Clindamycin Phosphate topical

Administration

Administer topically to the skin1 178 179 or intravaginally100 176 180 in appropriate formulations.

Topical skin preparations are for external use only and should not be used orally, intravaginally, or near or in eyes or mucous membranes.178 179

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

Topical Administration

Apply topically to the skin as a gel, lotion, or solution containing clindamycin 1%1 or as a gel containing clindamycin 1% in combination with benzoyl peroxide 5%.178 179 Apply to all areas of skin prone to acne.186

Do not use near eyes, nose, mouth, or other mucous membranes.178 179

Shake lotion well immediately prior to use.1

Remove solution-containing pledgets from their foil immediately before use; do not use if seal is broken.1 Use each pledget only once and then discard; may use more than 1 pledget for each application if needed to cover the affected area.1

Prepare BenzaClin topical gel containing clindamycin and benzoyl peroxide at the time of dispensing.179

Reconstitute vial containing clindamycin powder by adding 5 mL of purified water and shaking immediately to completely dissolve the drug; if needed, add additional purified water to bring level up to the mark on the vial.179

Add the reconstituted clindamycin solution to the benzyl peroxide gel provided by the manufacturer; stir until homogenous in appearance (1 to 1.5 minutes).179

Duac topical gel containing clindamycin and benzoyl peroxide does not need reconstitution and is used as provided by the manufacturer.178

Intravaginal Topical Administration

Administer intravaginally as a cream containing clindamycin 2% or as 100-mg vaginal suppositories.100 101 103 104 105 107 114 131 145 180

Dosage

Pediatric Patients

Maintenance therapy needed to prevent recurrence.186

Children ≥12 years of age: apply a thin film of gel, lotion, or solution to the cleansed affected area twice daily.1

Children ≥12 years of age: apply a thin film of BenzaClin gel to the cleansed affected area twice daily (morning and evening) or as directed by clinician.179

Children ≥12 years of age: apply a thin film of Duac gel to the cleansed affected areas once daily in the evening or as directed by clinician.178

Clindesse vaginal cream: One applicatorful (single dose).180

Vaginal suppositories: 1 suppository daily (preferably at bedtime) for 3 days.176

Adults

Maintenance therapy needed to prevent recurrence.186

Apply a thin film of gel, lotion, or solution to the cleansed affected area twice daily.1

BenzaClin gel: apply a thin film to the cleansed affected area twice daily (morning and evening) or as directed by clinician.179

Duac gel: apply a thin film to the cleansed affected areas once daily in the evening or as directed by clinician.178

Cleocin vaginal cream: 1 applicatorful once daily (preferably at bedtime) for 3 or 7 consecutive days.100 101 104 105 107 CDC recommends a 7-day regimen.101

Clindesse vaginal cream: One applicatorful (single dose).180

Vaginal suppositories: 1 suppository once daily (preferably at bedtime) for 3 consecutive days.101 176

Vaginal cream: 1 applicatorful once daily (preferably at bedtime) for 7 consecutive days.163 164

Absorption

Bioavailability

Absorbed systemically following topical or intravaginal administration.1 100 108 176

Approximately 5% of an intravaginal dose of clindamycin 2% vaginal cream (Cleocin) is absorbed systemically; peak serum concentrations attained approximately 14 hours after the intravaginal dose.100

Systemic absorption following intravaginal administration of Clindesse vaginal cream is reported to be lower than that following administration of Cleocin vaginal cream.180

Following intravaginal administration of vaginal suppository (100-mg vaginal suppository once daily for 3 days), almost 30% of the dose is absorbed systemically.176

Distribution

Not fully characterized following intravaginal administration.150

Elimination

Not fully characterized following intravaginal administration.150

Half-life

1.5–2.6 hours following intravaginal administration of vaginal cream (Cleocin).100

11 hours (range: 4–35 hours) following intravaginal administration of vaginal suppository.176

• May be bactericidal or bacteriostatic in action, depending on concentration attained at site of infection and susceptibility of the infecting organism.a

• Inhibits protein synthesis in susceptible organisms by reversible binding 50S ribosomal subunits.a

• Clindamycin phosphate is inactive until hydrolyzed in vivo to free clindamycin.1

• Exact mechanisms of action in treatment of acne vulgaris not fully elucidated; antibacterial activity may result in reduction of acne vulgaris lesions, but other mechanisms also appear to be involved.a

• Inhibits skin surface growth of susceptible organisms (primarily Propionibacterium acnes), reduces formation and concentration of comedogenic (and possibly inflammatory lesion-inducing) free fatty acid in sebum.a

• In vitro, inhibits leukocyte chemotaxis; if this occurs in vivo, may be another mechanism for suppression of inflammatory acne vulgaris lesions.a

• In vitro spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and many gram-positive and -negative anaerobic bacteria.5 6 10 Inactive against fungi and viruses.

• Clindamycin-resistant P. acnes have been reported.178

• Complete cross-resistance occurs between clindamycin and lincomycin; partial cross-resistance occurs between clindamycin, lincomycin, and erythromycin.a

• Importance of discontinuing use and notifying clinician if GI symptoms (e.g., diarrhea) occur.1 100 178 179

• Importance of notifying clinician if local reactions or any other adverse reactions occur.178 179

• Instruct patients regarding vaginal applicator use, and provide a copy of the manufacturer’s instructions.100

• Advise patients using topical gels containing clindamycin and benzyl peroxide that these preparations may bleach hair or colored fabric.178 179

• Advise women using intravaginal cream or suppositories not to engage in vaginal intercourse and to refrain from use of vaginal products (e.g., douches or tampons) during the entire course of therapy.100 103 105 107 131 176 180

• Advise women using Cleocin intravaginal cream or suppositories not to rely on latex or rubber products (e.g., condoms, vaginal contraceptive diaphragms) as contraceptives and/or microbial barriers if used within 72 hours following administration of the vaginal cream or suppository.100 176

• Advise women using Clindesse intravaginal cream not to rely on latex or rubber products (e.g., condoms, vaginal contraceptive diaphragms) as contraceptives and/or microbial barriers if used within 5 days following administration of the vaginal cream.180

• If using topical skin preparations, importance of avoiding contact with eyes, abraded skin, or mucous membranes; need to bathe area with copious amounts of cool water if contact occurs.1 178 179

• If using vaginal cream, importance of avoiding contact of the cream with eyes; need to irrigate eyes with copious amounts of cool water if contact occurs.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Before using clindamycin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic asthma or hay fever (atopic conditions), intestinal diseases (such as ulcerative colitis, enteritis, Clostridium difficile-associated diarrhea).

Tell your doctor if you are pregnant before using this medication.

It is not known if the medication in this product passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.