Clindesse (clindamycin phosphate)

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

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Because clindamycin can be absorbed systemically following intravaginal application, the possibility that drug interactions could occur with this route of administration should be considered.

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, clindamycin and erythromycin probably should not be used concomitantly.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Antimicrobials/Live Typhoid Vaccine

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1)

CLINICAL EFFECTS: Vaccination may be ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3)

DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Crohn's disease
• Ulcerative colitis

• Clostridioides difficile infection

There are no moderate contraindications for this drug.

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Rare or Very Rare

• Candidiasis
• Clostridioides difficile infection
• Endometriosis
• Pyelonephritis

More Frequent

• Constipation
• Headache disorder
• Urinary tract infection
• Vaginitis
• Vulvovaginal candidiasis

Less Frequent

• Abdominal pain with cramps
• Back pain
• Fatigue
• Genital organ pruritus
• Nausea
• Vomiting

Rare or Very Rare

• Abnormal vaginal bleeding
• Diarrhea
• Dizziness
• Dysgeusia
• Dysmenorrhea
• Dyspepsia
• Dysuria
• Edema
• Epistaxis
• Erythema
• Flank pain
• Flatulence
• Halitosis
• Hyperthyroidism
• Menstrual disorder
• Pelvic pain
• Skin rash
• Upper respiratory infection
• Urticaria
• Vaginal burning
• Vaginal discharge
• Vertigo
• Vulvar edema
• Vulvovaginal pruritus

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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/m2) 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(R)) during the first trimester of pregnancy or using clindamycin intravaginal suppositories or intravaginal clindamycin cream (Clindesse(R)) during pregnancy; Clindamycin phosphate vaginal cream (Cleocin(R)) should be used during the first trimester of pregnancy only when clearly needed, and intravaginal suppositories and intravaginal clindamycin cream (Clindesse(R)) 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.

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.

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