XACIATO clindamycin phosphate 100 mg/5g Gel — NDC 78206-189-01 (Billing 78206-0189-01)
This is a package of XACIATO clindamycin phosphate 100 mg/5g Gel from Organon LLC, marketed since Oct 2023 and currently FDA-listed; retail pharmacies pay about $18.87 per g (NADAC). It is this product's only package size.
Other active recalls for Clindamycin Phosphate (different manufacturers) — 6 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 083711
- GCN: 52753
- GPI-14 (Medi-Span): 55100018104020
- HICL (First Databank): 004045
- AHFS class code: 08:12.28.20
- RxCUI (RxNorm): 2587810
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Vaginal clindamycin is used to treat bacterial vaginosis (an infection caused by harmful bacteria in the vagina). Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Vaginal clindamycin is not used to treat vaginal irritation caused by yeast infections or by sexually transmitted diseases such as chlamydia and trichomoniasis.
Read the full MedlinePlus article ↗- Bacterial vaginosis happens when the normal balance of bacteria in the vagina gets disrupted, and certain bacteria overgrow. It can cause a thin, grayish discharge with a fishy odo...
- What exactly is bacterial vaginosis, and is this antibiotic the right treatment for it?
- It's a fair concern — vaginal yeast infection was actually one of the most commonly reported side effects in clinical trials, affecting roughly 8–10% of users. Antibiotics can disr...
- I'm worried about getting a yeast infection from this antibiotic. Is that common?
Patient education
Supplement & herbal interactions
Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $18.869 | $150.95 / 8 g |
| Medicaid paysCMS SDUD · 12 mo | $19.12 | $152.97 / 8 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 78206-0189-01 You're viewing this Main listing | 1 TUBE in 1 CARTON / 8 g in 1 TUBE | 2023-10-13 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Xaciato 100 mg/5gthis 78206-0189-01 | Organon | 1 tube | $18.869 | — | Availability likely | — |
| Clindesse 100 mg/5g 45802-0042-01 | Padagis | 1 applicator | $26.621 | — | Availability likely | +41% |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11129896 ↗ | Method of use | U-3293 | Sep 22, 2036 |
| US 12303563 ↗ | Drug product | — | Sep 22, 2036 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Dec 7, 2024 |
| GAIN | Qualified Infectious Disease Product (+5-year) | Dec 7, 2029 |
Is there a generic version of XACIATO 2% VAGINAL GEL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
-
UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 )
1.1Bacterial 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 )] .
⏱️ Dosage and Administration ▾
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.
Administer one applicatorful (5 g of gel containing 100 mg of clindamycin) once intravaginally as a single dose at any time of the day. ( 2 ) Not for ophthalmic, dermal, or oral use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Vaginal gel: 2% clindamycin (present as clindamycin phosphate) as a clear, colorless, viscous gel in an 8 g tube. One user-filled single-dose disposable applicator delivers 5 g of gel containing 100 mg of clindamycin. Vaginal gel: 2% clindamycin present as clindamycin phosphate in an 8 g tube. One single-dose, user-filled disposable applicator delivers 5 g of gel containing 100 mg of clindamycin. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS History of hypersensitivity to clindamycin or lincomycin. ( 4.1 )
4.1Hypersensitivity XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. [see Adverse Reactions ( 6.2 )] .
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Clostridioides difficile -Associated Diarrhea: Discontinue and evaluate if diarrhea occurs. ( 5.1 ) Use with Polyurethane Condoms: Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases.
Latex or polyisoprene condoms should be used ( 5.2 )
5.1Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which can lead to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Patients with inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, have a higher risk of developing CDAD. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions ( 6.2 )] .
5.2Use with Polyurethane Condoms XACIATO is not compatible with and may weaken polyurethane condoms; therefore, their use is not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used [see Use in Specific Populations ( 8.3 )] .
5.3Vaginal Candida Infections XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis which may require antifungal treatment [see Adverse Reactions ( 6.1 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.1 )] Use with Polyurethane Condoms [see Warnings and Precautions ( 5.2 )] Vaginal Candida Infections [see Warnings and Precautions ( 5.3 )] The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the placebo-controlled trial (Trial 1), 202 patients with bacterial vaginosis were treated with a single dose of XACIATO, and 103 patients were treated with a single dose of placebo gel. The median age of the patients in the trial was 35 years (range 15-59 years).
The population was 56% Black or African American and 41% White. Persons of Hispanic or Latino ethnicity made up 25% of the population. A history of prior bacterial vaginosis was noted in 89% of the population.
Most Common Adverse Reactions Adverse reactions were reported by 76/202 (38%) of patients who received XACIATO and 28/103 (27%) of patients who received placebo in Trial 1. Table 1 displays the most common adverse reactions (occurring in >2% of patients and at a higher rate in the XACIATO group than in the placebo group) in Trial 1. Table 1: Adverse Reactions Occurring in >2% of Patients Receiving XACIATO in Trial 1 Adverse Reaction XACIATO N=202 n (%) Placebo N=103 n (%) Vulvovaginal candidiasis 35 (17) 4 (4) Vulvovaginal discomfort Vulvovaginal discomfort includes the terms vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal erythema, vulvovaginal dryness, and vulvovaginal discomfort.
13 (6) 5 (5)
6.2Other Clindamycin Formulations XACIATO affords low peak serum levels and systemic exposure of clindamycin compared to an oral or intravenous dose of clindamycin [see Clinical Pharmacology ( 12.3 )] . Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available. The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin: Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridioides difficile -associated diarrhea [see Warnings and Precautions ( 5.1 )] .
Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports. Hypersensitivity Reactions: Maculopapular rash, vesiculobullous rash, and urticaria have been observed during drug therapy.
Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.
Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Musculoskeletal: Cases of polyarthritis have been reported. Renal: Acute kidney injury.
Immune: Drug reaction with eosinophilia with systemic symptoms (DRESS) cases have been reported.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Neuromuscular Blocking Agents Systemic clindamycin has 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Other clindamycin vaginal products have been used to treat pregnant women during the second and third trimester. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] .
Available data from published observational studies, based on first trimester exposure to oral and IV clindamycin, did not identify consistent increases in the rate of major birth defects. Available data from published observational studies and randomized controlled trials, based on second and third trimester exposure to oral and IV clindamycin, did not identify an increased risk of miscarriage or other adverse maternal or fetal outcomes. Most of the reported exposures to clindamycin occurred during the second and third trimesters of the pregnancy.
In animal reproduction studies, no adverse developmental outcomes were observed when XACIATO was vaginally administered to pregnant rats and rabbits during organogenesis at doses approximately equivalent to the recommended human dose. No evidence of any adverse developmental outcomes was observed when oral or subcutaneous doses of clindamycin were administered to pregnant rats and mice during organogenesis at doses 9 to 58 times the recommended human dose based on body surface area comparison (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies performed during organogenesis in pregnant rats (gestational days 6-17) and rabbits (gestational days 7-19) administered vaginal XACIATO at 0.1 g and 1 g/day (2 mg and 20 mg clindamycin phosphate/day) showed no evidence of developmental toxicity.
These doses are approximately equivalent to the applied recommended clinical dose based on g/cm 2 vaginal surface area and body surface area (BSA) comparisons. Reproduction studies performed during organogenesis (gestational days 6-15) in pregnant rats and mice that were administered oral doses of clindamycin up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on a body surface area comparison) or subcutaneous doses of clindamycin up to 250 mg/kg/day (24- and 12-times, respectively, the MRHD based on BSA comparisons) revealed no evidence of teratogenicity.
Vaginal administration of XACIATO to pregnant/lactating female rats during a pre- and post-natal development (gestation day 6 through gestation day 21) study at 2 mg clindamycin phosphate/day had no adverse effects on dams or their offspring.
8.2Lactation Risk Summary Systemic absorption following intravaginal administration of clindamycin is low; therefore, transfer of clindamycin into breastmilk is likely to be low and adverse effects on the breastfed infant are not expected [see Clinical Pharmacology ( 12.3 )] . There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.
8.3Males and Females of Reproductive Potential Contraception XACIATO is not compatible with and may weaken polyurethane condoms; therefore, use of polyurethane condoms is not recommended during and for 7 days following treatment with XACIATO. Advise patients to use latex or polyisoprene condoms for contraception during and for 7 days following treatment with XACIATO [s… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Other clindamycin vaginal products have been used to treat pregnant women during the second and third trimester. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] .
Available data from published observational studies, based on first trimester exposure to oral and IV clindamycin, did not identify consistent increases in the rate of major birth defects. Available data from published observational studies and randomized controlled trials, based on second and third trimester exposure to oral and IV clindamycin, did not identify an increased risk of miscarriage or other adverse maternal or fetal outcomes. Most of the reported exposures to clindamycin occurred during the second and third trimesters of the pregnancy.
In animal reproduction studies, no adverse developmental outcomes were observed when XACIATO was vaginally administered to pregnant rats and rabbits during organogenesis at doses approximately equivalent to the recommended human dose. No evidence of any adverse developmental outcomes was observed when oral or subcutaneous doses of clindamycin were administered to pregnant rats and mice during organogenesis at doses 9 to 58 times the recommended human dose based on body surface area comparison (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies performed during organogenesis in pregnant rats (gestational days 6-17) and rabbits (gestational days 7-19) administered vaginal XACIATO at 0.1 g and 1 g/day (2 mg and 20 mg clindamycin phosphate/day) showed no evidence of developmental toxicity.
These doses are approximately equivalent to the applied recommended clinical dose based on g/cm 2 vaginal surface area and body surface area (BSA) comparisons. Reproduction studies performed during organogenesis (gestational days 6-15) in pregnant rats and mice that were administered oral doses of clindamycin up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on a body surface area comparison) or subcutaneous doses of clindamycin up to 250 mg/kg/day (24- and 12-times, respectively, the MRHD based on BSA comparisons) revealed no evidence of teratogenicity.
Vaginal administration of XACIATO to pregnant/lactating female rats during a pre- and post-natal development (gestation day 6 through gestation day 21) study at 2 mg clindamycin phosphate/day had no adverse effects on dams or their offspring.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of XACIATO have been established in females aged 12 years and older for the treatment of bacterial vaginosis. Use of XACIATO for this indication is supported by the extrapolation of clinical trial data from adequate and well controlled clinical studies in adult women. The safety and effectiveness of XACIATO have not been established in pediatric patients younger than 12 years of age for the treatment of bacterial vaginosis.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies with XACIATO did not include any subjects 65 years of age or older to determine whether they respond differently than younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Clindamycin is an antibacterial drug [see Microbiology ( 12.4 )] .
12.3Pharmacokinetics Clindamycin phosphate is a water-soluble ester prodrug of clindamycin. Biologically inactive clindamycin phosphate is converted to active clindamycin. Following a single intravaginal dose of 100 mg of XACIATO administered to 21 healthy female subjects, the arithmetic mean (range) peak plasma concentration was 69.2 ng/mL (3.8 to 236 ng/mL).
The median (range) t max occurred at 6 hours (4 to 96 hours). The mean C max of clindamycin for XACIATO was approximately 0.5% of that observed after the IV infusion of Clindamycin Phosphate in 0.9% Sodium Chloride, 900 mg clindamycin, every 8 hours.
12.4Microbiology 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.
Resistance Resistance to clindamycin is most often caused by modification of the target site on the ribosome, usually by chemical modification of RNA bases by point mutations in RNA or occasionally in proteins. Cross resistance has been demonstrated between lincosamides, macrolides and streptogramins B in some organisms. Cross resistance has been demonstrated between clindamycin and lincomycin.
Antibacterial Activity Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see Clinical Studies ( 14 )] . Standard methodology for the susceptibility testing of the potential bacterial pathogens, Gardnerella vaginalis , Mobiluncus spp., or Mycoplasma hominis , has not been defined. The following in vitro data are available, but their clinical significance is unknown.
Clindamycin is active in vitro against most isolates of the following organisms reported to be associated with bacterial vaginosis: Bacteroides spp. Gardnerella vaginalis Mobiluncus spp. Mycoplasma hominis Peptostreptococcus spp.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Clindamycin is an antibacterial drug [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING XACIATO vaginal gel, 2% is a clear, colorless, viscous gel supplied in a carton containing one 8-gram tube of vaginal gel and one vaginal applicator. One single-dose, user-filled disposable applicator delivers 5 g of gel containing 100 mg of clindamycin. NDC 78206-189-01. Store at 68ºF to 77ºF (20ºC to 25ºC); excursions permitted to 59ºF to 86ºF (15ºC to 30ºC). [See USP Controlled Room temperature].
📋 Description ▾
11 DESCRIPTION XACIATO vaginal gel contains clindamycin phosphate, a lincosamide antibacterial. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-(alpha)-D-galacto- octopyranoside 2-(dihydrogenphosphate). It has a molecular weight of 504.95, and the molecular formula is C 18 H 34 ClN 2 O 8 PS.
The structural formula is represented below: XACIATO is a clear, colorless, viscous gel, which contains clindamycin at a concentration of 2%. A single-dose user-filled disposable applicator delivers 5 g of vaginal gel containing 100 mg of clindamycin (present as 119 mg of clindamycin phosphate). The gel also contains benzyl alcohol, citric acid monohydrate or citric acid anhydrous, poloxamer 407, purified water, sodium citrate dihydrate, and xanthan gum. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Vaginal Intercourse and Use with Vaginal Products Instruct the patients not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with XACIATO and for 3 days after using XACIATO. Use with Polyurethane Condoms Advise the patient that XACIATO may weaken polyurethane condoms.
Therefore, use of polyurethane condoms concurrently or for 7 days following treatment with XACIATO is not recommended. During this time period polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used [see Warnings and Precautions ( 5.2 )] .
Vaginal Candida Infections Inform the patient that vaginal yeast infections can occur following use of XACIATO and may require treatment with an antifungal drug [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . Distributed by: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA For patent information: www.organon.com/our-solutions/patent/ © 2025 Organon group of companies. All rights reserved. uspi-og9423-gl-2512r001
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Clindamycin phosphate is a water-soluble ester prodrug of clindamycin. Biologically inactive clindamycin phosphate is converted to active clindamycin. Following a single intravaginal dose of 100 mg of XACIATO administered to 21 healthy female subjects, the arithmetic mean (range) peak plasma concentration was 69.2 ng/mL (3.8 to 236 ng/mL).
The median (range) t max occurred at 6 hours (4 to 96 hours). The mean C max of clindamycin for XACIATO was approximately 0.5% of that observed after the IV infusion of Clindamycin Phosphate in 0.9% Sodium Chloride, 900 mg clindamycin, every 8 hours.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of XACIATO as a treatment of bacterial vaginosis (BV) in females 12 years of age and older was demonstrated in a randomized, double-blind, placebo-controlled clinical study (Trial 1, NCT04370548). A single dose of XACIATO (clindamycin phosphate vaginal gel, 2%) was compared to a single dose of placebo vaginal gel (hydroxyethylcellulose [HEC] Universal Placebo Gel) for the treatment of BV. Patients were evaluated at 3 timepoints: a Day 1 Screening/Randomization visit, a Day 7 to 14 Interim Assessment visit, and a Day 21 to 30 Test of Cure visit.
The total study duration was up to approximately 1 month for each individual patient. To be eligible, patients had to have a clinical diagnosis of BV defined as an off-white (milky or gray), thin, homogeneous discharge with minimal or absent pruritus and inflammation of the vulva and vagina, clue cells > 20% of the total epithelial cells on microscopic examination of the saline wet mount, vaginal secretion pH of > 4.5, and a fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e., a positive whiff test).
The 307 patients were randomized in a 2:1 ratio, with 204 in the XACIATO group and 103 in the placebo group. The modified Intent-To-Treat (mITT) Population excluded women with a positive test result for other concomitant vaginal or cervical infections at baseline, including a positive vaginal culture for Candida spp. or who had a baseline Nugent score of < 7. Clinical Cure was defined as resolution of the abnormal vaginal discharge associated with BV, a negative 10% KOH whiff test, and clue cells < 20% of the total epithelial cells in the saline wet mount.
Bacteriological Cure was defined as a Nugent score < 4. Therapeutic Cure was defined as the presence of both a Clinical Cure and Bacteriological Cure. In the mITT population, a statistically significantly greater percentage of patients experienced Clinical Cure, Bacteriological Cure, and Therapeutic Cure at the Test of Cure (Day 21-30) visit in the XACIATO arm compared to placebo (Table 2).
Statistically significant results for the endpoints were also achieved at the Interim Assessment visit (Day 7-14). Table 2: Summary of Clinical Cure, Bacteriological Cure, and Therapeutic Cure (Modified Intent-to-Treat Population) in Trial 1 Interim Assessment visit (day 7-14) Test of Cure visit (day 21-30) Parameter XACIATO (N = 122) n (%) Placebo (N = 59) n (%) Treatment Difference (%) [95% Confidence Interval] XACIATO (N = 122) n (%) Placebo (N = 59) n (%) Treatment Difference (%) [95% Confidence Interval] Clinical Cure 93 (76.2) 14 (23.7) 52.5 (38.0, 67.0) 86 (70.5) 21 (35.6) 34.9 (19.0, 50.8) Bacteriological Cure 50 (41.0) 2 (3.4) 37.6 (26.5, 48.7) 53 (43.4) 3 (5.1) 38.4 (26.7, 50.1) Therapeutic Cure 43 (35.2) 0 35.2 (25.5, 45.0) 45 (36.9) 3 (5.1) 31.8 (20.3, 43.3) All P-values for differences between treatment groups were <0.001 (from Cochran-Mantel-Haenszel test with strata of study site and race - African American or all other races).
The percentage of patients with Clinical Cure at the Test of Cure visit was also significantly higher in the XACIATO group compared to the placebo group among the subsets of patients defined by prior episodes of bacterial vaginosis (≤ 3 episodes and >3 episodes in the previous 12 months) at 71.3% (72/101) for XACIATO and 39.1% (18/46) placebo, and 70.0% (14/20) for XACIATO and 23.1% (3/13) placebo, respectively.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long term studies in animals to evaluate carcinogenic potential have not been performed with XACIATO, or the active ingredient, clindamycin phosphate. Mutagenesis The genotoxic potential of clindamycin has been evaluated in a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.
Impairment of Fertility Fertility studies in rats treated vaginally with 2 mg/day clindamycin phosphate (0.1g/day XACIATO) or orally with 300 mg/kg/day (doses that are approximately equivalent to or 29-times the MRHD based on BSA comparisons, respectively) revealed no effects on fertility or mating ability.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long term studies in animals to evaluate carcinogenic potential have not been performed with XACIATO, or the active ingredient, clindamycin phosphate. Mutagenesis The genotoxic potential of clindamycin has been evaluated in a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.
Impairment of Fertility Fertility studies in rats treated vaginally with 2 mg/day clindamycin phosphate (0.1g/day XACIATO) or orally with 300 mg/kg/day (doses that are approximately equivalent to or 29-times the MRHD based on BSA comparisons, respectively) revealed no effects on fertility or mating ability.
📄 Patient Package Insert ▾
PATIENT INFORMATION XACIATO ® (zah-she-AH-toe) (clindamycin phosphate) vaginal gel Important Information: XACIATO is for intravaginal use only. Do not use in the eyes, mouth, or on your skin. What is XACIATO?
XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older. It is not known if XACIATO is safe and effective in children under 12 years of age. Do not use XACIATO if you are: allergic to clindamycin or lincomycin.
Before using XACIATO, tell your healthcare provider about all of your medical conditions, including if you: have inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. are pregnant or plan to become pregnant. It is not known if XACIATO will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with XACIATO. are breastfeeding or plan to breastfeed.
The amount of XACIATO which passes into your breast milk is low and is not expected to harm your baby. Talk with your healthcare provider about the best way to feed your baby while using XACIATO. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use XACIATO? Use XACIATO exactly as your healthcare provider tells you to use it. Use 1 filled applicator of XACIATO in the vagina.
Do not use any medicine from the tube or applicator more than 1 time. XACIATO is for 1 time (single-use) only. Do not use in the eyes, mouth, or on your skin.
See the Instructions for Use at the end of this Patient Information leaflet for more information about how to fill the applicator and use XACIATO. What should I avoid while using XACIATO? After you insert XACIATO: Do not have vaginal sex or use vaginal products (such as tampons or douches) during treatment with XACIATO and for 3 days after using XACIATO.
You should not use polyurethane condoms during treatment with XACIATO and for 7 days after using XACIATO. XACIATO may weaken polyurethane condoms and they may not work well for preventing pregnancy or protecting against Human Immunodeficiency Virus (HIV) and other sexually transmitted diseases (STDs). Latex or polyisoprene condoms should be used.
What are the possible side effects of XACIATO? XACIATO may cause serious side effects, including diarrhea . One type of diarrhea is caused by an infection in your intestines called Clostridioides difficile -associated diarrhea (CDAD), which may range in severity from mild diarrhea to colitis that can lead to death.
If you have diarrhea after you use XACIATO, call your healthcare provider. The most common side effects of XACIATO include: Yeast infection in your vagina that may require treatment with an antifungal medicine. Vaginal discomfort including itching, burning, redness and dryness.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XACIATO. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store XACIATO?
Store XACIATO at room temperature between 68ºF and 77ºF (20ºC to 25ºC). Keep XACIATO and all medicines out of the reach of children. General information about the safe and effective use of XACIATO.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XACIATO for a condition for which it was not prescribed. Do not give XACIATO to other people, even if they have the same symptoms that you have.
It may harm them. You can ask your pharmacist or healthcare provider for information about XACIATO that is written for health professionals. What are the ingredients in XACIATO?
Active ingredient: clindamycin phosphate Inactive ingredients: benzyl alcohol, citric acid monohydrate or citric acid anhydrous, poloxamer 407… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 8g Carton NDC 78206-189-01 XACIATO ® (clindamycin phosphate) vaginal gel 2% 8g tube with one (1) 5g applicator Single-dose container Discard unused portion FOR INTRAVAGINAL USE ONLY Not for ophthalmic, dermal, or oral use Keep out of reach of children RECOMMENDED DOSAGE: See Prescribing Information ADMINISTRATION: See Instructions for Use Rx Only Net Wt. 8 grams Delivering 5 grams Carton
PRINCIPAL DISPLAY PANEL - 8g Tube NDC 78206-189-01 XACIATO ® (clindamycin phosphate) vaginal gel 2% FOR INTRAVAGINAL USE ONLY Not for ophthalmic, dermal, or oral use Keep out of reach of children Net Wt. 8 grams Rx Only label