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The recommended dose is one clindamycin vaginal ovule intravaginally, preferably at bedtime, for three consecutive days.
3-day treatment of bacterial vaginosis in non-pregnant women.
Hypersensitivity to clindamycin or lincomycin. History of regional enteritis, ulcerative colitis, history of “antibiotic-associated” colitis.
The use of clindamycin vaginal products may result in the overgrowth of nonsusceptible organisms, particularly yeasts. Orally and parenterally administered clindamycin, similar to virtually all other antibiotics, has been associated with diarrhea, and in some cases, antibiotic-associated colitis. If significant or prolonged diarrhea occurs during the use of any clindamycin vaginal product, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary. The patient should be instructed not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with clindamycin vaginal ovules. Clindamycin vaginal ovules contain ingredients which may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, use of these products during treatment with clindamycin vaginal ovules is not recommended.
Pediatric Use: Safety and efficacy in pediatric patients have not been established.
The safety of clindamycin vaginal ovules was evaluated in non-pregnant patients. The following treatment-related adverse events were reported by less than 10% of patients:
Gastrointestinal disorders: Abdominal cramps, localized abdominal pain, diarrhea, nausea, vomiting.
General disorders and administration site conditions: Fever, generalized pain, localized edema, applicationsite pain, pruritus (topical application site).
Infections and infestations: Vaginal candidiasis, pyelonephritis, vaginitis/vaginal infection, fungal infection, candidiasis (body).
Musculoskeletal and connective tissue disorders: Flank pain.
Nervous system disorders: Headache.
Renal and urinary disorders: Dysuria.
Reproductive system and breast disorders: Vulvovaginal disorder, vaginal pain, menstrual disorder, vaginal discharge.
Skin and subcutaneous tissue disorders: Pruritus (non-application site), rash.
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.
Pregnancy and Lactation
Pregnancy: In clinical trials, the use of clindamycin vaginal products in pregnant women in their second and third trimesters, and systemically administered clindamycin during their second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.
If clindamycin vaginal ovules are used during the second or third trimester (although no formal studies have been done with the ovule in pregnant women), the possibility of fetal harm appears remote. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clindamycin vaginal ovules should be used during the first trimester of pregnancy only if clearly needed.
Nursing Mothers: It is not known if clindamycin is excreted in breast milk following the use of vaginally administered clindamycin ovules. Orally and parenterally administered clindamycin have been reported to appear in breast milk. Therefore, a full benefit-risk assessment should be done when considering the use of either clindamycin vaginal cream or clindamycin vaginal ovules in a nursing mother.
Vaginally applied clindamycin phosphate contained in DALACIN Vaginal Ovules could be absorbed in sufficient amounts to produce systemic effects In the event of overdose, general symptomatic and supportive measures are indicated as required.