Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/15
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Bicillin L-A (Injection, Suspension)
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| dailymed-instance:dosage |
Streptococcal (Group A)
Upper Respiratory Infections (for example, pharyngitis) Adults���a single injection of 1,200,000 units; older
pediatric patients���a single injection of 900,000 units; infants
and pediatric patients under 60 lbs.���300,000 to 600,000 units. Syphilis Primary, secondary, and latent���2,400,000 units
(1 dose). Late (tertiary and neurosyphilis)���2,400,000 units
at 7-day intervals for three doses. Congenital���under
2 years of age: 50,000 units/kg/body weight; ages 2 to 12 years: adjust
dosage based on adult dosage schedule. Yaws, Bejel, and Pinta���1,200,000
units (1 injection). Prophylaxis���for rheumatic fever and glomerulonephritis. Following an acute attack, penicillin G benzathine (parenteral)
may be given in doses of 1,200,000 units once a month or 600,000 units
every 2 weeks.
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| dailymed-instance:descripti... |
Bicillin L-A (penicillin G benzathine injectable
suspension) is available for deep intramuscular injection. Penicilin
G benzathine is prepared by the reaction of dibenzylethylene diamine
with two molecules of penicillin G. It 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 N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs
as a white, crystalline powder and is very slightly soluble inwater
and sparingly soluble in alcohol. Its chemical structure is as follows: Bicillin L-A contains penicillin G benzathine
in aqueous suspension with sodium citrate buffer and, as w/v, approximately
0.5% lecithin, 0.6% carboxymethylcellulose, 0.6% povidone, 0.1% methylparaben,
and 0.01% propylparaben. Bicillin L-A suspension
in the disposable-syringe formulation is viscous and opaque. It is
available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent
of 600,000, 1,200,000 and 2,400,000 units respectively of penicillin
G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to
use.
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| dailymed-instance:clinicalP... |
General: Penicillin G benzathine has an extremely low solubility
and, thus, the drug is slowly released from intramuscular injection
sites. The drug is hydrolyzed to penicillin G. This combination of
hydrolysis and slow absorption results in blood serum levels much
lower but much more prolonged than other parenteral penicillins. Intramuscular administration of 300,000 units of penicillin
G benzathine in adults results in blood levels of 0.03 to 0.05 units
per mL, which are maintained for 4 to 5 days. Similar blood levels
may persist for 10 days following administration of 600,000 units
and for 14 days following administration of 1,200,000 units. Blood
concentrations of 0.003 units per mL may still be detectable 4 weeks
following administration of 1,200,000 units. 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 and the spinal fluid to a lesser degree. With normal
kidney function, the drug is excreted rapidly by tubular excretion.
In neonates and young infants and in individuals with impaired kidney
function, excretion is considerably delayed.<br/>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. The
following in vitro data are
available, but their clinical significance is unknown. Penicillin
G exerts high in 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 Neisseria gonorrhoeae, Corynebacterium diphtheriae,
Bacillus anthracis, Clostridia species, Actinomyces bovis, Streptobacillus moniliformis,
Listeria monocytogenes, and Leptospira species. Treponema pallidum is extremely susceptible
to the bactericidal action of penicillin G. Susceptibility Test: If the
Kirby-Bauer method of disc susceptibility is used, a 20-unit penicillin
disc should give a zone greater than 28 mm when tested against a penicillin-susceptible
bacterial strain.
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| dailymed-instance:contraind... |
A history of a previous hypersensitivity reaction
to any of the penicillins is a contraindication.
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| dailymed-instance:supply |
Bicillin L-A (penicillin G benzathine
injectable suspension) is supplied in packages of 10 disposable syringes
as follows: 1 mL size, containing 600,000 units
per syringe, (21 gauge, thin-wall 1 inch needle for pediatric use),
NDC 60793-700-10. 2 mL size, containing 1,200,000
units per syringe, (21 gauge, thin-wall 1-1/2 inch needle), NDC 60793-701-10. 4 mL size, containing 2,400,000 units per syringe (18
gauge x 1���1/2 inch needle), NDC 60793-702-10. Store in a refrigerator, 2��to 8��C
(36��to 46��F). Keep from freezing.
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| dailymed-instance:boxedWarn... |
WARNING: NOT FOR INTRAVENOUS
USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS.
THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION
OF PENCILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY
ARREST AND DEATH. Prior to administration of this drug, carefully
read the WARNINGS, ADVERSE REACTIONS, and DOSAGE ANDADMINISTRATION sections of the labeling.
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| dailymed-instance:precautio... |
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 injection may produce neurovascular damage. Prolonged use of antibiotics may promote the overgrowth
of nonsusceptible organisms, including fungi. Should superinfection
occur, appropriate measures should be taken. Diarrhea is a common problem caused by antibiotics which usually
ends when the antibiotic is discontinued. Sometimes after starting
treatment with antibiotics, patients can develop watery and bloody
stools (with or without stomach cramps and fever) even as late as
two or more months after having taken the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as
possible.<br/>Laboratory Tests: In streptococcal infections, therapy must be sufficient
to eliminate the organism; otherwise, the sequelae of streptococcal
disease may occur. Cultures should be taken following completion of
treatment to determine whether streptococci have been eradicated.<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/>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: Soluble penicillin G is excreted in breast milk.
Caution should be exercised when penicillin G benzathine is administered
to a nursing woman.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been conducted with
this drug.<br/>Pediatric Use:<br/>Geriatric Use: Clinical studies of penicillin G benzathine did not
include sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between
the elderly and younger patients. In general, dose selection for an
elderly patient should be cautious, usually starting at the low end
of the dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy. This drug 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, andit may
be useful to monitor renal function.
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| dailymed-instance:overdosag... |
Penicillin in overdosage has the potential to cause
neuromuscular hyperirritability or convulsive seizures.
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| dailymed-instance:genericMe... |
penicillin G benzathine
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Bicillin L-A (Injection, Suspension)
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| dailymed-instance:adverseRe... |
As with other penicillins, untoward reactions of
the sensitivity phenomena are likely to occur, particularly in individuals
who have previously demonstrated hypersensitivity to penicillins or
in those with a history of allergy, asthma, hay fever, or urticaria. As with other treatments for syphilis, the Jarisch-Herxheimer
reaction has been reported. The following have
been reported with parenteral penicillin G: General: Hypersensitivity
reactions including the following: skin eruptions (maculopapular to
exfoliative dermatitis), urticaria, laryngeal edema, fever, eosinophilia;
other serum sickness-like reactions (including chills, fever, edema,
arthralgia, and prostration); and anaphylaxis including shock and
death. Note: Urticaria, other skin rashes, and serum sickness-like
reactions may be controlled with antihistamines and, if necessary,
systemic corticosteroids. Whenever such reactions occur, penicillin
G should be discontinued unless, in the opinion of the physician,
the condition being treated is life-threatening and amenable only
to therapy with penicillin G. Serious anaphylactic reactions require
immediate emergency treatment with epinephrine. Oxygen, intravenous
steroids, and airway management, including intubation, should also
be administered as indicated. Gastrointestinal: Pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after
antibacterial treatment. Hematologic: Hemolytic anemia,
leukopenia, thrombocytopenia. Neurologic: Neuropathy. Urogenital: Nephropathy. The following adverse events have been temporally associated
with parenteral administration of penicillin G benzathine: Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritus,
fatigue, asthenia, and pain; aggravation of existing disorder; headache. Cardiovascular: Cardiac arrest; hypotension; tachycardia; palpitations; pulmonary
hypertension; pulmonary embolism; vasodilatation; vasovagal reaction;
cerebrovascular accident; syncope. Gastrointestinal: Nausea, vomiting;
blood in stool; intestinal necrosis. Hemic and Lymphatic: Lymphadenopathy. Injection Site: Injection site reactions including pain, inflammation, lump, abscess,
necrosis, edema, hemorrhage, cellulitis, hypersensitivity, atrophy,
ecchymosis, and skin ulcer. Neurovascular reactions including warmth,
vasospasm, pallor, mottling, gangrene, numbness of the extremities,
cyanosis of the extremities, and neurovascular damage. Metabolic: Elevated
BUN, creatinine, and SGOT. Musculoskeletal: Joint disorder; periostitis;
exacerbation of arthritis; myoglobinuria; rhabdomyolysis. Nervous System: Nervousness; tremors; dizziness; somnolence; confusion; anxiety;
euphoria; transverse myelitis; seizures; coma. A syndrome manifested
by a variety of CNS symptoms such as severe agitation with confusion,
visual and auditory hallucinations, and a fear of impending death
(Hoigne's syndrome), has been reported after administration of
penicillin G procaine and, less commonly, after injection of the combination
of penicillin G benzathine and penicillin G procaine. Other symptoms
associated with this syndrome, such as psychosis, seizures, dizziness,
tinnitus, cyanosis, palpitations, tachycardia, and/or abnormal perception
in taste, also may occur. Respiratory: Hypoxia; apnea; dyspnea. Skin: Diaphoresis. Special Senses: Blurred vision; blindness. Urogenital: Neurogenic bladder; hematuria;
proteinuria; renal failure; impotence; priapism.
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| dailymed-instance:warning |
WARNING: NOT FOR INTRAVENOUS
USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS.
THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION
OF PENCILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY
ARREST AND DEATH. Prior to administration of this drug, carefully
read the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling. Penicillin G benzathine should only be prescribed
for the indications listed in this insert.<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 BICILLIN
L-A, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN
ALLERGIC REACTION OCCURS, BICILLIN L-A 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. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly
all antibacterial agents, including Bicillin L-A, and may range in
severity from mild diarrhea to fatal colitis. Treatment with antibacterial
agents alters the normal flora of the colon leading to overgrowth
of C. difficile. C. difficile produces
toxins A and B which contribute to the development of CDAD. Hypertoxin
producing strains of C. difficile cause increased morbidity and mortality, as these infections can
be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea
following antibacterial use. Careful medical history is necessary
since CDAD has been reported to occur over two months after the administration
of antibacterial agents. If CDAD is suspected
or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.<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 Bicillin L-A 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
withan appropriate specialist is indicated if any evidence of compromise
of the blood supply occurs at, proximal to, or distal to the site
of injection. Do not inject intravenously or admix with other intravenous solutions.
There have been reports of inadvertent intravenous administration
of penicillin G benzathine which has been associated with cardiorespiratory
arrest and death. Quadriceps femoris fibrosis and atrophy have been reported
following repeated intramuscular injections of penicillin preparations
into the anterolateral thigh.
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| dailymed-instance:indicatio... |
Intramuscular penicillin G benzathine is indicated
in the treatment of infections due to penicillin-G-sensitive microorganisms
that are susceptible to the low and very prolonged serum levels common
to this particular dosage form. Therapy should be guided by bacteriological
studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate
dosage of intramuscular penicillin G benzathine: Mild-to-moderate infections of the upper-respiratory tract due to
susceptible streptococci. Venereal infections���Syphilis,
yaws, bejel, and pinta. Medical Conditions
in which Penicillin G Benzathine Therapy is Indicated as Prophylaxis: Rheumatic fever and/or chorea���Prophylaxis with penicillin G benzathine has proven effective
in preventing recurrence of these conditions. It has also been used
as follow-up prophylactic therapy for rheumatic heart disease and
acute glomerulonephritis.
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Bicillin L-A
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