Data from FDA - Curated by EPG Health - Last updated 21 December 2016
PRECAUTIONS General Review of experience to date suggests that
When clindamycin is indicated in these patients,
Clindamycin phosphate should be prescribed with
Clindamycin phosphate should be prescribed with
The use of clindamycin phosphate may result in overgrowth of nonsusceptible organisms - particularly yeasts.
Should superinfections occur,
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.
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
Prescribing clindamycin in
Information for Patients Patients should be counseled that antibacterial drugs including clindamycin should only be used to treat bacterial
They do not treat
When clindamycin is prescribed to treat a bacterial
Skipping doses or not completing the full course of therapy may (1)
Sometimes after starting treatment with antibiotics,
If this occurs, patients should contact their physician as soon as
Laboratory Tests During
Interactions Clindamycin has been shown to have
Therefore, it should be used with
Because of possible clinical significance, the two drugs should not be administered concurrently.
Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test.
Fertility studies in
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
Clindamycin should be used during the first trimester of pregnancy only if clearly needed.
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
Clindamycin contains benzyl alcohol.
Benzyl alcohol can cross the placenta (see WARNINGS).
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
Pediatric Use When clindamycin phosphate injection is administered to the pediatric population (birth to 16 years)
Usage in Newborns and Infants This product contains benzyl alcohol as a preservative.
Benzyl alcohol has been associated with a
Geriatric Use Clinical studies of clindamycin did not include
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
Pharmacokinetic studies with clindamycin have shown
Gastrointestinal Antibiotic-associated colitis (see WARNINGS), pseudomembranous colitis, abdominal
The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).
Hypersensitivity Reactions Maculopapular rash and urticaria have been observed during drug therapy.
Anaphylactoid reactions have also been reported.
If a hypersensitivity reaction occurs,
The usual agents (epinephrine, corticosteroids, antihistamines) should be
Skin and Mucous Membranes Pruritus, vaginitis, and
Liver Jaundice and
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 Injection site
Reactions can be minimized or
Musculoskeletal Polyarthritis have been reported.
(See DOSAGE AND ADMINISTRATION section.)
DOSAGE AND ADMINISTRATION If diarrhea occurs during therapy,
(See WARNING box).
Adults Parenteral (IM or IV Administration): Serious
For more serious
Doses of as much as 4800 mg daily have been given intravenously to adults.
See Dilution and Infusion Rates section below.
Alternatively, drug may be administered in the form of a single
To maintain serum clindamycin levels Rapid infusion rate Maintenance infusion rate Above 4 mcg/mL 10 mg /min for 30
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
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
Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the
In cases of?-hemolytic streptococcal
Dilution and Infusion Rates Clindamycin phosphate must be diluted prior to I.V. administration.
The concentration of
The usual infusion dilutions and rates are as follows:
Dose Diluent Time 300 mg 50 mL 10
Parenteral drug products should be inspected visually for particulate matter and
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
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.
|Date Last Revised||11-08-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|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
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
Because clindamycin therapy has been associated with
It should not be used in
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause
CDAD must be considered in all patients who present with diarrhea following antibiotic use.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against