Clindamycin Vaginal Cream

• It is used to treat vaginal infections.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to lincomycin, clindamycin, or any other part of clindamycin vaginal cream.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had any of these health problems: Very loose stools called antibiotic-associated colitis, regional enteritis, ulcerative colitis, or Crohn's disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take clindamycin vaginal cream with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature. Do not freeze.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 ng/mL). These peak concentrations were attained approximately 10 hours post-dosing (range 4–24 hours).

Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and less variable than that observed in healthy females. Approximately 5% (range 2% to 8%) of the dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 13 ng/mL (range 6 to 34 ng/mL) and on day 7 it averaged 16 ng/mL (range 7 to 26 ng/mL). These peak concentrations were attained approximately 14 hours post-dosing (range 4–24 hours).

There was little or no systemic accumulation of clindamycin after repeated vaginal dosing of clindamycin phosphate vaginal cream 2%. The systemic half-life was 1.5 to 2.6 hours.

MICROBIOLOGY

Clindamycin inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the process of peptide chain initiation. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis. (See INDICATIONS AND USAGE.) Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp., or Mycoplasma hominis, has not been defined.

Nonetheless, clindamycin is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

• Bacteroides spp.
• Gardnerella vaginalis
• Mobiluncus spp.
• Mycoplasma hominis
• Peptostreptococcus spp.

Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES.)

NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.

Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal and vaginal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated" colitis.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing Clindamycin phosphate vaginal cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment.

In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month posttherapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination.

Rx only

This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

LAB-0049-10.0
July 2017

Clindamycin Phosphate Vaginal Cream, USP

FOR INTRAVAGINAL USE ONLY

NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

DIRECTIONS FOR USE

Disposable plastic applicators are provided with this package. They are designed to allow proper vaginal administration of the cream.

Remove cap from cream tube. Screw a plastic applicator on the threaded end of the tube.

Rolling tube from the bottom, squeeze gently and force the medication into the applicator. The applicator is filled when the plunger reaches its predetermined stopping point.

Unscrew the applicator from the tube and replace the cap.

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.

REMEMBER TO APPLY ONE APPLICATORFUL EACH NIGHT BEFORE BEDTIME, OR AS PRESCRIBED BY YOUR DOCTOR.

Clindamycin is used to treat bacterial vaginosis.

This drug is available in many forms. It comes as an oral capsule, oral solution, topical foam, topical gel, topical lotion, topical swab, topical solution, vaginal suppository, and vaginal cream. It’s also available as an intravenous (IV) drug, which is only given by a healthcare provider. Some of these forms treat other infections.

Clindamycin vaginal cream is available as the brand-name drugs Clindesse and Cleocin. It’s also available as a generic drug.

• Diarrhea See Details

• Finish taking your drug See Details

What is clindamycin?

Clindamycin is a prescription drug. It’s available as an oral capsule, oral solution, topical foam, topical gel, topical lotion, topical swab, topical solution, vaginal suppository, and vaginal cream. It’s also available as an intravenous (IV) drug, which is only given by a healthcare provider.

The vaginal cream is available as the brand-name drugs Clindesse and Cleocin. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

Why it's used

Clindamycin is used to treat certain infections caused by bacteria. These infections include acne and bacterial vaginosis.

How it works

Clindamycin belongs to a class of drugs called antibiotics.

More Details