Xaciato dosage, forms, and strengths

Xaciato is a brand-name topical antibiotic approved by the U.S. Food and Drug Administration (FDA) to treat bacterial vaginosis. The antibiotic in Xaciato is clindamycin phosphate, a chemical version of clindamycin used for topical applications such as gels and creams. Xaciato gel is applied inside the vagina using a single-dose applicator. Only one dose is necessary.

Xaciato forms and strengths

Xaciato comes in one form: vaginal gel. It is used only once to treat bacterial vaginosis. The Xaciato carton contains both a tube of vaginal gel and an applicator. One applicator filled with gel will contain 5 grams of gel containing 100 mg of clindamycin phosphate. 

• Vaginal gel: 2% clindamycin phosphate 

Xaciato dosage for adults

Healthcare providers prescribe Xaciato as a single-dose treatment for bacterial vaginosis. The medicine can be administered into the vagina at any time of day. Contraindications include any history of allergic reactions to clindamycin or related lincosamide antibiotic called lincomycin.

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Xaciato dosage for bacterial vaginosis

Bacterial vaginosis is not so much an infection but an overgrowth of bacteria that already live in the vagina. Although most women do not experience symptoms, it is one of the most common vaginal infections and the most common cause of vaginal discharge. Clindamycin and metronidazole are the standard treatments for BV, though 30% of cases resolve without treatment. Additionally, some women may choose to use home remedies such as probiotics. Antibiotic treatment is usually indicated when BV is causing distress or discomfort. Cure rates with antibiotics are high (80% to 90% in one month). 

Xaciato is a single-dose treatment administered at home. Women will fill the applicator and apply the gel into the vagina, delivering a 100 mg dose of clindamycin phosphate onto the tissues in the vagina.

• Standard adult dosage for bacterial vaginosis: One applicatorful of gel (5 g gel, 100 mg clindamycin) administered intravaginally one time

• Maximum adult dosage for bacterial vaginosis: 100 mg single dose

Xaciato dosage for children

The FDA has approved Xaciato for use in children 12 years and older. Children take the same dose as adults.

• Standard pediatric dosage for bacterial vaginosis in children 12 years of age and older: One applicatorful of gel (5 g gel, 100 mg clindamycin) administered intravaginally one time

• Maximum pediatric dosage for bacterial vaginosis in children 12 years of age and older: 100 mg single dose

Xaciato dosage restrictions

Healthcare providers do not modify Xaciato doses for people with kidney disease, liver impairment, or other medical conditions. 

How to take Xaciato

Xaciato is applied once inside the vagina using an applicator. To achieve the best benefits of Xaciato, follow these instructions:

• Use this medicine only as instructed.

• Read the patient information sheet that comes with this medicine.

• Use only one applicator in the vagina.

• Do not apply Xaciato to the skin or get it in the eyes or mouth.

• How to apply a dose:

  • Inside the Xaciato carton is a tube of gel and an empty applicator.

  • Open the tube of Xaciato by unscrewing its cap and puncturing the tube’s seal using the pointed tip at the top of the cap.

  • Hold the applicator by its grip and screw the tip of the applicator onto the tube until it feels secure. Leave the plunger inside the applicator.

  • Squeeze the tube from the bottom. 

  • The gel will push the plunger up as the applicator fills. 

  • Continue to fill the applicator until you see the black line on the plunger pass the end of the applicator. 

  • Unscrew the applicator from the tube.

  • Lie on your back with your knees bent or in a comfortable position. 

  • Insert the applicator into the vagina as far as it will comfortably go. 

  • Slowly push the plunger until it stops. 

  • Remove the empty applicator from the vagina and place it in the original box that it came in, along with the tube, then throw the box away in the trash.

• Do not store or use any medicine left in the tube or applicator.

• Do not engage in sexual intercourse or use other vaginal products for three days after applying the gel.

• Do not use polyurethane condoms for the next seven days after applying the gel. Use another form of contraception, such as latex or polyisoprene condoms.

• Store Xaciato gel at room temperature. Do not refrigerate or freeze.

Xaciato dosage FAQs

How long does it take Xaciato to work?

Xaciato is formulated to stick to the vaginal wall to gradually release clindamycin phosphate onto the tissues. The clindamycin dose reaches its peak at two or three days after administration. Clinical signs should start improving on the first day, but it will take several days before they fade completely. In clinical studies, approximately 76% of participants had achieved clinical cure after seven to 14 days following the Xaciato dose.

How long does Xaciato stay in your system?

Xaciato is a topical medication applied intravaginally, so the amount of clindamycin that enters the bloodstream is very low. 

Because clindamycin has a half-life of two to three hours, any clindamycin that does enter the system breaks down completely in a few hours. However, Xaciato steadily releases clindamycin over a few days, so clindamycin levels hit their maximum about two or three days after the gel is applied. 

What happens if I miss a dose of Xaciato?

Xaciato is a one-dose treatment that can be applied at any time. If it’s forgotten, apply the dose when remembered.

How long can you take Xaciato?

Xaciato is a one-dose treatment. Do not use Xaciato a second time unless prescribed by a healthcare provider. Follow up with a healthcare provider about one month after the dose is administered.

How do I stop taking Xaciato?

Xaciato is a one-dose treatment. Take one dose and then stop. About 30 days later, the healthcare provider will determine if the infection has been cured. If it hasn’t been cured and Xaciato is not an option, healthcare providers might prescribe other topical formulations of clindamycin, such as Clindesse or Cleocin, switch to topical metronidazole, or antibiotic pills.

What is the maximum dosage for Xaciato?

The maximum dosage of Xaciato is a single 100 mg dose. 

Can you overdose on Xaciato?

Xaciato overdose is unlikely because the medicine is applied topically. However, there is a possibility that it can be used improperly. If too much Xaciato is used or if it gets in the eyes or mouth, call a poison helpline or get emergency medical attention.

What interacts with Xaciato?

Because very little clindamycin enters the bloodstream, Xaciato has very few drug interactions. Most importantly, women should not use vaginal products such as tampons or douches for three days following Xaciato dosing. Women who are using vaginal medications such as hormonal rings, vaginal gels, or vaginal suppositories should ask the prescriber for medical advice about using these medications in the days following a Xacialto dose.

What happens when you mix Xaciato and alcohol?

Using alcohol while taking Xaciato is not recommended. Talk to a healthcare provider about the use of Xaciato with certain foods or alcohol. 

Is it safe to take Xaciato during pregnancy?

Xaciato has not been tested during pregnancy, but other clindamycin medications have been used safely during the second and third trimesters. However, because Xaciato is applied intravaginally, very little of the medicine gets into the bloodstream, so use during pregnancy does not result in significant fetal exposure.

Is it safe to take Xaciato while breastfeeding?

Since so little medicine gets into the bloodstream, healthcare providers do not believe that Xaciato affects lactation or causes problems in infant nursing.

What are the side effects of Xaciato?

The most common side effects reported in clinical trials were yeast infections (vulvovaginal candidiasis) and vulvovaginal discomfort. Other serious side effects are relatively uncommon because very little Xaciato gets into the bloodstream, however, C. difficile-associated diarrhea (CDAD) has been reported with almost all antibacterial agents.

What are the serious side effects of Xaciato?

If enough clindamycin gets into the bloodstream, it can cause serious side effects. The most serious side effect is C. difficile-associated diarrhea (CDAD), an overgrowth of C. difficile bacteria in the colon. Characterized by severe diarrhea and colon swelling (colitis), CDAD is potentially life-threatening and could occur weeks after a dose of Xaciato. Do not try to treat the diarrhea at home with over-the-counter diarrhea medications. Anyone taking an antibiotic should talk to a healthcare provider if they experience severe, persistent, or bloody diarrhea. 

Sources

• Bacterial vaginosis, StatPearls

• Bacterial vaginosis, World Health Organization

• The prevalence of bacterial vaginosis in the United States 2001–2004: Associations with symptoms, sexual behaviors, and reproductive health, Sexually Transmitted Diseases

• Xaciato, Organon

• Xaciato clindamycin phosphate gel prescribing information, DailyMed (NIH National Library of Medicine)

• Xaciato HCP, Organon Pro