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GREENSTONE LLC.
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59762374302

clindamycin ph 1% gel

Generic
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Uses

Acne Vulgaris

Clindamycin phosphate is used topically alone or in conjunction with benzoyl peroxide in the treatment of inflammatory acne vulgaris. In weighing the potential benefits of topical clindamycin therapy, the possibility of serious adverse GI effects associated with the drug should be considered. Therapy of acne vulgaris must be individualized and frequently modified depending on the types of acne lesions which predominate and the response to therapy. Topical anti-infectives, including clindamycin, generally are effective in the treatment of mild to moderate inflammatory acne. However, use of topical anti-infectives as monotherapy may lead to bacterial resistance; this resistance is associated with decreased clinical efficacy.Topical clindamycin is particularly useful when used with benzoyl peroxide or topical retinoids. Results of clinical studies indicate that combination therapy results in a reduction in total lesion counts of 50-70%.

Bacterial Vaginosis

Clindamycin is used intravaginally as a vaginal cream or suppository or orally for the treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

Bacterial vaginosis is a noninflammatory vaginal syndrome characterized by replacement of the normal vaginal flora (predominantly hydrogen peroxide-producing Lactobacillus) with a mixed flora including Gardnerella vaginalis, anaerobes (e.g., Bacteroides ureolyticus, Prevotella, Porphyromonas, Peptostreptococcus, Mobiluncus), and Mycoplasma hominis; vaginal discharge may be an unreliable indicator of infection since many women are asymptomatic. While Gardnerella previously was thought to be the sole causative agent of this syndrome, it currently is thought that bacterial vaginosis is a polymicrobial condition in which Gardnerella acts synergistically with anaerobic bacteria and genital mycoplasmas. Clinical diagnosis of the syndrome generally is established by characteristic vaginal manifestations rather than bacteriologic determinations. The presence of at least 3 of the following manifestations is considered diagnostic for bacterial vaginosis: a nonirritating, odoriferous, thin, homogeneous, grayish-white, noninflammatory vaginal discharge that smoothly coats the vaginal walls; a vaginal pH exceeding 4.5; the elaboration of malodorous amines (''fishy'' odor) from discharge fluid after alkalinization with potassium hydroxide 10% (''whiff test''); and/or microscopic smears containing small coccobacillary organisms adherent to epithelial cells (''clue cells''). The presence of clue cells on wet mount examination of vaginal secretions is one of the most reliable indicators of bacterial vaginosis.

Gram stain results consistent with a diagnosis of bacterial vaginosis include markedly reduced or absent Lactobacillus morphology and predominance of Gardnerella morphotype. Although Gram stain of vaginal secretions also has been employed as a diagnostic test for bacterial vaginosis, accuracy of this method depends on evaluation by an experienced microbiologist; thus, this technique is used more often in research and hospital settings whereas diagnosis by clinical criteria typically is performed in an office setting. Gardnerella can be isolated from vaginal cultures in a large proportion of healthy women; because of this lack of specificity, culture for the organism is not recommended as a diagnostic method for bacterial vaginosis, and it is not used to guide therapy. The possibility of other pathogens commonly associated with vulvovaginitis or cervicitis (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, herpes simplex viruses) generally should be ruled out, particularly since coinfection with these organisms may occur.

Goals of treatment and recommended therapy for bacterial vaginosis differ for nonpregnant versus pregnant women. However, relief of signs and symptoms of infection is a principal goal of therapy, and all women with symptomatic bacterial vaginosis should be treated regardless of pregnancy status.

Nonpregnant Women

The principal goal in the treatment of bacterial vaginosis in nonpregnant women is to provide relief of vaginal manifestations and signs of infection. Other potential benefits include a reduction in other infectious complications, including human immunodeficiency virus (HIV) infection or other sexually transmitted diseases. The US Centers for Disease Control and Prevention (CDC) states that treatment of bacterial vaginosis is indicated in all nonpregnant women who are symptomatic. The regimens recommended by the CDC for the treatment of bacterial vaginosis in nonpregnant women are a 7-day regimen of oral metronidazole (500 mg twice daily), a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream. Alternative regimens recommended by the CDC for these women are a 7-day regimen of oral clindamycin or a 3-day regimen of intravaginal clindamycin suppositories. or

Intravaginal metronidazole therapy results in clinical cure rates comparable to those reported with a 7-day oral metronidazole regimen; intravaginal clindamycin cream appears to be less effective than the metronidazole regimens. The CDC suggests that intravaginal clindamycin is the preferred regimen for the treatment of bacterial vaginosis in women hypersensitive to metronidazole. Regardless of the therapy chosen, relapse or recurrence of bacterial vaginosis is common, and some clinicians suggest that an alternative regimen (e.g., oral therapy when intravaginal therapy was used initially) can be employed in such infections. Long-term maintenance therapy does not appear to be beneficial in women with recurrent or relapsing disease and is not recommended.

Results of several controlled studies indicate that intravaginal clindamycin cream (3- or 7-day regimen) is more effective than placebo for the treatment of bacterial vaginosis. Results of some randomized, double-blind studies for the treatment of symptomatic bacterial vaginosis indicate that 5 g of clindamycin phosphate (2% clindamycin) vaginal cream (100 mg of clindamycin) applied daily for 7 days is as effective as oral metronidazole 500 mg twice daily for 7 days. Patients who were treated with this regimen of intravaginal clindamycin cream had cure rates or combined cure and improvement rates of 57-94% at 4-10 days following completion of therapy, and, in one study, a combined cure and improvement rate of 83% was observed at 1 month following completion of therapy in patients receiving intravaginal clindamycin cream compared with 78% in those receiving oral metronidazole; microbiologic response to therapy paralleled clinical response. In a randomized controlled trial, similar cure rates were obtained with intravaginal clindamycin cream (86%), oral metronidazole (84%), or intravaginal metronidazole gel (75%) at 7-14 days following completion of therapy; interpretation of these results is limited by the statistical limitations of this study (i.e., small sample size, inadequate power, short-term follow-up), and further study is needed to fully establish the comparative efficacy of these treatments. Results of randomized clinical studies indicate that cure rates obtained following a 3-day regimen of clindamycin vaginal suppositories are superior to placebo and comparable to those obtained with a 7-day regimen of oral metronidazole. Results of other studies indicate that cure rates obtained with a single 5-g dose of clindamycin phosphate vaginal cream (Clindesse) are superior to placebo and comparable to those obtained with a 7-day regimen of clindamycin vaginal cream (Cleocin). Long-term follow-up of patients suggests high recurrence rates for bacterial vaginosis regardless of initial therapy.

Pregnant Women

An increased risk of obstetric complications, including intraamniotic infection, chorioamnionitis, premature rupture of membranes, preterm delivery, and low-birthweight infants, is associated with the presence of bacterial vaginosis in pregnant women, and the organisms found in increased concentrations in the genital flora of women with bacterial vaginosis are frequently found in patients with postpartum or postcesarean endometritis. Evidence from randomized, controlled trials indicates that systemic treatment of bacterial vaginosis reduces the rate of preterm birth in pregnant women at high risk for complications of pregnancy.

Because of the increased risk of adverse pregnancy outcomes associated with the presence of bacterial vaginosis, the CDC recommends that all symptomatic pregnant women be tested and treated for bacterial vaginosis. In addition, because there is evidence from randomized studies that treatment of bacterial vaginosis in asymptomatic pregnant women at high risk for complications of pregnancy (e.g., those who previously delivered a premature infant) has reduced preterm delivery, some experts recommend that all women at high risk be screened and treated for bacterial vaginosis. The CDC recommends that screening for bacterial vaginosis (if conducted) should be performed at the first prenatal visit and treatment initiated if needed. for a complete discussion of screening and treatment for bacterial vaginosis in pregnant women.)

The preferred regimens for the treatment of symptomatic bacterial vaginosis in pregnant women and for the treatment of asymptomatic women at high risk for complications of pregnancy are a 7-day regimen of oral metronidazole (500 mg twice daily or 250 mg 3 times daily) or a 7-day regimen of oral clindamycin (300 mg twice daily). and see Although some experts state that intravaginal therapy may be used solely for symptomatic relief (and not for prevention of adverse pregnancy outcomes) in women at low risk for preterm delivery, others prefer use of systemic therapy for all pregnant women, regardless of degree of risk for complications of pregnancy, because systemic treatment may be required to eradicate upper genital tract infection that may be associated with bacterial vaginosis. Use of intravaginal clindamycin to reduce preterm birth and treat bacterial vaginosis in pregnant women has been evaluated in several studies. In one study in women treated with intravaginal clindamycin early in the pregnancy (i.e., before 20 weeks' gestation), administration of clindamycin was associated with a reduction in preterm birth. In other studies, such therapy administered at 16-32 weeks' gestation did not reduce the incidence of adverse pregnancy outcomes. Therefore, the CDC states that intravaginal clindamycin should only be used during the first half of pregnancy.

Women Undergoing Gynecologic Procedures and Surgery

The goal of treatment of symptomatic bacterial vaginosis in women undergoing hysterectomy or abortion is to reduce the risk of infectious complications (e.g., pelvic inflammatory disease [PID]) following these procedures.

Treatment of asymptomatic bacterial vaginosis in patients who are about to undergo an invasive gynecologic procedure (e.g., endometrial biopsy, hysteroscopy, hysterosalpingography, hysterectomy, placement of an intrauterine device, uterine curettage), abortion, vaginal surgery, or abdominal surgery may be a reasonable consideration because of the association between this condition and various gynecologic infections (e.g., endometritis, PID, vaginal cuff cellulitis). While a reduction in postoperative PID in women with bacterial vaginosis undergoing first-trimester elective abortion has been established in at least one study employing oral metronidazole, further study is needed to determine the value of treating asymptomatic bacterial vaginosis in patients who are about to undergo other invasive procedures.

HIV-infected Women

Recommendations for treatment and preferred regimens for bacterial vaginosis in patients with concurrent HIV infection are the same as those for patients without HIV infection.

Sexual Contacts

Results of several randomized, double-blind, placebo-controlled trials indicate that concurrent treatment of male sexual contacts of a woman with symptomatic bacterial vaginosis generally does not appear to affect the clinical cure rate, including the risk of relapse or recurrence of the syndrome in the woman. Therefore, routine treatment of male sexual contacts currently is not recommended. However, despite the lack of controlled studies showing any benefit, some clinicians believe that treatment of male sexual contacts (with oral metronidazole) of women who have relapsing or recurrent bacterial vaginosis may be reasonable. Further study is needed to elucidate the possible role, if any, of sexual transmission in bacterial vaginosis.

Other Uses

For use of oral or parenteral clindamycin in the treatment or prevention of systemic infections,

Dosage and Administration

Administration

Clindamycin phosphate is applied topically to the skin or intravaginally in appropriate formulations.

Topical Administration

Clindamycin phosphate is applied topically to the skin as a gel, lotion, or solution containing clindamycin 1%. Clindamycin phosphate also is applied topically to the skin in the form of a gel containing clindamycin 1% in combination with benzoyl peroxide 5%. The gel, lotion, or solution should be applied to all areas of skin prone to acne.

Topical preparations containing clindamycin phosphate are for external use only and should not be used orally or intravaginally and use near or in the eyes, nose, mouth, or mucous membranes should be avoided.

The commercially available lotion containing clindamycin 1% should be shaken well immediately prior to use. The commercially available topical solution containing clindamycin 1% also is available in individual single-use pledget applicators. These pledgets should be removed from their foil immediately before use and should not be used if seal is broken. Each pledget should be used only once and then discarded; more than 1 pledget may be used for each application as needed to cover the affected area.

The commercially available gel containing clindamycin phosphate in fixed combination with benzoyl peroxide (Duac) is applied topically as provided by the manufacturer.

Alternatively, a combination topical gel containing clindamycin phosphate and benzoyl peroxide can be prepared at the time of dispensing (BenzaClin) by reconstituting clindamycin phosphate and admixing it with a gel containing benzoyl peroxide. After tapping the vial containing clindamycin phosphate provided by the manufacturer of BenzaClin to loosen the contents, 5 mL of purified water should be added to each vial containing 300 mg of clindamycin phosphate and the contents immediately shaken until the drug is completely dissolved. Additional purified water may be used if the contents do not reach the mark indicated on the vial. The clindamycin phosphate solution is then added to the benzoyl peroxide gel provided by the manufacturer and stirred for about 1-1.5 minutes until the gel appears homogeneous.

Intravaginal Administration

Clindamycin phosphate is administered intravaginally as a vaginal cream containing 2% clindamycin or as a vaginal suppository containing 100 mg of the drug. Patients should be instructed in the use of the vaginal applicator and should be given a copy of the instructions provided by the manufacturer.

Clindamycin phosphate vaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in the eyes.

Dosage

Acne Vulgaris

For the topical treatment of acne vulgaris, a thin film of the commercially available gel, lotion, or solution containing clindamycin 1% should be applied to the cleansed affected area twice daily. Alternatively, if the commercially available gel containing clindamycin 1% in fixed combination with benzoyl peroxide 5% as Duac is used for the topical treatment of acne vulgaris, a thin film of the gel is applied to the cleansed affected areas once daily in the evening or as directed. If the gel containing clindamycin 1% in combination with benzoyl peroxide 5% as BenzaClin is used for the treatment of acne vulgaris, a thin film of the gel is applied to the cleansed affected area twice daily.

Maintenance therapy is needed to prevent recurrence.

Bacterial Vaginosis

When Cleocin vaginal cream is used the treatment of bacterial vaginosis in nonpregnant women, one applicatorful (approximately 5 g) of clindamycin phosphate (2% clindamycin) vaginal cream (100 mg of clindamycin) is administered intravaginally once daily, preferably at bedtime, for 3 or 7 consecutive days. When Clindesse vaginal cream is used for the treatment of bacterial vaginosis, the usual dosage is a single applicatorful (approximately 5 g) of clindamycin phosphate (2% clindamycin) vaginal cream (100 mg of clindamycin) administered intravaginally. The US Centers for Disease Control and Prevention (CDC) recommends a 7-day regimen. Alternatively, one suppository containing 100 mg of clindamycin can be administered intravaginally, preferably at bedtime, for 3 consecutive days.

In pregnant women, one applicatorful (approximately 5 g) of clindamycin phosphate (2% clindamycin) vaginal cream (100 mg of clindamycin) intravaginally once daily, preferably at bedtime, for 7 consecutive days, was an effective treatment for bacterial vaginosis but did not reduce the incidence of adverse pregnancy outcomes; thus, use of intravaginal clindamycin for the prevention of adverse pregnancy outcomes associated with bacterial vaginosis in women at high risk for preterm delivery is not recommended, and systemic treatment with oral metronidazole or oral clindamycin currently is preferred, particularly in pregnant women at high risk for complications of pregnancy. and see CDC states that clindamycin vaginal preparations should only be used during the first half of pregnancy.

Cautions

Clindamycin phosphate applied topically to the skin alone or in fixed combination with benzoyl peroxide generally is well tolerated. However, mild to moderate local effects may occur and systemic adverse effects (e.g., GI effects) have been reported rarely.

Intravaginally applied clindamycin phosphate generally is well tolerated. Adverse effects occurred in about 10 or 20% of nonpregnant patients receiving intravaginal clindamycin phosphate suppositories or cream (3- or 7-day regimen), respectively, during clinical trials; discontinuance of the drug because of adverse effects was required in about 0.5 or 2-3% of patients receiving the drug as a suppository or cream, respectively. While systemically achieved concentrations of the drug generally are low at usual intravaginal dosages, this route of administration is not devoid of adverse systemic effects. Candidal infection (including vaginal or nonvaginal candidiasis and fungal infection, either symptomatic or confirmed by culture) has been reported in about 3 or 9-11% of nonpregnant patients receiving intravaginal clindamycin suppositories or cream, respectively.

Local Effects

Topical Administration

The most frequent adverse effects of topical therapy with clindamycin phosphate 1% gel, lotion, or solution are dryness of the skin and erythema. In clinical studies evaluating the clindamycin phosphate 1% topical gel, lotion, or solution, dryness was reported in 23, 18, or 19% of patients, respectively, whereas erythema was reported in 7, 14, or 16% of patients, respectively. Oiliness or oily skin was reported in 18, 10, or 1% of patients receiving the topical gel, lotion, or solution, respectively. Peeling occurred in 7 or 11% of patients receiving topical clindamycin phosphate lotion or solution, respectively. In addition, burning or pruritus were reported in 7-11% of patients receiving these topical preparations of clindamycin phosphate.

Commercially available clindamycin phosphate 1% topical solution contains alcohol which can burn and irritate the eyes. If clindamycin phosphate topical solution comes in contact with sensitive surfaces (e.g., eyes, abraded skin, mucous membranes), the surfaces should be bathed with copious amounts of cool water.

In clinical studies evaluating the commercially available gel containing clindamycin phosphate 1% in fixed combination with benzoyl peroxide 5% (Duac), mild to moderate erythema was reported during treatment in 5-26%, dryness in 1-19%, peeling in 2-17%, and burning in up to 5% of patients. In clinical studies evaluating the gel containing clindamycin phosphate 1% in combination with benzoyl peroxide 5% that is prepared at the time of dispensing (BenzaClin), dry skin was reported during treatment in 12% and erythema, peeling, pruritus, or sunburn were reported in 1-2% of patients. The manufacturer states that patients in these studies were allowed to use moisturizers in conjunction with the gel and that the incidence of dry skin might have been greater if moisturizers had not been used.

Genitourinary Effects

Intravaginal Administration

The most common adverse effects of therapy with clindamycin phosphate (2% clindamycin) vaginal cream or suppositories are vaginal candidiasis and vaginitis (including vulvovaginitis, vulvovaginal disorder, vaginal discharge, and trichomonal vaginitis).

Because clindamycin is highly active in vitro against Lactobacillus and metronidazole is inactive in vitro against most lactobacilli normally resident in the vagina, even at the high concentrations achieved with local application, it has been suggested that intravaginal application of clindamycin at usual concentrations may be more likely than intravaginal application of metronidazole to disrupt the normal vaginal flora. Limited evidence from a comparative study suggests that similar rates of vulvovaginal candidiasis occur following treatment with intravaginal clindamycin, intravaginal metronidazole, or oral metronidazole; however, further study is needed to establish the relative risk of this effect. In 2 unpublished comparative studies conducted by the manufacturer of metronidazole extended-release tablets, evaluation at 1 month following completion of therapy for bacterial vaginosis in nonpregnant women showed that vaginal pH and the balance of Lactobacillus in the vaginal flora were restored to normal in fewer patients receiving clindamycin phosphate vaginal cream than in those receiving oral metronidazole administered as extended-release tablets (65 versus 72% and 63 versus 74%, respectively), but the incidence rates of vulvovaginal candidiasis (12 versus 15%, respectively) did not differ. Approximately 1.5 or 8-12% of nonpregnant women have been reported to develop vaginal candidiasis during or immediately following therapy with clindamycin phosphate vaginal suppositories or cream, respectively. Higher cumulative frequencies of symptomatic vaginal candidiasis have been reported at 1 month following completion of intravaginal clindamycin phosphate cream therapy.

Vaginitis (including vulvovaginitis, vulvovaginal disorder, vaginal discharge, and trichomonal vaginitis) has been reported in 3.6 or 9-10.7% of nonpregnant women receiving clindamycin phosphate vaginal suppositories or cream, respectively. Vulvovaginitis has been reported in 6 or 4.4% and vulvovaginal disorder (including irritation) has been reported in 3.2 or 5.3% of nonpregnant women receiving clindamycin phosphate vaginal cream for 3 or 7 days, respectively. Vulvovaginal disorder or vaginal pain has been reported in 3.4 or 1.9%, respectively, of nonpregnant women receiving clindamycin vaginal suppositories. Trichomonas vaginalis infection reportedly occurs in 1.3% of nonpregnant women receiving clindamycin phosphate vaginal cream for 7 days. Vaginal discharge, metrorrhagia, urinary tract infection, pyelonephritis, dysuria, endometriosis, menstrual disorder, and vaginal pain each have been reported in less than 1% of patients receiving intravaginal clindamycin, and vaginal bleeding has been reported in at least one patient following use of clindamycin phosphate vaginal cream.

Sensitivity Reactions

Topical Administration

Contact dermatitis has been reported in at least one patient following use of the commercially available clindamycin phosphate topical solution. The possibility that patients who become sensitized to topical clindamycin also may be sensitive to systemic clindamycin or lincomycin should be considered.

Intravaginal Administration

Urticaria, rash, application-site pain, and pruritus occur rarely in patients receiving intravaginal clindamycin.

GI Effects

Topical Administration

Adverse GI effects including diarrhea, and less frequently, abdominal pain, bloody diarrhea, and colitis have been reported following topical application of clindamycin. In one survey, diarrhea reportedly occurred in less than 0.1% of 73,000 patients using extemporaneous preparations of clindamycin hydrochloride or clindamycin phosphate.

Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with the use of topical or systemic clindamycin.(See Cautions: Precautions and Contraindications.)

Intravaginal Administration

Heartburn, nausea, vomiting, diarrhea, constipation, and abdominal pain reportedly have occurred in patients receiving intravaginal clindamycin. CDAD, including fulminant pseudomembranous colitis, have been attributed to the use of intravaginal clindamycin.

Other Adverse Effects

Intravaginal Administration

Dizziness, headache, flank pain, localized edema, and vertigo reportedly occur in less than 1% of patients receiving clindamycin phosphate vaginal cream or suppositories. Systemic candidiasis (excluding vaginal candidiasis) has been reported in 1.3 or 0.2% of nonpregnant women receiving clindamycin vaginal cream for 3 or 7 days, respectively.

The possibility that other adverse effects reported with topical (e.g., contact dermatitis, erythema, irritation, peeling, oiliness, burning) or systemic clindamycin therapy could occur with intravaginal therapy or vice versa should be considered..)

Precautions and Contraindications

Topical or intravaginal use of clindamycin phosphate may result in overgrowth of nonsusceptible organisms. Treatment-related vaginal and nonvaginal candidiasis (moniliasis) and vaginitis (e.g., vulvovaginal disorder, vaginal discharge, vaginitis, vaginal infections) were reported in about 3-3.5% of nonpregnant women who received the drug in clinical studies for the treatment of bacterial vaginosis. In addition, gram-negative folliculitis has been reported rarely following topical use of clindamycin in the treatment of acne vulgaris. If suprainfection or superinfection occurs during clindamycin therapy, the drug should be discontinued and appropriate therapy instituted.

Patients receiving intravaginal clindamycin phosphate cream or suppositories should be instructed to not engage in vaginal intercourse and to refrain from use of vaginal products (tampons, douches) during the entire course of therapy since vaginal intercourse or vaginal products could reduce the efficacy of the preparations (e.g., by dislodgement and/or dilution, by increased vaginal pH secondary to deposition of semen). Because clindamycin phosphate vaginal cream and suppositories contain oleaginous bases (e.g., mineral oil) that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms, such products may not be effective as contraceptives and/or microbial barriers if used within 72 hours following treatment with clindamycin vaginal cream (Cleocin) or suppositories (Cleocin). In addition, latex or rubber products such as condoms or vaginal contraceptive diaphragms may not be effective as contraceptives and/or microbial barriers if used within 5 days following treatment with clindamycin vaginal cream (Clindesse). Because clindamycin phosphate vaginal cream may cause ocular burning and irritation, contact with the eyes should be avoided. If such contact occurs, the manufacturer recommends that the eyes be irrigated with copious amounts of cool water.

Because clindamycin is absorbed following topical or intravaginal application and because CDAD caused by overgrowth of toxin-producing clostridia has been reported with the use of topical or systemic clindamycin, it should be considered in the differential diagnosis of patients who develop diarrhea during or following topical or intravaginal clindamycin. Patients should be warned to discontinue use of clindamycin and to notify their clinician if GI symptoms such as diarrhea occur during topical or intravaginal therapy. Mild cases of colitis may respond to discontinuance of the drug alone, but diagnosis and management of moderate to severe cases should include appropriate bacteriologic and toxin studies and treatment with fluid, electrolyte, and protein supplementation as indicated. If colitis is severe or is not relieved by discontinuance of the drug, appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) should be administered.

Clindamycin phosphate topical solution has an unpleasant taste, and caution should be used when applying the solution around the mouth.

The manufacturer states that clindamycin phosphate topical 1% gel, lotion, and solution should be used with caution in atopic individuals.

Clindamycin phosphate 1% topical gel, lotion, and solution; gels containing clindamycin phosphate 1% in combination with benzoyl peroxide 5%; and clindamycin phosphate vaginal cream and suppositories are contraindicated in patients with a history of hypersensitivity to clindamycin, lincomycin, or any ingredient in the formulations. These topical and intravaginal preparations containing clindamycin phosphate also are contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Pediatric Precautions

Safety and efficacy of clindamycin phosphate (clindamycin 1%) topical gel, lotion, and solution and topical gels containing clindamycin phosphate (clindamycin 1%) in fixed combination with benzoyl peroxide 5% in pediatric patients younger than 12 years of age have not been established.

The manufacturer states that safety and efficacy of clindamycin phosphate vaginal cream (Cleocin) in children younger than 16 years of age have not been established. Safety and efficacy of the vaginal suppositories and clindamycin phosphate vaginal cream (Clindesse) in postmenarchal females have been established based on extrapolation of clinical trial data from adult women; safety and efficacy of the these preparations in premenarchal females have not been established.

Geriatric Precautions

Clinical studies of topical or intravaginal clindamycin did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients.

Carcinogenicity

Mutagenicity tests with clindamycin designed to assess genotoxicity (e.g., rat micronucleus test, Ames test) did not reveal evidence of mutagenic potential. Long-term studies in animals to determine the carcinogenic potential of topical or intravaginal clindamycin have not been performed to date.

Pregnancy, Fertility, and Lactation

Pregnancy

Reproduction studies in pregnant rats and mice receiving oral and parenteral dosages of clindamycin up to 600 mg/kg daily (62 and 25 times, respectively, the maximum human dosage based on mg/m) revealed no evidence of harm to the fetus. In one mouse strain, cleft palate was observed in fetuses of pregnant mice treated with clindamycin; this effect was not observed in other mouse strains or in other species.

Intravaginal clindamycin has been used to treat bacterial vaginosis in pregnant women during the second and third trimester of pregnancy (for 7 nights of therapy). In one clinical study of pregnant women receiving clindamycin phosphate vaginal cream or placebo during the second trimester of pregnancy, abnormal labor was reported in about 1.1 or 0.5% of patients, respectively. Adverse effects have been reported in about 23% of pregnant patients receiving intravaginal clindamycin and have required discontinuance of the drug in about 2% of such patients. Candidal infection (including vaginal and nonvaginal candidiasis; either symptomatic or confirmed by culture) and vaginitis (including vulvovaginitis, vulvovaginal disorder, vaginal discharge, and trichomonal vaginitis) have been reported in about 13.3 and 7.2% of pregnant patients receiving clindamycin phosphate vaginal cream for 7 days. Vaginal candidiasis and vulvovaginal disorders occurred in 13.3 and 6.7%, respectively, of pregnant women receiving intravaginal clindamycin for 7 days while each of these adverse effects was reported in 7.1% of pregnant patients receiving placebo. Dysuria, metrorrhagia, vaginal pain, pruritus (at the application site), and trichomonal vaginitis occurred in less than 1% of pregnant patients receiving clindamycin phosphate vaginal cream. Other adverse effects reported in pregnant patients receiving intravaginal clindamycin include fungal infections and pruritus (in areas other than at the application site) in 1.7 and 1.1%, respectively; these effects were not reported in pregnant women receiving placebo. Upper respiratory infection and erythema were reported in less than 1% of pregnant women receiving clindamycin phosphate vaginal cream.

There are no adequate and controlled studies to date using intravaginal clindamycin cream (Cleocin) during the first trimester of pregnancy or using clindamycin intravaginal suppositories or intravaginal clindamycin cream (Clindesse) during pregnancy; Clindamycin phosphate vaginal cream (Cleocin) should be used during the first trimester of pregnancy only when clearly needed, and intravaginal suppositories and intravaginal clindamycin cream (Clindesse) should be used during pregnancy only when clearly needed. In addition, because there are no adequate and controlled studies to date using topical preparations containing clindamycin phosphate (gel, solution, or lotion) or gels containing clindamycin phosphate in fixed combination with benzoyl peroxide during pregnancy, these preparations should be used during pregnancy only if clearly needed.

Screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated should be conducted during the first prenatal visit. In one study in women treated with intravaginal clindamycin early in the pregnancy (i.e., before 20 weeks' gestation), administration of clindamycin was associated with a reduction in preterm birth. In other studies, such therapy administered at 16-32 weeks' gestation did not reduce the incidence of adverse pregnancy outcomes. For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin is recommended. CDC states that clindamycin vaginal preparations should only be used during the first half of pregnancy.

Fertility

Reproduction studies in rats and mice using subcutaneous or oral clindamycin in dosages of 100-600 mg/kg daily have not revealed evidence of impaired fertility or harm to the fetus. Reproduction studies in rats receiving oral clindamycin dosages up to 300 mg/kg daily (31 times the usual human dosage) have not revealed evidence of impaired fertility or mating ability.

Lactation

Although it is not known whether clindamycin is distributed into milk following topical or intravaginal application, the drug is distributed into milk following systemic administration. Because of the potential for serious adverse reactions to clindamycin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue topical or intravaginal application of the drug, taking into account the importance of the drug to the woman.

Drug Interactions

Because clindamycin can be absorbed systemically following intravaginal application (see Pharmacokinetics: Absorption), the possibility that drug interactions could occur with this route of administration should be considered. For additional information on potential interactions with the drug, .

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the neuromuscular blocking action of other agents (e.g., ether, tubocurarine, pancuronium). Intravaginal clindamycin should be used with caution in patients receiving such agents and patients should be observed for prolongation of neuromuscular blockade.

Topical acne preparations containing peeling, desquamating, or abrasive agents (e.g., benzoyl peroxide, tretinoin, salicylic acid, sulfur) should be used cautiously in patients using topical anti-infectives because a cumulative irritant effect could occur. In addition, information on the physical and/or chemical compatibility of topical anti-infectives and other topical acne preparations is not available. Concurrent use of abrasive or medicated soaps or cosmetic products containing alcohol (e.g., astringents, after-shave lotions) may also cause a cumulative irritant or drying effect in patients using topical anti-infectives.

Because of possible competitive binding for the 50S ribosomal subunit (see Mechanism of Action), clindamycin and erythromycin probably should not be used concomitantly.

Pharmacokinetics

In all studies in the Pharmacokinetics section, clindamycin was administered topically, intravaginally, or parenterally as the phosphate ester and orally as the hydrochloride, unless otherwise noted; dosages and concentrations of the drug are expressed in terms of clindamycin.

Absorption

Topical Administration

Clindamycin phosphate is absorbed systemically following topical application of the drug. Animal studies indicate that topical application of clindamycin as the hydrochloride results in a more rapid rate of systemic absorption of clindamycin than does topical application of clindamycin as the phosphate. In humans, 0.7 mcg/mL or less of clindamycin has been detected in urine following twice daily application to the skin of a 1% hydroalcoholic solution of clindamycin as the hydrochloride (not commercially available in the US). Following multiple application to the skin of a 1% hydroalcoholic solution of clindamycin as the phosphate, low concentrations of the drug (0-3 ng/mL) have been detected in serum and less than 0.2% of the dose was detected in urine unchanged.

Because topical application of clindamycin as the phosphate appears to result in less systemic absorption of clindamycin than does topical application of clindamycin as the hydrochloride, clindamycin phosphate is the preferred salt for topical therapy. In vivo studies indicate that clindamycin penetrates comedones following topical application. In one study, comedonal concentrations of clindamycin averaged 597 mcg/g of comedonal material following twice daily application to the skin of the commercially available clindamycin phosphate topical solution.

In a comparative study in 78 patients evaluating the pharmacokinetics of a topical solution containing clindamycin 1% and a topical gel containing clindamycin phosphate 1% in fixed combination with benzoyl peroxide 5% (Duac), mean plasma clindamycin concentrations reported for both topical preparations were less than 0.5 ng/mL during the 4-week study. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid; less than 2% of the dose of benzoyl peroxide enters systemic circulation as benzoic acid.

Intravaginal Administration

Clindamycin phosphate is absorbed systemically following intravaginal application of the drug as a vaginal cream or suppositories. The systemic bioavailability of intravaginally administered clindamycin 2% vaginal cream (Cleocin) is about 5% and that of the suppositories after three 100 mg daily doses is almost 30%. Only low concentrations of the drug are achieved systemically following administration of usual intravaginal doses (e.g., 100 mg of clindamycin) relative to usual oral doses (e.g., 300 mg of clindamycin). Average serum clindamycin concentrations following IV administration of a single dose of the drug (approximately 48 mg of clindamycin) were up to 300-fold greater than those following intravaginal application of clindamycin 50 mg as the cream. In addition, the overall systemic bioavailability of clindamycin following intravaginal administration of the suppository is 2- to 20-fold lower than that with usual oral dosages and 40- to 50-fold lower than that with parenteral dosages of the drug.

Following intravaginal administration of 5 g of the 2% vaginal cream (Cleocin; 100 mg of clindamycin) daily for 7 consecutive days in a limited number of healthy women, approximately 5% (range: 0.6-11%) of the administered dose was absorbed systemically. Peak serum clindamycin concentrations approximately 10 hours (range: 4-24 hours) after administration averaged 18 ng/mL (range: 4-47 ng/mL) and 25 ng/mL (range: 6-61 ng/mL) on days 1 and 7 of therapy, respectively.

Following intravaginal administration of a single dose of clindamycin vaginal cream (Clindesse) in a limited number of healthy women, peak plasma concentrations averaged 6.6 ng/mL (range: 0.8-39 ng/mL).

Following intravaginal administration of the suppository (100 mg of clindamycin) once daily for 3 consecutive days in a limited number of healthy women, approximately 30% (range: 6-70%) of the administered dose was absorbed systemically on day 3 of therapy as measured by the area under the concentration-time curve (AUC). Peak serum clindamycin concentrations approximately 5 hours (range: 1-10 hours) after intravaginal administration averaged 0.27 mcg/mL (range: 0.03-0.67 mcg/mL) on day 3 of therapy.

Systemic absorption of intravaginal clindamycin cream (Cleocin) was slower and less variable in women with bacterial vaginosis than in healthy women. Following intravaginal administration of 5 g of the 2% vaginal cream (100 mg of clindamycin) daily for 7 consecutive days in a limited number of women with bacterial vaginosis, approximately 5% (range: 2-8%) of the administered dose was absorbed systemically. Peak serum clindamycin concentrations approximately 14 hours (range: 4-24 hours) after administration averaged 13 ng/mL (range: 6-34 ng/mL) and 16 ng/mL (range: 7-26 ng/mL) on days 1 and 7 of therapy, respectively. Little or no systemic accumulation of clindamycin appears to occur following repeated application of clindamycin 2% vaginal cream.

In a limited number of healthy women who received intravaginal application of a 1% vaginal cream (50 mg of clindamycin; not commercially available in the US) once daily for 7 days, average peak serum clindamycin concentrations at steady state ranged from 20-27 ng/mL; approximately 6% of the dose was absorbed systemically. In a limited number of healthy women who received intravaginal application of a 1% vaginal cream (50 mg of clindamycin) twice daily for 7 days, average peak serum clindamycin concentrations were 3-5 times higher than those in the group receiving the same dose once daily, and an average of 12-14% of the dose was absorbed systemically.

Distribution and Elimination

The distribution and elimination characteristics of clindamycin following intravaginal application of the drug have not been fully characterized. Following intravaginal application of 2% clindamycin cream (Cleocin), the systemic half-life of the drug appears to be about 1.5-2.6 hours. Following intravaginal administration of clindamycin suppositories, the apparent elimination half-life averaged about 11 hours (range: 4-35 hours). Elimination of clindamycin suppositories is considered to be limited by absorption rate.

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