Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2283
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Marcaine Spinal (Injection, Solution)
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The dose of any local anesthetic administered varies
with the anesthetic procedure, the area to be anesthetized, 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. The smallest dose and concentration required
to produce the desired result should be administered. Dosages of MARCAINE
Spinal should be reduced for elderly and debilitated patients and
patients with cardiac and/or liver disease. For specific techniques and procedures, refer to standard textbooks. The extent and degree of spinal anesthesia depend upon
several factors including dosage, specific gravity of the anesthetic
solution, volume of solution used, force of injection, level of puncture,
and position of the patient during and immediately after injection. Seven and one-half mg (7.5 mg or 1 mL) MARCAINE Spinal
has generally proven satisfactory for spinal anesthesia for lower
extremity and perineal procedures including TURP and vaginal hysterectomy.
Twelve mg (12 mg or 1.6 mL) has been used for lower abdominal procedures
such as abdominal hysterectomy, tubal ligation, and appendectomy.
These doses are recommended as aguide for use in the average adult
and may be reduced for the elderly or debilitated patients. Because
experience with MARCAINE Spinal is limited in patients below the age
of 18 years, dosage recommendations in this age group cannot be made. Obstetrical Use: Doses as low as 6 mg bupivacaine hydrochloride have been used for
vaginal delivery under spinal anesthesia. The dose range of 7.5 mg
to 10.5 mg (1 mL to 1.4 mL) bupivacaine hydrochloride has been used
for Cesarean section under spinal anesthesia. In recommended doses, MARCAINE Spinal produces complete motor
and sensory block. Unused portions of solutions
should be discarded following initial use. MARCAINE
Spinal should be inspected visually for discoloration and particulate
matter prior to administration; solutions which are discolored or
which contain particulate matter should not be administered.
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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. It has the following structural
formula: Dextrose is D-glucopyranose monohydrate and has the following structural
formula: MARCAINE' Spinal is available in sterile hyperbaric solution
for subarachnoid injection (spinal block). Bupivacaine
hydrochloride is related chemically and pharmacologically to the aminoacyl
local anesthetics. It is a homologue of mepivacaine and is chemically
related to lidocaine. All three of these anesthetics contain an amide
linkage between the aromatic nucleus and the amino or piperidine group.
They differ in this respect from the procaine-type local anesthetics,
which have an ester linkage. Each mL of
MARCAINE Spinal contains 7.5 mg bupivacaine hydrochloride (anhydrous)
and 82.5 mg dextrose (anhydrous). The pH of this solution is adjusted
to between 4.0 and 6.5 with sodium hydroxide or hydrochloric acid. The specific gravity of MARCAINE Spinal is between 1.030
and 1.035 at 25��C and 1.03 at 37��C. MARCAINE Spinal does not contain any preservatives.
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Local anesthetics block the generation and the conduction
of nerve impulses, presumably by increasing the threshold for electrical
excitation in the nerve, by slowing the propagation of the nerve impulse,
and by reducing the rate of rise of the action potential. In general,
the progression of anesthesia is related to the diameter, myelination,
and conduction velocity of affected nerve fibers. Clinically, the
order of loss of nerve function is as follows: (1) pain, (2) temperature,
(3) touch, (4) proprioception, and (5) skeletal muscle tone. Systemic absorption of local anesthetics produces
effects on the cardiovascular and central nervous systems (CNS). At
blood concentrations achieved with normal therapeutic doses, changes
in cardiac conduction, excitability, refractoriness, contractility,
and peripheral vascular resistance are minimal. However, toxic blood
concentrations depress cardiac conduction and excitability, which
may lead to atrioventricular block, ventricular arrhythmias, and cardiac
arrest, sometimes resulting in fatalities. In addition, myocardial
contractility is depressed and peripheral vasodilation occurs, leading
to decreased cardiac output and arterial blood pressure. Recent clinical
reports and animal research suggest that these cardiovascular changes
are more likely to occur after unintended direct intravascular injection
of bupivacaine. Therefore, when epidural anesthesia with bupivacaine
is considered, incremental dosing is necessary. Following systemic absorption, local anesthetics can produce
central nervous system stimulation, depression, or both. Apparent
central stimulation is manifested as restlessness, tremors and shivering,
progressing to convulsions, followed by depression and coma progressing
ultimately to respiratory arrest. However, the local anesthetics have
a primary depressant effect on the medulla and on higher centers.
The depressed stage may occur without a prior excited stage. Pharmacokinetics: The rate of systemic absorption of local anesthetics is dependent
upon the total dose and concentration of drug administered, the route
of administration, the vascularity of the administration site, and
the presence or absence of epinephrine in the anesthetic solution.
A dilute concentration of epinephrine (1:200,000 or 5 mcg/mL) usually
reduces the rate of absorption and peak plasma concentration of MARCAINE,
permitting the use of moderately larger total doses and sometimes
prolonging the duration of action. The
onset of action with MARCAINE is rapid and anesthesia is long lasting.
The duration of anesthesia is significantly longer with MARCAINE than
with any other commonly used local anesthetic. It has also been noted
that there is a period of analgesia that persists after the return
of sensation, during which time the need for strong analgesics is
reduced. The onset of sensory blockade
following spinal block with MARCAINE Spinal is very rapid (within
one minute); maximum motor blockade and maximum dermatome level are
achieved within 15 minutes in most cases. Duration of sensory blockade
(time to return of complete sensation in the operative site or regression
of two dermatomes) following a 12 mg dose averages 2 hours with
or without 0.2 mg epinephrine. The time to return of complete motor
ability with 12 mg MARCAINE Spinal averages 3 1/2 hours without
the addition of epinephrine and 4��hours if 0.2 mg epinephrine
is added. When compared to equal milligram doses of hyperbaric tetracaine,
the duration of sensory blockade was the same but the time to complete
motor recovery was significantly longer for tetracaine. Addition of
0.2 mg epinephrine significantly prolongs the motor blockade and time
to first postoperative narcotic with MARCAINE Spinal. Local anesthetics appear to cross the placenta by passive diffusion.
The rate and degree of diffusion is governed by (1) the degree of plasma
protein binding, (2) the degree of ionization, and (3) the degree
of lipid solubility. Fetal/maternal ratios of local anesthetics appear
to be inversely related to the degree of plasma protein binding, because
only the free, unbound drug is available for placental transfer. MARCAINE
with a high protein binding capacity (95%) has a low fetal/maternal
ratio (0.2 to 0.4). The extent of placental transfer is also determined
by the degree of ionization and lipid solubility of the drug. Lipid
soluble, nonionized drugs readily enter the fetal blood from the maternal
circulation. Depending upon the route of administration,
local anesthetics are distributed to some extent to all body tissues,
with high concentrations found in highly perfused organs such as the
liver, lungs, heart, and brain. Pharmacokinetic
studies on the plasma profiles of MARCAINE after direct intravenous
injection suggest a three-compartment open model. The first compartment
is represented by the rapid intravascular distribution of the drug.
The second compartment represents the equilibration of the drug throughout
the highly perfused organs such as the brain, myocardium, lungs, kidneys,
and liver. The third compartment represents an equilibration ofthe
drug with poorly perfused tissues, such as muscle and fat. The elimination
of drug from tissue distribution depends largely upon the ability
of binding sites in the circulation to carry it to the liver where
it is metabolized. Various pharmacokinetic
parameters of the local anesthetics can be significantly altered by
the presence of hepatic or renal disease, addition of epinephrine,
factors affecting urinary pH, renal blood flow, the route of drug
administration, and the age of the patient. The half-life of MARCAINE
in adults is 2.7 hours and in neonates 8.1 hours. In clinical studies,
elderly patients exhibited a greater spread and higher maximal level
of analgesia than younger patients. Elderly patients also reached
the maximal level of analgesia more rapidly than younger patients,
and exhibited a faster onset of motor blockade. The total plasma clearance
was decreased and the terminal half-life was lengthened in these patients. Amide-type local anesthetics such as MARCAINE are
metabolized primarily in the liver via conjugation with glucuronic
acid. Patients with hepatic disease, especially those with severe
hepatic disease, may be more susceptible to the potential toxicities
of the amide-type local anesthetics. Pipecolylxylidine is the major
metabolite of MARCAINE. The kidney is the main
excretory organ for most local anesthetics and their metabolites.
Urinary excretion is affected by urinary perfusion and factors affecting
urinary pH. Only 6% of bupivacaine is excreted unchanged in the urine. When administered in recommended doses and concentrations,
MARCAINE does not ordinarily produce irritation or tissue damage and
does not cause methemoglobinemia.
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MARCAINE Spinal is contraindicated in patients with
a known hypersensitivity to it or to any local anesthetic agent of
the amide-type. The following conditions
preclude the use of spinal anesthesia:
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Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride
with 165 mg dextrose), in Uni-Amp ampul pak of 10
(NDC 0409-1761-02) Store at 20 to 25��C
(68 to 77��F). [See USP Controlled Room Temperature.] MARCAINE Spinal solution may
be autoclaved once at 15 pound pressure, 121��C (250��F) for
15 minutes. Do not administer any solution which is discolored
or contains particulate matter. July,
2007
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General:: The safety and effectiveness of spinal anesthetics
depend on proper dosage, correct technique, adequate precautions,
and readiness for emergencies. Resuscitative equipment, oxygen, and
other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE
REACTIONS.) The patient should have IV fluids
running via an indwelling catheter to assure a functioning intravenous
pathway. The lowest dosage of local anesthetic that results in effective
anesthesia should be used. Aspiration for blood should be performed
before injection and injection should be made slowly. Tolerance varies
with the status of the patient. Elderly patients and acutely ill patients
may require reduced doses. Reduced doses may also be indicated in
patients with increased intra-abdominal pressure (including obstetrical
patients), if otherwise suitable for spinal anesthesia. There should be careful and constant monitoring of
cardiovascular and respiratory (adequacy of ventilation) vital signs
and the patient's state of consciousness after local anesthetic
injection. Restlessness, anxiety, incoherent speech, lightheadedness,
numbness and tingling of the mouth and lips, metallic taste, tinnitus,
dizziness, blurred vision, tremors, depression, or drowsiness may
be early warning signs of central nervous system toxicity. Spinal anesthetics should be used with caution in patients
with severe disturbances of cardiac rhythm, shock, or heart block. Sympathetic blockade occurring during spinal anesthesia
may result in peripheral vasodilation and hypotension, the extent
depending on the number of dermatomes blocked. Patients over 65 years,
particularly those with hypertension, may be at increased risk for
experiencing the hypotensive effects of MARCAINE Spinal. Blood pressure
should, therefore, be carefully monitored especially in the early
phases of anesthesia. Hypotension may be controlled by vasoconstrictors
in dosages depending on the severity of hypotension and response of
treatment. The level of anesthesia should be carefully monitored because
it is not always controllable in spinal techniques. Because amide-type local anesthetics such as MARCAINE are metabolized
by the liver, these drugs, especially repeat doses, should be used
cautiously in patients with hepatic disease. Patients with severe
hepatic disease, because of their inability to metabolize local anesthetics
normally, are at a greater riskof developing toxic plasma concentrations.
Local anesthetics should also be used with caution in patients with
impaired cardiovascular function because they may be less able to
compensate for functional changes associated with the prolongation
of AV conduction produced by these drugs. However, dosage recommendations
for spinal anesthesia are much lower than dosage recommendations for
other major blocks and most experience regarding hepatic and cardiovascular
disease dose-related toxicity is derived from these other major blocks. Serious dose-related cardiac arrhythmias may occur if
preparations containing a vasoconstrictor such as epinephrine are
employed in patients during or following the administration of potent
inhalation agents. In deciding whether to use these products concurrently
in the same patient, the combined action of both agents upon the myocardium,
the concentration and volume of vasoconstrictor used, and the time
since injection, when applicable, should be taken into account. Many drugs used during the conduct of anesthesia
are considered potential triggering agents for familial malignant
hyperthermia. Because it is not known whether amide-type local anesthetics
may trigger this reaction and because the need for supplemental general
anesthesia cannot be predicted in advance, it is suggested that a
standard protocol for management should be available. Early unexplained
signs of tachycardia, tachypnea, labile blood pressure, and metabolic
acidosis mayprecede temperature elevation. Successful outcome is
dependent on early diagnosis, prompt discontinuance of the suspect
triggering agent(s) and institution of treatment, including oxygen
therapy, indicated supportive measures, and dantrolene. (Consult dantrolene
sodium intravenous package insert before using.) The following conditions may preclude the use of spinal anesthesia,
depending upon the physician's evaluation of the situation
and ability to deal with the complications or complaints which may
occur:<br/>Information for Patients:: When appropriate, patients should be informed in
advance that they may experience temporary loss of sensation and motor
activity, usually in the lower half of the body, following proper
administration of spinal anesthesia. Also, when appropriate, the physician
should discuss other information including adverse reactions in the
MARCAINE Spinal package insert.<br/>Clinically Significant Drug
Interactions:: The administration of local anesthetic solutions
containing epinephrine or norepinephrine to patients receiving monoamine
oxidase inhibitors or tricyclic antidepressants may produce severe,
prolonged hypertension. Concurrent use of these agents should generally
be avoided. In situations when concurrent therapy is necessary, careful
patient monitoring is essential. Concurrent
administration of vasopressor drugs and of ergot-type oxytocic drugs
may cause severe persistent hypertension or cerebrovascular accidents. Phenothiazines and butyrophenones may reduce or reverse
the pressor effect of epinephrine.<br/>Carcinogenesis, Mutagenesis,
and Impairment of Fertility:: Long-term studies in animals of most local anesthetics
including bupivacaine to evaluate the carcinogenic potential have
not been conducted. Mutagenic potential or the effect on fertility
have not been determined. There is no evidence from human data that
MARCAINE Spinal may be carcinogenic or mutagenic or that it impairs
fertility.<br/>Pregnancy Category C:: Decreased pup survival in rats and an embryocidal
effect in rabbits have been observed when bupivacaine hydrochloride
was administered to these species in doses comparable to 230 and 130
times respectively the maximum recommended human spinal dose. There
are no adequate and well-controlled studies inpregnant women of the
effect of bupivacaine on the developing fetus. Bupivacaine hydrochloride
should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus. This does not exclude the use of
MARCAINE Spinal at term for obstetrical anesthesia. (See Labor and Delivery.)<br/>Labor and Delivery:: Spinal anesthesia has a recognized use during labor
and delivery. 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. Maternal hypotension has resulted from regional anesthesia.
Local anesthetics produce vasodilation by blocking sympathetic nerves.
Elevating the patient's legs and positioning her on her left
side will help prevent decreases in blood pressure. The fetal heart
rate also should be monitored continuously and electronic fetal monitoring
is highly advisable. It is extremely important
to avoid aortocaval compression by the gravid uterus during administrations
of regional block to parturients. To do this, the patient must be
maintained in the left lateral decubitus position or a blanket roll
or sandbag may be placed beneath the right hip and the gravid uterus
displaced to the left. Spinal anesthesia may
alter the forces of parturition through changes in uterine contractility
or maternal expulsive efforts. Spinal anesthesia has also been reported
to prolong the second stage of labor by removing the parturient's
reflex urge to bear down or by interfering with motor function. The
use of obstetrical anesthesia mayincrease the need for forceps assistance. The use of some local anesthetic drug products during
labor and delivery may be followed by diminished muscle strength and
tone for the first day or two of life. This has not been reported
with bupivacaine. There have been reports of
cardiac arrest during use of MARCAINE 0.75% solution for epidural
anesthesia in obstetrical patients. The package insert for MARCAINE
hydrochloride for epidural, nerve block, etc., has a more complete
discussion of preparation for, and management of, this problem. These
cases are compatible with systemic toxicity following unintended intravascular
injection of the much larger doses recommended for epidural anesthesia and have not occurred
within the dose range of bupivacaine hydrochloride 0.75% recommended
for spinal anesthesia in obstetrics. The 0.75% concentration of MARCAINE
is therefore not recommended for obstetrical epidural anesthesia.
MARCAINE Spinal (bupivacaine hydrochloride in dextrose injection)
is recommended for spinal anesthesia in obstetrics.<br/>Nursing Mothers:: Bupivacaine has been reported to be excreted in human
milk suggesting that the nursing infant could be theoretically exposed
to a dose of the drug. Because of the potential for serious adverse
reactions in nursing infants from bupivacaine, a decision should be
made whether to discontinue nursing or not administer bupivacaine,
taking into account the importance of the drug to the mother.<br/>Pediatric Use:: Until further experience is gained in patients younger
than 18 years, administration of MARCAINE Spinal in this age group
is not recommended.<br/>Geriatric Use:: Patients over 65 years, particularly those with hypertension,
may be at increased risk for developing hypotension while undergoing
spinal anesthesia with MARCAINE Spinal. (See PRECAUTIONS, General and ADVERSE
REACTIONS, Cardiovascular
System.) Elderly patients may
require lower doses of MARCAINE Spinal. (See PRECAUTIONS, General and DOSAGE
AND ADMINISTRATION.) In
clinical studies, differences in various pharmacokinetic parameters
have been observed between elderly and younger patients. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.) This
product is known to be substantially excreted by the kidney, and the
risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely
to have decreased renal function, care should be taken in dose selection,
and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.)
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Acute emergencies from local anesthetics are generally
related to high plasma levels encountered during therapeutic use or
to underventilation (and perhaps apnea) secondary to upward extension
of spinal anesthesia. Hypotension is commonly encountered during the
conduct of spinal anesthesia due to relaxation of sympathetic tone,
and sometimes, contributory mechanical obstruction of venous return. Management of Local Anesthetic
Emergencies: The first consideration is prevention, best
accomplished by careful and constant monitoring of cardiovascular
and respiratory vital signs and the patient's state of consciousness
after each local anesthetic injection. At the first sign of change,
oxygen should be administered. The first step in the management of systemic toxic
reactions, as well as underventilation or apnea due to a high or total
spinal, consists of immediate attention to the establishment and
maintenance of a patent airway and effective assisted or controlled
ventilation with 100% oxygen with a delivery system capable of permitting
immediate positive airway pressure by mask. This may prevent
convulsions if they have not already occurred. If necessary, use drugs to control the convulsions. A 50 mg
to 100 mg bolus IV injection of succinylcholine will paralyze the
patient without depressing the central nervous or cardiovascular systems
and facilitate ventilation. A bolus IV dose of 5 mg to 10 mg of diazepam
or 50 mg to 100 mg of thiopental will permit ventilation and
counteract central nervous system stimulation, but these drugs also
depress central nervous system, respiratory and cardiac function,
add to postictal depression and may result in apnea. Intravenous barbiturates,
anticonvulsant agents, or muscle relaxants should only be administered
by those familiar with their use. Immediately after the institution
of these ventilatory measures, the adequacy of thecirculation should
be evaluated. Supportive treatment of circulatory depression may require
administration of intravenous fluids, and, when appropriate, a vasopressor
dictated by the clinical situation (such as ephedrine or epinephrine
to enhance myocardial contractile force). Hypotension
due to sympathetic relaxation may be managed by giving intravenous
fluids (such as isotonic saline or lactated Ringer's solution),
in an attempt to relieve mechanical obstruction of venous return,
or by using vasopressors (such as ephedrine which increases the force
of myocardial contractions) and, if indicated, by giving plasma expanders
or whole blood. Endotracheal intubation, employing
drugs and techniques familiar to the clinician, may be indicated after
initial administration of oxygen by mask if difficulty is encountered
in the maintenance of a patent airway, or if prolonged ventilatory
support (assisted or controlled) is indicated. Recent clinical data from patients experiencing local anesthetic-induced
convulsions demonstrated rapid development of hypoxia, hypercarbia,
and acidosis with bupivacaine within a minute of the onset of convulsions.
These observations suggest that oxygen consumption and carbon dioxide
production are greatly increased during local anesthetic convulsions
and emphasize the importance of immediate and effective ventilation
with oxygen which may avoid cardiac arrest. If not treated immediately, convulsions with simultaneous hypoxia,
hypercarbia, and acidosis plus myocardial depression from the direct
effects of the local anesthetic may result in cardiac arrhythmias,
bradycardia, asystole, ventricular fibrillation, or cardiac arrest.
Respiratory abnormalities, including apnea, may occur. Underventilation
or apnea due to a high or total spinal may produce these same signs
and also lead to cardiac arrest if ventilatory support is not instituted.
If cardiac arrest should occur, standard cardiopulmonary resuscitative
measures should be instituted and maintained for a prolonged period
if necessary. Recovery has been reported after prolonged resuscitative
efforts. 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 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. The mean seizure dosage of bupivacaine in rhesus monkeys
was found to be 4.4 mg/kg with mean arterial plasma concentration
of 4.5 mcg/mL. The intravenous and subcutaneous LDin
mice is 6 mg/kg to 8 mg/kg and 38 mg/kg to 54 mg/kg respectively.
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Bupivacaine Hydrochloride
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Marcaine Spinal (Injection, Solution)
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Reactions to bupivacaine are characteristic of those
associated with other amide-type local anesthetics. The most commonly encountered acute adverse experiences which
demand immediate countermeasures following the administration of spinal
anesthesia are hypotension due to loss of sympathetic tone and respiratory
paralysis or underventilation due to cephalad extension of the motor
level of anesthesia. These may lead to cardiac arrest if untreated.
In addition, dose-related convulsions and cardiovascular collapse
may result from diminished tolerance, rapid absorption from the injection
site, or from unintentional intravascular injection of a local anesthetic
solution. Factors influencing plasma protein binding, such as acidosis,
systemic diseases which alter protein production, or competition of
other drugs for protein binding sites, may diminish individual tolerance. Respiratory System: Respiratory paralysis or underventilation may be noted as a result
of upward extension of the level of spinal anesthesia and may lead
to secondary hypoxic cardiac arrest if untreated. Preanesthetic medication,
intraoperative analgesics and sedatives, as well as surgical manipulation,
may contribute to underventilation. This will usually be noted within
minutes of the injection of spinal anesthetic solution, but because
of differing maximal onset times, differing intercurrent drug usage
and differing surgical manipulation, it may occur at any time during
surgery or the immediate recovery period. Cardiovascular System: Hypotension due
to loss of sympathetic tone is a commonly encountered extension of
the clinical pharmacology of spinal anesthesia. This is more commonly
observed in elderly patients, particularly those with hypertension,
and patients with shrunken blood volume, shrunken interstitial fluid
volume, cephalad spread of the local anesthetic, and/or mechanical
obstruction of venous return. Nausea and vomiting are frequently associated
with hypotensive episodes following the administration of spinal anesthesia.
High doses, or inadvertent intravascular injection, may lead to high
plasma levels and related depression of the myocardium, decreased
cardiac output, bradycardia, heart block, ventricular arrhythmias,
and, possibly, cardiac arrest. (See WARNINGS, PRECAUTIONS, and OVERDOSAGE sections.) Central Nervous System: Respiratory
paralysis or underventilation secondary to cephalad spread of the
level of spinal anesthesia (see Respiratory
System) and hypotension for the same reason (see Cardiovascular System) are the two most
commonly encountered central nervous system-related adverse observations
which demand immediate countermeasures. High
doses or inadvertent intravascular injection may lead to high plasma
levels and related central nervous system toxicity characterized by
excitement and/or depression. Restlessness, anxiety, dizziness, tinnitus,
blurred vision, or tremors may occur, possibly proceeding to convulsions.
However, excitement may be transient or absent, with depression being
the first manifestation of an adverse reaction. This may quickly be
followed bydrowsiness merging into unconsciousness and respiratory
arrest. Neurologic: The incidences of adverse neurologic reactions associated with the
use of local anesthetics may be related to the total dose of local
anesthetic administered and are also dependent upon the particular
drug used, the route of administration, and the physical status of
the patient. Many of these effects may be related to local anesthetic
techniques, with or without a contribution from the drug. Neurologic effects following spinal anesthesia may
include loss of perineal sensation and sexual function; persistent
anesthesia, paresthesia, weakness and paralysis of the lower extremities,
and loss of sphincter control all of which may have slow, incomplete,
or no recovery; hypotension, high or total spinal block; urinary retention;
headache; backache; septic meningitis, meningismus; arachnoiditis;
slowing of labor; increased incidence of forceps delivery; shivering;
cranial nerve palsies due to traction on nerves from loss of cerebrospinal
fluid; and fecal and urinary incontinence. Allergic: Allergic-type reactions are
rare and may occur as a result of sensitivity to the local anesthetic.
These reactions are characterized by signs such as urticaria, pruritus,
erythema, angioneurotic edema (including laryngeal edema), tachycardia,
sneezing, nausea, vomiting, dizziness, syncope, excessive sweating,
elevated temperature, and, possibly, anaphylactoid-like symptomatology
(including severe hypotension). Cross sensitivity among members of
the amide-type local anesthetic group has been reported. The usefulness
of screening for sensitivity has not been definitely established. Other: Nausea
and vomiting may occur during spinal anesthesia.
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LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS
WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY
AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE
EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS,
CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES
NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES.
(See also ADVERSE REACTIONS and PRECAUTIONS.) DELAY IN PROPER MANAGEMENT
OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED
SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST,
AND, POSSIBLY, DEATH. Spinal anesthetics should
not be injected during uterine contractions, because spinal fluid
current may carry the drug further cephalad than desired. A free flow of cerebrospinal fluid during the performance
of spinal anesthesia is indicative of entry into the subarachnoid
space. However, aspiration should be performed before the anesthetic
solution is injected to confirm entry into the subarachnoid space
and to avoid intravascular injection. MARCAINE
solutions containing epinephrine or other vasopressors should not
be used con-comitantly with ergot-type oxytocic drugs, because a severe
persistent hypertension may occur. Likewise, solutions of MARCAINE
containing a vasoconstrictor, such as epinephrine, should be used
with extreme caution in patients receiving monoamine oxidase inhibitors
(MAOI) or antidepressants of the triptyline or imipramine types, because
severe prolonged hypertension may result. Until
further experience is gained in patients younger than 18 years, administration
of MARCAINE in this age group is not recommended. Mixing or the prior or intercurrent use of any other local anesthetic
with MARCAINE cannot be recommended because of insufficient data on
the clinical use of such mixtures.
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MARCAINE Spinal is indicated for the production
of subarachnoid block (spinal anesthesia). Standard
textbooks should be consulted to determine the accepted procedures
and techniques for the administration of spinal anesthesia.
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Marcaine Spinal
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