Data from FDA - Curated by EPG Health - Last updated 21 December 2016


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 WARNING box, 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 pyogenes, Staphylococcus aureus, and anaerobes.

Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.

Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.

Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.

Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin and other antibacterial drugs, clindamycin 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.

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Advisory information

CONTRAINDICATIONS This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
Special warnings and precautions

PRECAUTIONS General Review 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 phosphate should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin phosphate 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 phosphate may result in overgrowth of nonsusceptible organisms - particularly yeasts.

Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Clindamycin phosphate 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



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 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 Patients Patients should be counseled that antibacterial drugs including clindamycin should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When clindamycin 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 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, 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 Tests During prolonged therapy periodic liver and kidney function tests and blood counts should be performed.


Interactions Clindamycin 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 Fertility Long 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/ m 2) revealed no effects on fertility or mating ability.

Pregnancy: Teratogenic Effects Pregnancy Category B In 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 pregnant women during the first trimester of pregnancy.

Because 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/ m 2, 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/ m 2, respectively) revealed no evidence of teratogenicity.

Clindamycin contains benzyl alcohol.

Benzyl alcohol can cross the placenta (see WARNINGS).

Nursing Mothers

Clindamycin 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 Use When clindamycin phosphate injection is administered to the pediatric population (birth to 16 years) appropriate monitoring of organ system functions is desirable.

Usage in Newborns and Infants This 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 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 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 clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.

Adverse reactions

ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin.

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 occasionally 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).

Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin.

Anaphylactoid reactions have also been reported.

If a hypersensitivity reaction occurs, the drug should be discontinued.

The usual agents (epinephrine, corticosteroids, antihistamines) should be available for emergency treatment of serious reactions.

Skin and Mucous Membranes Pruritus, vaginitis, 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 have been made.

No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune system Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Local Reactions Injection site irritation, pain, induration and sterile abscess have been reported after intramuscular injection and thrombophlebitis after intravenous infusion.

Reactions can be minimized or avoided by giving deep intramuscular injections and avoiding prolonged use of indwelling intravenous catheters.

Musculoskeletal Polyarthritis have been reported.

Cardiovascular Cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration.


Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION If diarrhea occurs during therapy, this antibiotic should be discontinued.

(See WARNING box).

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 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 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 and Infusion Rates section below.

Single IM 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:

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 Neonates (less than 1 month) 15 to 20 mg/kg/day in three to four equal doses.

The lower dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years) Parenteral (IM or IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.

The higher doses would be used for more severe infections.

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 clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

In cases of?-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

Dilution and Infusion Rates Clindamycin phosphate must be diluted prior to I.V. administration.

The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute.

The usual infusion dilutions and rates are as follows:

Dose Diluent Time 300 mg 50 mL 10 min 600 mg 50 mL 20 min 900 mg 50-100 mL 30 min 1200 mg 100 mL 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.

No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

Physico-Chemical Stability of Diluted Solutions of Clindamycin Room temperature: 6, 9, and 12 mg /mL (equivalent to clindamycin base) in 5 % Dextrose Injection, 0.9 % Sodium Chloride Injection, or Lactated Ringer 's Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

Also, 18 mg /mL (equivalent to clindamycin base) in 5 % Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Refrigeration: 6, 9 and 12 mg /mL (equivalent to clindamycin base) in 5 % Dextrose Injection, 0.9 % Sodium Chloride Injection, or Lactated Ringer 's Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C. IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.

Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

Frozen: 6, 9 and 12 mg /mL (equivalent to clindamycin base) in 5 % Dextrose Injection, 0.9 % Sodium Chloride Injection, or Lactated Ringer 's Injection in minibags demonstrated physical and chemical stability for at least eight weeks at - 10°C. Frozen solutions should be thawed at room temperature and not refrozen.

More information

Category Value
Authorisation number ANDA062800
Orphan designation No
Product NDC 69101-715
Date Last Revised 11-08-2015
RXCUI 1737244
Marketing authorisation holder Burke Therapeutics, LLC

WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, 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 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, as described in the INDICATIONS AND USAGE section.

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 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.