Push the plunger to release the cream (See Figure 4).
Remove the empty applicator from the vagina and throw it away.Important Instructions:One pre-filled applicator of Clindesse™ should be administered.There are no adequate and well-controlled studies in pregnant women.Clindesse™ should be used during pregnancy only under the supervision of a physician.
Clindesse™ is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.
There are no adequate and well-controlled studies of Clindesse™ in pregnant women.Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually 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 cells.Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N.gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
Clindesse™ is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream.Clindesse™ is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms.
Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse™.
During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases.Using the Clindesse™ Prefilled Disposable Applicator3 Easy Steps:One disposable plastic applicator is provided with this package.It is designed to allow proper vaginal administration of the cream.