Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/19
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Penicillin G Procaine (Injection)
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Do not inject into or near an artery
or nerve. Injection into or near a nerve may result in permanent neurologic
damage . Penicillin G procaine (aqueous)
is for intramuscular injection only. Administer by
DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock.
In neonates, infants and small children, the midlateral aspect of the thigh
may be preferable. When doses are repeated, vary the injection site. The TUBEX cartridge for this product
incorporates several features that are designed to facilitate the visualization
of blood on aspiration if a blood vessel is inadvertently entered. The
design of this cartridge is such that blood which enters its needle will be
quickly visualized as a red or dark-colored���spot.���This���spot���will appear on the barrel of the glass cartridge immediately proximal to the
blue hub. The TUBEX is designed with two
orientation marks, in order to determine where this���spot���can
be seen. First insert and secure the cartridge in the TUBEX injector in the usual fashion. Locate the yellow rectangle at the
base of the blue hub. This yellow rectangle is aligned with the blood visualization���spot.���An imaginary straight line, drawn from this yellow rectangle
to the shoulder of the glass cartridge, will point to the area on the cartridge
where the���spot���can be visualized. When the needle cover is
removed, a second yellow rectangle will be visible. The second yellow rectangle
is also aligned with the blood visualization���spot���to assist
the operator in locating this���spot.���If the 2 mL metal or plastic
syringe is used, the glass cartridge should be rotated by turning the plunger
of the syringe clockwise until the yellow rectangle is visualized. If the
1 mL metal syringe is used, it will not be possible to continue to rotate
the glass cartridge clockwise once it is properly engaged and fully threaded;
itcan, however, then be rotated counterclockwise as far as necessary to properly
orient the yellow rectangles and locate the observation area. (In this same
area in some cartridges, a dark spot may sometimes be visualized prior to
injection. This is the proximal end of the needle and does not represent a
foreign body in, or other abnormality of, the suspension.) Thus,
before the needle is inserted into the selected muscle, it is important for
the operator to orient the yellow rectangles so that any blood which may enter
after needle insertion and during aspiration can be visualized in the area
on the cartridge where it will appear and not be obscured by any obstructions. After
selection of the proper site and insertion of the needle into the selected
muscle, aspirate by pulling back on the plunger. While maintaining negative
pressure for 2 to 3 seconds, carefully observe the barrel of the cartridge
in the area previously identified (see above) for the appearance of a red
or dark-colored���spot.��� Blood or���typical
blood color���may not be seen if a blood vessel has been entered-only
a mixture of blood and Penicillin G Procaine Injectable Suspension. The appearance
of any discoloration is reason to withdraw the needle and discard the glass TUBEX cartridge. If it is elected to inject at
another site, a new cartridge should be used. If no blood or discoloration
appears, inject the contents of the cartridge slowly. Discontinue delivery
of the dose if the subject complains of severe immediate pain at the injection
site or if, especially in neonates, infants and young children, symptoms or
signs occur suggesting onset of severe pain. Some TUBEX cartridges may contain a small air bubble
which should be disregarded, since it does not affect administration of the
product. DO NOT clear any air bubbles from the cartridge or needle as this
may interfere with the visualization of any blood or discoloration during
aspiration. Because of the high concentration of suspended
material in this product, the needle may be blocked if the injection is not
made at a slow, steady rate. Pneumonia (pneumococcal),
moderately severe (uncomplicated): 600,000 to 1,000,000 units daily. Streptococcal
infections (Group A), moderately severe to severe tonsillitis, erysipelas,
scarlet fever, upper respiratory tract, skin and soft tissue: 600,000 to 1,000,000
units daily for 10-day minimum. Staphylococcal infections,
moderately severe to severe: 600,000 to 1,000,000 units daily. In
pneumonia, streptococcal (Group A) and staphylococcal infections in pediatric
patients under 60 pounds: 300,000 units daily. Bacterial
endocarditis (Group A streptococci) only in extremely sensitive infections:
600,000 to 1,000,000 units daily. Penicillin G procaine
is not recommended for prophylaxis against bacterial endocarditis. For prophylaxis
against bacterial endocarditis in patients with congenital heart disease or
rheumatic or other acquired valvular heart disease when undergoing dental
procedures or surgical procedures of the upper respiratory tract, use penicillin
V. For patients unable to take oral medications, aqueous penicillin G is recommended.<br/>Syphilis: Primary, secondary, and latent with a negative spinal fluid
in adults and pediatric patients over 12 years of age: 600,000 units daily
for 8 days-total 4,800,000 units. Late (tertiary, neurosyphilis,
and latent syphilis with positive spinal-fluid examination or no spinal-fluid
examination): 600,000 units daily for 10 to 15 days-total 6 to 9 million units. Congenital
syphilis under 70-lb. body weight: 50,000 units/kg/day for 10 days. Yaws,
Bejel, and Pinta: Treatment as for syphilis in corresponding stage of disease. Diphtheria-adjunctive
therapy with antitoxin: 300,000 to 600,000 units daily. Diphtheria
carrier state: 300,000 units daily for 10 days. Anthrax-cutaneous:
600,000 to 1,000,000 units/day. Anthrax-inhalational
(post-exposure): 1,200,000 units every 12 hours in adults, 25,000 units per
kilogram of body weight (maximum 1,200,000 unit) every 12 hours in children.
The available safety data for penicillin G procaine at this dose would best
support a duration of therapy of 2 weeks or less. Treatment for inhalational
anthrax (post-exposure) must be continued for a total of 60 days. Physicians
must consider the risks and benefits of continuing administration of penicillin
G procaine for more than 2 weeks or switching to an effective alternative
treatment. Vincent's infection (fusospirochetosis):
600,000 to 1,000,000 units/day. Erysipeloid: 600,000
to 1,000,000 units/day. Streptobacillus
moniliformis and Spirillum minus (rat-bite
fever): 600,000 to 1,000,000 units/day. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
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This product is designed to provide a stable aqueous suspension
of penicillin G procaine, ready for immediate use. This eliminates the necessity
for addition of any diluent, required for the usual dry formulation of injectable
penicillin. Penicillin G procaine is chemically designated
as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid compound with 2-(diethylamino)ethyl p-aminobenzoate
(1:1) monohydrate. Its molecular formula is CHNOS���CHNO���HO with a molecular
weight of 588.72. Its structural formula is as follows: Each TUBEX; Sterile Cartridge-Needle
Unit, 1,200,000 units (2 mL size) or 600,000 units (1 mL size), contains penicillin
G procaine in a stabilized aqueous suspension with sodium citrate buffer;
and as w/v, approximately 0.5% lecithin, 0.5% carboxymethylcellulose, 0.5%
povidone, 0.1% methylparaben, and 0.01% propylparaben. Penicillin
G Procaine Injectable Suspension in the TUBEX formulation
is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND
ADMINISTRATION sections prior to use.
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Penicillin G procaine is an equimolecular compound of procaine
and penicillin G, administered intramuscularly as a suspension. It dissolves
slowly at the site of injection, giving a plateau type of blood level at about
4 hours which falls slowly over a period of the next 15 to 20 hours. Approximately
60% of penicillin G is bound to serum protein. The drug is distributed throughout
the body tissues in widely varying amounts. Highest levels are found in the
kidneys with lesser amounts in the liver, skin, and intestines. Penicillin
G penetrates into all other tissues to a lesser degree with a very small level
found in the cerebrospinal fluid. With normal kidney function, the drug is
excreted rapidly by tubular excretion. In neonates and young infants and in
individuals with impaired kidney functions, excretion is considerably delayed.
Approximately 60 to 90 percent of a dose of parenteral penicillin G is excreted
in the urine within 24 to 36 hours. Microbiology: Penicillin
G exerts a bactericidal action against penicillin-susceptible microorganisms
during the stage of active multiplication. It acts through the inhibition
of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing
bacteria, which include many strains of staphylococci. Whilein
vitro studies have demonstrated the susceptibility of most strains
of the following organisms, clinical efficacy for infections other than those
included in the INDICATIONS
AND USAGE section has not been documented. Penicillin
G exerts highin vitro activity against
staphylococci (except penicillinase-producing strains), streptococci (Groups
A, C, G, H, L, and M), and pneumococci. Other organisms susceptible to penicillin
G are Corynebacterium diphtheriae, Bacillus anthracis, Clostridium species, Actinomyces bovis, Streptobacillus
moniliformis, Listeria monocytogenes, and Leptospira species. Treponemapallidum is extremely susceptible
to the bactericidal action of penicillin G.<br/>Susceptibility Testing: Ten unit Penicillin G Susceptibility Discs may be used to
determine microbial susceptibility to penicillin G using one of the followingstandard methods recommended by the National Committee for Laboratory Standards: M2-T4,���Performance Standards for Antimicrobial Disc Susceptibility Tests��� M7-T2,���Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria
that Grow Aerobically��� Tests should be interpreted
by the following criteria: Interpretations of susceptible, intermediate, and resistant
correlate zone size diameters with MIC values. A laboratory report of���susceptible���indicates that the suspected causative microorganism most likely will respond
to therapy with penicillin G. A laboratory report of���resistant���indicates that the infecting microorganism most likely will not respond to
therapy. A laboratory report of���moderately susceptible���indicates
that the microorganism is most likely susceptible if a high dosage of penicillin
G is used, or if the infection is such that high levels of penicillin G may
be attained as in urine. A report of���intermediate���using the
disc diffusion method may be considered an equivocal result, and dilution
tests may be indicated. Control organisms are recommended
for susceptibility testing. Each time the test is performed the following
organism should be included. The range for zones of inhibition is shown below:
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A previous hypersensitivity reaction to any penicillin is
a contraindication.
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Penicillin G Procaine Injectable Suspension is supplied in
packages of 10 TUBEX Sterile
Cartridge-Needle Units as follows: 1 mL size, containing
600,000 units per TUBEX (21
gauge, thin-wall 1-1/4 inch needle), NDC 61570-085-10. 2
mL size, containing 1,200,000 units per TUBEX (21 gauge, thin-wall 1-1/4 inch needle), NDC 61570-086-10. Store in a refrigerator, 2��to 8��C (36��to
46��F). Keep
from freezing.
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Prior to administration of the drug, carefully read the WARNINGS, ADVERSE
REACTIONS, and DOSAGE and ADMINISTRATION sections
of the labeling.
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General: Penicillin should be used with caution in individuals with
histories of significant allergies and/or asthma. Care
should be taken to avoid intravenous or intra-arterial administration, or
injection into or near major peripheral nerves or blood vessels, since such
injections may produce neurovascular damage. A
small percentage of patients are sensitive to procaine. If there is a history
of sensitivity, make the usual test: Inject intradermally 0.1 mL of a 1 to
2 percent procaine solution. Development of an erythema, wheal, flare, or
eruption indicates procaine sensitivity. Sensitivity should be treated by
the usual methods, including barbiturates, and procaine penicillin preparations
should not be used. Antihistaminics appear beneficial in treatment of procaine
reactions. The use of antibiotics may result in overgrowth
of nonsusceptible organisms. Constant observation of the patient is essential.
If new infections due to bacteria or fungi appear during therapy, the drug
should be discontinued and appropriate measures taken. Whenever
allergic reactions occur, penicillin should be withdrawn unless, in the opinion
of the physician, the condition being treated is life-threatening and amenable
only to penicillin therapy.<br/>Laboratory Tests: In suspected staphylococcal infections, proper laboratory
studies, including susceptibility tests, should be performed. In
prolonged therapy with penicillin, and particularly with high-dosage schedules,
periodic evaluation of the renal and hematopoietic systems is recommended.
In such situations, use of penicillin for more than 2 weeks may be associated
with an increased risk of neutropenia and an increased incidence of serum
sickness-like reactions. When treating gonococcal infections
in which primary or secondary syphilis may be suspected, proper diagnostic
procedures, including dark-field examinations, should be done. In all cases
in which concomitant syphilis is suspected, monthly serological tests should
be made for at least four months.<br/>Drug Interactions: Tetracycline, a bacteriostatic antibiotic, may antagonize
the bactericidal effect of penicillin and concurrent use of these drugs should
be avoided. Concurrent administration of penicillin
and probenecid increases and prolongs serum penicillin levels by decreasing
the apparent volume of distribution and slowing the rate of excretion by competitively
inhibiting renal tubular secretion of penicillin.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been conducted with these
drugs.<br/>Pregnancy: Teratogenic effects���Pregnancy
Category B: Reproduction studies performed in the mouse, rat, and
rabbit have revealed no evidence of impaired fertility or harm to the fetus
due to penicillin G. Human experience with the penicillins during pregnancy
has not shown any positive evidence of adverse effects on the fetus. There
are, however, no adequate and well-controlled studies in pregnant women showing
conclusively that harmful effects of these drugs on the fetus can be excluded.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.<br/>Nursing Mothers: Penicillins are excreted in human milk. Caution should be
exercised when penicillins are administered to a nursing woman.<br/>Pediatric Use: Because of incompletely developed renal function in newborns,
penicillin elimination may be delayed. Guidelines for administration of this
drug to pediatric patients are presented in DOSAGE AND ADMINISTRATION.
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Penicillin G and procaine
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Penicillin G Procaine (Injection)
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Allergic Reactions: Penicillin is a substance of low toxicity but does possess
a significant index of sensitization. The following hypersensitivity reactions
associated with use of penicillin have been reported: Skin rashes, ranging
from maculopapular eruptions to exfoliative dermatitis; urticaria; serum-sicknesslike
reactions, including chills, fever, edema, arthralgia, and prostration. Severe
and often fatal anaphylaxis has been reported . As with other treatments
for syphilis, the Jarisch-Herxheimer reaction has been reported. Procaine
toxicity manifestations and hypersensitivity reactions have been reported
.<br/>Gastrointestinal: Pseudomembranous colitis has been reported with the use of
penicillin G. Onset of pseudomembranous colitis symptoms may occur during
or after antibiotic treatment .
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Penicillin G procaine should only be prescribed for the indications
listed in this insert. NOTE: This drug is no longer
indicated in the treatment of gonorrhea.<br/>Anaphylaxis: SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC)
REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS
ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY
AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS
OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED
SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY
WITH ANY PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS.IF AN ALLERGIC
REACTION OCCURS, THE DRUG SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY
TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT,
INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.<br/>Pseudomembranous Colitis: Pseudomembranous colitis has been
reported with nearly all antibacterial agents, including penicillin G, and
may range in severity from mild to life-threatening. Therefore, it is important
to consider this diagnosis in patients who present with diarrhea subsequent
to the administration of antibacterial agents. Treatment
with antibacterial agents alters the normal flora of the colon and may permit
overgrowth of clostridium. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of���antibiotic-associated colitis.��� After
the diagnosis of pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis usually
respond to drug discontinuation alone. In moderate to severe cases, consideration
should be given to management of fluids and electrolytes, protein supplementation
and treatment with an antibacterial drug clinically effective against C. difficile colitis.<br/>Procaine Reactions: Immediate toxic reactions to procaine
may occur in some individuals, particularly when a large single dose is administered
(4.8 million units). These reactions may be manifested by mental disturbances,
including anxiety, confusion, agitation, depression, weakness, seizures, hallucinations,
combativeness, and expressed���fear of impending death.���The
reactions noted in carefully controlled studies occurred in approximately
one in 500 patients who received large doses of penicillin G procaine. Reactions
are transient, lasting from 15 to 30 minutes.<br/>Method of Administration: Do not inject into or near an artery
or nerve. Injection
into or near a nerve may result in permanent neurological damage. Inadvertent
intravascular administration, including inadvertent direct intra-arterial
injection or injection immediately adjacent to arteries, of Penicillin G Procaine
Injectable Suspension and other penicillin preparations has resulted in severe
neurovascular damage, including transverse myelitis with permanent paralysis,
gangrene requiring amputation of digits and more proximal portions of extremities,
and necrosis and sloughing at and surrounding the injection site. Such severe
effects have been reported following injections into the buttock, thigh, and
deltoid areas. Other serious complications of suspected intravascular administration
which have been reported include immediate pallor, mottling, or cyanosis of
the extremity, both distal and proximal to the injection site, followed by
bleb formation; severe edema requiring anterior and/or posterior compartment
fasciotomy in the lower extremity. The above-described severe effects and
complications have most often occurred in infants and small children. Prompt
consultation with an appropriate specialist is indicated if any evidence of
compromise of the blood supply occurs at, proximal to, or distal to the site
of injection.(See PRECAUTIONS, and DOSAGE AND
ADMINISTRATION.) Quadriceps femoris
fibrosis and atrophy have been reported following repeated intramuscular injections
of penicillin preparations into the anterolateral thigh.
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Penicillin G procaine is indicated in the treatment of moderately
severe infections in both adults and pediatric patients due to penicillin-G-susceptible
microorganisms that are susceptible to the low and persistent serum levels
common to this particular dosage form in the indications listed below. Therapy
should be guided by bacteriological studies (including susceptibility tests)
and by clinical response. NOTE: When high, sustained
serum levels are required, aqueous penicillin G, either IM or IV, should be
used. The following infections will usually respond
to adequate dosages of intramuscular penicillin G procaine: Moderately severe
to severe infections of the upper respiratory tract, skin and soft-tissue
infections, scarlet fever, and erysipelas due to susceptible streptococci
(Group A-without bacteremia). NOTE: Streptococci
in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups,
including Group D (enterococcus), are resistant. Aqueous penicillin is recommended
for streptococcal infections with bacteremia. Moderately
severe infections of the respiratory tract due to susceptible pneumococci. NOTE: Severe pneumonia, empyema, bacteremia,
pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology
are better treated with aqueous penicillin G during the acute stage. Moderately
severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible). NOTE:
Reports indicate an increasing number of strains of staphylococci resistant
to penicillin G, emphasizing the need for culture and sensitivity studies
in treating suspected staphylococcal infections. Indicated surgical procedures
should be performed. Fusospirochetosis (Vincent's
gingivitis and pharyngitis). Moderately severe infections of the oropharynx
due to susceptible fusiform bacilli and spirochetes. NOTE:
Necessary dental care should be accomplished in infections involving the gum
tissue. Syphilis (all stages) due to susceptible Treponema pallidum. NOTE:
This drug should not be used in the treatment of beta-lactamase producing
organisms which include most strains of Neisseria
gonorrhea. Yaws, Bejel, Pinta due to susceptible
organisms. Penicillin G procaine is an adjunct to antitoxin
for prevention of the carrier stage of diphtheria due to susceptible C. diphtheriae. Anthrax
due to Bacillus anthracis, including
inhalational anthrax (post-exposure): to reduce the incidence or progression
of the disease following exposure to aerosolized Bacillus
anthracis. Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum
minus organisms. Erysipeloid due to susceptible Erysipelothrix rhusiopathiae. Subacute
bacterial endocarditis, only in extremely sensitive infections, due to susceptible
Group A streptococci.
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Penicillin G Procaine
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