clindamycin phosphate
Gel · Topical, Intravenous, Vaginal
Current shortage
Clindamycin Phosphate, Injection, 300 mg/50 mL (NDC 0338-9545-50) – Available (Baxter Healthcare, updated Sep 17, 2026)
Clindamycin Phosphate, Injection, 900 mg/50 mL (NDC 0338-3814-50) – Limited Availability (Baxter Healthcare, updated Sep 17, 2026)
Estimated recovery: November 2026
Clindamycin Phosphate, Injection, 300 mg/50 mL (NDC 0338-9549-50) – Available (Baxter Healthcare, updated Sep 17, 2026)
Clindamycin Phosphate, Injection, 600 mg/50 mL (NDC 0338-3612-50) – Unavailable (Baxter Healthcare, updated Sep 17, 2026)
Estimated recovery: October 2026
Clindamycin Phosphate, Injection, 300 mg/50 mL (NDC 0338-3410-50) – Available (Baxter Healthcare, updated Sep 17, 2026)
Clindamycin Phosphate, Injection, 900 mg/50 mL (NDC 0338-9553-50) – Available (Baxter Healthcare, updated Sep 17, 2026)
Uses
Clindamycin Phosphate in Sodium Chloride Injection contains clindamycin, a lincosamide antibacterial indicated for the treatment of the following in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved:
• Serious infections caused by susceptible anaerobic bacteria ( 1.1 )
• Infections Due to Susceptible Isolates of Streptococci, Pneumococci and Staphylococci. ( 1.2 )
• Lower Respiratory Tract Infections. ( 1.3 )
• Skin and Skin Structure Infections. ( 1.4 )
• Gynecological Infections. ( 1.5 )
• Intra-abdominal Infections. ( 1.6 )
• Septicemia. ( 1.7 )
• Bone and Joint Infections. ( 1.8 ) Limitation of use Since clindamycin does not diffuse adequately into the cerebrospinal fluid, Clindamycin Phosphate in Sodium Chloride Injection should not be used in the treatment of meningitis ( 1.9 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Phosphate in Sodium Chloride Injection and other antibacterial drugs, Clindamycin Phosphate in Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.10 ) 1.1 Infections Due to Susceptible Anaerobic Bacteria Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.3 - 1.7) ] . 1.2 Infections Due to Susceptible Isolates of Streptococci, Pneumococci and Staphylococci Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious infections due to susceptible isolates of streptococci, pneumococci, and staphylococci in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 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 antibacterial drug-associated pseudomembranous colitis, [see 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 antibacterial therapy. 1.3 Lower Respiratory Tract Infections Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by susceptible isolates of anaerobes, Streptococcus pneumoniae , other streptococci (except E. faecalis ), and Staphylococcus aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 1.4 Skin and Skin Structure Infections Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious skin and skin structure infections caused by susceptible isolates of Streptococcus pyogenes , Staphylococcus aureus , and anaerobes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 1.5 Gynecological Infections Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 1.6 Intra-abdominal Infections Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 1.7 Septicemia Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious septicemia caused by susceptible isolates of Staphylococcus aureus , streptococci (except Enterococcus faecalis ), and susceptible anaerobes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 1.8 Bone and Joint Infections Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious bone and joint infections including acute hematogenous osteomyelitis caused by susceptible isolates of Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. 1.9 Limitations of Use Since clindamycin does not diffuse adequately into the cerebrospinal fluid, Clindamycin Phosphate in Sodium Chloride Injection should not be used in the treatment of meningitis [see Clinical Pharmacology (12.3) ] . 1.10 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Phosphate in Sodium Chloride Injection and other antibacterial drugs, Clindamycin Phosphate in Sodium Chloride Injection 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.
Dosage and administration
• If a dose of Clindamycin Phosphate in Sodium Chloride Injection is required that does not equal 300 mg 600 mg or 900 mg, this product is not recommended for use and an alternative formulation of clindamycin should be considered. ( 2.1 )
• Recommended Adult Dosage: Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis , Peptococcus species and Clostridioides species other than Clostridium perfringens ): 600–1200 mg/day in 2, 3 or 4 equal doses by intravenous infusion. ( 2.2 )
• 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 by intravenous infusion. ( 2.2 )
• Dosage in Pediatric Patients (1 Month of Age to 16 Years): 20 to 40 mg/kg/day in 3 or 4 equal doses by intravenous infusion. ( 2.3 )
• Alternative Pediatric Patients Dosing: 350 mg/m 2 /day for serious infections and 450 mg/m2/day for more severe infections. ( 2.3 )
• Dosage in Neonates (Less than 1 Month of Age): 15 to 20 mg/kg/day in 3 to 4 equal doses by intravenous infusion. ( 2.3 ) 2.1 Important Administration and Discontinuation Instructions If a dose of Clindamycin Phosphate in Sodium Chloride Injection is required that does not equal 300 mg 600 mg or 900 mg, this product is not recommended for use and an alternative formulation of clindamycin should be considered. Administer Clindamycin Phosphate in Sodium Chloride Injection by intravenous infusion over at least 10 minutes. Infusion rates should NOT exceed 30 mg per minute. The usual infusion rates are described in Table 1 . Table 1: Usual Infusion Rates for the Administration of Clindamycin Phosphate in Sodium Chloride Injection Dose Time 300 mg 10 min 600 mg 20 min 900 mg 30 min Discontinue Clindamycin Phosphate in Sodium Chloride Injection if diarrhea occurs during therapy [see Boxed Warning ]. 2.2 Recommended Adult Dosage The recommended dosing regimen for Clindamycin Phosphate in Sodium Chloride Injection is 600-1200 mg/day in 2, 3, or 4 equal doses by intravenous infusion for 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 ). For more severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens, the recommended dosing regimen is 1200-2700 mg/day in 2, 3, or 4 equal doses by intravenous infusion. In life-threatening situations, these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous intravenous infusion as follows: Table 2: Infusion Rates for the Administration of Clindamycin Injection by Single Rapid Infusion followed by Continuous Intravenous Infusion for the Maintenance of Serum Clindamycin Levels 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 2.3 Dosage in Pediatric Patients If a dose of Clindamycin Phosphate in Sodium Chloride Injection is required that does not equal 300 mg, 600 mg or 900 mg, this product is not recommended for use and an alternative formulation of clindamycin should be considered. The recommended pediatric dosing regimen of Clindamycin Phosphate in Sodium Chloride Injection is as follows: Pediatric patients (1 month of age to 16 years old): The recommended dosage is 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/m 2 /day for serious infections and 450 mg/m 2 /day for more severe infections. Parenteral therapy may be changed to oral formulations of clindamycin 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) Less than or equal to 32 5 8 Greater than or equal to 32 weeks to less than or equal to 40 7 8 PMA: Post-Menstrual Age 2.4 Directions for Use of Clindamycin Phosphate in Sodium Chloride Injection in GALAXY Plastic Container Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Premixed Clindamycin Phosphate in Sodium Chloride Injection is for intravenous infusion 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. 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.
Dosage forms and strengths
Injection: Clindamycin Phosphate in Sodium Chloride Injection is a clear, colorless and sterile solution available in three strengths:
• 300 mg/50 mL (6 mg/mL): Each 50 mL single-dose GALAXY container contains 300 mg clindamycin (as clindamycin phosphate, USP) in 0.9% sodium chloride.
• 600 mg/50 mL (12 mg/mL): Each 50 mL single-dose GALAXY container contains 600 mg clindamycin (as clindamycin phosphate, USP) in 0.9% sodium chloride.
• 900 mg/50 mL (18 mg/mL): Each 50 mL single-dose GALAXY container contains 900 mg clindamycin (as clindamycin phosphate, USP) in 0.9% sodium chloride. Each 50 mL of Clindamycin Phosphate in Sodium Chloride Injection, 300 mg/50 mL (6 mg/mL), 600 mg/50 mL (12 mg/mL), and 900 mg/50 mL (18 mg/mL) contains 300 mg, 600 mg, or 900 mg clindamycin, respectively (as clindamycin phosphate, USP), in a single-dose GALAXY container. ( 3 )
Contraindications
Clindamycin Phosphate in Sodium Chloride Injection is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. Individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. ( 4 )
Warnings and precautions
• Anaphylactic shock, anaphylactic reactions and severe hypersensitivity reactions have been reported. Discontinue treatment if such reactions occur. ( 5.2 )
• Cases with acute kidney injury (AKI) have been reported during treatment with clindamycin. Consider renal function monitoring, particularly in certain patients (e.g., those with pre-existing renal dysfunction). Discontinue treatment, if AKI occurs and no other etiology is identified. ( 5.3 )
• Elderly patients with associated severe illness may have a greater risk of developing adverse reactions from diarrhea. Monitor these patients carefully for change in bowel frequency. ( 5.4 )
• Avoid use of Clindamycin Phosphate in Sodium Chloride Injection in individuals with a history of gastrointestinal disease, particularly colitis. ( 5.5 )
• Avoid use of Clindamycin Phosphate in Sodium Chloride Injection in atopic individuals. ( 5.6 )
• During prolonged therapy, perform periodic liver and kidney function tests and blood counts. ( 5.7 )
• The use of Clindamycin Phosphate in Sodium Chloride Injection may result in overgrowth of nonsusceptible organisms-particularly yeasts. Take appropriate measures, if this occurs. ( 5.8 ) 5.1 Clostridioides difficile -Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Phosphate in Sodium Chloride 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 isolates 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 antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Boxed Warning ]. 5.2 Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported [see Adverse Reactions (6) ]. Severe hypersensitivity reactions, including acute myocardial ischemia with or without myocardial infarction, and severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported [see Adverse Reactions (6) ]. 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. 5.3 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 Clindamycin Phosphate in Sodium Chloride Injection when no other etiology is identified [see Adverse Reactions (6) ]. 5.4 Diarrhea in Elderly Patients with Associated Severe Illness Elderly patients with associated severe illness may have a greater risk of developing adverse reactions from diarrhea. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency [see Use in Specific Populations (8.5) ] . 5.5 Use in Patients with Gastrointestinal Disease Clindamycin Phosphate in Sodium Chloride Injection products should be avoided in individuals with a history of gastrointestinal disease, particularly colitis. 5.6 Use in Atopic Individuals Clindamycin Phosphate in Sodium Chloride Injection should be avoided in atopic individuals. 5.7 Laboratory Tests: Monitoring to Assess Safety During prolonged therapy periodic liver and kidney function tests and blood counts should be performed. Clindamycin 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. 5.8 Overgrowth of Nonsusceptible Organisms The use of Clindamycin Phosphate in Sodium Chloride Injection may result in overgrowth of nonsusceptible organisms-particularly yeasts. If such infections occur, appropriate measures should be taken as indicated by the clinical situation. 5.9 Development of Drug-Resistant Bacteria Prescribing Clindamycin Phosphate in Sodium Chloride 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.
Side effects
The following serious adverse reactions to clindamycin are described below and elsewhere in the labeling:
• Clostridioides difficile- Associated Diarrhea [see Warnings and Precautions (5.1) ]
• Anaphylactic and Severe Hypersensitivity Reactions [see Warnings and Precautions (5.2) ]
• Nephrotoxicity [see Warnings and Precautions (5.3) ] The following adverse reactions associated with the use of clindamycin were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably, or to establish a causal relationship to drug exposure. Infections and Infestations Clostridioides difficile colitis Gastrointestinal Antibacterial drug-associated colitis [see Warnings and Precautions (5.1) ] , pseudomembranous colitis, abdominal pain, nausea, and vomiting. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.1) ] . 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 and Precautions (5.2) ] . Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. Anaphylactic shock, anaphylactic reaction, hypersensitivity, and acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction have also been reported [see Warnings and Precautions (5.2) ]. Cutaneous vasculitis and symmetrical drug-related intertriginous and flexural exanthema have also been reported. Skin and Mucous Membranes Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported [see Warnings and Precautions (5.2) ]. Liver Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Renal Acute kidney injury [see Warnings and Precautions (5.3) ]. Hematopoietic Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. Immune System Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Local Reactions Thrombophlebitis has been reported after intravenous infusion. Avoid 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 (2) ] . Most common adverse reactions: gastrointestinal (abdominal pain, nausea, vomiting) and hypersensitivity reactions (anaphylaxis, urticaria, skin rash). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
• Neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. ( 7.1 )
• Monitor for adverse reactions when strong CYP3A4 and/or CYP3A5 inhibitors are coadministered with clindamycin. ( 7.2 )
• In the presence of strong CYP3A4 and/or CYP3A5 inducers such as rifampicin, monitor for loss of effectiveness. ( 7.3 ) 7.1 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be avoided in patients receiving such agents. 7.2 Inhibitors of CYP3A4 and CYP3A5 Inhibitors of CYP3A4 and/or CYP3A5 may increase plasma concentrations of clindamycin [ see Clinical Pharmacology (12.3) ]. Monitor for adverse reactions when strong CYP3A4 and/or CYP3A5 inhibitors are coadministered with clindamycin. 7.3 Inducers of CYP3A4 and CYP3A5 Inducers of CYP3A4 and/or CYP3A5 may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 and/or CYP3A5 inducers such as rifampicin, monitor for loss of effectiveness.
Use in specific populations
• Pediatric Use: Appropriate monitoring of organ system functions is desirable. ( 8.4 )
• Geriatric Use: Monitor for development of diarrhea. ( 8.5 ) 8.1 Pregnancy Risk Summary In limited published 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 major birth defects. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes [see Data ]. In animal reproduction studies, no evidence of any adverse developmental outcomes was observed when oral or subcutaneous doses of clindamycin were administered to pregnant rats and mice during organogenesis at doses half to twice the highest clinically relevant dose based on body surface area comparison [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. From these observational data, it is not possible to draw any conclusions on the rate of specific major birth defects associated with clindamycin. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy. Animal Data Reproduction studies performed during organogenesis (gestational days 6-15) in pregnant rats and mice that were administered oral doses of clindamycin up to 600 mg/kg/day (twice or equivalent to the highest recommended adult human dose based on a body surface area comparison, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (equivalent to or half the highest recommended adult human dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity. 8.2 Lactation Risk Summary Clindamycin has been reported to appear in 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 breastfed infant’s gastrointestinal flora. 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. Clinical Considerations 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 infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or blood in the stool indicating possible antibacterial drug-associated colitis. 8.4 Pediatric Use Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, infections due to susceptible isolates of streptococci, pneumococci and staphylococci, lower respiratory tract Infections, skin and skin structure infections, gynecological infections, intra-abdominal infections, septicemia and bone and joint infections in pediatric patients for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1-1.8) ] and Dosage and Administration (2.3) ]. When Clindamycin Phosphate in Sodium Chloride Injection is administered to the pediatric population (less than 1 month to 16 years old) appropriate dosing and monitoring of organ system functions is desirable. Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Clindamycin Phosphate in Sodium Chloride Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Clindamycin Phosphate in Sodium Chloride Injection is required that does not equal 300 mg 600 mg or 900 mg is required and an alternative formulation of clindamycin should be considered [see Dosage and Administration (2.3) ]. The potential for the toxic effect in the pediatric population from chemicals that may leach from the single dose premixed Clindamycin Phosphate in Sodium Chloride Injection preparation in plastic has not been evaluated. 8.5 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 antibacterial drug-associated colitis and diarrhea (due to Clostridioides difficile ) seen in association with most antibacterial drugs 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 [ see Clinical Pharmacology (12.3) ].
Pregnancy
8.1 Pregnancy Risk Summary In limited published 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 major birth defects. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes [see Data ]. In animal reproduction studies, no evidence of any adverse developmental outcomes was observed when oral or subcutaneous doses of clindamycin were administered to pregnant rats and mice during organogenesis at doses half to twice the highest clinically relevant dose based on body surface area comparison [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. From these observational data, it is not possible to draw any conclusions on the rate of specific major birth defects associated with clindamycin. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy. Animal Data Reproduction studies performed during organogenesis (gestational days 6-15) in pregnant rats and mice that were administered oral doses of clindamycin up to 600 mg/kg/day (twice or equivalent to the highest recommended adult human dose based on a body surface area comparison, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (equivalent to or half the highest recommended adult human dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity.
Pediatric use
8.4 Pediatric Use Clindamycin Phosphate in Sodium Chloride Injection is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, infections due to susceptible isolates of streptococci, pneumococci and staphylococci, lower respiratory tract Infections, skin and skin structure infections, gynecological infections, intra-abdominal infections, septicemia and bone and joint infections in pediatric patients for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1-1.8) ] and Dosage and Administration (2.3) ]. When Clindamycin Phosphate in Sodium Chloride Injection is administered to the pediatric population (less than 1 month to 16 years old) appropriate dosing and monitoring of organ system functions is desirable. Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Clindamycin Phosphate in Sodium Chloride Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Clindamycin Phosphate in Sodium Chloride Injection is required that does not equal 300 mg 600 mg or 900 mg is required and an alternative formulation of clindamycin should be considered [see Dosage and Administration (2.3) ]. The potential for the toxic effect in the pediatric population from chemicals that may leach from the single dose premixed Clindamycin Phosphate in Sodium Chloride Injection preparation in plastic has not been evaluated.
Geriatric use
8.5 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 antibacterial drug-associated colitis and diarrhea (due to Clostridioides difficile ) seen in association with most antibacterial drugs 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 [ see Clinical Pharmacology (12.3) ].
Overdosage
Significant mortality was observed in mice at an intravenous dose of 855 mg/kg (~3 times the human dose based on body surface area) and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg (~18 times the human dose based on body surface area). In the mice, convulsions and depression were observed and in rats depression was observed prior to death. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
Description
Clindamycin Phosphate in Sodium Chloride Injection contains clindamycin phosphate, a water-soluble ester of clindamycin. Clindamycin is a semisynthetic antibacterial produced by a 7( S )-chloro-substitution of the 7( R )-hydroxyl group of the parent antibacterial 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]01-thio-, 2-(dihydrogen phosphate), (2S- trans )-. The molecular formula is C 18 H 34 CIN 2 O 8 PS and the molecular weight is 504.96. The structural formula is represented below: Clindamycin Phosphate in Sodium Chloride Injection is a clear, colorless and sterile solution for intravenous infusion available in three strengths, 300 mg/50 mL, 600 mg/50 mL, and 900 mg/50 mL, containing 300 mg, 600 mg or 900 mg clindamycin, respectively (as clindamycin phosphate, USP). Each 50 mL of all the strengths of Clindamycin Phosphate in Sodium Chloride Injection also contains, 450 mg of sodium chloride USP, 2 mg of edetate disodium dihydrate USP, and water for Injection USP. The pH is adjusted with sodium hydroxide and /or hydrochloric acid. Clindamycin Phosphate in Sodium Chloride Injection is filled in GALAXY plastic container fabricated from a specially designed multilayer plastic. 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. Clindamycin Structural Formula
Mechanism of action
12.1 Mechanism of Action Clindamycin is an antibacterial drug [see Microbiology (12.4) ] .
How supplied
Clindamycin Phosphate in Sodium Chloride Injection is a clear, colorless and sterile solution for intravenous infusion. Each 50 mL of Clindamycin in Phosphate in Sodium Chloride Injection, 300 mg/50 mL, 600mg/50mL, and 900 mg/50 mL, contains 300 mg, 600 mg or 900 mg clindamycin, respectively (as clindamycin phosphate, USP) in 0.9% sodium chloride solution. Clindamycin Phosphate in Sodium Chloride Injection in single-dose GALAXY containers is available as follows: 2G3455 Twenty-four (24)-300 mg/50 mL containers NDC 0338-9545-24 2G3456 Twenty-four (24)-600 mg/50 mL containers NDC 0338-9549-24 2G3457 Twenty-four (24)-900 mg/50 mL containers NDC 0338-9553-24 Exposure of pharmaceutical products, including clindamycin phosphate in sodium chloride, to heat should be minimized. It is recommended that GALAXY plastic containers be stored at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30°C.
Patient information
17 PATIENT COUNSELING INFORMATION C. difficile- Associated Diarrhea (CDAD) Advise patients that diarrhea is a common problem caused by antibacterial drugs including Clindamycin Phosphate in Sodium Chloride Injection, that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial drugs, including Clindamycin Phosphate in Sodium Chloride Injection, 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 antibacterial drugs. If this occurs, contact physician as soon as possible [see Warnings and Precautions (5.1) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including Clindamycin Phosphate in Sodium Chloride Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Clindamycin Phosphate in Sodium Chloride 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 Phosphate in Sodium Chloride Injection or other antibacterial drugs in the future. Lactation Advise a woman to monitor the breastfed infant for diarrhea and bloody stools [see Use in Specific Populations (8.2) ] . Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA. Baxter and Galaxy are registered trademarks of Baxter International Inc. 07-19-00-090
Label text from the FDA structured product label by Baxter Healthcare Company (revised Apr 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Clindamycin Phosphate in 71 products
clindamycin phosphate NDC products (71)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6593 | Clindamycin Phosphate 10 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-1932 | Clindamycin Phosphate 10 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-2611 | Clindamycin Phosphate 10 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-5779 | Clindamycin Phosphate 11.9 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-6072 | Clindamycin Phosphate 10 mg/g Gel | A-S Medication Solutions | ANDA |
| 50090-5958 | Clindamycin Phosphate 10 mg/g Gel | A-S Medication Solutions | ANDA |
| 62332-623 | Clindamycin Phosphate 10 mg/g Gel | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-623 | Clindamycin Phosphate 10 mg/g Gel | Alembic Pharmaceuticals Limited | ANDA |
| 69238-2031 | Clindamycin Phosphate 1 g/100mL Gel | Amneal Pharmaceuticals NY LLC | ANDA |
| 59651-806 | Clindamycin Phosphate 10 mg/g Gel | Aurobindo Pharma Limited | ANDA |
| 0338-4114 | Clindamycin Phosphate 900 mg/50mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 0338-3814 | Clindamycin Phosphate 900 mg/50mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 0338-3616 | Clindamycin Phosphate 600 mg/50mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 0338-3612 | Clindamycin Phosphate 600 mg/50mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 0338-3410 | Clindamycin Phosphate 300 mg/50mL Injection, Solution | Baxter Healthcare Company | ANDA |
| 43066-993 | Clindamycin Phosphate 600 mg/50mL Injection, Solution | Baxter Healthcare Corporation | ANDA |
| 43066-995 | Clindamycin Phosphate 900 mg/50mL Injection, Solution | Baxter Healthcare Corporation | ANDA |
| 63629-9459 | Clindamycin Phosphate 10 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 72162-2147 | Clindamycin Phosphate 10 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 72162-1436 | Clindamycin Phosphate 10 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-8628 | Clindamycin Phosphate 10 mg/g Aerosol, Foam | Bryant Ranch Prepack | ANDA |
| 72162-1418 | Clindamycin Phosphate 10 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 72162-1395 | Clindamycin Phosphate 10 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 71335-2953 | Clindamycin Phosphate 10 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 71335-2863 | Clindamycin Phosphate 10 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 71335-2861 | Clindamycin Phosphate 10 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 63629-9309 | Clindamycin Phosphate 10 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-8629 | Clindamycin Phosphate 10 mg/g Aerosol, Foam | Bryant Ranch Prepack | ANDA |
| 63629-8630 | Clindamycin Phosphate 10 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-8631 | Clindamycin Phosphate 10 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-8632 | Clindamycin Phosphate 10 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 63629-8633 | Clindamycin Phosphate 10 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 63629-8634 | Clindamycin Phosphate 10 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 80005-131 | Clindamycin Phosphate 10 mg/mL Solution | Carnegie Pharmaceuticals, LLC | ANDA |
| 62135-478 | Clindamycin Phosphate 10 mg/mL Solution | Chartwell RX, LLC | ANDA |
| 0168-0201 | Clindamycin Phosphate 10 mg/mL Solution | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0277 | Clindamycin Phosphate 20 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0202 | Clindamycin Phosphate 10 mg/g Gel | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0203 | Clindamycin Phosphate 10 mg/mL Lotion | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 21922-027 | Clindamycin Phosphate 10 mg/g Gel | Encube Ethicals, Inc. | ANDA |
| 21922-036 | Clindamycin Phosphate 10 ug/mL Lotion | Encube Ethicals, Inc. | ANDA |
| 68462-866 | Clindamycin Phosphate 10 mg/g Gel | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 68462-605 | Clindamycin Phosphate 10 mg/g Aerosol, Foam | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 72319-696 | Clindamycin Phosphate 10 mg/mL Solution | i3 Pharmaceuticals, LLC | ANDA |
| 16714-161 | Clindamycin Phosphate 10 mg/g Gel | NORTHSTAR RX LLC | ANDA |
| 16714-246 | Clindamycin Phosphate 10 ug/mL Lotion | NORTHSTAR RX LLC | ANDA |
| 45802-263 | Clindamycin Phosphate 10 mg/mL Solution | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-128 | Clindamycin Phosphate 10 mg/mL Lotion | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-562 | Clindamycin Phosphate 10 mg/mL Solution | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-660 | Clindamycin Phosphate 10 mg/g Aerosol, Foam | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-900 | Clindamycin Phosphate 10 mg/g Gel | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 68788-7990 | Clindamycin Phosphate 10 mg/mL Solution | Preferred Pharmaceuticals Inc | ANDA |
| 68788-8423 | Clindamycin Phosphate 10 mg/g Gel | Preferred Pharmaceuticals Inc. | ANDA |
| 16571-256 | Clindamycin Phosphate 10 mg/mL Solution | Rising Pharma Holdings, Inc. | ANDA |
| 73473-300 | Clindamycin Phosphate 10 mg/g Gel | Solaris Pharma Corporation | ANDA |
| 73473-302 | Clindamycin Phosphate 1 g/10mL Gel | Solaris Pharma Corporation | ANDA |
| 51672-4081 | Clindamycin Phosphate 10 mg/mL Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1399 | Clindamycin Phosphate 10 mg/g Gel | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1400 | Clindamycin Phosphate 10 mg/mL Lotion | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4194 | Clindamycin Phosphate 10 mg/g Aerosol, Foam | Sun Pharmaceutical Industries, Inc. | ANDA |
| 72578-084 | Clindamycin Phosphate 10 mg/mL Solution | Viona Pharmaceuticals Inc | ANDA |
| 72578-118 | Clindamycin Phosphate 10 mg/g Gel | Viona Pharmaceuticals Inc | ANDA |
| 70771-1855 | Clindamycin Phosphate 10 mg/g Gel | Zydus Lifesciences Limited | ANDA |
| 70771-1414 | Clindamycin Phosphate 10 mg/mL Solution | Zydus Lifesciences Limited | ANDA |
| 0338-9553 | Clindamycin Phosphate 900 mg/50mL Injection, Solution | Baxter Healthcare Company | NDA |
| 0338-9549 | Clindamycin Phosphate 600 mg/50mL Injection, Solution | Baxter Healthcare Company | NDA |
| 0338-9545 | Clindamycin Phosphate 300 mg/50mL Injection, Solution | Baxter Healthcare Company | NDA |
| 59762-5009 | Clindamycin Phosphate 20 mg/g Cream | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 59762-3744 | Clindamycin Phosphate 10 mg/mL Lotion | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 59762-3743 | Clindamycin Phosphate 10 mg/g Gel | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 68682-462 | Clindamycin Phosphate 10 mg/mL Gel | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC |
clindamycin phosphate recalls
- D-0808-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0815-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0816-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0817-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0818-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0257-2026 Jan 21, 2026 · Class III · Ongoing
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Frequently asked questions
What is clindamycin phosphate used for?
Clindamycin Phosphate in Sodium Chloride Injection contains clindamycin, a lincosamide antibacterial indicated for the treatment of the following in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • Serious infections caused by susceptible anaerobic bacteria ( 1.1 ) • Infections Due to Susceptible Isolates of Streptococci, Pneumococci and…
What are the side effects of clindamycin phosphate?
The following serious adverse reactions to clindamycin are described below and elsewhere in the labeling: • Clostridioides difficile- Associated Diarrhea [see Warnings and Precautions (5.1) ] • Anaphylactic and Severe Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Nephrotoxicity [see Warnings and Precautions (5.3) ] The following adverse reactions associated with the use of… See the full label for the complete list.
Who makes clindamycin phosphate?
clindamycin phosphate is listed by 25 labelers in the FDA NDC directory, including A-S Medication Solutions, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Amneal Pharmaceuticals NY LLC.
Has clindamycin phosphate been recalled?
The FDA enforcement database lists 6 recalls for clindamycin phosphate, most recently D-0808-2026 (class ii): CGMP Deviations