NDC 54868-3695 Clindamycin Phosphate

NDC Product Code 54868-3695

NDC 54868-3695-0

Package Description: 1 TRAY in 1 CASE > 25 VIAL, SINGLE-DOSE in 1 TRAY > 2 mL in 1 VIAL, SINGLE-DOSE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Clindamycin Phosphate with NDC 54868-3695 is a product labeled by Physicians Total Care, Inc.. The generic name of Clindamycin Phosphate is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Dosage Form: -

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Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Product Labeler Information

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Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 02-27-1997 What is the Start Marketing Date?
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Information for Patients

Clindamycin Injection

Clindamycin Injection is pronounced as (klin'' da mye' sin)

Why is clindamycin injection medication prescribed?
Clindamycin injection is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, bones, joints, female reproductive organs, a...
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Clindamycin Phosphate Product Label Images

Clindamycin Phosphate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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Fliptop VialRx onlyTo 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 bacteria.

Printed in USAEN-1754Hospira, Inc., Lake Forest, IL 60045
USARelabeling of "Additional Barcode Label" by:Physicians Total Care, Inc.Tulsa, OK      74146

Boxed Warning

WARNINGClostridium 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.

Description

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-α-D-galacto-octopyranoside
2-(dihydrogen phosphate).The molecular formula is C18H34ClN2O8PS 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.

Clinical Pharmacology

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 2½ 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 necessary for the elderly with normal hepatic function and
normal (age-adjusted) renal function1.Serum assays for active clindamycin require an inhibitor to prevent in vitro hydrolysis of clindamycin phosphate.Table 1 Average Peak and Trough Serum Concentrations of Active
Clindamycin After Dosing with Clindamycin PhosphateDosage RegimenPeakmcg/mLTroughmcg/mLHealthy Adult Males (Post equilibrium)600 mg I.V. in 30 min q6h600 mg I.V. in 30 min q8h 900 mg I.V. in 30 min q8h 600 mg I.M. q12* 10.910.814.1921.11.7Pediatric Patients (first dose)*5-7 mg/kg I.V. in 1 hour 5-7 mg/kg I.M.3-5 mg/kg I.M.1084*Data in this group from patients being treated for infection.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:Aerobic gram positive cocci,including:  Staphylococcus aureus           (penicillinase and non-penicillinase producing strains). When tested by in
vitro methods, some staphylococcal strains                                                      originally resistant to
erythromycin rapidly develop resistance to clindamycin.  Staphylococcus epidermidis  (penicillinase and non-penicillinase producing strains). When tested by in
vitro methods, some staphylococcal strains                                                      originally resistant to
erythromycin rapidly develop resistance to clindamycin.  Streptococci (exceptEnterococcus faecalis)  PneumococciAnaerobic gram negative bacilli,including:  Bacteroides species (including Bacteroides
fragilis group and Bacteroides melaninogenicus
group)  Fusobacterium speciesAnaerobic gram positive nonsporeforming
bacilli, including:  Propionibacterium  Eubacterium  Actinomyces speciesAnaerobic and microaerophilic gram positive cocci,
including:  Peptococcus species  Peptostreptococcus speciesMicroaerophilic streptococci  Clostridia: Clostridia are more resistant than most anaerobes to
clindamycin. Most Clostridium perfringens are
susceptible, but other species, e.g., Clostridium sporogenes and Clostridium tertium are frequently resistant to
clindamycin. Susceptibility testing should be done.Cross resistance has been demonstrated between clindamycin and
lincomycin.Antagonism has been demonstrated betweeen clindamycin and erythromycin.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 procedure2 has been recommended for use with disks
to test susceptibility to clindamycin.Reports from a laboratory using the standardized single-disk susceptibility
test1 with 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 range of 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.3 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.

Indications And Usage

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 should consider 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.

Contraindications

This drug is contraindicated in individuals with a history of
hypersensitivity to preparations containing clindamycin or lincomycin.

Warnings

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.

Precautions

GeneralReview 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.Information for PatientsPatients 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.Laboratory TestsDuring prolonged therapy periodic liver and kidney function tests
and blood counts should be performed.Drug InteractionsClindamycin 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.Carcinogenesis, Mutagenesis, Impairment of
FertilityLong 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/m2) revealed no effects on fertility or mating
ability.Pregnancy:Teratogenic Effects:Pregnancy Category BReproduction 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/m2, 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/m2,
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.Nursing MothersClindamycin 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.Pediatric UseWhen clindamycin phosphate injection is administered to the
pediatric population (birth to 16 years) appropriate monitoring of organ system
functions is desirable.Usage in Newborns and InfantsThis 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.Geriatric UseClinical 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.

Adverse Reactions

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).

Overdosage

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.

Dosage And Administration

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:To maintain serumclindamycin levelsAbove 4 mcg/mLAbove 5 mcg/mLAbove 6 mcg/mLRapid infusionrate10 mg/min for 30 min15 mg/min for 30 min20 mg/min for 30 minMaintenance infusionrate0.75 mg/min1 mg/min1.25 mg/minNeonates (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/m2/day
for serious infections and 450 mg/m2/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 β-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:DoseDiluentTime300 mg600 mg900 mg1200 mg50 mL50 mL50-100 mL100 mL10 min20 min30 min40 minAdministration 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.

How Supplied

Clindamycin Injection, USP (150 mg/mL) is supplied as
follows:List No.VolumeType ContainerClindamycin baseTotal Content54868-3695-02 mLSingle-dose fliptop vial/25 vials per tray300 mgStore at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.

Animal Toxicology

One year oral toxicity studies in Spartan Sprague− Dawley rats
and beagle dogs at dose levels up to 300 mg/kg/day (approximately 1.1 and 3.6
times the highest recommended adult human dose based on mg/m2, respectively) have shown clindamycin to be well tolerated.
No appreciable difference in pathological findings has been observed between
groups of animals treated with clindamycin and comparable control groups. Rats
receiving clindamycin hydrochloride at 600 mg/kg/day (approximately 2.1 times
the highest recommended adult human dose based on mg/m2)
for 6 months tolerated the drug well; however, dogs dosed at this level
(approximately 7.2 times the highest recommended adult human dose based on
mg/m2) vomited, would not eat, and lost weight.Revised: March, 2008

References

  • Smith RB, Phillips JP: Evaluation of Clindamycin Hydrochloride
  • And Clindamycin Phosphate in an Aged Population. Upjohn TR:8147-9122-021,
  • December 1982.Bauer AW, Kirby WMM, Sherris JC, Turck M: Antibiotic
  • Susceptibility testing by a standardized single disk method, Am J Clin Path, 45:493-496, 1966. Standardized Disk
  • Susceptibility Test, Federal Register 37:20527-29,
  • 1972.National Committee for Clinical Lab. Standards. Methods for
  • Antimicrobial Susceptibility Testing of Anaerobic Bacteria-Second Edition;
  • Tentative Standard. NCCLS publication M11-T2. Villanova, PA; NCCLS;
  • 1988.

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