NDC 52584-090 Clindamycin

Clindamycin Phosphate

NDC Product Code 52584-090

NDC 52584-090-02

Package Description: 1 VIAL in 1 BAG > 2 mL in 1 VIAL

NDC 52584-090-04

Package Description: 1 VIAL in 1 BAG > 4 mL in 1 VIAL

NDC 52584-090-06

Package Description: 1 VIAL, SINGLE-DOSE in 1 BAG > 6 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Clindamycin with NDC 52584-090 is a a human prescription drug product labeled by General Injectables And Vaccines, Inc.. The generic name of Clindamycin is clindamycin phosphate. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

Labeler Name: General Injectables And Vaccines, Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clindamycin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CLINDAMYCIN PHOSPHATE 150 mg/mL

Inactive Ingredient(s)

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

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

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Lincosamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lincosamides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: General Injectables And Vaccines, Inc.
Labeler Code: 52584
FDA Application Number: ANDA090108 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-30-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Clindamycin Product Labeling Information

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

Product Labeling Index

Description

Clindamycin Injection, USP, a clear colorless to pale yellow sterile solution, 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. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. Clindamycin is a semisynthetic antibiotic producted 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-A-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbony|]amino]-1-thio-,2-(dihydrogen phosphate), (2S-trans)-.The molecular formula is C18H34CIN2O8PS and the molecular weight is 504.96. The structural formual is represented below:

Clinical Pharmacology

DistributionBiologically 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 levels 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.ExcretionBiologically inactive clindamycin phosphate disappears rapidly from the serum; the average elimination half-life is 6 minutes; however, the serum elimination half-life of active clindamycin is about 3 hours in adults and 2 1/2 hours in pediatric patients.Special PopulationsRenal/Hepatic ImpairmentThe 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 ElderlyPharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4 hours (range 3.4 to 5.1 h) in the elderly, compared to 3.2 hours (range 1.2 to 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.MicrobiologyMechanism of ActionClindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.ResistanceResistance to clindamycin is most often caused by modification of specific bases of the 23S rebosomal 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 ActivityClindamycin 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 BacteriaStaphylococcus aureus (methicillin-susceptible strains)Streptococcus pneumoniae (penicillin-susceptible strains)Streptococcus pyogenesAnaerobic BacteriaClostridium perfringensFusobacterium necrophorumFusobacterium nucleatumPeptostreptococcus anaerobiusPrevotella melaninogenicaAt 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 BacteriaStaphylococcus epidermidis (methicillin-susceptible strains)Streptococcus agalactiaeStreptococcus anginosusStreptococcus mitisStreptococcus oralisAnaerobic BacteriaActinomyces israeliiClostridium clostridioformeEggerthella lentaFinegoldia (Peptostreptococcus) magnaMicromonas (Petopstreptococcus) microsPrevotella biviaPrevotella intermediaPropionibacterium acnesSusceptibility Testing MethodsWhen 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 physicians in selecting an antibacterial drug for treatment.Dilution TechniquesQuantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs povide 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 TechniquesQuantitative 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 TechniquesFor 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.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 concentation usually achievable at the infection site; other therapy should be selected.Quallity ControlStandardized 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 test2,3,4,5. Standard clindamycin powder should provide the MIC ranges in Table 3. For the disk diffusion technique using the 2mcg clindamycin disk the criteria provided in Table 2 should be achieved.NA-Not ApplicableATCC is a registred trademark of the American type Culture Collection

Indications And Usage

Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the 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.Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.Skin and skin structure infections caused by Streptococcus pyogens, 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 susceptile anaerobes.Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection, USP and other antibacterial drugs, Clindamycin Injection, USP 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 WARNINGClostridium difficile Associated DiarrheaClostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin injection, 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 ReactionsAnaphylactic 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-Johnsons 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

GeneralReview of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.Clindamycin injection products should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.Clindamycin injection should be prescribed with caution in atopic individuals.Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy.The use of clindamycin injection may result in overgrowth of nonsusceptible organisms-particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.Clindamycin injection should not be injected intravenously undiluted as a bolus, but should be infused over at least 10 to 60 minutes as directed in the DOSAGE AND ADMINISTRATION section.Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However periodic liver enzyme determinations should be made when treating patients with severe liver disease.Prescribing clindamycin injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.Information for PatientsPatients should be counseled that antibacterial drugs including clindamycin injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin injection 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 which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.Laboratory TestsDuring prolonged therapy periodic liver and kidney function tests and blood counts should be performed.Drug InteractionsClindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, the two drugs should not be administered concurrently.Carcinogenesis, Mutagenesis, Impairment of FertilityLong term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.1 times the highest recommended adult human dose based on mg/m2) revealed no effects on fertility or mating ability.Pregnancy: Teratogenic effectsPregnancy Category BIn 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 pregnancy women during the first trimester of pregnancy. Because of 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.Clindamycin injection contains benzyl alcohol. Benzyl alcohol can cross the placenta. See WARNINGS.Nursing MothersClindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL at dosages of 150 mg orally to 600 mg intravenously. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.Pediatric UseWhen clindamycin injection is administered to the pediatric population (birth to 16 years) appropriate monitoring organ system functions is desirable.Usage in Newborns and InfantsThis product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. 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 UseClinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether the 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 clinicially 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 Epideraml 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 hae 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 infustion. 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).To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 injection IM adminstration should be used undiluted.Clindamycin injection 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 mg to 1200 mg/day in 2, 3, or 4 equal doses.More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:1200 mg to 2700 mg/day in 2, 3 or 4 equal doses.For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution 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: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.Premature 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 clindamycin flavored granules (clindamycin palmitate hydrochloride) or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.In cases of B-hemolytic streptoccol 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:Administration of more than 1200 mg in a single 1-hour infusion is not recommended.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin injection (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 imcompatible 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 affairs department toll-free at 1-866-625-1618.Physio-Chemical Stability of Diluted Solutions of Clindamycin InjectionRoom 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 minibags, demonstrated physical and chemical stability for at least 16 days at 25C. Also, 18 mg/mL (equivalent to clindamycin base) indextrose injection 5%, in minibags, demonstrated physical and chemical stability for at least 16 days at 25C.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 minibags, demonstrated physical and chemical stability for at least 32 days at 4C.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 minibags demonstrated physical and chemical stability for at least eight weeks at -10C.Frozen solutions should be thawed at room temperature and not refrozen.

How Supplied

Each mL of Clindamycin Injection, USP contains clindamycin phosphate equivalent to 150 mg of clindamycin. Also contains 0.5 mg disodium edetate; and 9.45 mg benzyl alcohol as a preservative. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.Clindamycin Injection, USP is supplied as follows:Storage ConditionsStore at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] Do not refrigerate.Sterile, Nonpyrogenic.The container closure is not made with natural rubber latex.

References

SAGENTMfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in India2016 Sagent Pharamceuticals, Inc.Revised: August 2016

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