MARCAINE - SPINAL Highlights

MARCAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia). (1)

The dosage of MARCAINE 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:

• MARCAINE SPINAL 6 mg is generally adequate for vaginal delivery. (2.2)
• MARCAINE SPINAL 7.5 mg is generally adequate for spinal anesthesia for lower extremity and perineal procedures. (2.2)
• MARCAINE SPINAL 12 mg is generally adequate for lower abdominal procedures. (2.2)
• MARCAINE SPINAL 7.5 mg to 10.5 mg is generally adequate for Cesarean section. (2.2)

Injection: 15 mg/2 mL (7.5 mg/mL) in single-dose glass ampules. (3)

• Intravenous regional anesthesia (Bier Block). (4)
• Septicemia. (4)
• Severe hemorrhage, severe hypotension or shock, and arrhythmias, such as complete heartblock, which severely reduce cardiac output. (4)
• Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of MARCAINE SPINAL. (4)
• Local infection at the site of proposed lumbar puncture. (4)

• Use of Spinal Anesthetics During Uterine Contractions: Spinal anesthetics, including MARCAINE 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 MARCAINE 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 MARCAINE 0.75% solution for epidural anesthesia in obstetrical patients. MARCAINE 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)

Most common adverse reactions are hypotension due to loss of sympathetic tone, and diaphragmatic paralysis or hypoventilation due to cephalad spread and high motor block. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• 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)

• Pediatric Use: Administration of MARCAINE SPINAL in patients younger than 18 years is not recommended. (8.4)
• Geriatric Use: Patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing spinal anesthesia with MARCAINE SPINAL. (8.5)
• Moderate to Severe Hepatic Impairment: Consider increased monitoring for bupivacaine systemic toxicity. (8.6)