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TARO PHARM USA
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51672126003

clotrimazole 1% solution

Generic
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Uses

Oropharyngeal Candidiasis

Clotrimazole is used orally in the form of a lozenge for the topical treatment of oropharyngeal candidiasis which has been confirmed by potassium hydroxide microscopic mounts and/or culture. Clotrimazole lozenges also are used prophylactically to reduce the incidence of oropharyngeal candidiasis in patients who are immunocompromised as the result of immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation therapy) used for the treatment of leukemia, solid tumor, or renal transplantation. Clotrimazole lozenges should not be used for the treatment of systemic fungal infections, including systemic candidiasis.

Treatment of Oropharyngeal Candidiasis

In one study in cancer patients with oropharyngeal candidiasis receiving one 10-mg clotrimazole lozenge 5 times daily, the median duration of oral candidiasis following initiation of clotrimazole therapy was 4 days. In another study, oral topical administration of clotrimazole in the form of a 10-mg lozenge administered 5 times daily was effective in the treatment of oropharyngeal candidiasis in some patients who did not respond to topical oral nystatin or topical gentian violet therapy. However, when clotrimazole therapy was stopped, the infection invariably recurred within 2-4 weeks, presumably because the underlying defect that predisposed the patients to oropharyngeal candidiasis was not corrected.

Topical therapy with oral clotrimazole is used in the treatment of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Some clinicians consider topical therapy with oral clotrimazole or oral nystatin the treatment of choice for uncomplicated oropharyngeal candidiasis in HIV-infected patients and recommend that systemic antifungal agents (e.g., oral fluconazole, oral itraconazole, oral ketoconazole) be reserved for the treatment of oropharyngeal candidiasis unresponsive to topical agents or for the treatment of severe oropharyngeal candidiasis with esophageal involvement. However, other clinicians prefer to use an oral azole antifungal agent for initial therapy of oropharyngeal candidiasis in HIV-infected individuals. Topical oral therapy with clotrimazole is ineffective for the treatment of esophageal candidiasis in HIV-infected patients.

Prophylaxis of Oropharyngeal Candidiasis

Oral clotrimazole in the form of a lozenge has been effective for prophylaxis against oropharyngeal candidiasis in neutropenic patients receiving immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation therapy) for treatment of leukemia, solid tumor, or renal transplantation. However, safety and efficacy of oral clotrimazole for prophylaxis of oropharyngeal candidiasis in patients immunocompromised as the result of primary immunodeficiency or other causes have not been determined. Although oral clotrimazole has been used for prophylaxis against oropharyngeal candidiasis in HIV-infected individuals, the drug is no longer included in the prophylaxis guidelines of the Prevention of Opportunistic Infections Working Group of the US Public Health Service and Infectious Diseases Society of America (USPHS/IDSA). If prophylaxis of oropharyngeal candidiasis is indicated in HIV-infected individuals, the USPHS/IDSA recommends oral fluconazole or, alternatively, oral itraconazole solution.

Dermatophytoses and Cutaneous Candidiasis

Clotrimazole is used topically as a cream, lotion, or solution for the treatment of tinea corporis, tinea cruris, and tinea pedis caused by T. rubrum, T. mentagrophytes, E. floccosum, or M. canis and for the treatment of cutaneous candidiasis. Clotrimazole topical cream or solution also may be used topically for self-medication of tinea pedis, tinea cruris, and tinea corporis caused by T. rubrum, T. mentagrophytes, E. floccosum, or M. canis. The combination preparation containing clotrimazole and betamethasone dipropionate has been used topically for the treatment of tinea pedis, tinea cruris, and tinea corporis caused by T. rubrum, T. mentagrophytes, or E. floccosum.

Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; however, an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised because of coexisting disease or concomitant therapy. Many clinicians consider topical imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) or topical allylamine antifungals (e.g., naftifine, terbinafine) the drugs of first choice for the topical treatment of tinea corporis or tinea cruris, although other topical antifungal agents (e.g., ciclopirox olamine, butenafine hydrochloride, tolnafate, undecylenic acid) also can be effective in the treatment of these infections. While topical antifungals usually are effective for the treatment of uncomplicated tinea manuum and tinea pedis, an oral antifungal usually is necessary for the treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for the treatment of tinea unguium (onychomycosis).

Clinical studies to date indicate that clotrimazole is effective for the topical treatment of these infections and appears to be equivalent in efficacy and safety to other topical imidazole derivatives (e.g., econazole, ketoconazole). Additional controlled, comparative studies are needed to establish the relative efficacy of clotrimazole and other currently available topical antifungal agents. Like other imidazole derivatives (e.g., econazole, ketoconazole, miconazole, oxiconazole, sulconazole) and ciclopirox olamine, clotrimazole has an advantage over some other topical antifungal agents (e.g., nystatin, tolnaftate) in the treatment of mixed infections or for empiric treatment pending identification of the causative organism, since the drug is active against both dermatophytes and Candida.

Pityriasis (Tinea) Versicolor

Clotrimazole is used topically as a cream, lotion, or solution for the treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale). Pityriasis (tinea) versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%). However, an oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical agent, in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.

Vulvovaginal Candidiasis

Uncomplicated Vulvovaginitis

Clotrimazole is used intravaginally for the treatment of vulvovaginal candidiasis. Prior to initial use of clotrimazole in a woman who has signs and symptoms of uncomplicated vulvovaginal candidiasis, the diagnosis should be confirmed either by demonstrating yeast or pseudohyphae with direct microscopic examination of vaginal discharge (saline or 10% potassium hydroxide [KOH] wet mounts or Gram stain) or by culture; identifying Candida by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10-20% of women harbor Candida or other yeasts in the vagina. Clotrimazole vaginal tablets or cream may be used for self-medication of vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having a recurrence of similar symptoms. When an adequate response is not achieved following a course of clotrimazole therapy for vulvovaginal candidiasis or there is recurrence of symptoms within 2 months, appropriate microbiologic studies should be performed to confirm the diagnosis and identify unusual Candida species (e.g., C. glabrata).

Up to 75% of women reportedly have at least one episode of vulvovaginal candidiasis and 40-45% have 2 or more episodes during their lifetime, but a small percentage of women (up to 5%) have recurrent vulvovaginal candidiasis (i.e., 4 or more episodes of symptomatic vulvovaginal candidiasis each year). While certain factors may precipitate a sporadic attack of vulvovaginal candidiasis and have been associated with an increased risk for recurrent vulvovaginal candidiasis (e.g., uncontrolled diabetes mellitus, pregnancy, oral contraceptive use, corticosteroid or other immunosuppressive therapy, immunodeficiency, use of intravaginal sponges or devices, repeated courses of topical or systemic antibacterial agents), these factors are not present in most women who have recurrent episodes.

Azole antifungals (imidazole and triazole derivatives) are considered the drugs of choice for the treatment of vulvovaginal candidiasis. The US Centers for Disease Control and Prevention (CDC) and other clinicians generally recommend that uncomplicated vulvovaginal (defined as vulvovaginal candidiasis that is mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, or occurring in immunocompetent women) should be treated with an intravaginal azole antifungal (e.g., butoconazole, clotrimazole, miconazole, terconazole, tioconazole) given in appropriate single-dose or short-course regimens or, alternatively, oral fluconazole given in a single-dose regimen. These regimens generally have been associated with clinical and mycologic cure rates of 80-90% in otherwise healthy, nonpregnant women with uncomplicated infections, and there is no clear evidence that any one intravaginal azole antifungal regimen is superior to any other intravaginal azole regimen available for the treatment of these infections. While intravaginal nystatin also can be used for the treatment of uncomplicated vulvovaginal candidiasis, it generally is less effective than intravaginal azole antifungals. A longer duration of therapy (i.e., 7-14 days) with an intravaginal or oral azole antifungal generally is necessary for the treatment of complicated vulvovaginal candidiasis, including recurrent and severe disease. Complicated vulvovaginal candidiasis is defined as infections that are recurrent or severe, caused by Candida other than C. albicans, or occurring in pregnant women or women with underlying disease such as uncontrolled diabetes, debilitation, or immunosuppression.(See Complicated and Recurrent Vulvovaginal Candidiasis under Uses: Vulvovaginal Candidiasis.)

Clinical trials using clotrimazole vaginal tablets in the treatment of vulvovaginal candidiasis have shown that, in nonpregnant women, a treatment regimen using two 100-mg tablets daily for 3 days is as effective as a regimen using one 100-mg tablet daily for 7 days; however, in pregnant women, symptomatic vulvovaginal candidiasis may be more difficult to cure and the 3-day regimen may be less effective than the 7-day regimen. In clinical trials using clotrimazole vaginal cream, 7-14 days of treatment were generally effective; however, treatment regimens of 14 days had a higher cure rate than shorter regimens.

Vulvovaginal candidiasis usually is not acquired through sexual activity, and treatment of sexual partner(s) is not recommended but may be considered in women who have recurrent infections. However, male sexual partners who have symptomatic balanitis or penile dermatitis may benefit from treatment with a topical antifungal agent to relieve symptoms.

Complicated and Recurrent Vulvovaginal Candidiasis

Optimum regimens for the treatment of recurrent vulvovaginal candidiasis (usually defined as 4 or more episodes of symptomatic vulvovaginal candidiasis each year) have not been established. Although each individual episode caused by C. albicans may respond to usual short-course intravaginal antifungal regimens or a single-dose of oral fluconazole, a longer duration of initial therapy may be necessary to achieve mycologic remission and chronic maintenance therapy may be necessary to prevent relapse. The CDC recommends use of an initial intensive regimen consisting of 7-14 days of an intravaginal azole antifungal or a 3-dose regimen of oral fluconazole (100-, 150-, or 200-mg doses given every third day for a total of 3 doses) followed by a maintenance antifungal regimen (given for 6 months). For the maintenance regimen, the CDC recommends oral fluconazole (100-, 150-, or 200-mg doses once weekly). If this oral regimen cannot be used, some clinicians recommend intravaginal clotrimazole (200 mg twice weekly or 500 mg once weekly) or other intravaginal treatments used intermittently. These maintenance regimens can be effective in reducing recurrent infections; however, 30-50% of women will have recurrent disease once maintenance therapy is discontinued.

The response rate to short-course antifungal regimens is lower in patients with severe vulvovaginal candidiasis (i.e., extensive vulvar erythema, edema, excoriation, and fissure formation) and either a 2-dose regimen of oral fluconazole (150 mg repeated 3 days later) or 7-14 days therapy with an intravaginal azole antifungal is recommended for these infections. These more prolonged regimens may also be necessary for the treatment of vulvovaginal candidiasis in women with underlying debilitating medical conditions (e.g., those with uncontrolled diabetes mellitus or those receiving corticosteroid therapy).

For the treatment of vulvovaginal candidiasis during pregnancy, the CDC recommends use of a 7-day regimen of an intravaginal azole antifungal.

Vulvovaginal candidiasis may occur more frequently and may be more severe in women with human immunodeficiency virus (HIV) infection than in women without HIV infection and these infections have been recognized as an early manifestation of acquired immunodeficiency syndrome (AIDS) in women. While optimum therapy for recurrent vulvovaginal candidiasis in HIV-infected women has not been established, there is no evidence to date that these women have a lower response rate to the intravaginal or oral antifungal regimens usually recommended for the treatment of vulvovaginal candidiasis. Therefore, the CDC and other clinicians recommend that treatment of vulvovaginal candidiasis in HIV-infected women be the same as that in women without HIV infection.

Recurrent vulvovaginal candidiasis rarely may be caused by resistant strains of C. albicans or, more commonly, by other Candida with reduced susceptibility to azole antifungals (e.g., C. glabrata). It has been suggested that repeated treatment of recurrent vulvovaginal candidiasis with intravaginal azole antifungals and widespread and/or injudicious use of these agents for self-medication of vulvovaginal candidiasis may favor the selection of Candida resistant to azole antifungals. Optimum therapy for the treatment of vulvovaginal candidiasis caused by Candida with reduced susceptibility to azole antifungals has not been determined to date. For the treatment of vulvovaginal candidiasis caused by Candida other than C. albicans, the CDC recommends 7-14 days of therapy with an antifungal agent other than fluconazole; if recurrence occurs, intravaginal boric acid (600-mg capsule once daily for 2 weeks) is recommended. Referral to a specialist is advised.

Dosage and Administration

Administration

Clotrimazole is administered topically to the oropharyngeal area as an oral lozenge, topically to the skin as a cream, lotion, or solution, or intravaginally as a vaginal cream or tablet.

Dosage

Oropharyngeal Candidiasis

Clotrimazole lozenges are administered orally and dissolved slowly in the mouth over approximately 15-30 minutes. For the topical treatment of oropharyngeal candidiasis, the usual dosage of oral clotrimazole is one 10-mg lozenge 5 times daily for 14 consecutive days. Because limited data are available on the safety and effectiveness of prolonged therapy with clotrimazole lozenges, therapy should be limited to short-term use, if possible.

For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients who are immunocompromised as the result of immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation therapy) used for the treatment of leukemia, solid tumor, or renal transplantation, the usual dosage of oral clotrimazole is one 10-mg lozenge 3 times daily for the duration of chemotherapy or until corticosteroid therapy is reduced to maintenance levels.

Dermatophytoses and Cutaneous Candidiasis

For dermatologic use, clotrimazole 1% cream, 1% lotion, or 1% solution should be applied sparingly and rubbed gently into the cleansed, affected area and surrounding skin twice daily (in the morning and evening). Clinical improvement and relief of pruritus usually occur within 1 week; however, up to 8 weeks of therapy may be required for mycological cures, especially in the treatment of tinea pedis. If clinical improvement does not occur after 4 weeks of treatment, the diagnosis should be reevaluated.

When clotrimazole topical cream or solution is used for self-medication, tinea cruris should usually be treated for 2 weeks and tinea pedis or corporis for 4 weeks; if adequate response has not been achieved after these treatment periods, the drug should be discontinued and a physician or pharmacist consulted.

For dermatologic use, the fixed-combination cream containing clotrimazole 1% and betamethasone 0.05% should be applied sparingly and rubbed gently into the cleansed, affected area and surrounding skin in the morning and evening. Clinical improvement and relief of pruritus and erythema usually occur within 3-5 days; however, mycologic cures generally require prolonged therapy, especially in the treatment of tinea pedis, and therapy should be continued for 2 weeks in the treatment of tinea cruis or tinea corporis and for 4 weeks in the treatment of tinea pedis. If clinical improvement does not occur after 1 week in the treatment of tinea cruris or tinea corporis or after 2 weeks in the treatment of tinea pedis, the diagnosis should be reevaluated. If the condition persists for longer than 2 weeks in patients with tinea cruris or tinea corporis or for longer than 4 weeks in patients with tinea pedis, the combination preparation should be discontinued and therapy with clotrimazole alone may be initiated. Occlusive dressings should not be used with the combination preparation.

In patients with mycotic keratitis, 1% clotrimazole in sterile peanut oil has been applied to the eyes every 2-4 hours for up to 6 weeks. Commercially available clotrimazole topical cream, lotion, or solution should not be applied to the eye.

Pityriasis (Tinea) Versicolor

For the treatment of pityriasis (tinea) versicolor, clotrimazole 1% cream, 1% lotion, or 1% solution should be applied sparingly and rubbed gently into the cleansed, affected area and surrounding skin twice daily (in the morning and evening). If clinical improvement does not occur after 4 weeks of treatment, the diagnosis should be reevaluated.

Vulvovaginal Candidiasis

For the treatment of vulvovaginal candidiasis, 2 vaginal tablets containing 100-mg of clotrimazole each (200 mg total) may be inserted intravaginally once daily (preferably at bedtime) for 3 consecutive days or one vaginal tablet containing 100 mg of the drug may be inserted intravaginally once daily (preferably at bedtime) for 7 consecutive days. The manufacturers state that the 3-day regimen should not be used in pregnant women, since this regimen may be less effective than the 7-day regimen in these women.

If clotrimazole vaginal cream is used, one applicatorful of the 1% cream (approximately 5 g) may be inserted intravaginally once daily (preferably at bedtime) for 7-14 consecutive days. In patients who do not respond, the diagnosis should be reevaluated before instituting another course of therapy. When 1% clotrimazole vaginal cream is used for self-medication in the treatment of vulvovaginal candidiasis, one applicatorful of the cream may be inserted intravaginally once daily (preferably at bedtime) for 7 days. Alternatively, if the commercially available 2% clotrimazole vaginal cream is used, one applicatorful of the 2% cream should be inserted intravaginally once daily at bedtime for 3 consecutive days.

If vulvovaginal candidiasis does not improve within 3 days or if the condition persists beyond 7 days, self-medication should be discontinued and the patient should consult a physician.

Cautions

Adverse Effects

Although clotrimazole is usually well tolerated when administered topically to the skin, blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, skin fissures, and general irritation of the skin occasionally have occurred.

Mild burning has occasionally occurred in patients receiving clotrimazole vaginal tablets; rarely, itching and vulval irritation, have been reported. Vaginal burning, erythema, irritation, burning, and intercurrent cystitis have been reported following use of clotrimazole vaginal cream.

Contact dermatitis has been reported following topical application of imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, miconazole, oxiconazole, sulconazole, tioconazole). Cross-sensitization appears to occur among the imidazole derivatives; however, cross-sensitivity appears to be unpredictable. The fact that patients with contact sensitivity to one imidazole-derivative azole antifungal may be sensitive to other similar drugs should be considered. If irritation or sensitization occurs following topical application of clotrimazole, the drug should be discontinued.

Abnormal liver function tests have been reported in patients receiving clotrimazole lozenges. Elevated serum AST (SGOT) concentrations have been reported in approximately 15% of patients receiving clotrimazole lozenges; however, in most patients, the elevations in serum AST were minimal and could not always be directly attributed to the drug. Nausea, vomiting, unpleasant mouth sensations, and pruritus have been reported in patients receiving clotrimazole lozenges.

Precautions and Contraindications

To achieve maximum therapeutic effect of clotrimazole when the drug is administered orally as a lozenge, the lozenge must be dissolved slowly in the mouth. Therefore, patients receiving clotrimazole lozenges must be of such age and physical and/or mental condition that they can comprehend and follow administration instructions. Liver function tests should be conducted periodically during oral therapy with clotrimazole lozenges, especially in patients with preexisting hepatic impairment.

Clotrimazole topical cream, lotion, and solution are not intended for ophthalmic use. In addition to the usual precautions associated with clotrimazole, the usual precautions associated with topical corticosteroids must be considered when the combination preparation containing betamethasone dipropionate is used. (See Cautions in the Topical Corticosteroids General Statement 84.06.) If irritation occurs or if the patient's dermatologic condition does not improve within 2 weeks for tinea cruris or within 4 weeks for tinea pedis or tinea corporis during self-medication with clotrimazole cream or solution, treatment should be discontinued and the patient should consult a physician or pharmacist.

If vulvovaginal candidiasis does not improve within 3 days or if the condition persists beyond 7 days during self-medication with clotrimazole vaginal tablets or cream, the patient should consult a physician, as a condition other than vulvovaginal candidiasis may exist. If symptoms of vulvovaginal candidiasis recur within 2 months of using clotrimazole vaginal tablets or cream for self-medication, the patient should consult a physician.

Clotrimazole is contraindicated in patients who are hypersensitive to the drug or any ingredient in the formulation.

Patients who are considering use of clotrimazole vaginal cream or tablets for self-medication should be advised not to use the drug if they have abdominal pain, fever, or malodorous vaginal discharge, as a condition more serious than vulvovaginal candidiasis may exist; such patients should consult a physician immediately. Patients who are considering use of clotrimazole vaginal cream or tablets for self-medication also should be advised not to use the drug if vaginal pruritus or discomfort is occurring for the first time; such patients should consult their physician.

Pediatric Precautions

Safety and effectiveness of clotrimazole lozenges in children younger than 3 years of age have not been established; the manufacturer states that use of clotrimazole lozenges in children younger than 3 years of age is not recommended.

For self-medication, clotrimazole topical cream or solution should not be used in children younger than 2 years of age unless otherwise instructed by a physician. For self-medication, clotrimazole vaginal tablets or cream should not be used in children younger than 12 years of age.

Use of the combination preparation containing clotrimazole and betamethasone in children younger than 17 years of age is not recommended.

Carcinogenicity

No carcinogenic effects were observed with clotrimazole following an 18-month oral dosing study in rats.

Pregnancy and Lactation

Pregnancy

Clotrimazole has been shown to be embryotoxic in rats and mice when given in oral doses 100 times the usual human dose; this effect may be secondary to maternal toxicity. Clotrimazole has not been teratogenic in mice, rabbits, or rats when given in oral doses up to 200, 180, or 100 times the human dose, respectively. In addition, reproduction studies in mice using oral clotrimazole, at a dosage 120 times the usual human dose and administered from 9 weeks prior to mating through weaning, resulted in impairment of mating, decreased number of viable young, and decreased survival to weaning; no effects were observed when doses 60 times the usual human dose were used. In similar studies in rats using oral doses 50 times the usual human dose, there was a slight decrease in the number of pups per litter and decreased pup viability.

There are no adequate and controlled studies to date using oral clotrimazole in pregnant women, and clotrimazole lozenges should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Clotrimazole topical cream, lotion, and solution should be used during the first trimester of pregnancy only if clearly indicated.

Lactation

Since it is not known whether clotrimazole is distributed into milk, the drug should be used with caution in nursing women.

Pharmacokinetics

Following oral administration of a lozenge containing 10 mg of clotrimazole and dissolution of the lozenge in the mouth (which takes approximately 15-30 minutes), concentrations of clotrimazole sufficient to inhibit most species of Candida are present in saliva for up to 3 hours. Administration of a 10-mg clotrimazole lozenge every 3 hours reportedly maintains salivary concentrations of clotrimazole greater than the MIC of the drug for most species of Candida. The long-term effective concentration of clotrimazole in saliva appears to be related to slow release of the drug from the oral mucosa to which the drug is apparently bound. The total amount of clotrimazole absorbed following dissolution in the mouth of a lozenge containing the drug has not been determined to date.

Only very small amounts of clotrimazole appear to be absorbed systemically following topical application to the skin. Following application to the skin, highest concentrations of clotrimazole are present in the stratum corneum; lower drug concentrations occur in the stratum spinosum and the papillary and reticular dermis.

Small amounts of clotrimazole are absorbed systemically when the drug is administered intravaginally. Following intravaginal administration of radiolabeled clotrimazole in patients with normal or inflamed vaginal mucosa, peak serum concentrations of clotrimazole 24 hours after insertion of a single 100-mg tablet of the drug are 0.03 mcg/mL and peak serum concentrations 24 hours after administration of a cream containing 50 mg of the drug are 0.01 mcg/mL. About 3-10% of an intravaginal dose of the drug reaches systemic circulation, principally as metabolites.

Vaginal fluid concentrations of clotrimazole show considerable interindividual variation following intravaginal insertion of vaginal tablets of the drug. Following intravaginal insertion of single doses as two 100-mg or one 200-mg vaginal tablet daily for 3 days in one study, mean vaginal fluid concentrations of clotrimazole were about 1 mg/mL, 30 mcg/mL, and 10 mcg/mL 24, 48, and 72 hours after the third dose, respectively.

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