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Novocain
Overview
What is Novocain?
Procaine hydrochloride is benzoic acid, 4-amino-, 2-(diethylamino)
ethyl ester, monohydrochloride, the ester of diethylaminoethanol and
para-aminobenzoic acid, with the following structural formula:
It is a white crystalline,
odorless powder that is freely soluble in water, but less soluble
in alcohol and has a molecular weight of 272.78.
The solutions are made isotonic with sodium chloride
and the pH is adjusted between 3 and 5.5 with sodium hydroxide
and/or hydrochloric acid.
Procaine hydrochloride
is related chemically and pharmacologically to the ester-type local
anesthetics. It contains an ester linkage between the aromatic nucleus
and the amino group.
NOVOCAIN is available as
sterile solutions in concentrations of 1% and 2% for injection via
local infiltration and peripheral nerve block.
What does Novocain look like?
What are the available doses of Novocain?
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What should I talk to my health care provider before I take Novocain?
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How should I use Novocain?
NOVOCAIN is indicated for the production of local
or regional analgesia and anesthesia by local infiltration and peripheral
nerve block techniques.
The routes of administration
and concentrations are: for local infiltration use 0.25% to 0.5% (via
dilution) and for peripheral nerve blocks use 0.5% (via dilution),
1%, and 2%. (See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the
accepted procedures and techniques for the administration of NOVOCAIN.
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 NOVOCAIN
should be reduced for elderly and debilitated patients and patients
with cardiac and/or liver disease. The rapid injection of a large
volume of local anesthetic solution should be avoided and fractional
doses should be used when feasible.
For specific
techniques and procedures, refer to standard textbooks.
For infiltration anesthesia, 0.25% or 0.5% solution; 350
mg to 600 mg is generally considered to be a single safe total dose.
To prepare 60 mL of a 0.5% solution (5 mg/mL), dilute 30 mL of the
1% solution with 30 mL sodium chloride injection 0.9%. To prepare
60 mL of a 0.25% solution (2.5 mg/mL), dilute 15 mL of the 1% solution
with 45 mL sodium chloride injection 0.9%. An anesthetic solution
of 0.5 mL to 1 mL of epinephrine 1:1,000 per 100 mL may be added for
vasoconstrictive effect (1:200,000 to 1:100,000). (See WARNINGS and
PRECAUTIONS.)
For peripheral nerve block, 0.5%
solution (up to 200 mL), 1% solution (up to 100 mL), or 2% solution
(up to 50 mL). The use of the 2% solution should usually be limited
to cases requiring a small volume of anesthetic solution (10 mL to
25 mL). An anesthetic solution of 0.5 mL to 1 mL of epinephrine 1:1,000
per 100 mL may be added for vasoconstrictive effect (1:200,000 to
1:100,000). (See WARNINGS and PRECAUTIONS.)
THE USUAL TOTAL DOSE DURING ONE TREATMENT
SHOULD NOT EXCEED 1,000 MG.
This product
should be inspected visually for particulate matter and discoloration
prior to administration whenever solution and container permit. Do
not use solutions if crystals, cloudiness, or discoloration is observed.
Examine solution carefully before use. Reautoclaving increases likelihood
of crystal formation. Solutions which are discolored or which contain
particulate matter should not be administered.
Unused portions of solutions not containing preservatives should
be discarded.
Pediatric
Use:
In pediatric patients 15 mg/kg
of a 0.5% solution for local infiltration is the maximum recommended
dose.
What interacts with Novocain?
NOVOCAIN is contraindicated in patients with a known hypersensitivity to procaine, drugs of a similar chemical configuration, or para-aminobenzoic acid or its derivatives.
It is also contraindicated in patients with a known hypersensitivity to other components of solutions of NOVOCAIN.
What are the warnings of Novocain?
As the rate of theophylline clearance may be dose-dependent (i.e., steady-state serum concentrations may increase disproportionately to the increase in dose), an increase in dose based upon a sub-therapeutic serum concentration measurement should be conservative. In general, limiting dose increases to about 25% of the previous total daily dose will reduce the risk of unintended excessive increases in serum theophylline concentration (see ).
Contains acetone sodium bisulfite, a sulfite that
may cause allergic-type reactions including anaphylactic symptoms
and life-threatening or less severe asthmatic episodes in certain
susceptible people. The overall prevalence of sulfite sensitivity
in the general population is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people.
It is
essential that aspiration for blood or cerebrospinal fluid, where
applicable, be done prior to injecting any local anesthetic, both
the original dose and all subsequent doses, to avoid intravascular
or subarachnoid injection. However, a negative aspiration does not
ensure against an intravascular or subarachnoid injection.
Reactions resulting in fatality have occurred on rare
occasions with the use of local anesthetics, even in the absence of
a history of hypersensitivity. Large doses of local anesthetics should
not be used in patients with heartblock.
NOVOCAIN
with epinephrine or other vasopressors should not be used concomitantly
with ergot-type oxytocic drugs, because a severe persistent hypertension
may occur. Likewise, solutions of NOVOCAIN 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
or disturbances of cardiac rhythm may occur.
Local anesthetic procedures should be used with caution when there
is inflammation and/or sepsis in the region of the proposed injection.
Mixing or the prior or intercurrent use of any local anesthetic
with NOVOCAIN cannot be recommended because of insufficient data on
the clinical use of such mixtures.
What are the precautions of Novocain?
General:
The safety and effectiveness of local 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.) During major regional nerve blocks,
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
to avoid high plasma levels and serious adverse effects. Injections
should be made slowly, with frequent aspirations before and during
the injection to avoid intravascular injection. Current opinion favors
fractional administration with constant attention to the patient,
rather than rapid bolus injection. Syringe aspirations should also
be performed before and during each supplemental injection in continuous
(intermittent) catheter techniques. An intravascular injection is
still possible even if aspirations for blood are negative.
Injection of repeated doses of local anesthetics may cause
significant increases in plasma levels with each repeated dose due
to slow accumulation of the drug or its metabolites or to slow metabolic
degradation. Tolerance to elevated blood levels varies with the status
of the patient. Debilitated, elderly patients and acutely ill patients
should be given reduced doses commensurate with their age and physical
status. Local anesthetics should also be used with caution in patients
with severe disturbances of cardiac rhythm, shock, heartblock, or
hypotension.
Careful and constant monitoring
of cardiovascular and respiratory (adequacy of ventilation) vital
signs and the patient’s state of consciousness should be performed
after each local anesthetic injection. It should be kept in mind at
such times that restlessness, anxiety, incoherent speech, light-headedness,
numbness, and tingling of the mouth and lips, metallic taste, tinnitus,
dizziness, blurred vision, tremors, twitching, depression, or drowsiness
may be early warning signs of central nervous system toxicity.
Local anesthetic solutions containing a vasoconstrictor
should be used cautiously and in carefully circumscribed quantities
in areas of the body supplied by end arteries, or those areas having
otherwise compromised blood supply such as digits, nose, external
ear, penis. Patients with peripheral vascular disease and hypertensive
vascular disease may exhibit an exaggerated vasoconstrictor response.
Ischemic injury or necrosis may result.
NOVOCAIN
should be used with caution in patients with known allergies and sensitivities.
A thorough history of the patient’s prior experience with NOVOCAIN
or other local anesthetics as well as concomitant or recent drug use
should be taken. (See CONTRAINDICATIONS and WARNINGS.)
Because ester-type local anesthetics such as NOVOCAIN
are hydrolyzed by plasma cholinesterase produced by the liver and
excreted by the kidneys, these drugs, especially repeat doses, should
be used cautiously in patients with hepatic disease. Because of their
inability to metabolize local anesthetics normally, patients with
severe hepatic disease are at a greater risk of 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.
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 anesthetics. 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 conduction
of anesthesia are considered potential triggering agents for familial
malignant hyperthermia. Because it is not known whether ester-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 may precede 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.)
Use in Head and Neck
Area:
Small doses of local anesthetics
injected into the head and neck area may produce adverse reactions
similar to systemic toxicity seen with unintentional intravascular
injections of larger doses. Confusion, convulsions, respiratory depression
and/or respiratory arrest, and cardiovascular stimulation or depression
have been reported.
These reactions may be due
to intra-arterial injection of the local anesthetic with retrograde
flow to the cerebral circulation. Patients receiving these blocks
should have their circulation and respiration monitored and be constantly
observed. Resuscitative equipment and personnel for treating adverse
reactions should be immediately available. Dosage recommendations
should not be exceeded.
Information for Patients:
When appropriate, patients should be informed, in
advance, that they may experience temporary loss of sensation and
motor activity following proper administration of regional anesthesia.
Also, when appropriate, the physician should discuss other information
including adverse reactions in the package insert.
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.
The clinical
observation has been made that despite adequate sulfonamide therapy,
local infections have occurred in areas infiltrated with procaine
hydrochloride prior to diagnostic punctures and drainage procedures.
Therefore, NOVOCAIN should not be used in any condition in which a
sulfonamide drug is being employed since para-aminobenzoic acid inhibits
the action of the sulfonamide.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Long-term studies in animals of most local anesthetics,
including procaine hydrochloride, 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
NOVOCAIN may be carcinogenic, or mutagenic, or that it impairs fertility.
Pregnancy Category C:
Animal reproduction studies have not been conducted
with NOVOCAIN. It is not known whether procaine can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity.
NOVOCAIN should be given to a pregnant woman only if clearly needed
and the potential benefits outweigh the risk. This does not exclude
the use of procaine hydrochloride at term for obstetrical anesthesia
or analgesia. (See .)
Labor and Delivery:
Local anesthetics rapidly cross the placenta, and
when used for paracervical or pudendal block anesthesia, can cause
varying degrees of maternal, fetal, and neonatal toxicity. (See CLINICAL
PHARMACOLOGY.) 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 central nervous system, peripheral
vascular tone, and cardiac function.
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.
Paracervical or pudendal anesthesia
may alter the forces at parturition through changes in uterine contractility
or maternal expulsive efforts. In one study, paracervical block anesthesia
was associated with a decrease in the mean duration of first stage
labor and facilitation of cervical dilation. The use of obstetrical
anesthesia may increase 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. The long-term significance
of these observations is unknown.
Fetal bradycardia
which frequently follows paracervical block may be indicative of high
fetal blood concentrations of procaine with resultant fetal acidosis.
Fetal heart rate should be monitored prior to and during paracervical
block. Added risk appears to be present in prematurity, toxemia of
pregnancy, and fetal distress. The physician should weigh the considering
paracervical block in these conditions. Careful adherence to recommended
dosage is of the utmost importance in paracervical block. Failure
to achieve adequate analgesia with these doses should arouse suspicion
of intravascular or fetal injection.
Cases compatible
with unintended fetal intracranial injection of local anesthetic solution
have been reported following intended paracervical or pudendal block
or both. Babies so affected present with unexplained neonatal depression
at birth, which correlates with high local anesthetic serum levels,
and usually manifest seizures within six hours. Prompt use of supportive
measures combined with forced urinary excretion of the local anesthetic
has been used successfully to manage this complication.
Case reports of maternal convulsions and cardiovascular
collapse following use of some local anesthetics for paracervical
block in early pregnancy (as anesthesia for elective abortion) suggest
that systemic absorption under these circumstances may be rapid. The
recommended maximum dose of the local anesthetic should not be exceeded.
Injection should be made slowly and with frequent aspiration. Allow
a five-minute interval between sides.
It is
extremely important to avoid aortocaval compression by the gravid
uterus during administration 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.
Nursing Mothers:
It is not known whether local anesthetic drugs are
excreted in human milk. Because many drugs are excreted in human milk,
caution should be exercised when local anesthetics are administered
to a nursing woman.
Pediatric Use:
(See DOSAGE AND ADMINISTRATION.)
What are the side effects of Novocain?
Reactions to procaine are characteristic of those
associated with other ester-type local anesthetics. A major cause
of adverse reactions to this group of drugs is excessive plasma levels
which may be due to overdosage, rapid absorption, inadvertent intravascular
injection, or slow metabolic degradation.
A
small number of reactions may result from hypersensitivity, idiosyncrasy,
or diminished tolerance to normal dosage.
Systemic:
The most commonly encountered acute adverse experiences which demand
immediate countermeasures are related to the central nervous system
and the cardiovascular system. These adverse experiences are generally
dose related and due to high plasma levels which may result from overdosage,
rapid absorption from the injection site, diminished tolerance, or
from unintentional intravascular injection of the local anesthetic
solution. In addition to systemic dose-related toxicity, unintentional
subarachnoid injection of drug during the intended performance of
nerve blocks near the vertebral column (especially in the head and
neck region), may result in underventilation or apnea (“Total
or High Spinal”). 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.
Plasma cholinesterase
deficiency may also account for diminished tolerance to ester-type
local anesthetics.
Central Nervous System Reactions:
These are characterized by excitation 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
by drowsiness merging into unconsciousness and respiratory arrest.
The incidence of convulsions associated with the use of
local anesthetics varies with the procedure used and the total dose
administered.
Cardiovascular Reactions:
High doses
or inadvertent intravascular injection may lead to high plasma levels
and related depression of the myocardium, decreased cardiac output,
heartblock, hypotension (or sometimes hypertension), bradycardia,
ventricular arrhythmias, and cardiac arrest. (See WARNINGS, PRECAUTIONS,
and OVERDOSAGE sections.)
Allergic:
Allergic-type reactions are rare and may occur as a result of sensitivity
to the local anesthetic or to other formulation ingredients, such
as the antimicrobial preservative chlorobutanol contained in multiple-dose
vials. 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 ester-type local anesthetic group has been reported.
The usefulness of screening for sensitivity has not been definitely
established.
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.
What should I look out for while using Novocain?
NOVOCAIN is contraindicated in patients with a known
hypersensitivity to procaine, drugs of a similar chemical configuration,
or para-aminobenzoic acid or its derivatives.
It is also contraindicated in patients with a known hypersensitivity
to other components of solutions of NOVOCAIN.
Contains acetone sodium bisulfite, a sulfite that
may cause allergic-type reactions including anaphylactic symptoms
and life-threatening or less severe asthmatic episodes in certain
susceptible people. The overall prevalence of sulfite sensitivity
in the general population is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people.
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.
It is
essential that aspiration for blood or cerebrospinal fluid, where
applicable, be done prior to injecting any local anesthetic, both
the original dose and all subsequent doses, to avoid intravascular
or subarachnoid injection. However, a negative aspiration does not
ensure against an intravascular or subarachnoid injection.
Reactions resulting in fatality have occurred on rare
occasions with the use of local anesthetics, even in the absence of
a history of hypersensitivity. Large doses of local anesthetics should
not be used in patients with heartblock.
NOVOCAIN
with epinephrine or other vasopressors should not be used concomitantly
with ergot-type oxytocic drugs, because a severe persistent hypertension
may occur. Likewise, solutions of NOVOCAIN 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
or disturbances of cardiac rhythm may occur.
Local anesthetic procedures should be used with caution when there
is inflammation and/or sepsis in the region of the proposed injection.
Mixing or the prior or intercurrent use of any local anesthetic
with NOVOCAIN cannot be recommended because of insufficient data on
the clinical use of such mixtures.
What might happen if I take too much Novocain?
Acute emergencies from local anesthetics are generally
related to high plasma levels encountered during therapeutic use of
local anesthetics or to unintended subarachnoid injection of local
anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.)
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 unintentional
subarachnoid injection of drug solution, 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.
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 the circulation should he 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).
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 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 unintentional subarachnoid injection of local anesthetic
solution 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 intravenous and subcutaneous and intraperitoneal LD of procaine hydrochloride in mice is 46 mg/kg to 80 mg/kg and 400
mg/kg and 200 mg/kg respectively.
How should I store and handle Novocain?
Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Single-dose containers and multiple-dose containers of NOVOCAIN may be sterilized by autoclaving at 15-pound pressure, 121°C (250°F) for 15 minutes. Do not use solutions if crystals, cloudiness, or discoloration is observed. Examine solution carefully before use. Reautoclaving increases likelihood of crystal formation. Do not administer solutions which are discolored or which contain particulate matter. Protect solutions from light.Unused portions of solutions not containing preservatives, i.e., those supplied in ampuls, should be discarded following initial use.November, 2004©Hospira 2004 EN-0665 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USASingle-dose containers and multiple-dose containers of NOVOCAIN may be sterilized by autoclaving at 15-pound pressure, 121°C (250°F) for 15 minutes. Do not use solutions if crystals, cloudiness, or discoloration is observed. Examine solution carefully before use. Reautoclaving increases likelihood of crystal formation. Do not administer solutions which are discolored or which contain particulate matter. Protect solutions from light.Unused portions of solutions not containing preservatives, i.e., those supplied in ampuls, should be discarded following initial use.November, 2004©Hospira 2004 EN-0665 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USASingle-dose containers and multiple-dose containers of NOVOCAIN may be sterilized by autoclaving at 15-pound pressure, 121°C (250°F) for 15 minutes. Do not use solutions if crystals, cloudiness, or discoloration is observed. Examine solution carefully before use. Reautoclaving increases likelihood of crystal formation. Do not administer solutions which are discolored or which contain particulate matter. Protect solutions from light.Unused portions of solutions not containing preservatives, i.e., those supplied in ampuls, should be discarded following initial use.November, 2004©Hospira 2004 EN-0665 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USASingle-dose containers and multiple-dose containers of NOVOCAIN may be sterilized by autoclaving at 15-pound pressure, 121°C (250°F) for 15 minutes. Do not use solutions if crystals, cloudiness, or discoloration is observed. Examine solution carefully before use. Reautoclaving increases likelihood of crystal formation. Do not administer solutions which are discolored or which contain particulate matter. Protect solutions from light.Unused portions of solutions not containing preservatives, i.e., those supplied in ampuls, should be discarded following initial use.November, 2004©Hospira 2004 EN-0665 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USASingle-dose containers and multiple-dose containers of NOVOCAIN may be sterilized by autoclaving at 15-pound pressure, 121°C (250°F) for 15 minutes. Do not use solutions if crystals, cloudiness, or discoloration is observed. Examine solution carefully before use. Reautoclaving increases likelihood of crystal formation. Do not administer solutions which are discolored or which contain particulate matter. Protect solutions from light.Unused portions of solutions not containing preservatives, i.e., those supplied in ampuls, should be discarded following initial use.November, 2004©Hospira 2004 EN-0665 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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: pain, temperature,
touch, proprioception, and skeletal muscle tone. Procaine lacks topical
anesthetic activity.
Systemic absorption of
local anesthetics produces effects on the cardiovascular and central
nervous systems. 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 and ultimately to cardiac
arrest. In addition, myocardial contractility is depressed and peripheral
vasodilation occurs, leading to decreased cardiac output and arterial
blood pressure.
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 μg/mL) usually reduces the rate
of absorption and plasma concentration of NOVOCAIN. It also will promote
local hemostasis and increase the duration of anesthesia.
Onset of anesthesia with NOVOCAIN is rapid, the time of
onset for sensory block ranging from about two to five minutes depending
upon such factors as the anesthetic technique, the type of block,
the concentration of the solution, and the individual patient. The
degree of motor blockade produced is dependent on the concentration
of the solution.
The duration of anesthesia
also varies depending upon the technique and type of block, the concentration,
and the individual. NOVOCAIN will normally provide anesthesia which
is adequate for one hour.
Local anesthetics
are bound to plasma proteins in varying degrees. Generally, the lower
the plasma concentration of drug, the higher the percentage of drug
bound to plasma.
Local anesthetics appear to
cross the placenta by passive diffusion. The rate and degree of diffusion
is governed by the degree of plasma protein binding, the degree of
ionization, and the degree at 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. 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 fetalblood 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.
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 plasma half-life
of NOVOCAIN in adults is 40 ± 9 seconds and in neonates 84 ±
30 seconds.
NOVOCAIN is readily absorbed following
parenteral administration and is rapidly hydrolyzed by plasma cholinesterase
to para-aminobenzoic acid and diethylaminoethanol.
The para-aminobenzoic acid metabolite inhibits the action of the
sulfonamides. (See PRECAUTIONS.)
For NOVOCAIN,
approximately 90% of the para-aminobenzoic acid metabolite and its
conjugates and 33% of the diethylaminoethanol metabolite are recovered
in the urine, while less than 2% of the administered dose is recovered
unchanged in the urine.
Non-Clinical Toxicology
NOVOCAIN is contraindicated in patients with a known hypersensitivity to procaine, drugs of a similar chemical configuration, or para-aminobenzoic acid or its derivatives.It is also contraindicated in patients with a known hypersensitivity to other components of solutions of NOVOCAIN.
Contains acetone sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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.
It is essential that aspiration for blood or cerebrospinal fluid, where applicable, be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection.
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity. Large doses of local anesthetics should not be used in patients with heartblock.
NOVOCAIN with epinephrine or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of NOVOCAIN 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 or disturbances of cardiac rhythm may occur.
Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.
Mixing or the prior or intercurrent use of any local anesthetic with NOVOCAIN cannot be recommended because of insufficient data on the clinical use of such mixtures.
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.
The clinical observation has been made that despite adequate sulfonamide therapy, local infections have occurred in areas infiltrated with procaine hydrochloride prior to diagnostic punctures and drainage procedures. Therefore, NOVOCAIN should not be used in any condition in which a sulfonamide drug is being employed since para-aminobenzoic acid inhibits the action of the sulfonamide.
The safety and effectiveness of local 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.) During major regional nerve blocks, 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 to avoid high plasma levels and serious adverse effects. Injections should be made slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Current opinion favors fractional administration with constant attention to the patient, rather than rapid bolus injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative.
Injection of repeated doses of local anesthetics may cause significant increases in plasma levels with each repeated dose due to slow accumulation of the drug or its metabolites or to slow metabolic degradation. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical status. Local anesthetics should also be used with caution in patients with severe disturbances of cardiac rhythm, shock, heartblock, or hypotension.
Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness, and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity.
Local anesthetic solutions containing a vasoconstrictor should be used cautiously and in carefully circumscribed quantities in areas of the body supplied by end arteries, or those areas having otherwise compromised blood supply such as digits, nose, external ear, penis. Patients with peripheral vascular disease and hypertensive vascular disease may exhibit an exaggerated vasoconstrictor response. Ischemic injury or necrosis may result.
NOVOCAIN should be used with caution in patients with known allergies and sensitivities. A thorough history of the patient’s prior experience with NOVOCAIN or other local anesthetics as well as concomitant or recent drug use should be taken. (See CONTRAINDICATIONS and WARNINGS.)
Because ester-type local anesthetics such as NOVOCAIN are hydrolyzed by plasma cholinesterase produced by the liver and excreted by the kidneys, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Because of their inability to metabolize local anesthetics normally, patients with severe hepatic disease are at a greater risk of 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.
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 anesthetics. 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 conduction of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Because it is not known whether ester-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 may precede 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.)
Use in Head and Neck Area:
Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression and/or respiratory arrest, and cardiovascular stimulation or depression have been reported.
These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded.
Reactions to procaine are characteristic of those associated with other ester-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels which may be due to overdosage, rapid absorption, inadvertent intravascular injection, or slow metabolic degradation.
A small number of reactions may result from hypersensitivity, idiosyncrasy, or diminished tolerance to normal dosage.
Systemic:
The most commonly encountered acute adverse experiences which demand immediate countermeasures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and due to high plasma levels which may result from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of nerve blocks near the vertebral column (especially in the head and neck region), may result in underventilation or apnea (“Total or High Spinal”). 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.
Plasma cholinesterase deficiency may also account for diminished tolerance to ester-type local anesthetics.
Central Nervous System Reactions:
These are characterized by excitation 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 by drowsiness merging into unconsciousness and respiratory arrest.
The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered.
Cardiovascular Reactions:
High doses or inadvertent intravascular injection may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, heartblock, hypotension (or sometimes hypertension), bradycardia, ventricular arrhythmias, and cardiac arrest. (See WARNINGS, PRECAUTIONS, and OVERDOSAGE sections.)
Allergic:
Allergic-type reactions are rare and may occur as a result of sensitivity to the local anesthetic or to other formulation ingredients, such as the antimicrobial preservative chlorobutanol contained in multiple-dose vials. 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 ester-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitely established.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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