Bupivacaine Spinal

Clinical summary

Indications and usage BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). Standard dosing The dosage of BUPIVACAINE SPINAL administered varies with the anesthetic procedure, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result. The following are general dosage guidelines: • BUPIVACAINE SPINAL 6 mg is generally adequate for vaginal delivery. ( 2.2 ) • BUPIVACAINE SPINAL 7.5 mg is generally adequate for spinal anesthesia for lower extremity and perineal procedures. ( 2.2 ) • BUPIVACAINE SPINAL 12 mg is generally adequate for lower abdominal procedures. ( 2.2 ) • BUPIVACAINE SPINAL 7.5 mg to 10.5 mg is generally adequate for Cesarean section. ( 2.2 ) Contraindications BUPIVACAINE SPINAL is contraindicated in: • intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.8) ] . • patients with septicemia. • patients with severe hemorrhage, severe hypotension or shock, due to a reduced cardiac output. • patients with clinically significant arrhythmias, such as complete heartblock, due a reduced cardiac output. • patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of BUPIVACAINE SPINAL. • patients with local infection at the site of proposed lumbar puncture. Key warnings • Use of Spinal Anesthetics During Uterine Contractions : Spinal anesthetics, including BUPIVACAINE SPINAL, should not be injected during uterine contractions because cerebrospinal fluid current may carry the drug further cephalad than desired, resulting in a high motor block. ( 5.1 ) • Patients with Hypertension : Sympathetic blockade due to spinal anesthesia may result in peripheral vasodilation and hypotension. Monitor blood pressure frequently. Hypotension may be controlled by administration of vasoconstrictor agents in titrated dosages depending on the severity of hypotension and response to treatment. Monitor the onset of adequate spinal anesthesia frequently. ( 5.2 ) • Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of BUPIVACAINE SPINAL. ( 5.3 ) • Risk of Systemic Toxicities with Unintended Intravascular Injection : Unintended intravascular injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood and cerebrospinal fluid (where applicable) prior to each dose. ( 5.4 ) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. ( 5.5 ) • Risk of Cardiac Arrest with Use of Epidural Bupivacaine in Obstetrical Anesthesia : There have been reports of cardiac arrest during use of bupivacaine hydrochloride 0.75% solution for epidural anesthesia in obstetrical patients. BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is recommended for spinal anesthesia in obstetrical patients. ( 5.6 ) • Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including bupivacaine following arthroscopic and other surgical procedures is an unapproved use, and there have been post‑marketing reports of chondrolysis in patients receiving such infusions. ( 5.7 ) • Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block) : There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). ( 5.8 ) Drug interactions • Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. ( 7.2 ) Pregnancy guidance Risk Summary The available data on the use of BUPIVACAINE SPINAL in pregnant women do not establish the presence or absence of developmental toxicity related to the use of BUPIVACAINE SPINAL. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis and decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning). These effects were observed at dose levels approximately 30 times the daily maximum recommended human dose (MRHD) on a body surface a