Bupivacaine
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. This should be considered when selecting the MARCAINE SPINAL dosage [see Use in Specific Populations ] .
Dosing in liver impairment
Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity.
Therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with MARCAINE SPINAL [see Warnings and Precautions ] .
Preparation and administration
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Important Dosage and Administration Information
Visually inspect this product for particulate matter and discoloration prior to administration. MARCAINE SPINAL is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE SPINAL is not recommended because of insufficient data on the clinical use of such mixtures.
Discard unused portions of MARCAINE SPINAL following initial use. Administration Precautions
MARCAINE SPINAL is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed.
Use MARCAINE SPINAL only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [ see Warnings and Precautions , Adverse Reactions , Overdosage ].
The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with MARCAINE SPINAL [see Warnings and Precautions , Drug Interactions , Overdosage] .
Aspirate for blood and cerebrospinal fluid prior to injecting MARCAINE SPINAL, for both the initial dose and all subsequent doses (where applicable), to avoid intravascular injection and to confirm entry into the subarachnoid space. Aspiration of cerebrospinal fluid into a MARCAINE SPINAL-filled syringe will result in an identifiable swirl in the solution.
A negative aspiration for blood does not ensure against an intravascular injection [see Warnings and Precautions ] .
Avoid rapid injection of MARCAINE SPINAL.
The patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of MARCAINE SPINAL that results in effective spinal anesthesia should be used to avoid a high motor block and serious adverse reactions.
Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient's level of consciousness during spinal anesthesia. Conditions Which May Preclude Use of Spinal Anesthesia The following conditions may preclude the use of spinal anesthesia, depending upon the physician's evaluation of the patient:
Pre-existing diseases of the central nervous system (CNS), such as those attributable to pernicious anemia, poliomyelitis, syphilis, or tumor.
Hematological disorders predisposing to coagulopathies or patients on anticoagulant therapy. Trauma to a blood vessel during the conduct of spinal anesthesia may, in some instances, result in uncontrollable CNS hemorrhage, soft tissue hemorrhage, or development of a hematoma.
Chronic backache and preoperative headache.
Hypotension and hypertension.
Technical problems (persistent paresthesias, persistent bloody tap).
Arthritis or spinal deformity.
Extremes of age.
Psychosis, dementia, or other illnesses resulting in poor patient cooperation.
Drug interactions
Check bupivacaine against a medication listLabel text (4 paragraphs)
7 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 )
7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE SPINAL cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1) , Warnings and Precautions (5.3) ] .
7.2 Drugs Associated with Methemoglobinemia Patients who are administered MARCAINE SPINAL are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions (5.5) ] .
Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine
Contraindications
4 CONTRAINDICATIONS MARCAINE 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 MARCAINE SPINAL. o patients with local infection at the site of proposed lumbar puncture. • 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 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary The available data on the use of MARCAINE SPINAL in pregnant women do not establish the presence or absence of developmental toxicity related to the use of MARCAINE 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 area (BSA) basis.
Based on animal data, advise pregnant women of the potential risk to a fetus ( see Data ) . Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology (12.3) ]. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the CNS, peripheral vascular tone, and cardiac function.
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Maternal Adverse Reactions Maternal hypotension has resulted from regional and neuraxial anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves.
The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension, or fetal bradycardia following regional or neuraxial block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs and right-side-up positioning will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable.
Labor or Delivery Spinal anesthesia is commonly used during labor and delivery. Bupivacaine hydrochloride, when…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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