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Xaciato Generic Name & Formulations
Legal Class
Rx
General Description
Clindamycin (as phosphate) 2%; vaginal gel.
Pharmacological Class
Lincosamide.
How Supplied
Gel—25g (w. applicator)
Manufacturer
Generic Availability
NO
Mechanism of Action
Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is predominantly bacteriostatic. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts it to active clindamycin.
Xaciato Indications
Indications
Bacterial vaginosis.
Xaciato Dosage and Administration
Adult
1 applicatorful intravaginally as a single dose at any time of the day.
Children
<12yrs: not established.
Xaciato Contraindications
Contraindications
Previous hypersensitivity to lincomycin.
Xaciato Boxed Warnings
Not Applicable
Xaciato Warnings/Precautions
Warnings/Precautions
Increased risk of C. difficile-associated diarrhea (CDAD) in those with inflammatory bowel disease, including ulcerative colitis and Crohn disease. Discontinue if CDAD is suspected or confirmed. Not compatible with and may weaken polyurethane condoms. Advise patients to use latex or polyisoprene condoms for contraception during and for 7 days after treatment. Pregnancy. Nursing mothers.
Xaciato Pharmacokinetics
Absorption
Following a single intravaginal dose of 100 mg of Xaciato, the arithmetic mean (range) peak plasma concentration was 69.2 ng/mL (3.8 to 236 ng/mL). The median (range) tmax occurred at 6 hours (4–96 hours).
Xaciato Interactions
Interactions
May potentiate neuromuscular blockers; caution.
Xaciato Adverse Reactions
Adverse Reactions
Vulvovaginal candidiasis, vulvovaginal discomfort.
Xaciato Clinical Trials
See Literature
Xaciato Note
Not Applicable
Xaciato Patient Counseling
See Literature
