clindamycin vaginal (Rx)

Brand and Other Names:Clindesse Vaginal Cream, Cleocin Vaginal Cream, more...Cleocin Vaginal Ovules, Xaciato
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal cream

  • 2% (5g/100mg) (Clindesse Vaginal Cream, Cleocin Vaginal Cream)

vaginal suppository

  • 100mg (Cleocin Vaginal Ovules)

vaginal gel

  • 2% (Xaciato)

Bacterial Vaginosis

Indicated for bacterial vaginosis

Clindesse Vaginal Cream: 1 full applicator inserted intravaginally as a single dose in nonpregnant patients

Cleocin Vaginal Cream: 1 full applicator inserted intravaginally qHS for 3 or 7 consecutive days in nonpregnant patients and for 7 consecutive days in pregnant patients

Cleocin Vaginal Ovules: Insert 1 suppository into vagina qHS for 3 consecutive days

Xaciato: 1 applicatorful (100 mg clindamycin per 5 g of gel) intravaginally as a single dose

Dosing Considerations

Bacterial vaginosis formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis

Safety and efficacy not established

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Adverse Effects

>10%

Clindesse vaginal cream

  • Fungal vaginosis (14%)
  • Cleocin vaginal cream H4
  • Vaginal moniliasis (7.1-13.3%)

Xaciato

  • Vulvovaginal candidiasis (17%)

1-10%

Clindesse vaginal cream

  • Headache (7%)
  • Back pain (5%)
  • Constipation (2%)
  • Urinary tract infection (2%)

Cleocin vaginal cream

  • Vulvovaginitis (4.4-6%)
  • Vulvovaginal disorder (3.2-7.1%)
  • Trichomonal vaginitis (1.3%)
  • Moniliasis, body (0.2-1.3%)
  • Pruritus, nonapplication site (1.1%)

Cleocin vaginal suppository

  • Vulvovaginal disorder (3.4%)
  • Vaginal pain (1.9%)
  • Vaginal moniliasis (1.5%)
  • Fungal infection (1%)

Xaciato

  • Vulvovaginal candidiasis (17%)

<1%

Body as a whole: Upper respiratory infection

Dermatologic: Pruritic rash, pruritus, erythema

Gastrointestinal: Diarrhea, vomiting

General: Fatigue

Immune System: Hypersensitivity

Nervous System: Dizziness

Reproductive System: Dysfunctional uterine bleeding, dysuria, dysmenorrhea, intermenstrual bleeding, menorrhagia, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema, vulvitis, vulvovaginal discomfort/pain, vulvovaginal dryness, vulvovaginitis

Postmarketing Reports

Pseudomembranous colitis

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Warnings

Contraindications

Hypersensitivity to clindamycin or other lincosamides

Regional enteritis, ulcerative colitis, or history of Clostridium difficile-associated diarrhea

Cautions

Clostridium 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; if suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued; initiate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile

Do not use barrier contraceptives (eg, condoms, diaphragms) not recommended concurrently or for 5 days following treatment with clindamycin vaginal creams or suppositories; the creams contain mineral oil and the suppositories contain an oleaginous base that may weaken latex or rubber products

Xaciato

  • May result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis which may require antifungal treatment
  • Use of polyurethane condoms
    • Not compatible with and may weaken polyurethane condoms
    • Use is not recommended during treatment or for 7 days following treatment
    • During this period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases
    • Use latex or polyisoprene condoms

Drug interaction overview

  • Neuromuscular blocking agents
    • Caution advised
    • PO or IV administered clindamycin has neuromuscular blocking properties that may enhance action of other neuromuscular blocking agents
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Pregnancy & Lactation

Pregnancy

Other clindamycin vaginal products have been used to treat pregnant females during the second and third trimester

Not studied in pregnant females

Clindesse vaginal cream

  • Use during pregnancy only if clearly needed
  • No adequate and well-controlled studies in pregnant females have been conducted

Cleocin vaginal cream or suppositories

  • There are no adequate and well-controlled studies in pregnant females during first trimester; use only if clearly needed and benefits outweigh risks
  • In clinical trials with pregnant women, systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities
  • Studied in pregnant females during the second trimester; in those treated for 7 days, abnormal labor was reported in 1.1% of patients who received clindamycin vaginal cream compared with 0.5% of patients who received placebo

Xaciato

  • Based on the low systemic absorption following the intravaginal route of administration in nonpregnant females, maternal use is not likely to result in significant fetal exposure to the

Contraception

  • Not compatible with and may weaken polyurethane condoms; therefore, use of polyurethane condoms is not recommended during and for 7 days following treatment
  • Advise patients to use latex or polyisoprene condoms for contraception during and for 7 days following treatment

Lactation

Unknown if excreted in human breast milk following use of vaginally administered clindamycin phosphate; detected in human milk after PO or IV administration

Clindamycin has the potential to cause adverse effects on breastfed infants’ gastrointestinal flora

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Lincosamide antibacterial

Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacterial and affects the process of peptide chain initiation

Clindamycin phosphate is inactive in vitro, in vivo hydrolysis converts this compound to the antibacterially active clindamycin

Absorption

Clindesse Vaginal Cream

  • Peak plasma time: 20 hr
  • AUC: 175 ng⋅hr/mL
  • Peak plasma concentration
    • 6.6 ng/mL
    • Mean peak concentration ~0.3%, 0.1%, and 7.6% of that observed after administration of 150 mg Cleocin oral capsule (2.5 mcg/mL), 600 mg Cleocin IV (10.9 mcg/mL), and single dose of 100 mg of Cleocin vaginal cream (86.5 ng/mL)

Cleocin Vaginal Cream

  • Peak plasma time: 14 hr
  • Peak plasma concentration: 18 ng/mL (day 1); 25 ng/mL (day 7)

Cleocin Vaginal Suppository

  • Peak plasma time: 5 hr
  • AUC: 3.2 mcg⋅hr/mL (day 3); 11 mcg⋅hr/mL (single dose)
  • Peak plasma concentration: 0.27 mcg/mL (day 3); 3.7 mcg/mL (single dose)

Metabolism

Hydrolysis converts clindamycin phosphate to the antibacterially active clindamycin

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Administration

Intravaginal Administration

For vaginal use only

Administration at bedtime decreases leakage

Vaginal cream

  • While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort
  • Slowly push the plunger until it stops
  • Carefully withdraw applicator from vagina, and discard applicator

Vaginal suppository

  • Remove suppository from foil and place suppository in supplied applicator as instructions describe
  • Hold applicator as shown in packaging and gently insert the end of the applicator with the suppository into the vagina as far as it will go comfortably
  • This can be done while lying on your back with your knees bent or while standing with your feet apart and your knees bent
  • Once inside the vagina, the suppository melts
  • Carefully withdraw applicator from vagina, and wash applicator

Xaciato

  • One single-dose, user-filled disposable applicator delivers 5 g of gel containing 100 mg of clindamycin
  • Use 1 filled applicator gel in your vagina
  • Do not use any medicine from the tube or applicator more than 1 time; gel is for 1 time (single-use) only
  • Do not have vaginal sex or use vaginal products (such as tampons or douches) during treatment with gel and for 3 days after using gel
  • Do not use polyurethane condoms during treatment with gel and for 7 days after using gel; gel may weaken polyurethane condoms
  • Use latex or polyisoprene condoms

Storage

Vaginal cream

  • Store at 20-25ºC (68-77ºF)
  • Avoid heat above 30ºC (86ºF)
  • Do not freeze

Vaginal suppositories

  • Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86F)
  • Avoid heat above 30ºC (86ºF)
  • Avoid high humidity

Vaginal gel

  • Store at 20-25ºC (68-77ºF)
  • Do not refrigerate or freeze
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Images

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.