Get your patient on Cleocin - Clindamycin Phosphate suppository (Clindamycin Phosphate)

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, and moniliasis.

Digestive system: Diarrhea, nausea, and vomiting.

Skin: Nonapplication-site pruritis, rash, application-site pain, and application-site pruritis.

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:

Infections and Infestations: Clostridioides difficile colitis

Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, diarrhea, and pseudomembranous colitis. (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. Cases of Acute Generalized Exanthematous Pustulosis (AGEP), 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: Cases of polyarthritis have been reported.

Renal: Acute kidney injury

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

There have been reports of pseudomembranous colitis following the administration of clindamycin vaginal cream.

Clindamycin is an antibacterial drug (See MICROBIOLOGY ).

Systemic absorption of clindamycin was estimated following a once-a-day intravaginal dose of one clindamycin phosphate vaginal suppository (equivalent to 100 mg clindamycin) administered to 11 healthy female volunteers for 3 days. Approximately 30% (range 6% to 70%) of the administered dose was absorbed systemically on day 3 of dosing based on area under the concentration-time curve (AUC). Systemic absorption was estimated using a subtherapeutic 100 mg intravenous dose of clindamycin phosphate as a comparator in the same volunteers. The mean AUC following day 3 of dosing with the suppository was 3.2 µg hr/mL (range 0.42 to 11 µg hr/mL). The C _max observed on day 3 of dosing with the suppository averaged 0.27 µg/mL (range 0.03 to 0.67 µg/mL) and was observed about 5 hours after dosing (range 1 to 10 hours). In contrast, the AUC and C _max after the single intravenous dose averaged 11 µg hr/mL (range 5.1 to 26 µg hr/mL) and 3.7 µg/mL (range 2.4 to 5.0 µg/mL), respectively. The mean apparent elimination half-life after dosing with the suppository was 11 hours (range 4 to 35 hours) and is considered to be limited by the absorption rate.

The results from this study showed that systemic exposure to clindamycin (based on AUC) from the suppository was, on average, three-fold lower than that from a single subtherapeutic 100 mg intravenous dose of clindamycin. In addition, the recommended daily and total doses of intravaginal clindamycin suppository are far lower than those typically administered in oral or parenteral clindamycin therapy (100 mg of clindamycin per day for 3 days equivalent to about 30 mg absorbed per day from the ovule relative to 600 to 2700 mg/day for up to 10 days or more, orally or parenterally). 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).

Important Information: Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature].

Caution: Avoid heat over 30°C (86°F). Avoid high humidity. See end of carton for the lot number and expiration date.