Label: CLEOCIN PHOSPHATE- clindamycin phosphate injection, solution

  • NDC Code(s): 0009-0302-02, 0009-0302-25, 0009-0602-04, 0009-0602-25, view more
    0009-0901-06, 0009-0901-25, 0009-3470-01, 0009-3470-02, 0009-6780-01, 0009-6780-02, 0009-9890-01, 0009-9890-02
  • Packager: Pharmacia and Upjohn Company LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated July 25, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    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

  • BOXED WARNING (What is this?)

    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.

  • 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:

    Chemical Structure

    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.

  • CLINICAL PHARMACOLOGY

    Distribution

    Biologically inactive clindamycin phosphate is converted to active clindamycin. By the end of short-term intravenous infusion, peak serum concentrations of active clindamycin are reached.

    After intramuscular injection of clindamycin phosphate, peak concentrations of active clindamycin are reached within 3 hours in adults and 1 hour in pediatric patients. Serum concentration-time curves may be constructed from IV peak serum concentrations as given in Table 1 by application of elimination half-lives (see Excretion).

    Serum concentrations 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 concentrations of clindamycin are attained in the cerebrospinal fluid even in the presence of inflamed meninges.

    Metabolism

    In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin.

    Excretion

    Biologically inactive clindamycin phosphate disappears from the serum with 6 minutes of the average elimination half-life; however, the average serum elimination half-life of active clindamycin is about 3 hours in adults and 2½ hours in pediatric patients.

    Specific Populations

    Patients with 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.

    Elderly Patients

    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, the average 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.

    Table 1. Average Peak and Trough Serum Concentrations of Active Clindamycin After Dosing with Clindamycin Phosphate
    Dosage RegimenPeak
    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 q6h10.92.0
      600 mg IV in 30 min q8h10.81.1
      900 mg IV in 30 min q8h14.11.7
      600 mg IM q12h*9
    Pediatric Patients (first dose)*
      5–7 mg/kg IV in 1 hour10
      5–7 mg/kg IM8
      3–5 mg/kg IM4

    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 [see Indications and Usage (1)]:

    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

    The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for clindamycin against isolates of a similar genus or organism group. However, the efficacy of clindamycin in treating clinical infections due to these bacteria 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

    For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

  • INDICATIONS AND USAGE

    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.

    Anaphylactic and Severe Hypersensitivity Reactions

    Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS).

    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 (see ADVERSE REACTIONS).

    In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy.

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

    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 liver and kidneys' 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.

    Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore, inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

    In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

    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

    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

    Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL at dosages of 150 mg orally to 600 mg intravenously. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

    The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.

    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 (see WARNINGS).

    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.

  • 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 levelsRapid infusion rateMaintenance infusion rate
    Above 4 mcg/mL10 mg/min for 30 min0.75 mg/min
    Above 5 mcg/mL15 mg/min for 30 min1.00 mg/min
    Above 6 mcg/mL20 mg/min for 30 min1.25 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:

    DoseDiluentTime
    300 mg50 mL10 min
    600 mg50 mL20 min
    900 mg50–100 mL30 min
    1200 mg  100 mL40 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 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 vialsNDC 0009-0302-25
    25-4 mL vialsNDC 0009-0602-25
    25-6 mL vialsNDC 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 mL24 Single Dose BagsNDC 0009-3470-02
    600 mg/50 mL24 Single Dose BagsNDC 0009-6780-02
    900 mg/50 mL24 Single Dose BagsNDC 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.
  • SPL UNCLASSIFIED SECTION

    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

    Logo

    PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

    CLEOCIN PHOSPHATE IV Solution in 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-0696-12.0
    Revised: 7/2019

  • 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

    PREMIERProRx®

    PRINCIPAL DISPLAY PANEL - 2 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 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

    PREMIERProRx®

    Rx only

    PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton
  • 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

    PREMIERProRx®

    PRINCIPAL DISPLAY PANEL - 4 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 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

    PREMIERProRx®

    Rx only

    PRINCIPAL DISPLAY PANEL - 4 mL Vial Carton
  • 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

    PREMIERProRx®

    PRINCIPAL DISPLAY PANEL - 6 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 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

    PREMIERProRx®

    Rx only

    PRINCIPAL DISPLAY PANEL - 6 mL Vial Carton
  • 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

    Code 2G3470
    Sterile, Nonpyrogenic

    GALAXY Single Dose Container

    PREMIERProRx®

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

    PREMIERProRx® is a registered trademark
    of Premier Healthcare Alliance, L.P.,
    used under license.

    PRINCIPAL DISPLAY PANEL - 300 mg/50 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 300 mg/50 mL Bag Box Label

    2 x 12 x 50 mL Single Dose Containers
    Contains 2 boxes of 12 of NDC 0009-3470-01

    Cleocin Phosphate® IV Solution
    clindamycin injection

    PREMIERProRx®

    300 mg/ 50 mL*
    in 5% Dextrose
    Rx only

    NDC 0009-3470-02
    Contains 24 of NDC 0009-3470-01
    Code 2G3470

    PRINCIPAL DISPLAY PANEL - 300 mg/50 mL Bag Box Label
  • PRINCIPAL DISPLAY PANEL - 600 mL/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

    Code 2G3471
    Sterile, Nonpyrogenic

    GALAXY Single Dose Container

    PREMIERProRx®

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

    PREMIERProRx® is a registered trademark
    of Premier Healthcare Alliance, L.P.,
    used under license.

    PRINCIPAL DISPLAY PANEL - 600 mL/50 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 600 mg/50 mL Bag Box Label

    2 x 12 x 50 mL Single Dose Containers
    Contains 2 boxes of 12 of NDC 0009-6780-01

    Cleocin Phosphate® IV Solution
    clindamycin injection

    PREMIERProRx®

    600 mg/ 50 mL*
    in 5% Dextrose
    Rx only

    NDC 0009-6780-02
    Contains 24 of NDC 0009-6780-01
    Code 2G3471

    PRINCIPAL DISPLAY PANEL - 600 mg/50 mL Bag Box Label
  • 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

    Code 2G3472
    Sterile, Nonpyrogenic

    GALAXY Single Dose Container

    PREMIERProRx®

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

    PREMIERProRx® is a registered trademark
    of Premier Healthcare Alliance, L.P.,
    used under license.

    PRINCIPAL DISPLAY PANEL - 900 mg/50 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 900 mg/50 mL Bag Box Label

    2 x 12 x 50 mL Single Dose Containers
    Contains 2 boxes of 12 of NDC 0009-9890-01

    Cleocin Phosphate® IV Solution
    clindamycin injection

    PREMIERProRx®

    900 mg/ 50 mL*
    in 5% Dextrose
    Rx only

    NDC 0009-9890-02
    Contains 24 of NDC 0009-9890-01
    Code 2G3472

    PRINCIPAL DISPLAY PANEL - 900 mg/50 mL Bag Box Label
  • INGREDIENTS AND APPEARANCE
    CLEOCIN PHOSPHATE 
    clindamycin phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-0302
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-0302-2525 in 1 CARTON04/10/2014
    1NDC:0009-0302-022 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05044104/10/2014
    CLEOCIN PHOSPHATE 
    clindamycin phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-0602
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-0602-2525 in 1 CARTON04/10/2014
    1NDC:0009-0602-044 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05044104/10/2014
    CLEOCIN PHOSPHATE 
    clindamycin phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-0901
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-0901-2525 in 1 CARTON04/10/2014
    1NDC:0009-0901-066 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05044104/10/2014
    CLEOCIN PHOSPHATE 
    clindamycin phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-3470
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-3470-0224 in 1 BOX09/26/2014
    1NDC:0009-3470-0150 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05063909/26/2014
    CLEOCIN PHOSPHATE 
    clindamycin phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-6780
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-6780-0224 in 1 BOX09/26/2014
    1NDC:0009-6780-0150 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05063909/26/2014
    CLEOCIN PHOSPHATE 
    clindamycin phosphate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-9890
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN18 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-9890-0224 in 1 BOX09/26/2014
    1NDC:0009-9890-0150 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05063909/26/2014
    Labeler - Pharmacia and Upjohn Company LLC (618054084)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Pharmaceuticals LLC829084545LABEL(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
    NameAddressID/FEIBusiness Operations
    Pharmacia and Upjohn Company LLC618054084ANALYSIS(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)