Professional Information
Clindamycin (Vaginal)
VA CLASSIFICATION
Primary: GU309
Commonly used brand name(s): Cleocin; Dalacin.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Anti-infective (vaginal)—
Indications
Accepted
Vaginosis, bacterial (treatment)—Vaginal clindamycin is indicated in the local treatment of bacterial vaginosis (previously known as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). {01}
—In addition to its use in nonpregnant patients, vaginal clindamycin is indicated for use during the second and third trimesters of pregnancy {01} {14}. However, in a controlled clinical trial, no difference was found between vaginal clindamycin and placebo in reducing the risk of adverse pregnancy outcomes, such as premature rupture of the membranes, preterm labor, or preterm delivery {14}. The best results are achieved when high-risk pregnant patients are screened early in the second trimester and asymptomatic high-risk and symptomatic low-risk patients are treated with oral metronidazole or oral clindamycin {03} {16}. Although some experts prefer the use of systemic therapy for low-risk pregnant patients to treat possible subclinical upper gential tract infections, vaginal metronidazole may be used in low-risk pregnant patients as an alternative therapy {03}.
—Not all species or strains of a particular organism may be susceptible to clindamycin.
Unaccepted
Vaginal clindamycin is not effective in the treatment of vulvovaginitis caused by Trichomonas vaginalis , Chlamydia trachomatis , Neisseria gonorrhoeae , Candida albicans , or Herpes simplex virus. {01}
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
Clindamycin phosphate: 504.97 {07}
Mechanism of action/Effect:
Clindamycin phosphate is hydrolyzed in vivo to clindamycin, which inhibits protein synthesis in susceptible bacteria by binding to the 50 S subunits of bacterial ribosomes and prevents peptide bond formation. {01}
Absorption:
Approximately 2 to 8% of the administered dose (100 mg) is absorbed systemically; little or no systemic accumulation has been produced with multiple dosing. {01}
Biotransformation:
Inactive clindamycin phosphate undergoes rapid hydrolysis in vivo to active clindamycin. {01}
Half-life:
Systemic—1.5 to 2.6 hours. {01}
Time to peak concentration:
Approximately 16 hours (range, 8 to 24 hours). {01}
Peak serum concentration:
Steady state—Approximately 16 mcg/L (0.032 micromoles/L). {01}
Precautions to Consider
Cross-sensitivity and/or related problems
Patients hypersensitive to lincomycin may be hypersensitive to clindamycin also. {01} {06}
Carcinogenicity/Tumorigenicity
Long-term studies in animals have not been done. {01}
Mutagenicity
No evidence of mutagenicity was found in tests, including the Ames test and a rat micronucleus test. {01}
Pregnancy/Reproduction
Fertility—
No evidence of adverse effects on fertility was found in rats when they were treated with oral doses of 300 mg per kg of body weight (mg/kg) a day (31 times the human exposure based on mg per square meter [mg/m 2] of body surface area). {01}
Pregnancy—
Systemic clindamycin crosses the placenta; up to 8% of vaginal clindamycin is systemically absorbed. {01} {06}
Well-controlled clinical trials using vaginal clindamycin during the second and third trimesters showed no adverse effects in the fetus; {01} {14} there is inadequate information on its use during the first trimester {01} {03}.
Although vaginal clindamycin is effective in treating bacterial vaginosis in pregnant and nonpregnant women, it frequently causes cervicitis or vaginitis with or without candidiasis, especially in pregnant patients {01} {14}. Pregnant patients were not re-treated in clinical trials even though bacterial vaginosis returned in about 50% of patients several weeks after initial treatment {14}. In general, best results for treatment and pregnancy outcomes are associated with treatment early in the second trimester {03} {14} {15} {16}. The incidence of bacterial vaginosis appears to lessen by an unknown mechanism as pregnancy continues into the third trimester {14}.
Reproduction studies in animals in which high systemic doses of clindamycin were used showed no evidence of fetal malformations, except one small study in which the fetuses of treated mice developed cleft palates. This result has not been duplicated in other animals or other mouse strains. {01}
FDA Pregnancy Category B.
Breast-feeding
Systemic clindamycin is distributed into breast milk. {01} {06} Problems in humans have not been documented. It is not known if vaginally administered clindamycin phosphate is distributed into breast milk. {01}
Pediatrics
No information is available on the relationship of age to the effects of vaginal clindamycin in pediatric patients. Safety and efficacy have not been established. {01}
Geriatrics
No information is available on the relationship of age to the effects of clindamycin in geriatric patients.
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problems exist
» Gastrointestinal disease, history of, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis (systemically and topically administered clindamycin may cause diarrhea and, rarely with topical administration, colitis—including pseudomembranous colitis; although only up to 8% of the vaginal dose may be systemically absorbed, vaginal use may potentially worsen these conditions {01} {10})
» Hypersensitivity to lincomycin or clindamycin{01}{06}
Side/Adverse Effects
Note: The side effects listed below are those reported in studies with vaginal clindamycin administration. Systemic side effects may occur since up to 8% of the vaginal dose is absorbed systemically. {01} {10} Pseudomembranous colitis has occurred rarely with topical use of clindamycin but has not been reported with vaginal administration. {01}
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence more frequent
Cervicitis, vaginitis, or vulvovaginal pruritus, primarily due to Candida albicans (itching of the vagina or genital area; pain during sexual intercourse; thick, white vaginal discharge with no odor or with a mild odor)—incidence of 33% for pregnant patients and 16% for nonpregnant patients{01}{04}{05}{06}{11}{12}
Incidence less frequent
CNS effects (dizziness; headache)
gastrointestinal disturbances {01}{06}{13}(diarrhea; nausea or vomiting; stomach pain or cramps)
Incidence rare
Hypersensitivity {01}{06}(burning, itching, redness, skin rash, swelling, or other signs of skin irritation not present before therapy)
Those indicating possible need for medical attention if they occur after medication is discontinued
Cervicitis, vaginitis, or vulvovaginal pruritus, primarily due to Candida albicans {01}{04}{05}{06}{11}{12}(itching of the vagina or genital area; pain during sexual intercourse; thick, white vaginal discharge with no odor or with a mild odor)
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Clindamycin (Vaginal) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Hypersensitivity to clindamycin or lincomycin
Pregnancy—Systemic clindamycin crosses the placenta; up to 8% of vaginal clindamycin is systemically absorbed
Breast-feeding—Systemically administered clindamycin is distributed into breast milk. It is not known if vaginal clindamycin also is distributed into breast milk
Other medical problems, especially history of gastrointestinal disease (particularly ulcerative colitis, regional enteritis, or antibiotic-associated colitis)
Proper use of this medication
Washing hands immediately before and after vaginal administration
Avoiding getting medication into the eyes; washing eyes out immediately with large amounts of cool tap water if medication does get into eyes; checking with physician if eyes continue to be painful
Reading patient directions carefully before use
Proper administration technique: Following directions regarding the filling of the applicator, insertion technique, and discarding the applicator after each use
» Compliance with full course of therapy, even during menstruation
» Not missing doses; using at evenly spaced times
» Proper dosing
Missed dose: Inserting as soon as possible; not inserting if almost time for next dose
» Proper storage
Precautions while using this medication
Checking with physician if no improvement within a few days
Follow-up visit to physician after treatment for bacterial vaginosis to ensure that infection has been properly treated
Caution if dizziness occurs
Protecting clothing because of possible soiling with vaginal clindamycin; avoiding use of tampons
» Using hygienic measures to help cure infection and prevent reinfection, e.g., wearing freshly washed cotton panties instead of synthetic panties
» Sexual abstinence is recommended during treatment to prevent a dilution of the dose, which may result in reduced efficacy of the medication and a relapse of the infection
» Not using latex contraceptives for up to 72 hours after vaginal clindamycin treatment, as oils in the clindamycin weaken latex products and may affect their efficacy
Side/adverse effects
Signs of potential side effects, especially cervicitis, vaginitis, or vulvovaginal pruritus, due to Candida albicans ; CNS effects; gastrointestinal disturbances; and hypersensitivity
General Dosing Information
Use of vaginal latex or rubber products, such as condoms, cervical caps, or diaphragms, is not recommended for up to 72 hours after completion of vaginal clindamycin treatment. Vaginal clindamycin cream contains mineral oil that can weaken or damage these products and reduce their efficacy. {01}
Concurrent treatment of the male partner is generally unnecessary when treating bacterial vaginosis. {08}
Vaginal applicators should be used with caution after the sixth month of pregnancy. {09}
Vaginal Dosage Form
CLINDAMYCIN PHOSPHATE VAGINAL CREAM USP
Usual adult and adolescent dose
Anti-infective (vaginal)
For nonpregnant females: Intravaginal, 100 mg (one applicatorful) into vagina once a day, preferably at bedtime, for three or seven consecutive days. {01} {17}
For pregnant females (second or third trimesters): Intravaginal, 100 mg (one applicatorful) into vagina once a day, preferably at bedtime, for seven consecutive days. {01}
Usual pediatric dose
Safety and efficacy have not been established.
Strength(s) usually available
U.S.—
2% (Rx) [Cleocin (benzyl alcohol) (cetostearyl alcohol) (mineral oil){01}]
Canada—
2% (Rx) [Dalacin (benzyl alcohol) (cetostearyl alcohol) (mineral oil){06}]
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in well-closed containers {02}.
Auxiliary labeling:
• May cause dizziness.
• Continue medicine for full time of treatment.
• For vaginal use only.
Note: Include patient package insert (PPI) when dispensing.
Revised: 08/11/98
References
- Cleocin package insert (Pharmacia & Upjohn—US), Rev 3/98, Rec 3/98.
- The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995) NF 18th ed (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention, Inc; 1996 (Supplement 4, 1996). p. 3141.
- Centers for Disease Control and Prevention. 1998 guideline for treatment of sexually transmitted diseases. MMWR Morb Mortal Wkly Rep 1998 Jan; 47 (No. RR-1): 1-118.
- Stein GE, Christensen SL, Mummaw NL, et al. Placebo-controlled trial of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis. Ann Pharmacother 1993 Nov; 27: 1343-5.
- Fischbach F, Petersen EE, Weissenbacher ER, et al. Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis. Obstet Gynecol 1993 Sep; 82(3): 405-10.
- Dalacin product monograph (Pharmacia & Upjohn—Canada), Rev 12/93, Rec 5/94.
- Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1997. p. 177.
- Livengood CH, Thomason JL, Hill GB. Bacterial vaginosis: diagnostic and pathogenetic findings during topical clindamycin therapy. Am J Obstet Gynecol 1990 Aug; 163(2): 515-20.
- Reviewers' consensus on Metronidazole (Vaginal) monograph revision of 4/94.
- Reviewers' consensus on monograph revision of 5/94.
- Panel comment, 5/94.
- Panel comment, 5/94.
- Panel comment, 5/94.
- McGregor JA, French JI, Jones W, et al. Bacterial vaginosis is associated with prematurity and vaginal fluid mucinase and sialidase: results of a controlled trial of topical clindamycin cream. Am J Obstet Gynecol 1994 Apr; 170(4): 1048-60.
- McGregor JA, French JI, Parker R, et al. Prevention of premature birth by screening and treatment for common genital tract infections: results of a prospective controlled evaluation. Am J Obstet Gynecol 1995 Jul; 173(1): 157-67.
- Joesoef MR, Hillier SL, Wiknjosastro G, et al. Intravaginal clindamycin treatment for bacterial vaginosis: effects on preterm delivery and low birth weight. Am J Obstet Gynecol 1995; 173(5): 1527-31.
- Dhar J, Arya OP, Timmins DJ, et al. Treatment of bacterial vaginosis with a three day course of 2% clindamycin vaginal cream: a pilot study. Genitourin Med 1994 Apr; 70(2): 121-3.
| Link to this page |  |
Printable Version |  |
Email Page |
