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 ].
5.2Anaphylactic 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.
5.3Nephrotoxicity
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) ].
5.4Diarrhea 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) ] .
5.5Use 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.
5.6Use in Atopic Individuals Clindamycin Phosphate in Sodium Chloride
Injection should be avoided in atopic individuals.
5.7Laboratory 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.
5.8Overgrowth 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.
