Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2222
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Erythrocin Lactobionate (Injection, Powder, For Solution)
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For the treatment of severe infections in adults and children,
the recommended intravenous dose of erythromycin lactobionate is 15 to 20
mg/kg/day. Higher doses, up to 4 g/day, may be given for severe infections.
Erythrocin Lactobionate-I.V. (sterile erythromycin lactobionate) in the ADD-Vantage
system should be administered by intermittent intravenous infusion. Due to
the irritative properties of erythromycin, I.V. push is an unacceptable route
of administration. Continuous infusion of erythromycin
lactobionate has been preferred due to the slower infusion rate and lower
concentration of erythromycin; however, intermittent infusion at six hour
intervals is effective. Intravenous erythromycin should be replaced by oral
erythromycin as soon as possible. The
drug should be administered as a single dose from the ADD-Vantage flexible
diluent container. Discard any unused portion. For
intermittent infusion: administer one-fourth the total daily dose of erythromycin
lactobionate by intravenous infusion in 20 to 60 minutes at intervals not
greater than every six hours. The final diluted solution of erythromycin lactobionate
is prepared to give a concentration of 1 to 5 mg/mL. No less than 100 mL of
I.V. diluent should be used. Infusion should be sufficiently slow to minimize
pain along the vein. For treatment of acute pelvic inflammatory
disease caused by N. Gonorrhoeae. In
female patients hypersensitive to penicillins, administer 500 mg erythromycin
lactobionate every six hours for three days, followed by oral administration
of 250 mg erythromycin stearate or base every six hours for seven days. For
treatment of Legionnaires' Disease: Although optimal doses have not been established,
doses utilized in reported clinical data were 1 to 4 grams daily in divided
doses. In the treatment of Group A beta-hemolytic streptococcal
infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis),
the therapeutic dosage of erythromycin should be administered for ten days.
The American Heart Association suggests a dosage of 250 mg of erythromycin
orally, twice a day in long-term prophylaxis of streptococcal upper respiratory
tract infections for the prevention of recurring attacks of rheumatic fever
in patients allergic to penicillin and sulfonamides. In
prophylaxis against bacterial endocarditis (see INDICATIONS
AND USAGE section) the oral regimen for penicillin allergic patients
is erythromycin 1 gram, 1 hour before the procedure followed by 500 mg six
hours later. Preparation
of Solution: The Erythrocin Lactobionate-I.V.
ADD-Vantage vial may be used with either 0.9% Sodium Chloride Injection, USP,
or 5% Dextrose Injection, USP in the ADD-Vantage flexible diluent container.
The 500 mg and 1 g ADD-Vantage vials must be used as single doses with the
100 mL and 250 mL ADD-Vantage flexible diluent containers, respectively. The
resulting solutions will contain erythromycin activity equal to approximately
5 mg/mL and 4 mg/mL, respectively. Do
not administer unless solution is clear and container is undamaged. Discard
any unused portion.
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Erythrocin Lactobionate-I.V. (sterile erythromycin
lactobionate) is a lyophilized powder for intravenous infusion only. It is
prepared as a solution and lyophilized in its final container. The Erythrocin
Lactobionate-I.V. ADD-Vantage vial is designed for use only
with the ADD-Vantage Flexible Diluent Container. After appropriate dilution,
the Erythrocin Lactobionate-I.V. ADD-Vantage Delivery System contains erythromycin
lactobionate equivalent to either 500 mg of erythromycin activity in 100 mL
or 1 g erythromycin activity in 250 mL. The solutions
contain no bacteriostat, antimicrobial agent (except erythromycin) or buffer
and are intended for use as a single-dose injection only with the ADD-Vantage
Flexible Diluent Container. Erythromycin is produced
by a strain of Streptomyces erythraeus and
belongs to the macrolide group of antibiotics. It is basic and readily forms
salts with acids. Erythromycin lactobionate has the following structure:
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Erythromycin diffuses readily into most body fluids. In the
absence of meningeal inflammation, low concentrations are normally achieved
in the spinal fluid but the passage of the drug across the blood-brain barrier
increases in meningitis. Erythromycin crosses the placental barrier and is
excreted in breast milk. Erythromycin is not removed by peritoneal dialysis
or hemodialysis. In the presence of normal hepatic function,
erythromycin is concentrated in the liver and is excreted in the bile; the
effect of hepatic dysfunction on biliary excretion of erythromycin is not
known. From 12 to 15 percent of intravenously administered erythromycin is
excreted in active form in the urine. Intravenous infusion
of 500 mg of erythromycin lactobionate at a constant rate over 1 hour in fasting
adults produced a mean serum erythromycin level of approximately 7 mcg/mL
at 20 minutes, 10 mcg/mL at 1 hour, 2.6 mcg/mL at 2.5 hours, and 1 mcg/mL
at 6 hours.
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Erythromycin is contraindicated in patients with known hypersensitivity
to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine
or astemizole. (See PRECAUTIONS���Drug Interactions .)
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Erythrocin Lactobionate-I.V. (sterile erythromycin lactobionate)
is supplied as a sterile, lyophilized powder as follows: Store at 20 to 25��C (68 to 77��F). [See USP Controlled
Room Temperature.] Covered by one or more of the following
U.S. patents: 4,614,515; 4,614,267.
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General:: Since erythromycin is principally excreted by the liver,
caution should be exercised when erythromycin is administered to patients
with impaired hepatic function. (See CLINICAL
PHARMACOLOGY and WARNINGS sections.) There
have been reports that erythromycin may aggravate the weakness of patients
with myasthenia gravis. Prolonged or repeated use of
erythromycin may result in an overgrowth of non-susceptible bacteria or fungi.
If superinfection occurs, erythromycin should be discontinued and appropriate
therapy instituted. When indicated, incision and drainage
or other surgical procedures should be performed in conjunction with antibiotic
therapy. Prescribing erythromycin in the absence of
a proven or strongly suspected bacterial infection or a prophylactic indication
is unlikely to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.<br/>Laboratory Tests:: Erythromycin interferes with the fluorometric determination
of urinary catecholamines.<br/>Drug Interactions:: Erythromycin use in patients who are receiving high doses
of theophylline may be associated with an increase of serum theophylline levels
and potential theophylline toxicity. In case of theophylline toxicity and/or
elevated serum theophylline levels, the dose of theophylline should be reduced
while the patient is receiving concomitant erythromycin therapy. There
have been published reports suggesting that when oral erythromycin is given
concurrently with theophylline there is a significant decrease in erythromycin
serum concentrations. This decrease could result in subtherapeutic concentrations
of erythromycin. Erythromycin administration in patients
receiving carbamazepine has been reported to cause increased serum levels
of carbamazepine with subsequent development of signs of carbamazepine toxicity. Concomitantadministration of erythromycin and digoxin has been reported to result in
elevated serum digoxin levels. There have been reports
of increased anticoagulant effects when erythromycin and oral anticoagulants
were used concomitantly. Erythromycin has been reported
to significantly alter the metabolism of the nonsedating antihistamines, terfenadine
and astemizole, when taken concomitantly. Rare cases of serious cardiovascular
adverse events, including electrocardiographic QT/QTc interval prolongation,
cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have
been observed. (See CONTRAINDICATIONS.)
In addition, deaths have been reported rarely with concomitant administration
of terfenadine and erythromycin. The use of erythromycin
in patients concurrently taking drugs metabolized by the cytochrome P450 system
may be associated with the elevations in serum levels of these other drugs.
There have been reports of interactions of erythromycin with carbamazepine,
cyclosporine, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin
bromocriptine, valproate, terfenadine, and astemizole. Serum concentrations
of drugs metabolized by the cytochrome P450 system should be monitored closely
in patients concurrently receiving erythromycin.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Long-term animal data with erythromycin lactobionate for
use in determination of possible carcinogenic effects are not available. However,
long-term oral studies in rats with erythromycin ethylsuccinate and erythromycin
base did not provide evidence of tumorigenicity. Mutagenicity studies have
not been conducted. There was no apparent effect on male or female fertility
in rats fed erythromycin (base) at levels up to 0.25% of diet.<br/>Pregnancy: Pregnancy Category B:: There was no evidence of teratogenicity or any other adverse
effect on reproduction in female rats fed erythromycin base (up to 0.25% of
diet) prior to and during mating, during gestation, and through weaning of
two successive litters. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy only
if clearly needed. Erythromycin has been reported to cross the placental barrier
in humans, but fetal plasma levels are generally low.<br/>Labor and Delivery:: The effect of erythromycin on labor and delivery is unknown.<br/>Nursing Mothers:: Erythromycin is excreted in breast milk. Caution should be
exercised when erythromycin is administered to a nursing woman.<br/>Pediatric Use:: See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATIONsections.<br/>Information for Patients:: Patients should be counseled that antibacterial drugs including
erythromycin should only be used to treat bacterial infections. They do not
treat viral infections (e.g., the common cold). When erythromycin is prescribed
to treat a bacterial infection, the patient should be told that although it
is common to feel better early in the course of therapy, the medication should
be taken exactly as directed. Skipping doses or not completing the full course
of therapy may (1) decrease the effectiveness of the immediate treatment and
(2) increase the likelihood that bacteria will develop resistance and will
not be treatable by erythromycin or other antibacterial drugs in the future.
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In the case of overdosage, erythromycin infusion should be
discontinued. Erythromycin is not removed by peritoneal
dialysis or hemodialysis.
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Erythromycin Lactobionate
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Erythrocin Lactobionate (Injection, Powder, For Solution)
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Side effects following the use of intravenous erythromycin
are rare. Occasional venous irritation has been encountered, but if the infusion
is given slowly, in dilute solution, preferably by continuous intravenous
infusion or intermittent infusion in no less than 20 to 60 minutes, pain and
vessel trauma are minimized. Life-threatening episodes
of ventricular tachycardia associated with prolonged QT intervals (torsadesde pointes) have been reported in some patients after intravenous administration
of erythromycin lactobionate. Allergic reactions, ranging
from urticaria to anaphylaxis, have occurred. Skin reactions ranging from
mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic
epidermal necrolysis have been reported rarely. There
have been isolated reports of reversible hearing loss occurring chiefly in
patients with renal insufficiency and in patients receiving high doses of
erythromycin.
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There have been reports of hepatic dysfunction, with or without
jaundice occurring in patients receiving oral erythromycin products.
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Erythrocin Lactobionate-I.V. (sterile erythromycin lactobionate)
is indicated in the treatment of infections caused by susceptible strains
of the designated organisms in the diseases listed below when oral administration
is not possible or when the severity of the infection requires immediate high
serum levels of erythromycin. Intravenous therapy should be replaced by oral
administration at the appropriate time. Upper respiratory
tract infections of mild to moderate degree caused by Streptococcus
pyogenes (Group A beta-hemolytic streptococci); Streptococcus
pneumoniae(Diplococcus pneumoniae); Haemophilus influenzae (when
used concomitantly with adequate doses of sulfonamides, since many strains
of H. influenzae are not susceptible
to the erythromycin concentrations ordinarily achieved). (See appropriate
sulfonamide labeling for prescribing information.) Lower
respiratory tract infections of mild to moderate severity caused by Streptococcuspyogenes (Group A beta-hemolytic streptococci); Streptococcus
pneumoniae(Diplococcuspneumoniae). Respiratory
tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild
to moderate severity caused by Streptococcuspyogenes and Staphylococcusaureus (resistant staphylococci
may emerge during treatment). Diphtheria���As
an adjunct to antitoxin in infections due to Corynebacterium
diphtheriae to prevent establishment of carriers and to eradicate
the organism in carriers. Erythrasma���In the
treatment of infections due to Corynebacterium
minutissimum. Acute pelvic inflammatory disease
caused by Neisseria gonorrhoeae: Erythrocin
Lactobionate-I.V. (sterile erythromycin lactobionate) followed by erythromycin
stearate or base orally, as an alternative drug in treatment of acute pelvic
inflammatory disease caused by N. gonorrhoeaein female patients witha history of sensitivity to penicillin. Before
treatment of gonorrhea, patients who are suspected of also having syphilis
should have a microscopic examination for T.
pallidum (by immunofluorescence or darkfield) before receiving erythromycin
and monthly serologic tests for a minimum of 4 months thereafter. Legionnaires'
Disease caused by Legionella pneumophila.
Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data
suggest that erythromycin may be effective in treating Legionnaires' Disease. Prevention
of Initial Attacks of Rheumatic Fever���Penicillin is considered by
the American Heart Association to be the drug of choice in the prevention
of initial attacks of rheumatic fever (treatment of Group A beta-hemolytic
streptococcal infections of the upper respiratory tract e.g., tonsillitis,
or pharyngitis).Erythromycin is indicated for the treatment of
penicillin-allergic patients. The therapeutic dose should be administered
for ten days. Prevention of Recurrent Attacks of Rheumatic
Fever���Penicillin or sulfonamides are considered by the American Heart
Association to be the drugs of choice in the prevention of recurrent attacks
of rheumatic fever. In patients who are allergic to penicillin and sulfonamides,
oral erythromycin is recommended by the American Heart Association in the
long-term prophylaxis of streptococcal pharyngitis (for theprevention of
recurrent attacks of rheumatic fever). Prevention
of Bacterial Endocarditis���Although no controlled clinical efficacy
trials have been conducted, oral erythromycin has been recommended by the
American Heart Association for prevention of bacterial endocarditis in penicillin-allergic
patients with prosthetic cardiac valves, most congenital cardiac malformations,
surgically constructed systemic pulmonary shunts, rheumatic or other acquired
valvular dysfunction, idiopathic hypertrophic subaortic stenosis (IHSS), previous
history of bacterial endocarditis and mitral valve prolapse with insufficiency
when they undergo dental procedures and surgical procedures of the upper respiratory
tract. To reduce the development of drug-resistant
bacteria and maintain the effectiveness of erythromycin and other antibacterial
drugs, erythromycin should be used only to treat or prevent infections that
are proven or strongly suspected to be caused by susceptible bacteria. When
culture and susceptibility information are available, they should be considered
in selecting or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to the empiric
selection of therapy.
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Erythrocin Lactobionate
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