Clindamycin Phosphate (Topical) (Monograph)
Brand names: Cleocin, Cleocin T, Clinda-Derm, Clindagel, Clindesse, Clindets
Drug class: Antibacterials
Introduction
Antibacterial; broad-spectrum antibiotic derived from lincomycin.5 6 7 100
Uses for Clindamycin Phosphate (Topical)
Acne Vulgaris
Treatment of inflammatory acne vulgaris; used alone or in conjunction with benzoyl peroxide.1 178 179 186 187
Generally effective for treatment of mild to moderate inflammatory acne.a 186 187
May induce bacterial resistance when used as monotherapy;186 187 resistance associated with decreased clinical efficacy.186
Particularly useful when used in combination with benzoyl peroxide or topical retinoids;186 187 reduction in total lesion count of 50–70% reported when combination therapy used.186
Bacterial Vaginosis
Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).100 101 102 103 104 105 107 109 114 115 120 131 132 133 145 176 177 180
CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).101 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.101
Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.101
Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole; a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream;101 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.101 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or oral clindamycin.101
Regardless of regimen used, relapse or recurrence is common;101 102 114 115 132 136 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.101 120
Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.101
Clindamycin Phosphate (Topical) Dosage and Administration
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
Reconstitution
BenzaClin
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
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
Acne Vulgaris
Maintenance therapy needed to prevent recurrence.186
Single-entity Clindamycin Preparations
TopicalChildren ≥12 years of age: apply a thin film of gel, lotion, or solution to the cleansed affected area twice daily.1
Clindamycin and Benzoyl Peroxide Combination Preparations
TopicalChildren ≥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
Bacterial Vaginosis
Treatment in Nonpregnant Postmenarchal Females
IntravaginalClindesse vaginal cream: One applicatorful (single dose).180
Vaginal suppositories: 1 suppository daily (preferably at bedtime) for 3 days.176
Adults
Acne Vulgaris
Maintenance therapy needed to prevent recurrence.186
Treatment with Single-entity Clindamycin Preparations
TopicalApply a thin film of gel, lotion, or solution to the cleansed affected area twice daily.1
Treatment with Clindamycin and Benzoyl Peroxide Combination Preparations
TopicalBenzaClin 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
Bacterial Vaginosis
Treatment in Nonpregnant Women
IntravaginalCleocin 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
Treatment in Pregnant Women
IntravaginalVaginal cream: 1 applicatorful once daily (preferably at bedtime) for 7 consecutive days.163 164
Cautions for Clindamycin Phosphate (Topical)
Contraindications
-
Hypersensitivity to clindamycin, lincomycin, or any ingredient in the formulations.1 100 178 179
-
History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.1 100 176 178 179
Warnings/Precautions
Warnings
Clostridium difficile-associated Diarrhea
Treatment with anti-infectives may permit overgrowth of Clostridium difficile.1 100 176 178 179 180 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with use of topical or systemic clindamycin.1 100 176 178 179 180 Consider CDAD if diarrhea develops during or following topical or intravaginal clindamycin therapy and manage accordingly.1 100 176 178 179 180 181 182 183 184 185
Some mild cases of CDAD may respond to discontinuance alone.1 100 176 178 179 180 181 182 183 184 185 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.1 100 176 178 179 180 181 182 183 184 185
Sensitivity Reactions
Contact dermatitis has been reported following use of topical clindamycin.a
Consider possibility that patients who become sensitized to topical clindamycin also may be sensitive to systemic clindamycin or lincomycin.a
Urticaria, rash, application-site pain, and pruritus occur rarely.100 145 176
Use topical gel, lotion, and solution with caution in atopic individuals.1
General Precautions
Superinfection
Possible emergence and overgrowth of nonsusceptible bacteria or fungi.176 178 179
Vaginal and nonvaginal candidiasis (moniliasis) and vaginitis have occurred with intravaginal clindamycin.176
Gram-negative folliculitis has been reported rarely following topical clindamycin.a
If suprainfection or superinfection occurs, discontinue the drug and institute appropriate therapy.a 178 179
Vaginal Intercourse and Use of Vaginal Products
Patients receiving intravaginal clindamycin should not engage in vaginal intercourse and should refrain from use of vaginal products (e.g., douches, tampons) during the entire course of therapy.100 103 105 107 131 176
Efficacy of clindamycin could be reduced (e.g., by dislodgment and/or dilution, by increased vaginal pH secondary to deposition of semen).120 147
Latex or rubber products (e.g., condoms, vaginal contraceptive diaphragms) are weakened by oleaginous bases (e.g., mineral oil) in vaginal cream and suppositories and may not be effective as contraceptives and/or microbial barriers if used within 72 hours following intravaginal Cleocin or within 5 days following intravaginal Clindesse.100 176 180
Systemic Adverse Effects
Clindamycin is absorbed following topical or intravaginal application,1 100 176 178 179 and can be absorbed in sufficient amounts to produce systemic effects.1 100 176
Administration Precautions
Vaginal cream may cause ocular burning and irritation; avoid contact with the eyes, and irrigate eyes with copious amounts of cool water if contact occurs.100 150
Topical solution contains alcohol which can burn and irritate sensitive surfaces (e.g., eyes, abraded skin, mucous membranes); bathe surfaces with copious amounts of cool water if contact occurs.1
Topical solution has an unpleasant taste; use caution when applying around the mouth.a
Specific Populations
Pregnancy
Category B (topical and vaginal single-entity clindamycin preparations).a 1 100 180
Category C (topical combination preparations containing clindamycin and benzoyl peroxide).178 179
CDC states clindamycin vaginal preparations should be used only during the first half of pregnancy.101
Lactation
Distributed into milk following systemic administration; not known whether clindamycin is distributed into milk following topical or intravaginal administration.1 100
Discontinue nursing or the drug.1 100 178 179
Pediatric Use
Safety and efficacy of single-entity topical gel, lotion, or solution containing clindamycin not established in children <12 years of age.1
Safety and efficacy of topical gels containing clindamycin in combination with benzoyl peroxide not established in children <12 years of age.178 179
Safety and efficacy of vaginal cream (Cleocin) not established in children <16 years of age.100 150
Safety and efficacy of vaginal suppositories (Cleocin) and vaginal cream (Clindesse) established in postmenarchal females based on extrapolation of data from adult women; safety and efficacy not established in premenarchal females.176 180
Geriatric Use
Insufficient experience with vaginal or topical clindamycin preparations in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1 100 176 180
Common Adverse Effects
Topical application to the skin: burning, pruritus, dryness, erythema, oily skin, peeling.1 178 179
Intravaginal administration: vaginal candidiasis, vulvovaginitis, vulvovaginal disorder, trichomonal vaginitis, vaginal pain, body moniliasis, fungal infection.100 176 180
Drug Interactions
Because clindamycin can be absorbed systemically following topical application to the skin or following intravaginal administration, the possibility that drug interactions could occur with these routes should be considered.100 108
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Alcohol (e.g., in astringents, after-shave lotions) |
Possible cumulative irritant or drying effecta |
|
Erythromycin |
||
Neuromuscular blocking agents (e.g., ether, tubocurarine, pancuronium) |
Systemically absorbed clindamycin after intravaginal administration has potential for enhanced neuromuscular blocking action100 125 126 176 |
Use intravaginal clindamycin with caution in patients receiving neuromuscular blocking agents; observe for neuromuscular blockade prolongation 100 125 126 176 |
Salicylic acid |
Possible cumulative irritant effecta |
Use with cautiona |
Soap (abrasive, medicated) |
Possible cumulative irritant or drying effecta |
|
Sulfur |
Possible cumulative irritant effecta |
Use with cautiona |
Tretinoin |
Possible cumulative irritant effecta |
Use with cautiona |
Clindamycin Phosphate (Topical) Pharmacokinetics
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
Stability
Storage
Topical
Gel, Lotion, or Solution
Tight container at 20–25°C; do not freeze.1
Clindamycin and Benzoyl Peroxide Gel Combinations
BenzaClin: room temperature ≤25°C before or after dispensing.179 Stable for 3 months following reconstitution of clindamycin powder and mixture with benzoyl peroxide gel.179
Duac: 2–8°C before dispensing.178 Stable at room temperature ≤25°C for 60 days after dispensing; do not freeze.178
Intravaginal
Cream
Cleocin: 20–25°C; do not freeze.1
Clindesse: 25°C (may be exposed to 15–30°C).180 Avoid temperatures >30°C.180
Suppositories
25°C (may be exposed to 15–30°C).176 Avoid temperatures >30°C and avoid high humidity.176
Actions and Spectrum
-
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
Advice to Patients
-
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.
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Preparations
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
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Topical |
Gel |
1% (of clindamycin)* |
Cleocin T |
Pfizer |
Clindagel |
Galderma |
|||
Lotion |
1% (of clindamycin) |
Cleocin T |
Pfizer |
|
Pledgets (saturated with solution) |
1% (of clindamycin)* |
Cleocin T Pledgets |
Pfizer |
|
Clindamycin Phosphate Pledgets |
||||
Clindets Pledgets |
Stiefel |
|||
Solution |
1% (of clindamycin)* |
Cleocin T 1% |
Pfizer |
|
Clinda-Derm |
Paddock |
|||
Clindamycin Phosphate Topical Solution |
||||
Vaginal |
Cream |
2% (of clindamycin) |
Cleocin (with 7 disposable vaginal applicators) |
Pfizer |
Clindesse (available in prefilled, disposable applicators) |
Ther-Rx |
|||
Suppositories |
100 mg (of clindamycin) |
Cleocin Vaginal Ovules (with vaginal applicator) |
Pfizer |
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Topical |
For gel |
300 mg (of clindamycin phosphate to prepare a clindamycin 1% gel) with Benzoyl Peroxide 5% |
BenzaClin (with 1 or 2 vials containing clindamycin phosphate [300 mg of clindamycin] powder and container of benzoyl peroxide gel 5%) |
Dermik |
Gel |
1% (of clindamycin) with Benzoyl Peroxide 5% |
Duac |
Stiefel |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions October 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
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150. The Upjohn Company, Kalamazoo, MI: Personal communication.
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