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Cleocin Phosphate

Generic Name: clindamycin phosphate
Dosage Form: injection, solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cleocin Phosphate and other antibacterial drugs, Cleocin Phosphate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Sterile Solution is for Intramuscular and Intravenous Use

Warning

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cleocin Phosphate 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 Cleocin Phosphate 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.

Cleocin Phosphate Description

Cleocin Phosphate Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. 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 L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-.

The molecular formula is C18H34CIN208PS and the molecular weight is 504.96.

The structural formula is represented below:

Cleocin Phosphate IV Solution in the GALAXY plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid.

The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

Cleocin Phosphate - Clinical Pharmacology

Distribution

Biologically inactive clindamycin phosphate is converted to active clindamycin.

By the end of short-term intravenous infusion, peak serum levels of active clindamycin are reached.

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 IV peak serum levels as given in Table 1 by application of elimination half-lives (see Excretion).

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.

No significant levels of clindamycin are attained in the cerebrospinal fluid even in the presence of inflamed meninges.

Excretion

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.

Special Populations

Renal/Hepatic Impairment

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.

Use in Elderly

Pharmacokinetic studies in elderly volunteers (61–79 years) and younger adults (18–39 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 IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4.0 hours (range 3.4–5.1 h) in the elderly, compared to 3.2 hours (range 2.1–4.2 h) in younger adults. The extent of absorption, however, is not different between 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 Phosphate
Dosage Regimen Peak
mcg/mL
Trough
mcg/mL
*
Data in this group from patients being treated for infection.
Healthy Adult Males
(Post equilibrium)
  600 mg IV in 30 min q6h 10.9 2.0
  600 mg IV in 30 min q8h 10.8 1.1
  900 mg IV in 30 min q8h 14.1 1.7
  600 mg IM q12h* 9
Pediatric Patients (first dose)*
  5–7 mg/kg IV in 1 hour 10
  5–7 mg/kg IM 8
  3–5 mg/kg IM 4

Microbiology

Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

Resistance

Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria. Macrolide-resistant isolates of staphylococci and beta-hemolytic streptococci should be screened for induction of clindamycin resistance using the D-zone test.

Antimicrobial Activity

Clindamycin has been shown to be active against most of the isolates of the following microorganisms, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section.

Gram-positive Bacteria

 
Staphylococcus aureus (methicillin-susceptible strains)
 
Streptococcus pneumoniae (penicillin-susceptible strains)
 
Streptococcus pyogenes

Anaerobic Bacteria

 
Clostridium perfringens
 
Fusobacterium necrophorum
 
Fusobacterium nucleatum
 
Peptostreptococcus anaerobius
 
Prevotella melaninogenica

At least 90% of the microorganisms listed below exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the clindamycin susceptible MIC breakpoint for organisms of a similar type to those shown in Table 2. However, the efficacy of clindamycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.

Gram-positive Bacteria

 
Staphylococcus epidermidis (methicillin-susceptible strains)
 
Streptococcus agalactiae
 
Streptococcus anginosus
 
Streptococcus mitis
 
Streptococcus oralis

Anaerobic Bacteria

 
Actinomyces israelii
 
Clostridium clostridioforme
 
Eggerthella lenta
 
Finegoldia (Peptostreptococcus) magna
 
Micromonas (Peptostreptococcus) micros
 
Prevotella bivia
 
Prevotella intermedia
 
Propionibacterium acnes

Susceptibility Testing Methods

When available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method2,3 (broth and/or agar). The MIC values should be interpreted according to the criteria provided in Table 2.

Diffusion Techniques

Quantitative methods that require the measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized method2,5. This procedure uses paper disks impregnated with 2 mcg of clindamycin to test the susceptibility of bacteria to clindamycin. The disk diffusion breakpoints are provided in Table 2.

Anaerobic Techniques

For anaerobic bacteria, the susceptibility to clindamycin can be determined by a standardized test method2,4. The MIC values obtained should be interpreted according to the criteria provided in Table 2.

Table 2. Susceptibility Test Interpretive Criteria for Clindamycin
Susceptibility Interpretive Criteria
Pathogen Minimal Inhibitory Concentrations
(MIC in mcg/mL)
Disk Diffusion
(Zone Diameters in mm)
NA=not applicable

Staphylococcus spp.
S
≤0.5
I
1–2
R
≥4
S
≥21
I
15–20
R
≤14
Streptococcus pneumoniae and other Streptococcus spp. ≤0.25 0.5 ≥1 ≥19 16–18
≤15
Anaerobic Bacteria ≤2 4 ≥8 NA NA NA

A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small, uncontrolled technical factors from causing major discrepancies in interpretation.

A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test.2,3,4,5 Standard clindamycin powder should provide the MIC ranges in Table 3. For the disk diffusion technique using the 2 mcg clindamycin disk the criteria provided in Table 2 should be achieved.

Table 3. Acceptable Quality Control Ranges for Clindamycin
Acceptable Quality Control Ranges
QC Strain Minimum Inhibitory Concentration Range
(mcg/mL)
Disk Diffusion Range
(Zone Diameters in mm)
NA=Not applicable
ATCC® is a registered trademark of the American Type Culture Collection
*
Enterococcus faecalis has been included in this table for quality control purposes only.
Quality control for C. difficile is performed using the agar dilution method only, all other obligate anaerobes may be tested by either broth microdilution or agar dilution methods.
Enterococcus faecalis*
ATCC 29212
4–16 NA
Staphylococcus aureus
ATCC 29213
0.06–0.25 NA
Staphylococcus aureus
ATCC 25923
NA 24–30
Streptococcus pneumoniae
ATCC 49619
0.03–0.12
19–25
Bacteroides fragilis
ATCC 25285
0.5–2 NA
Bacteroides thetaiotaomicron
ATCC 29741
2–8 NA
Clostridium difficile
ATCC 700057
2–8 NA
Eggerthella lenta
ATCC 43055
0.06–0.25 NA

Indications and Usage for Cleocin Phosphate

Cleocin Phosphate products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Cleocin Phosphate products are 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 BOXED WARNING, 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.

Cleocin Phosphate 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 Cleocin Phosphate and other antibacterial drugs, Cleocin Phosphate 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 BOXED WARNING.

Clostridium difficile associated diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cleocin Phosphate, 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.

Hypersensitivity

Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported. In case of such an event, treatment should be permanently discontinued.

A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

SERIOUS ANAPHYLACTOID OR ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN AND INTRAVENOUS CORTICOSTEROIDS SHOULD ALSO BE ADMINISTERED AS INDICATED.

Benzyl Alcohol Toxicity in Pediatric Patients ("Gasping Syndrome")

This product contains benzyl alcohol as a preservative. The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low birth weight infants may be more likely to develop toxicity.

Usage in Meningitis

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

Precautions

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.

Cleocin Phosphate products should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cleocin 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 Cleocin Phosphate may result in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Cleocin 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 Cleocin Phosphate 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 Patients

Patients should be counseled that antibacterial drugs including Cleocin Phosphate should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cleocin Phosphate 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 Cleocin Phosphate 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 Tests

During prolonged therapy periodic liver and kidney function tests and blood counts should be performed.

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.

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/m2) revealed no effects on fertility or mating ability.

Pregnancy

Teratogenic effects

Pregnancy Category B

In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.

Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.

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/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.

Cleocin Phosphate Sterile Solution contains benzyl alcohol. Benzyl alcohol can cross the placenta. See WARNINGS.

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 serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.

Pediatric Use

When Cleocin Phosphate Sterile Solution is administered to the pediatric population (birth to 16 years) appropriate monitoring of organ system functions is desirable.

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. See WARNINGS.

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. See WARNINGS.

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.

Adverse Reactions

The following reactions have been reported with the use of clindamycin.

Infections and Infestations

Clostridium difficile colitis

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 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.

Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (see WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. Anaphylactic shock, anaphylactic reaction and hypersensitivity have also 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, angioedema 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.

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.

Immune System

Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Local Reactions

Injection site irritation, 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

Polyarthritis cases have been reported.

Cardiovascular

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.

Cleocin Phosphate Dosage and Administration

If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

Clindamycin phosphate IM administration should be used undiluted.

Clindamycin phosphate IV administration should be diluted (see Dilution for IV use and IV infusion rates below).

Adults

Parenteral (IM or IV 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):

600–1200 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:

1200–2700 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 for IV use and IV Infusion Rates section below).

Single intramuscular 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 IV infusion as follows:

To maintain serum clindamycin levels Rapid infusion rate Maintenance infusion rate
Above 4 mcg/mL 10 mg/min for 30 min 0.75 mg/min
Above 5 mcg/mL 15 mg/min for 30 min 1.00 mg/min
Above 6 mcg/mL 20 mg/min for 30 min 1.25 mg/min

Neonates (less than 1 month)

15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

Pediatric patients 1 month of age to 16 years

Parenteral (IM or IV) 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 oral CLEOCIN PEDIATRIC® Flavored Granules (clindamycin palmitate hydrochloride) or CLEOCIN HCl® Capsules (clindamycin hydrochloride) 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 for IV use and IV Infusion Rates

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:

Dose Diluent Time
300 mg 50 mL 10 min
600 mg 50 mL 20 min
900 mg 50–100 mL 30 min
1200 mg   100 mL 40 min

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 Cleocin Phosphate Sterile Solution (clindamycin phosphate) in IV 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. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact the Medical and Drug Information Unit, Pharmacia & Upjohn Company (Division of Pfizer Inc).

Physico-Chemical Stability of Diluted Solutions of Cleocin Phosphate

Room Temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles, 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 dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles, 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.

DIRECTIONS FOR USE

Cleocin Phosphate IV Solution in GALAXY Plastic Container

Premixed Cleocin Phosphate IV Solution is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use unless solution is clear and seal is intact.

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.

Preparation for Administration

  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

How is Cleocin Phosphate Supplied

Each mL of Cleocin Phosphate Sterile Solution contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate; 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. Cleocin Phosphate is available in the following packages:

25-2 mL vials NDC 0009-0302-25
25-4 mL vials NDC 0009-0602-25
25-6 mL vials NDC 0009-0901-25

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Cleocin Phosphate IV Solution in GALAXY plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. The single dose GALAXY plastic containers are available as follows:

300 mg/50 mL 24 Single Dose Bags NDC 0009-3470-02
600 mg/50 mL 24 Single Dose Bags NDC 0009-6780-02
900 mg/50 mL 24 Single Dose Bags NDC 0009-9890-02

Exposure of pharmaceutical products to heat should be minimized. It is recommended that GALAXY plastic containers be stored at room temperature (25°C). Avoid temperatures above 30°C.

REFERENCES

1.
Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and Cleocin Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.
2.
CLSI. Performance Standards for Antimicrobial Susceptibility Testing: 26th ed CLSI supplement M100S. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
3.
CLSI. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
4.
CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. CLSI document M11-A8. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
5.
CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Twelfth Edition. CLSI document M02-A12. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Distributed by Pharmacia & Upjohn Co.
Division of Pfizer Inc.
New York, NY 10017

PremierProRx® is a registered trademark of Premier, Inc., used under license.

Cleocin Phosphate IV Solution in the GALAXY plastic containers is manufactured for Pfizer Inc by Baxter Healthcare Corporation, Deerfield, IL 60015.

GALAXY® is a registered trademark of Baxter International Inc.

LAB-0696-4.0
April 2016

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

2 mL Vial
NDC 0009-0302-02

Cleocin
Phosphate
®
clindamycin injection, USP
300 mg/2 mL*

(150 mg/mL)
Rx only

For intramuscular or intravenous use

PREMIERPro™Rx

PRINCIPAL DISPLAY PANEL - 25—2 mL Vial Carton

NDC 0009-0302-25
Contains 25 of NDC 0009-0302-02

25—2 mL Single Dose Vials

Cleocin Phosphate®
clindamycin injection, USP
300 mg/2 mL*

(150 mg/mL)

For intramuscular or intravenous use

PREMIERPro™Rx
Rx only

PRINCIPAL DISPLAY PANEL - 4 mL Vial Label

4 mL Vial
NDC 0009-0602-04

Cleocin Phosphate®
clindamycin injection, USP
600 mg/4 mL*

(150 mg/mL)
Rx only

For intramuscular or intravenous use

PREMIERPro™Rx

PRINCIPAL DISPLAY PANEL - 25—4 mL Vial Carton

NDC 0009-0602-25
Contains 25 of NDC 0009-0602-04

25—4 mL Single Dose Vials

Cleocin Phosphate®
clindamycin injection, USP
600 mg/4 mL*

(150 mg/mL)

For intramuscular or intravenous use

PREMIERPro™Rx
Rx only

PRINCIPAL DISPLAY PANEL - 6 mL Vial Label

6 mL Vial
NDC 0009-0901-06

Cleocin Phosphate®
clindamycin injection, USP
900 mg/6 mL*

(150 mg/mL)
Rx only

For intramuscular or intravenous use

PREMIERPro™Rx

PRINCIPAL DISPLAY PANEL - 25—6 mL Vial Carton

NDC 0009-0901-25
Contains 25 of NDC 0009-0901-06

25—6 mL Single Dose Vials

Cleocin Phosphate®
clindamycin injection, USP
900 mg/6 mL*

(150 mg/mL)

For intramuscular or intravenous use

PREMIERPro™Rx
Rx only

PRINCIPAL DISPLAY PANEL - 300 mg/50 mL Bag Label

NDC 0009-3470-01

Cleocin Phosphate® IV Solution
clindamycin injection
300 mg/ 50 mL* in 5% DEXTROSE
Rx only

For Intravenous Use

PRINCIPAL DISPLAY PANEL - 300 mg/50 mL Carton Label

12 x 50 mL Single Dose Containers
Contains 12 of NDC 0009-3470-01

Cleocin Phosphate® IV Solution
clindamycin injection

PREMIERPro ™ Rx

300 mg/ 50 mL*
in 5% Dextrose

Rx only

NDC 0009-3470-02
Code 2G3470

PRINCIPAL DISPLAY PANEL - 600 mg/50 mL Bag Label

NDC 0009-6780-01

Cleocin Phosphate® IV Solution
clindamycin injection
600 mg/ 50 mL* in 5% DEXTROSE
Rx only

For Intravenous Use

PRINCIPAL DISPLAY PANEL - 600 mg/50 mL Carton Label

12 x 50 mL Single Dose Containers
Contains 12 of NDC 0009-6780-01

Cleocin Phosphate® IV Solution
clindamycin injection

PREMIERPro ™ Rx

600 mg/ 50 mL*
in 5% Dextrose

Rx only

NDC 0009-6780-02
Code 2G3471

PRINCIPAL DISPLAY PANEL - 900 mg/50 mL Bag Label

NDC 0009-9890-01

Cleocin Phosphate® IV Solution
clindamycin injection
900 mg/ 50 mL* in 5% DEXTROSE
Rx only

For Intravenous Use

PRINCIPAL DISPLAY PANEL - 900 mg/50 mL Carton Label

12 x 50 mL Single Dose Containers
Contains 12 of NDC 0009-9890-01

Cleocin Phosphate® IV Solution
clindamycin injection

PREMIERPro ™ Rx

900 mg/ 50 mL*
in 5% Dextrose

Rx only

NDC 0009-9890-02
Code 2G3472

Cleocin Phosphate 
clindamycin phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-0302
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 150 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.5 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0009-0302-25 25 VIAL in 1 CARTON
1 NDC:0009-0302-02 2 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050441 04/10/2014
Cleocin Phosphate 
clindamycin phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-0602
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 150 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.5 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0009-0602-25 25 VIAL in 1 CARTON
1 NDC:0009-0602-04 4 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050441 04/10/2014
Cleocin Phosphate 
clindamycin phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-0901
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 150 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.5 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0009-0901-25 25 VIAL in 1 CARTON
1 NDC:0009-0901-06 6 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050441 04/10/2014
Cleocin Phosphate 
clindamycin phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-3470
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 6 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.5 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0009-3470-02 24 BAG in 1 BOX
1 NDC:0009-3470-01 50 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050639 09/26/2014
Cleocin Phosphate 
clindamycin phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-6780
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 12 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.5 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0009-6780-02 24 BAG in 1 BOX
1 NDC:0009-6780-01 50 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050639 09/26/2014
Cleocin Phosphate 
clindamycin phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-9890
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 18 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.5 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0009-9890-02 24 BAG in 1 BOX
1 NDC:0009-9890-01 50 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050639 09/26/2014
Labeler - Pharmacia and Upjohn Company LLC (618054084)
Establishment
Name Address ID/FEI Operations
Chongqing Carelife Pharmaceutical Co., Ltd 531132009 API MANUFACTURE(0009-9890, 0009-6780, 0009-3470, 0009-0901, 0009-0602, 0009-0302)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 LABEL(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890), PACK(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890), API MANUFACTURE(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890), LABEL(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890), MANUFACTURE(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890), PACK(0009-0302, 0009-0602, 0009-0901, 0009-3470, 0009-6780, 0009-9890)
Revised: 04/2016
 
Pharmacia and Upjohn Company LLC
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