CLINDESSE

Following a single intravaginal application of Clindesse cream to 20 healthy women, the mean (range) AUC 0-inf and C max estimates were 175 (38.6 to 541) ng/mL

• hr and 6.6 (0.8 to 39) ng/mL, respectively. The mean C max of clindamycin for Clindesse was approximately 0.3%, 0.1%, and 7.6% of that observed after the administration of a 150 mg Cleocin oral capsule (2.5 mcg/mL), a 600 mg Cleocin intravenous injection (10.9 mcg/mL), and a single dose of 100 mg of Cleocin Vaginal Cream (86.5 ng/mL), res...

Two clinical studies were conducted to evaluate the efficacy of Clindesse for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood ...

Most common adverse reactions reported in ≥2% of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%), and urinary tract infection (2%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates obse...

• History of hypersensitivity to clindamycin or other lincosamides ( 4.1 )
• History of regional enteritis, ulcerative colitis, or a history of Clostridioides difficile- associated diarrhea ( 4.2 , 5.1 ) 4.1 Hypersensitivity Clindesse is contraindicated in individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin in...

• Clostridioides difficile -Associated Diarrhea: Discontinue and evaluate if diarrhea occurs ( 5.1 )
• Use with Condoms and Vaginal Contraceptive Diaphragms: The use of barrier contraceptives (condoms or vaginal contraceptive diaphragms) is not recommended concurrently or for 5 days following treatment. Condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases during this time period ( 5.2 , 8.3 ) 5.1 Clostridioides...

7 DRUG INTERACTIONS No formal drug interaction studies have been conducted for Clindesse. Neuromuscular blocking agents: Enhanced action of neuromuscular blocking agents can occur; use with caution ( 7.1 ) 7.1 Neuromuscular Blocking Agents Orally or intravenously administered clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. There...