0.25% and 0.5%), 5 mL and 10 mL Single-Dose Ampules in the United States. (nih.gov)
  • There are key differences between the labeling of the FDA approved Bupivacaine Hydrochloride Injection and Areva's imported Bupivicana Fisiopharma. (nih.gov)
  • There is a risk of contamination by glass particles when opening the 5 mL and 10 mL Bupivacaine Hydrochloride Injection ampules. (nih.gov)
  • Please refer to the FDA-approved package insert for the full prescribing information of Bupivacaine Hydrochloride Injection. (nih.gov)
  • These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION safely and effectively. (nih.gov)
  • Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic indicated in adults for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. (nih.gov)
  • Recommended concentrations and dosages of bupivacaine hydrochloride injection according to type of block. (nih.gov)
  • Bupivacaine hydrochloride injection is available in multiple concentrations. (nih.gov)
  • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride injection. (nih.gov)
  • Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. (asahq.org)
  • Meitheal will offer Bupivacaine Hydrochloride Injection, USP in 0.25%, 125mg/50mL and 0.5%, 250mg/50mL multiple dose vials in 1 Case (1 x 50). (meithealpharma.com)
  • Areva's product is labeled Bupivacaina Fisiopharma 2,5 mg/mL which means 2.5 mg/mL and is equivalent to 0.25% bupivacaine hydrochloride. (nih.gov)
  • The highest no-effect dose (HNED) for the local anaesthetic effect of bupivacaine was determined to be 0.25 mg by using an abaxial sesamoid local anaesthetic model. (illinois.edu)
  • Here, we examine dose-duration relationships and sciatic nerve histology following local nerve blocks with combinations of Tectin with bupivacaine 0.25% (2.5 mg/mL) solutions, with or without epinephrine 5 μg/mL (1:200,000) in rats. (wustl.edu)
  • Combinations of Tectin in bupivacaine 0.25% with epinephrine 5 μg/mL appear promising for prolonged duration of local anesthesia. (wustl.edu)
  • In another 35 patients, ultrasound guided field block performed using 20 ml of 0.25% plain bupivacaine at the end of surgery. (ipmj.org)
  • There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride for epidural anesthesia in obstetrical patients. (nih.gov)
  • The 0.75% (7.5 mg/mL) concentration of bupivacaine hydrochloride is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary ( 5.1 ). (nih.gov)
  • There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). (nih.gov)
  • Bupivacaine is a prescription medication used to prevent pain and induce spinal anesthesia. (rxwiki.com)
  • Bupivacaine injection should not be used in obstetrical paracervical block (local anesthetic injection around cervix) anesthesia. (rxwiki.com)
  • To compare the effects of hyperbaric and isobaric bupivacaine spinal anesthesia on hemodynamics and heart rate variability (HRV) in nonobstetric surgery. (tubitak.gov.tr)
  • Group I (n = 30) received 15 mg (3 mL) of hyperbaric bupivacaine and Group II (n = 30) received 15 mg (3 mL) of isobaric bupivacaine for spinal anesthesia. (tubitak.gov.tr)
  • Bupivacaine Noridem is used to create long-term local anesthesia through percutaneous infiltration, intra-articular blockade, peripheral nerve block (s) and central neural block (caudal or epidural). (frostpharma.se)
  • Bupivacaine hydrochloride, when administered properly, via the epidural route in doses 10 to 12 times the amount used in spinal anesthesia has been used for obstetrical analgesia and anesthesia without evidence of adverse effects on the fetus. (pfizermedicalinformation.com)
  • The mean dose of bupivacaine used for spinal anesthesia in parturients of short stature was 9.8 ± 1.0 mg (P (bvsalud.org)
  • The mean intrathecal bupivacaine dose used in combined spinal epidural anesthesia was 10.5 mg (interquartile range, 9-10.9) in parturients of short stature (P = .002). (bvsalud.org)
  • Adequate surgical anesthesia was achieved with reduced dosing of spinal bupivacaine in parturients of short stature without an increase in adverse outcomes. (bvsalud.org)
  • Intervention: Patients were randomly assigned to receive either conventional IV anesthesia (CON) or general anesthesia combined with thoracic epidural anesthesia followed by postoperative epidural analgesia (TEA) with bupivacaine. (the-medical-dictionary.com)
  • Intra-articular infusions of local anesthetics including bupivacaine hydrochloride following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. (nih.gov)
  • Bupivacaine is contraindicated in patients with known hypersensitivity reactions to bupivacaine or amino-amide anesthetics. (wikipedia.org)
  • This retrospective study compares the effect of using LB versus plain bupivacaine on postoperative pain control, length of hospital stay and cost among patients undergoing vaginal reconstructive surgery. (canjurol.com)
  • SABER™ Bupivacaine, a novel extended-release formulation of bupivacaine for postoperative pain control. (clinicaltrialsnz.com)
  • SABER™- Bupivacaine, a novel extended-release formulation of bupivacaine for postoperative pain control demonstrates dose-response, safety and no impact on surgical wound healing following inguinal herniorrhaphy. (clinicaltrialsnz.com)
  • Bupivacaine and lidocaine compared for postoperative pain control. (bvsalud.org)
  • Liposomal formulations of bupivacaine (brand name EXPAREL) have not shown clinical benefit compared to plain bupivacaine when used in traditional perineural injections, although some industry-funded studies have suggested benefits when used in local infiltration. (wikipedia.org)
  • Patients who underwent vaginal reconstructive surgery with levatorplasty and received an injection of 20 cc of either plain bupivacaine or LB for pudendal nerve block were included. (canjurol.com)
  • Between June 2016 and December 2021, 25 patients had received LB as a pudendal nerve block and 25 had received plain bupivacaine. (canjurol.com)
  • LB is not superior to plain bupivacaine for controlling pain following vaginal reconstructive surgery, and justification for the exponentially greater cost of LB is not supported. (canjurol.com)
  • In 37 of them 10 ml of 0.5% plain bupivacaine was instilled (irrigated) into the wound by the surgeon for 1 minute. (ipmj.org)
  • Using liposomal bupivacaine to control pain in patients after gynecological surgery reduced the amount of narcotics needed and may lead to faster recovery times, a recent study found. (contemporaryobgyn.net)
  • In the study, which included about 400 surgical patients, researchers compared the efficacy of liposomal bupivacaine and bupivacaine hydrochloride (HCl) for controlling postoperative pain after laparotomy for gynecological malignancies. (contemporaryobgyn.net)
  • The use of liposomal bupivacaine, compared with use of bupivacaine HCl, following gynecologic surgery decreased the need for narcotics and reduced the use of patient-controlled analgesia. (contemporaryobgyn.net)
  • Bupivacaine HCl treats pain for about 6 to 8 hours, whereas liposomal bupivacaine works for multiple days. (contemporaryobgyn.net)
  • Unsurprisingly, the researchers found that patients who received liposomal bupivacaine following complex cytoreductive surgery required significantly fewer doses of intravenous opioids during the first and second postoperative days than those whose pain was managed with bupivacaine HCl. (contemporaryobgyn.net)
  • During the first day following surgery, 21.5% of the patients treated with liposomal bupivacaine required opioids, while 46.9% of patients who received bupivacaine HCI were given opioids to control pain. (contemporaryobgyn.net)
  • By day two, just 7.4% of patients treated with liposomal bupivacaine were given opioids compared with 27.2% in the other group. (contemporaryobgyn.net)
  • Similarly, when the researchers looked at opioid use among women who underwent staging laparotomy, they found that pain scores were similar between those who received liposomal bupivacaine and those who were given bupivacaine HCl. (contemporaryobgyn.net)
  • Still, the data pointed to a reduction in use of patient-controlled analgesia among those who were treated with liposomal bupivacaine (1.4% vs 8.3%, P=.05). (contemporaryobgyn.net)
  • This was also found among women who underwent cytoreductive surgeries, with 4.1% of the women treated with liposomal bupivacaine using patient-controlled analgesia compared with 33.3% of women in the control group. (contemporaryobgyn.net)
  • Liposomal bupivacaine (LB) is a depot formulation of bupivacaine, which releases the drug over 72 hours to prolong local pain control. (canjurol.com)
  • Liposomal bupivacaine-a new tool in our armamentarium? (ox.ac.uk)
  • Liposomal bupivacaine has been integrated into clinical practice within many surgical disciplines to reduce post-operative pain and opioid consumption. (openmedicalpublishing.org)
  • The purpose of the present investigation is to summarize the current use of liposomal bupivacaine after total hip arthroplasty and to shed light on the prospect of liposomal bupivacaine to reduce opioid use after total hip arthroplasty. (openmedicalpublishing.org)
  • A total of 9 articles were included regarding the use of liposomal bupivacaine in total hip arthroplasty. (openmedicalpublishing.org)
  • Liposomal bupivacaine reduces postoperative opioid use, patient-reported outcomes, length of stay, and time to ambulation, yet is more expensive than traditional bupivacaine. (openmedicalpublishing.org)
  • Liposomal bupivacaine represents a useful adjunct for multimodal pain strategies in total hip arthroplasty with sufficient evidence to suggest that it may be useful in decreasing postoperative opioid use. (openmedicalpublishing.org)
  • Bupivacaine Hydrochloride is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. (nih.gov)
  • Solutions of Bupivacaine Hydrochloride may be autoclaved if they do not contain epinephrine. (nih.gov)
  • The Test Dose formulation of Bupivacaine Hydrochloride contains 15 mg of bupivacaine and 15 mcg of epinephrine in a volume of 3 mL. (druglib.com)
  • Percutaneous sciatic blockade was performed in Sprague-Dawley rats, and intensity and duration of sensory blockade was tested blindly with different Tectin-bupivacaine-epinephrine combinations. (wustl.edu)
  • Bupivacaine, marketed under the brand name Marcaine among others, is a medication used to decrease feeling in a specific area. (wikipedia.org)
  • The bupivacaine from Fisiopharma is approved in Italy for intrathecal use and differs from the US-approved Marcaine Spinal in that the Fisiopharma bupivacaine formulation is an isobaric solution and has two presentations: a concentration of 2.5 mg/mL and 5 mg/mL. (nih.gov)
  • An implantable formulation of bupivacaine (Xaracoll) was approved for medical use in the United States in August 2020. (wikipedia.org)
  • SABER-Bupivacaine is an extended release formulation of bupivacaine in a resorbable matrix which provides delivery of bupivacaine at the site of administration over a period of 3 days. (clinicaltrialsnz.com)
  • The formulation consists of three components: common local anesthetic bupivacaine (12%), organic matrix sucrose acetate isobutyrate, and a diluent, benzyl alcohol. (clinicaltrialsnz.com)
  • SABER-Bupivacaine formulation, a translucent thick solution, is designed to provide continuous delivery of bupivacaine once placed in the surgical wound at the same rate of 10-20 mg/h as delivered by elastomeric pumps through indwelling catheters. (clinicaltrialsnz.com)
  • Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. (anesthesiaexperts.com)
  • Our study has shown an increased survival time with both levosimendan and dobutamine infusion following bupivacaine toxicity in rats. (medscape.com)
  • Shenfu injection reduces toxicity of bupivacaine in rats. (qxmd.com)
  • To investigate the effects of injecting Shenfu, an extract of traditional Chinese herbal medicines, on the central nervous system (CNS) and the cardiac toxicity of bupivacaine in rats. (qxmd.com)
  • The Shenfu injection is able to reduce the toxicity of bupivacaine to CNS and cardiac system in rats. (qxmd.com)
  • Genetic Toxicity Evaluation of Bupivacaine in Salmonella/E.coli Mutagenicity Test or Ames Test. (nih.gov)
  • Bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at doses 30-times the MHRD. (pfizermedicalinformation.com)
  • Objective: To compare two different doses of hyperbaric bupivacaine in unilateral spinal anaesthesia among geriatric patients in hemiarthroplasty surgery. (fortuneonline.org)
  • Bupivacaine is often administered by spinal injection prior to total hip arthroplasty. (the-medical-dictionary.com)
  • 2.5 mg / m 5 ampoules x20 ml contains bupivacaine hydrochloride (as monohydrate) equivalent to 50 mg anhydrous bupivacaine hydrochloride. (frostpharma.se)
  • Bupivacaine Hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. (nih.gov)
  • If you are allergic (hypersensitive) to bupivacaine hydrochloride monohydrate or local anaesthetics of the amide type or to any of the other ingredients in this medicine. (imedi.co.uk)
  • This will normally between 15-150mg of Bupivacaine hydrochloride monohydrate. (imedi.co.uk)
  • The comparison of analgesic efficacy between ultrasound-guided continuous thoracic paravertebral block and continuous thoracic epidural block using bupivacaine - fentanyl in patients undergoing lung surgery: A prospective, randomized, controlled trial. (iasp-pain.org)
  • The aim of this prospective, double blind, randomised trial was to compare the analgesic and adverse effectsof three concentrations of the thoracic epidural sufentanil with bupivacaine in patients undergoing thoracotomy . (bvsalud.org)
  • We studied 60 (randomised) patients who were to receive a 10 ml bolus dose of sufentanil , 1µg/ml, 2 µg/ml and3 µg/ml, in bupivacaine 0.125%, via thoracic epidural. (bvsalud.org)
  • The fixed-dose combination of bupivacaine with Type I collagen (brand name Xaracoll) is indicated for acute postsurgical analgesia (pain relief) for up to 24 hours in adults following open inguinal hernia repair. (wikipedia.org)
  • To compare the postoperative pain relief provided by simple bupivacaine wound instillation and ultrasound guided inguinal hernia field block. (ipmj.org)
  • Bupivacaine instillation is as effective as ultrasound guided field block for inguinal hernia repair pain. (ipmj.org)
  • Bupivacaine (Posimir) is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. (wikipedia.org)
  • Multiple trials are ongoing to investigate safety and efficacy of SABER-Bupivacaine in various surgical procedures. (clinicaltrialsnz.com)
  • Liposome bupivacaine has a similar safety and side effect profile to bupivacaine HCl and normal saline, suggesting that most of the more common AEs are related to either opioid rescue or the surgical procedure itself. (anesthesiaexperts.com)
  • Xaracoll is placed directly into the surgical site during surgery and, after placement, releases bupivacaine immediately and over time. (med-chemist.com)
  • Overall, it appears that with good breastfeeding support epidural bupivacaine with or without fentanyl or one of its derivatives has little or no adverse effect on breastfeeding success. (nih.gov)
  • Group A was received 10 mg hyperbaric bupivacaine plus 20 µg fentanyl and Group B was received 7.50 mg hyperbaric bupivacaine plus 20 µg fentanyl. (fortuneonline.org)
  • Group I recived 9 mg bupivacaine 0.5% and 20 mcg fentanil (total 2 ml), and Group II received 9 mg levobupivacaine 0.5% and 20 mcg fentanyl (total 2.6 ml). (jceionline.org)
  • Comparison of continuous epidural infusion of fentanyl and fentanyl-bupivacaine for post cholecystectomy pain control. (tmu.edu.tw)
  • We tried to combine low concentrations of fentanyl with bupivacaine to minimize side effects and to see if synergistic effect existed. (tmu.edu.tw)
  • In conclusion, the continuous infusion of dilute bupivacaine with fentanyl provides synergistic analgesia with minimal side effects. (tmu.edu.tw)
  • Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after injection of bupivacaine hydrochloride. (nih.gov)
  • Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine. (nih.gov)
  • The concentration of bupivacaine or its metabolites after administration of a HNED dose are detectable by mass spectrometric techniques. (illinois.edu)
  • The aim of this work was to determine the effects of different time of tobacco smoke exposure on pharmacokinetics of bupivacaine in mice. (lih.lu)
  • Additionally, bupivacaine can cause chondrolysis after continuous infusion into a joint space. (wikipedia.org)
  • Animals in the control group received a saline injection 10 ml/kg while animals in the Shenfu group received an injection of Shenfu 10 ml/kg intraperitoneally 30 minutes before intravenous infusion of bupivacaine. (qxmd.com)
  • The femoral vein was cannulated for the infusion of bupivacaine. (qxmd.com)
  • The dose of bupivacaine was then calculated at the corresponding time point. (qxmd.com)
  • The test dose should also contain 10 mg to 15 mg of Bupivacaine Hydrochloride or an equivalent amount of another local anesthetic to detect an unintended intrathecal administration. (druglib.com)
  • Bupivacaine contains 3.15 mg/ml (0.14 mmol) sodium per dose. (imedi.co.uk)
  • The primary outcome was dose of intrathecal bupivacaine . (bvsalud.org)
  • Predicting inter-individual variability during lipid resuscitation of bupivacaine cardiotoxicity in rats: a virtual populatio. (ornl.gov)
  • During epidural administration of Bupivacaine Hydrochloride, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. (druglib.com)
  • Bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, and 40 mg/kg and to rabbits at doses of 1.3, 5.8, and 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). (pfizermedicalinformation.com)
  • Previous studies showed that in rats, combinations of tetrodotoxin (TTX) with bupivacaine had supra-additive effects on sciatic block durations. (wustl.edu)
  • Five crystal forms of the amide-type local anesthetic S-bupivacaine hydrochloride (levobupivacaine) were prepared and characterized by means of thermal analytical methods, FTIR- and Raman-spectroscopy, powder X-ray diffractometry, and moisture sorption analysis. (unboundmedicine.com)
  • Bupivacaine hydrochloride is a long-acting local anesthetic of the amide type with both anesthetic and analgesic effects. (frostpharma.se)
  • A comparison of the effects of hyperbaric and isobaric bupivacaine spi" by MEHMET TOPTAŞ, SİNAN UZMAN et al. (tubitak.gov.tr)
  • Conclusion: Hyperbaric bupivacaine caused a significantly greater decrease in LF/HF ratios and a significantly greater increase in HF values. (tubitak.gov.tr)
  • Bupivacaine is available as a generic medication. (wikipedia.org)
  • In the case of bupivacaine, there are no specific foods that you must exclude from your diet when receiving this medication. (rxwiki.com)
  • Bupivacaine solution, a medication used to decrease feeling in a specific area, alongside sodium chloride used as a saline solution. (pslhub.org)
  • At least 1 serious AE occurred in 8% of subjects receiving liposome bupivacaine compared with 10% of those receiving placebo (none assessed by investigators as related to study medication). (anesthesiaexperts.com)
  • We aimed to compare the anesthetic potencies and hemodynamic effects of levobupivacaine and bupivacaine with fentanil intrathecally administered in patients undergoing ano-rectal surgery. (jceionline.org)
  • Levobupivacaine is a derivative, specifically an enantiomer, of bupivacaine. (the-medical-dictionary.com)
  • Motor block onset time was longer in bupivacaine group than levobupivacaine group but motor block regression time was shorter in group levobupivacaine. (jceionline.org)
  • Our results shows that levobupivacaine which has similar features with bupivacaine in terms of sensory block may be a good alternative to bupivacaine in the operations in which development of the motor blocks is unwanted. (jceionline.org)
  • An overview of Genetic Toxicology Bacterial Mutagenicity study conclusions related to Bupivacaine (38396-39-3). (nih.gov)
  • See the "Bupivacaine Precautions" section. (rxwiki.com)
  • Bupivacaine belongs to a group of drugs called local anesthetics. (rxwiki.com)