Xaciato Vaginal Gel
Generic name:clindamycin phosphate
Dosage form: vaginal gel
Drug class:Vaginal anti-infectives
Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
1. INDICATIONS AND USAGE
. Bacterial Vaginosis
XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older [see Use in Specific Populations (8.1) and Clinical Studies (14)].
2. DOSAGE AND ADMINISTRATION
The recommended dosage of XACIATO is one applicatorful (5 g of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day [see Clinical Studies (14)]. Place the used tube with any remaining gel and used applicator in the container box and deposit in a trash container after use [see Instructions for Use].
XACIATO is not for ophthalmic, dermal, or oral use.
3. DOSAGE FORMS AND STRENGTHS
Vaginal gel: 2% clindamycin (present as clindamycin phosphate) as a clear, colorless, viscous gel in a 25 g tube. One user-filled single-dose disposable applicator delivers 5 g of gel containing 100 mg of clindamycin.
4. CONTRAINDICATIONS
. Hypersensitivity
XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. [see Adverse Reactions (6.2)].
5. WARNINGS AND PRECAUTIONS
. Clostridioides difficile-Associated Diarrhea (CDAD)
