xaciato
Pharmaranks rates Xaciato 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Xaciato (Clindamycin Phosphate) is a lincosamide antibacterial used to treat Acne Vulgaris, Actinomycetales Infections, Bacteroides Infections, Pneumocystis Pneumonia.
Clindamycin Phosphate · by Organon
Available as a generic: Clindamycin Phosphate
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Clindamycin Phosphate
- Drug class
- Lincosamide Antibacterial
- Form
- Topical
- Strength
- Clindamycin Phosphate EQ 2% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Organon
- Half-life
- about 2.4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.18 per gm — not your price
- FDA application
- NDA215650
What is Xaciato?
From the FDA label: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
How to use
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 )
Side effects
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. 6.1 Clinical 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…
Warnings
Important safety information
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 ) 5.1 Clostridioides 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 )] . 5.2 Use 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 )] . 5.3 Vaginal 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 )] .
Who should not take Xaciato
History of hypersensitivity to clindamycin or lincomycin. ( 4.1 ) 4.1 Hypersensitivity XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. [see Adverse Reactions ( 6.2 )] .
Interactions
7.1 Neuromuscular 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.
How long does Clindamycin Phosphate stay in your body?
The elimination half-life of clindamycin phosphate is about 2.4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label gives an average biological (elimination) half-life of 2.4 hours for oral clindamycin hydrochloride, the active form. It runs slightly longer in older adults (about 4.0 hours, range 3.4–5.1, vs 3.2 hours, range 2.1–4.2, in younger adults) and is increased slightly in people with markedly reduced kidney or liver function. Clindamycin palmitate (oral pediatric solution) and clindamycin phosphate (injection) are inactive prodrugs that are hydrolyzed in the body to this same active clindamycin. Half-life reflects how fast the drug leaves the blood, not how long a drug test can detect it.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride) capsule — FDA label, DailyMed.
Drug class
How this class works, per Clindamycin - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- acne vulgaris
- actinomycetales infections
- bacteroides infections
- pneumocystis pneumonia
- staphylococcal infections
- streptococcal infections
See how Xaciato ranks — best-rated lincosamide antibacterial for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Xaciato treat?
- Xaciato (Clindamycin Phosphate) may be used to treat acne vulgaris, actinomycetales infections, bacteroides infections, pneumocystis pneumonia, staphylococcal infections, streptococcal infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Xaciato work?
- Xaciato is a lincosamide antibacterial. Lincosamides such as clindamycin attach to the bacterial ribosome, the cell's protein-building machine, and stop it from linking amino acids together. Because the bacteria can no longer make the proteins they need, their growth is halted or, depending on the organism and dose, they are killed.
- How is Xaciato rated?
- pharmaranks gives Xaciato a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Xaciato cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.18 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Xaciato?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Xaciato. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Xaciato?
- Xaciato is marketed by Organon. You can see Organon's full profile, rating, and other products on pharmaranks.
- Is Xaciato a brand-name or generic drug?
- Xaciato is a brand-name product with the active ingredient Clindamycin Phosphate. Lower-cost generic equivalents containing Clindamycin Phosphate are available — ask your pharmacist.
- Is Xaciato available over the counter?
- No. Xaciato is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Xaciato come in?
- Xaciato is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Xaciato?
- Xaciato is classified as lincosamide antibacterial, per the FDA's Established Pharmacologic Class.
- Is Xaciato FDA-registered?
- Xaciato is on record with the U.S. FDA under application number NDA215650. You can verify this on its official FDA label.
- Has Xaciato been recalled by the FDA?
- Xaciato has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Xaciato safe?
- There's no single safe-or-not verdict. pharmaranks gives Xaciato a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Xaciato?
- Xaciato's side effects are taken directly from its FDA label. From the label: 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 an… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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xaciato
70/100