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Clindamycin Phosphate topical

Pronunciation

Class: Antibacterials
VA Class: DE101
CAS Number: 24729-96-2
Brands: BenzaClin, Cleocin, Cleocin T, Clinda-Derm, Clindagel, Clindesse, Clindets, Duac

Introduction

Antibacterial; broad-spectrum antibiotic derived from lincomycin.5 6 7 100

Uses for Clindamycin Phosphate

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

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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 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
Topical

Children ≥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
Topical

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

Bacterial Vaginosis
Treatment in Nonpregnant Postmenarchal Females
Intravaginal

Clindesse 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
Topical

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

Treatment with Clindamycin and Benzoyl Peroxide Combination Preparations
Topical

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

Bacterial Vaginosis
Treatment in Nonpregnant Women
Intravaginal

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

Treatment in Pregnant Women
Intravaginal

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

Cautions for Clindamycin Phosphate

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 (See Clostridium difficile-associated Colitis under Cautions.)

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

Interactions for Clindamycin Phosphate

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

In vitro evidence of antagonisma 179

Do not use concomitantlya 178 179

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 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. (See Cautions.)

Preparations

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

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

Clindamycin Phosphate

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

Clindamycin Phosphate Combinations

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Acanya 1.2-2.5% Gel (VALEANT): 50/$252.99 or 150/$738.94

BenzaClin 1-5% Gel (DERMIK): 25/$119.99 or 50/$219.98

BenzaClin with Pump 1-5% Gel (DERMIK): 50/$229.99 or 150/$669.96

Cleocin 100MG Suppositories (PFIZER U.S.): 3/$80.83 or 9/$226.75

Cleocin 2% Cream (PFIZER U.S.): 40/$90.29 or 120/$262.46

Cleocin-T 1% Gel (PFIZER U.S.): 30/$66.14 or 90/$184.78

Cleocin-T 1% Gel (PFIZER U.S.): 60/$116.54 or 180/$321.28

Cleocin-T 1% Lotion (PFIZER U.S.): 60/$94.92 or 180/$261.62

Cleocin-T 1% Solution (PFIZER U.S.): 60/$75.99 or 180/$216.23

Cleocin-T 1% Swabs (PFIZER U.S.): 60/$89.99 or 180/$259.97

Clindagel 1% Gel (GALDERMA): 40/$265.66 or 120/$751.69

Clindagel 1% Gel (GALDERMA): 75/$425.98 or 225/$1,249.95

ClindaMax 1% Lotion (PHARMADERM): 60/$75.40 or 180/$211.71

Clindamax 2% Cream (PHARMADERM): 40/$59.99 or 120/$169.97

Clindamycin Phos-Benzoyl Perox 1-5% Gel (MYLAN): 50/$190.99 or 150/$552.96

Clindamycin Phosphate 1% Foam (PERRIGO PHARMACEUTICALS): 50/$159.98 or 150/$445.97

Clindamycin Phosphate 1% Foam (PERRIGO PHARMACEUTICALS): 100/$265.99 or 300/$744.01

Clindamycin Phosphate 1% Gel (FOUGERA): 30/$29.99 or 90/$71.97

Clindamycin Phosphate 1% Gel (FOUGERA): 60/$45.99 or 180/$105.97

Clindamycin Phosphate 1% Lotion (FOUGERA): 60/$45.99 or 180/$119.97

Clindamycin Phosphate 1% Solution (GREENSTONE): 30/$15.99 or 90/$37.97

Clindamycin Phosphate 1% Solution (GREENSTONE): 60/$33.99 or 180/$89.97

Clindamycin Phosphate 1% Swabs (PERRIGO PHARMACEUTICALS): 60/$39.99 or 120/$69.98

Clindamycin Phosphate 2% Cream (GREENSTONE): 40/$54.99 or 120/$155.98

ClindaReach 1% Kit (SIRIUS LABORATORIES): 1/$182.59 or 3/$516.97

Duac 1-5% Gel (GLAXO SMITH KLINE): 45/$200.99 or 135/$580.95

Evoclin 1% Foam (GLAXO SMITH KLINE): 50/$205.99 or 150/$575.99

Evoclin 1% Foam (GLAXO SMITH KLINE): 100/$322.00 or 300/$914.00

Veltin 1.2-0.025% Gel (GLAXO SMITH KLINE): 30/$165.98 or 90/$479.95

Ziana 1.2-0.025% Gel (MEDICIS): 30/$248.44 or 90/$730.82

Ziana 1.2-0.025% Gel (MEDICIS): 60/$472.13 or 180/$1,347.81

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

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