Clindamycin phosphate injection
Other products: Clindamycin
Package labels
Loading package label images…
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS 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. Because Clindamycin Phosphate in Sodium Chloride Injection therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate [ see Indications and Usage ( 1 ) ] .
It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following 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 Warnings and Precautions ( 5.1 ) ]. WARNING: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS See full prescribing information for complete boxed warning. 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 ( 5.1 ). Because Clindamycin Phosphate in Sodium Chloride Injection therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate (1). It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing…
Dosing in kidney impairment
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. During prolonged therapy, perform periodic liver and kidney function tests and blood counts.
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 ]. 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 ] . 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.
IV preparation card
Loading IV preparation…
Preparation and administration
Prepare this dose
Your numbers for clindamycin phosphate injection. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
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 . [See table below.] Discontinue Clindamycin Phosphate in Sodium Chloride Injection if diarrhea occurs during therapy [see Boxed Warning ].
| Dose | Time |
| 300 mg | 10 min |
| 600 mg | 20 min |
| 900 mg | 30 min |
| 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 |
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Clindamycin phosphate injection
Label text (4 paragraphs)
7 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.
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
BLikelihood score B: Highly likely cause of clinically apparent liver injury.
Clindamycin is a broad spectrum antibiotic used orally, topically and parenterally for bacterial infections due to sensitive organisms. Clindamycin has been linked to rare instances of acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
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.
Breastfeeding (LactMed)
Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If a nursing mother requires oral or intravenous clindamycin, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. Vaginal application is unlikely to cause infant side effects, although about 30% of a vaginal dose is absorbed. Infant side effects are unlikely with topical administration for acne; however, topical application to the breast may increase the risk of diarrhea if the infant ingests it.
- Amoxicillin and Clavulanic Acid
- Doxycycline
- Erythromycin
- Minocycline
- Trimethoprim-Sulfamethoxazole
- Vancomycin
- Metronidazole
- Azelaic Acid
- Benzoyl Peroxide
- Tretinoin
- Bacitracin
- Mupirocin
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.