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.

tinued. 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 neonates ("gasping syndrome") this product contains benzyl alcohol as a preservative. the administration of intravenous solutions containing the preservative benzyl alcohol has been associated with the "gasping syndrome", and death in neonates. symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. although the normal therapeutic dose of this product delivers 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 and total daily benzyl alcohol exposure may be increased by concomitant medications. 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. nephrotoxicity clindamycin is potentially nephrotoxic and cases with acute kidney injury have been reported. consider monitoring of renal function particularly in patients with pre-existing renal dysfunction or those taking concomitant nephrotoxic drugs. in case of acute kidney injury, discontinue cleocin phosphate when no other etiology is identified. usage in meningitis since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

lindamycin dosage modification is not 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.

f 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: table 2: serum clindamycin levels maintained, rapid infusion rate and maintenance infusion rate 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 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. clindamycin should be dosed based on total body weight regardless of obesity. as an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m 2 /day for serious infections and 450 mg/m 2 /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. pediatric patients less than 1 month the recommended dosage is 15 to 20 mg/kg/day in 3 to 4 equal doses. see table 3 regarding the dosing regimen for pediatric patients with post-menstrual age (pma) less than or equal to 32 weeks, or greater than 32 weeks to less than or equal to 40 weeks. table 3: dosing regimens for pediatric patients with pma less than or equal to 32 weeks, or greater than 32 weeks to less than or equal to 40 weeks pma (weeks) dose (mg/kg) dosing interval (hours) pma: post-menstrual age less than or equal to 32 5 8 greater than or equal to 32 to less than or equal to 40 7 8 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. 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 or mini-bag containers, demonstrated physical and chemical stability for at least 16 days at 25°c. also, 18 mg/ml (equivalent to clindamycin base) in dextrose injection 5%, in mini-bag containers, 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 or mini-bag containers, 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 dextrose injection 5%, sodium chloride injection 0.9%, or lactated ringers injection in mini-bag containers demonstrated physical and chemical stability for at least eight weeks at -10°c. frozen solutions should be thawed at room temperature and not refrozen. directions for dispensing pharmacy bulk package — not for direct infusion the pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. entry into the vial should be made with a small diameter sterile transfer set or other small diameter sterile dispensing device, and contents dispensed in aliquots using aseptic technique. multiple entries with a needle and syringe are not recommended. after entry use entire contents of vial promptly. any unused portion must be discarded within 24 hours after initial entry. 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. preparation of cleocin phosphate in add-vantage system for iv use only. cleocin phosphate 300 mg, 600 mg and 900 mg may be reconstituted in 50 ml (for 300 mg and 600 mg) or 100 ml (for 900 mg) of dextrose injection 5% or sodium chloride injection 0.9% in the add-diluent container. refer to separate instructions for add-vantage system.

iated 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: acute kidney injury (see warnings ). 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 ).

contains benzyl alcohol. benzyl alcohol can cross the placenta. see warnings .

ome 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 do not need to be modified in patients with renal or hepatic disease. geriatric 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 function 1 . pharmacokinetics in pediatric patients with pma ≤32 weeks, or >32 to ≤40 weeks systemic clearance (cl) in premature infants increases with increases in body weight (kg) and post-menstrual age (pma). the dosing regimens for pediatric patients ≤32 weeks pma (5 mg/kg) and >32 to ≤ 40 weeks pma (7 mg/kg), both administered intravenously every 8 hours, achieve exposures comparable to therapeutic exposures in adults (weighing 70 kg) administered clindamycin 600 mg every 8 hours (table 1). table 1. predicted drug exposure (mean ± sd) of clindamycin in adults and in pediatric patients with pma ≤32 weeks, or >32 to ≤40 weeks age adult (70 kg) pma ≤32 weeks pma>32 – ≤40 weeks pma: post-menstrual age; auc ss,0–8 hour : area under the concentration-time curve during a dosing interval at steady state; c max,ss : maximum drug concentration at steady state; c min,ss : minimum or trough drug concentration at steady state. dose (every 8 hours) 600 mg 5 mg/kg 7 mg/kg auc ss,0–8 hour (mcg∙h/ml) 50.5 (30.95) 52.5 (17.0) 55.9 (23.55) c max,ss (mcg/ml) 12.0 (3.49) 9.0 (2.02) 10.5 (2.79) c min,ss (mcg/ml) 3.1 (3.34) 4.6 (2.00) 4.4 (2.77) obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years an analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. 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 ] : 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 cutibacterium 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.

81-02 24-600 mg/50 ml containers ndc 0009-3375-02 24-900 mg/50 ml containers ndc 0009-3382-02 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.

ths after having taken the last dose of the antibiotic. if this occurs, patients should contact their physician as soon as possible.