Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2224
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Clindamycin (Injection, Solution)
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If diarrhea occurs during therapy, this antibiotic
should be discontinued. (See WARNING box). Adults: Parenteral (I.M. or I.V. Administration): Serious infections due to aerobic gram-positive cocci
and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600 to 1200 mg/day in 2, 3 or 4 equal doses. More severe infections, particularly those due to proven
or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 to 2700 mg/day in 2, 3 or 4 equal doses. For more serious infections, these doses may have to be
increased. In life-threatening situations due to either aerobes or
anaerobes, these doses may be increased. Doses of as much as 4800
mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below. Single I.M. injections of greater than 600 mg are not
recommended. Alternatively, drug may be administered
in the form of a single rapid infusion of the first dose followed
by continuous I.V. infusion as follows: Neonates (less than 1
month): 15 to 20 mg/kg/day in three
to four equal doses. The lower dosage may be adequate for small prematures. Pediatric patients (1 month
of age to 16 years): Parenteral (I.M.
or I.V.) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.
The higher doses would be used for more severe infections. As an alternative
to dosing on a body weight basis, pediatric patients may be dosed
on the basis of square meters body surface: 350 mg/m/day
for serious infections and 450 mg/m/day for more severe
infections. Parenteral therapy may be changed
to clindamycin palmitate hydrochloride for oral solution or clindamycin
hydrochloride capsules when the condition warrants and at the discretion
of the physician. In cases of��-hemolytic
streptococcal infections, treatment should be continued for at least
10 days. Dilution
and Infusion Rates: Clindamycin phosphate must be diluted prior to I.V.
administration. The concentration of clindamycin in diluent for infusion
should not exceed 18 mg per mL. Infusion rates should not exceed 30
mg per minute. The usual infusion dilutions and rates are
as follows: Administration of more than 1200 mg in a single
1-hour infusion is not recommended. Parenteral
drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit. Dilution and
Compatibility: Physical and biological
compatibility studies monitored for 24 hours at room temperature have
demonstrated no inactivation or incompatibility with the use of clindamycin
phosphate in I.V. solutions containing sodium chloride, glucose, calcium
or potassium, and solutions containing vitamin B complex in concentrations
usually used clinically. No incompatibility has been demonstrated
with the antibiotics cephalothin, kanamycin, gentamicin, penicillin
or carbenicillin. The following drugs are physically
incompatible with clindamycin phosphate: ampicillin sodium, phenytoin
sodium, barbiturates, aminophylline, calcium gluconate, and magnesium
sulfate. The compatibility and duration of stability
of drug admixtures will vary depending on concentration and other
conditions. Physico-Chemical
Stability of Diluted Solutions of Clindamycin: Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin
base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or
Lactated Ringer's Injection in glass bottles or minibags, demonstrated
physical and chemical stability for at least 16 days at 25��C.
Also, 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection,
in minibags, demonstrated physical and chemical stability for at least
16 days at 25��C. Refrigeration: 6, 9 and
12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection,
0.9% Sodium Chloride Injection, or Lactated Ringer's Injection
in glass bottles or minibags, demonstrated physical and chemical stability
for at least 32 days at 4��C. IMPORTANT:
This chemical stability information in no way indicates that it would
be acceptable practice to use this product well after the preparation
time. Good professional practice suggests that compounded admixtures
should be administered as soon after preparation as is feasible. Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base)
in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated
Ringer's Injection in minibags demonstrated physical and chemical
stability for at least eight weeks at -10��C. Frozen solutions should be thawed at room temperature and not refrozen. Caution: Do not use
plastic containers in series connections. Such use could result in
air embolism due to residual air being drawn from the primary container
before administration of the fluid from the secondary container is
complete.
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Clindamycin Injection, USP, a water soluble ester
of clindamycin and phosphoric acid, is a sterile solution for intramuscular
or intravenous use. May contain sodium hydroxide
and/or hydrochloric acid for pH adjustment. pH is 6.5 range 5.5 to
7.0. Clindamycin is a semisynthetic antibiotic
produced by a 7(S)-chloro-substitution of the 7 (R)-hydroxyl
group of the parent compound lincomycin. The
chemical name of clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-��-D-galacto-octopyranoside 2-(dihydrogen
phosphate). The molecular formula is CHClNOPS and the molecular weight
is 504.97. The structural formula is represented
below: Each mL contains clindamycin phosphate equivalent to 150 mg clindamycin,
0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as a preservative.
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Biologically inactive clindamycin phosphate is rapidly
converted to active clindamycin. By the end
of short-term intravenous infusion, peak serum levels of active clindamycin
are reached. Biologically inactive clindamycin phosphate disappears
rapidly from the serum; the average elimination half-life is 6 minutes;
however, the serum elimination half-life of active clindamycin is
about 3 hours in adults and 2��hours in pediatric patients. After intramuscular injection of clindamycin phosphate,
peak levels of active clindamycin are reached within 3 hours in adults
and 1 hour in pediatric patients. Serum level curves may be constructed
from I.V. peak serum levels as given in Table 1 by application of
elimination half-lives listed above. Serum levels
of clindamycin can be maintained above the in vitro minimum inhibitory concentrations for most indicated
organisms by administration of clindamycin phosphate every 8 to 12
hours in adults and every 6 to 8 hours in pediatric patients, or by
continuous intravenous infusion. An equilibrium state is reached by
the third dose. The elimination half-life of
clindamycin is increased slightly in patients with markedly reduced
renal or hepatic function. Hemodialysis and peritoneal dialysis are
not effective in removing clindamycin from the serum. Dosage schedules
need not be modified in the presence of mild or moderate renal or
hepatic disease. No significant levels of clindamycin
are attained in the cerebrospinal fluid, even in the presence of inflamed
meninges. Pharmacokinetic studies in elderly
volunteers (61 to 79 years) and younger adults (18 to 39 years)
indicate that age alone does not alter clindamycin pharmacokinetics
(clearance, elimination half-life, volume of distribution, and area
under the serum concentration-time curve) after I.V. administration
of clindamycin phosphate. After oral administration of clindamycin
hydrochloride, elimination half-life is increased to approximately
4 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours
(range 2.1 to 4.2 h) in younger adults. The extent of absorption,
however, is not different between the age groups and no dosage alteration
is necessaryfor the elderly with normal hepatic function and normal
(age-adjusted) renal function. Serum
assays for active clindamycin require an inhibitor to prevent in vitro hydrolysis of clindamycin phosphate. Microbiology: Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active
clindamycin. Clindamycin has been shown to have in vitro activity against isolates of
the following organisms: In vitro Susceptibility Testing: Disk diffusion technique-Quantitative methods that require
measurement of zone diameters give the most precise estimates of antibiotic
susceptibility. One such procedurehas been recommended
for use with disks to test susceptibility to clindamycin. Reports from a laboratory using the standardized single-disk
susceptibility testwith a 2 mcg clindamycin disk should
be interpreted according to the following criteria: Susceptible organisms produce zones of 17 mm or greater, indicating
that the tested organism is likely to respond to therapy. Organisms of intermediate susceptibility produce zones
of 15-16 mm, indicating that the tested organism would be susceptible
if a high dosage is used or if the infection is confined to tissues
and fluids (e.g., urine), in which high antibiotic levels are attained. Resistant organisms produce zones of 14 mm or less, indicating
that other therapy should be selected. Standardized
procedures require the use of control organisms. The 2 mcg clindamycin
disk should give a zone diameter between 24 and 30 mm for S. aureus ATCC 25923. Dilution techniques���A bacterial isolate may be considered
susceptible if the minimum inhibitory concentration (MIC) for clindamycin
is not more than 1.6 mcg/mL. Organisms are considered moderately susceptible
if the MIC is greater than 1.6 mcg/mL and less than or equal to 4.8 mcg/mL.
Organisms are considered resistant if the MIC is greater than 4.8
mcg per mL. The rangeof MIC's for the control strains are
as follows: S. aureus ATCC 29213, 0.06 to 0.25 mcg/mL. E. faecalis ATCC 29212,
4 to 16 mcg/mL. For anaerobic bacteria the minimum
inhibitory concentration (MIC) of clindamycin can be determined by
agar dilution and broth dilution (including microdilution) techniques.If MICs are not determined routinely, the disk broth method
is recommended for routine use. The KIRBY-BAUER DISK DIFFUSION METHOD
AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES.
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This drug is contraindicated in individuals with
a history of hypersensitivity to preparations containing clindamycin
or lincomycin.
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Clindamycin Injection, USP (150 mg/mL) is supplied
as follows: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Do not refrigerate.
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WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly
all antibacterial agents, including clindamycin, 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. Because clindamycin therapy has been associated with severe
colitis which may end fatally, it should be reserved for serious infections
where less toxic antimicrobial agents are inappropriate, as described
in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections
such as most upper respiratory tract infections. 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 antibiotic 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.
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General: Review of experience to date suggests that a subgroup
of older patients with associated severe illness may tolerate diarrhea
less well. When clindamycin is indicated in these patients, they should
be carefully monitored for change in bowel frequency. Clindamycin phosphate should be prescribed with caution in individuals
with a history of gastrointestinal disease, particularly colitis. Clindamycin phosphate should be prescribed with caution
in atopic individuals. Certain infections may
require incision and drainage or other indicated surgical procedures
in addition to antibiotic therapy. The use of
clindamycin phosphate may result in overgrowth of nonsusceptible organisms���particularly yeasts. Should superinfections occur, appropriate
measures should be taken as indicated by the clinical situation. Clindamycin phosphate should not be injected intravenously
undiluted as a bolus, but should be infused over at least 10-60 minutes
as directed in the DOSAGE AND ADMINISTRATION section. Clindamycin dosage modification may
not be necessary in patients with renal disease. In patients with
moderate to severe liver disease, prolongation of clindamycin half-life
has been found. However, it was postulated from studies that when
given every eight hours, accumulation should rarely occur. Therefore,
dosage modification in patients with liver disease may not be necessary.
However, periodic liver enzyme determinations should be made when
treating patients with severe liver disease. Prescribing clindamycin 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/>Information for Patients: Patients should be counseled that antibacterial drugs
including clindamycin should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When clindamycin
is prescribed to treat a bacterial infection, patients 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
clindamycin or other antibacterial drugs in the future. 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: During prolonged therapy periodic liver and kidney
function tests and blood counts should be performed.<br/>Drug Interactions: Clindamycin has been shown to have neuromuscular
blocking properties that may enhance the action of other neuromuscular
blocking agents. Therefore, it should be used with caution in patients
receiving such agents. Antagonism has been demonstrated
between clindamycin and erythromycin in vitro. Because of possible clinical significance, the
two drugs should not be administered concurrently.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility: Long term studies in animals have not been performed
with clindamycin to evaluate carcinogenic potential. Genotoxicity
tests performed included a rat micronucleus test and an Ames Salmonella
reversion test. Both tests were negative. Fertility
studies in rats treated orally with up to 300 mg/kg/day (approximately
1.1 times the highest recommended adult human dose based on mg/m) revealed no effects on fertility or mating ability.<br/>Pregnancy:: Teratogenic Effects: Pregnancy Category B Reproduction studies performed in rats and mice using
oral doses of clindamycin up to 600 mg/kg/day (2.1 and 1.1 times
the highest recommended adult human dose based on mg/m, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day
(0.9 and 0.5 times the highest recommended adult human dose based
on mg/m, respectively) revealed no evidence of teratogenicity. There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always
predictive of the human response, this drug should be used during
pregnancy only if it is clearly needed.<br/>Nursing Mothers: Clindamycin has been reported to appear in breast
milk in the range of 0.7 to 3.8 mcg/mL at dosages of 150 mg orally
to 600 mg intravenously. Because of the potential for adverse reactions
due to clindamycin in neonates (see Pediatric
Use), the decision to discontinue the drug should be made,
taking into account the importance of the drug to the mother.<br/>Pediatric Use: When clindamycin phosphate injection is administered
to the pediatric population (birth to 16 years) appropriate monitoring
of organ system functions is desirable.<br/>Usage in Newborns and Infants: This product contains benzyl alcohol as a preservative.
Benzyl alcohol has been associated with a fatal���Gasping Syndrome���in premature infants. The potential for the
toxic effect in the pediatric population from chemicals that may leach
from the single dose premixed IV preparation in plastic has not been
evaluated.<br/>Geriatric Use: Clinical studies of clindamycin did not include sufficient
numbers of patients age 65 and over to determine whether they respond
differently from younger patients. However, other reported clinical
experience indicates that antibiotic-associated colitis and diarrhea
(due to Clostridium difficile) seen in association with most antibiotics occur more frequently
in the elderly (>60 years) and may be more severe. These patients
should be carefully monitored for the development of diarrhea. Pharmacokinetic studies with clindamycin have shown no
clinically important differences between young and elderly subjects
with normal hepatic function and normal (age-adjusted) renal function
after oral or intravenous administration.
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Significant mortality was observed in mice at an
intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous
dose of approximately 2618 mg/kg. In the mice, convulsions and depression
were observed. Hemodialysis and peritoneal dialysis
are not effective in removing clindamycin from the serum.
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clindamycin phosphate
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Clindamycin (Injection, Solution)
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The following reactions have been reported with the
use of clindamycin. Gastrointestinal: Antibiotic-associated colitis (see WARNINGS), pseudomembranous colitis
abdominal pain, nausea and vomiting. The onset of pseudomembranous
colitis symptoms may occur during or after antibacterial treatment
(see WARNINGS). An unpleasant
or metallic taste occasionally has been reported after intravenous
administration of the higher doses of clindamycin phosphate. Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed during drug
therapy. Generalized mild to moderate morbilliform-like skin rashes
are the most frequently reported of all adverse reactions. Rare instances
of erythema multiforme, some resembling Stevens-Johnson syndrome,
have been associated with clindamycin. A few cases of anaphylactoid
reactions have been reported. If a hypersensitivity reaction occurs,
the drug should be discontinued. The usual agents (epinephrine, corticosteroids,
antihistamines) should be available for emergency treatment of serious
reactions. Skin and
Mucous Membranes: Pruritus, vaginitis, and rare instances
of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions). Liver: Jaundice and
abnormalities in liver function tests have been observed during clindamycin
therapy. Renal: Although no direct relationship of clindamycin to renal damage has
been established, renal dysfunction as evidenced by azotemia, oliguria,
and/or proteinuria has been observed in rare instances. Hematopoietic: Transient
neutropenia (leukopenia) and eosinophilia have been reported. Reports
of agranulocytosis and thrombocytopenia have been made. No direct
etiologic relationship to concurrent clindamycin therapy could be
made in any of the foregoing. Local Reactions: Pain, induration and sterile
abscess have been reported after intramuscular injection and thrombophlebitis
after intravenous infusion. Reactions can be minimized or avoided
by giving deep intramuscular injections and avoiding prolonged use
of indwelling intravenous catheters. Musculoskeletal: Rare instances of polyarthritis
have been reported. Cardiovascular: Rare instances of cardiopulmonary arrest
and hypotension have been reported following too rapid intravenous
administration. (See DOSAGE AND
ADMINISTRATION).
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See WARNING box. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly
all antibacterial agents, including clindamycin, 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 antibiotic 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. A careful inquiry should be made concerning previous sensitivities
to drugs and other allergens. This product contains
benzyl alcohol as a preservative. Benzyl alcohol has been associated
with a fatal���Gasping Syndrome���in premature infants.
(See PRECAUTIONS���Pediatric Use). Usage in Meningitis: Since clindamycin
does not diffuse adequately into the cerebrospinal fluid, the drug
should not be used in the treatment of meningitis. SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT
WITH EPINEPHRINE. OXYGEN AND INTRAVENOUS CORTICOSTEROIDS SHOULD ALSO
BE ADMINISTERED AS INDICATED.
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Clindamycin Injection, USP is indicated in the treatment
of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is also indicated in the treatment
of serious infections due to susceptible strains of streptococci,
pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic
patients or other patients for whom, in the judgment of the physician,
a penicillin is inappropriate. Because of the risk of antibiotic-associated
pseudomembranous colitis, as described in the WARNING box, before selecting clindamycin the physician
shouldconsider the nature of the infection and the suitability of
less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative
organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction
with antibiotic therapy. Clindamycin Injection,
USP is indicated in the treatment of serious infections caused by
susceptible strains of the designated organisms in the conditions
listed below: Lower respiratory tract infections
including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci
(except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal
tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal
cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal
abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus
aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous
osteomyelitis caused by Staphylococcus
aureus and as adjunctive therapy in the surgical treatment
of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and
maintain the effectiveness of clindamycin and other antibacterial
drugs, clindamycin 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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Clindamycin
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