Generic Name and Formulations:
Bupivacaine HCl 2.5mg/mL, 5mg/mL, 7.5mg/mL; soln for inj.
Indications for MARCAINE:
Production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures (0.25% and 0.5% only).
See full labeling for recommended dosages based on procedures. Epidural anesthesia: administer test dose first; monitor for CNS or cardiovascular toxicity. 0.25% soln when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solns. 0.5% soln provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential. 0.75% soln produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia. For most indications, a single dose is sufficient. Max 400mg/day. Debilitated, elderly, acutely ill: reduce dose.
Obstetrical paracervical block.
0.75% concentration not recommended for obstetrical anesthesia: cardiac arrest with difficult resuscitation or death has occurred.
To be administered under the supervision of experienced clinicians. Have intubation, artificial respiration, oxygen therapy and reversal agents available. 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. Solns containing antimicrobial preservatives: do not use for epidural or caudal anesthesia. IV regional anesthesia (Bier Block): not recommended. Cardiovascular disease. Hepatic or renal impairment. Monitor cardiovascular and respiratory vital signs. Malignant hyperthermia. Head and neck administration. Elderly. Labor & delivery. Pregnancy. Nursing mothers: not recommended.
Increased risk of methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, others. Additive effects with other products containing local anesthetics. Epinephrine: concomitant ergot-type oxytocic drugs not recommended; severe persistent hypertension may occur. Caution with MAOIs, triptyline and imipramine type antidepressants; avoid. Phenothiazines, butyrophenones may reduce or reverse pressor effect of epinephrine.
CNS effects (eg, excitation, depression, restlessness, anxiety, dizziness, tremors), cardiovascular effects (eg, myocardium depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, cardiac arrest), allergic-type reactions, neurologic effects (eg, spinal block, urinary retention, paresthesia, weakness, headache, paralysis of lower extremities).
Marcaine: Single-dose vials (10mL, 30mL)—10; Multi-dose vials 0.25%, 0.5% (50mL)—1 (contains methylparaben). Marcaine with epinephrine: Single-dose vials (10mL, 30mL)—10; Multi-dose vials (50mL)—1 (contains sodium metabisulfite)