In clinical trials, 3 (0.5%) of 589 nonpregnant women who
received treatment with CLEOCIN Vaginal Ovules discontinued therapy due to
drug-related adverse events. Adverse events judged to have a reasonable
possibility of having been caused by clindamycin phosphate vaginal
suppositories were reported for 10.5% of patients. Events reported by 1% or
more of patients receiving CLEOCIN Vaginal Ovules were as follows:
Urogenital system: Vulvovaginal disorder (3.4%),
vaginal pain (1.9%), and vaginal moniliasis (1.5%).
Body as a whole: Fungal infection (1.0%).
Other events reported by < 1% of patients included:
Urogenital system: Menstrual disorder, dysuria,
pyelonephritis, vaginal discharge, and vaginitis/vaginal infection.
Body as a whole: Abdominal cramps, localized
abdominal pain, fever, flank pain, generalized pain, headache, localized edema,
Digestive system: Diarrhea, nausea, and vomiting.
Skin: Nonapplication-site pruritis, rash,
application-site pain, and application-site pruritis.
Other clindamycin formulations
The overall systemic exposure to clindamycin from CLEOCIN
Vaginal Ovules is substantially lower than the systemic exposure from
therapeutic doses of oral clindamycin hydrochloride (two-fold to 20-fold lower)
or parenteral clindamycin phosphate (40-fold to 50-fold lower) (see CLINICAL
PHARMACOLOGY). Although these lower levels of exposure are less likely to
produce the common reactions seen with oral or parenteral clindamycin, the
possibility of these and other reactions cannot be excluded.
The following adverse reactions and altered laboratory
tests have been reported with the oral or parenteral use of clindamycin
and may also occur following administration of CLEOCIN Vaginal Ovules:
Gastrointestinal: Abdominal pain, esophagitis,
nausea, vomiting, and diarrhea (See WARNINGS).
Hematopoietic: Transient neutropenia (leukopenia),
eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No
direct etiologic relationship to concurrent clindamycin therapy could be made
in any of these reports.
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. Rare instances of erythema multiforme, some resembling
Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of
anaphylactoid reactions have been reported. If a hypersensitivity reaction
occurs, the drug should be discontinued.
Liver: Jaundice and abnormalities in liver
function tests have been observed during clindamycin therapy.
Musculoskeletal: Rare instances of polyarthritis
have been reported.
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 in rare
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.