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Clindamycin (Topical)


VA CLASSIFICATION
Primary: DE752
Secondary: DE101{05}

Commonly used brand name(s): Cleocin T Gel; Cleocin T Lotion; Cleocin T Topical Solution; Clinda-Derm; Dalacin T Topical Solution.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiacne agent (topical)—

antibacterial (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Acne vulgaris(treatment)—Topical clindamycin is indicated in the treatment of acne vulgaris. {06} {14} {25} It may be effective in grades II and III acne, which are characterized by inflammatory lesions such as papules and pustules. Topical antibacterials are not generally considered to be as effective as systemic antibacterials in the treatment of acne, especially more severe inflammatory acne. However, some studies have shown that clindamycin phosphate topical solution may be as effective as low-dose tetracycline for moderate cases of inflammatory acne. {06}

[Skin infections, bacterial, minor (treatment)]1—Topical clindamycin is used in the topical treatment of erythrasma caused by Corynebacterium minutissimum , rosacea, periorificial facial dermatitis, folliculitis, stasis, chronic lymphedema, and familial pemphigus.

[Ulcer, dermal (treatment)]1—Clindamycin phosphate topical solution is used in the treatment of dermal ulcers. {01}

—Not all species or strains of a particular organism may be susceptible to clindamycin.

Unaccepted
Topical clindamycin is not effective in the treatment of deep cystic lesions or noninflammatory lesions.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    504.96 {07}

Mechanism of action/Effect:

Antiacne agent (topical)—Probably due to its antibacterial activity. Topical clindamycin is thought to reduce free fatty acid concentrations on the skin and {04} to suppress the growth of Propionibacterium acnes (Corynebacterium acnes) , an anaerobe found in sebaceous glands and follicles. P. acnes produces proteases, hyaluronidases, lipases, and chemotactic factors, all of which can produce inflammatory components or inflammation directly. {06}

Absorption:

Approximately 1.7% absorbed through the skin following topical application of the solution every 12 hours for 4 days to approximately 300 cm 2 of skin surface. {04} {11}

Mean comedonal extract concentration

597 mcg per gram after 4 weeks of topical application. {06}

Biotransformation:

Clindamycin phosphate is inactive in vitro , but is rapidly hydrolyzed in vivo by tissue phosphatases to active clindamycin. {06}

Peak serum concentration:

<1 to 6 nanograms per mL following topical application of the solution every 12 hours for 4 days. {04} {11}

Urine concentration

<1 to 53 nanograms per mL following topical application of the solution every 12 hours for 4 days. {04} {11}

Elimination:
    Renal—0.15 to 0.25% of cumulative dose excreted in urine following topical application of the solution every 12 hours. {04} {11}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to one lincomycin may be sensitive to other lincomycins also. {06}

Pregnancy/Reproduction
Fertility—
Studies in rats and mice receiving subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg per kg per day have not shown that clindamycin causes impaired fertility. {06}

Pregnancy—
Adequate and well-controlled studies in humans have not been done. {25}

Studies in rats and mice receiving subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg per kg per day have not shown that clindamycin causes adverse effects on the fetus.

FDA Pregnancy Category B. {06}

Breast-feeding

It is not known whether topical clindamycin is distributed into breast milk. {25} Since systemically administered clindamycin is distributed into breast milk, topical clindamycin may be also. {25} However, clindamycin is unlikely to be distributed into breast milk in significant amounts following topical administration, since the total daily dose is small and only approximately 1.7% {04} of the dose is absorbed through the skin.

Pediatrics

Appropriate studies on the relationship of age to the effects of topical clindamycin have not been performed in children up to 12 years of age. Safety and efficacy have not been established. {22}


Geriatrics


No information is available on the relationship of age to the effects of topical clindamycin in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Abrasive or medicated soaps or cleansers or
Acne preparations or preparations containing a peeling agent, such as:
Resorcinol
Salicylic acid
Sulfur, or
Alcohol-containing preparations, topical, such as:
After-shave lotions
Astringents
Perfumed toiletries
Shaving creams or lotions, or
Cosmetics or soaps with a strong drying effect or
Isotretinoin or
Medicated cosmetics or ``cover-ups''    (concurrent use with clindamycin phosphate topical solution may cause a cumulative irritant or drying effect, especially with the application of peeling, desquamating, or abrasive agents, resulting in excessive irritation of the skin)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Sensitivity to clindamycin or lincomycin
Risk-benefit should be considered when the following medical problems exist {06}
Antibiotic-associated colitis, ulcerative colitis, or regional enteritis, history of    (topical clindamycin may precipitate problems that may occur days, weeks, or months after start of therapy; also may occur up to several weeks after discontinuation of therapy)


Atopic reactions, history of

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Endoscopy, large bowel    (if severe diarrhea not controlled by administration of vancomycin occurs and persists during therapy, large bowel endoscopy may be required as an aid in the diagnosis of pseudomembranous colitis {06})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive: {06}

Those indicating need for medical attention
Incidence less frequent
    
Contact dermatitis or{16} hypersensitivity (skin rash, itching, redness, swelling, or other sign of irritation not present before therapy)

Incidence rare
    
Pseudomembranous colitis{16} (abdominal or stomach cramps, pain, and bloating, severe; diarrhea, watery and severe, which may also be bloody; fever; increased thirst; nausea or vomiting; unusual tiredness or weakness; weight loss, unusual)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Dryness, scaliness, or peeling of skin —for the topical solution{16}

Incidence less frequent
    
Gastrointestinal disturbances{16} (abdominal pain; mild diarrhea)
    
irritation, sensitization or oiliness of skin{16}
    
stinging or burning feeling of skin —for the topical solution



Those indicating possible pseudomembranous colitis and the need for medical attention if they occur after medication is discontinued {16}
    
Abdominal or stomach cramps, pain, and bloating, severe
    
diarrhea, watery and severe, which may also be bloody
    
fever
    
increased thirst
    
nausea or vomiting
    
unusual tiredness or weakness
    
weight loss, unusual




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Clindamycin (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to clindamycin or lincomycin





Breast-feeding—May be distributed into breast milk in small quantities since systemic clindamycin is distributed into breast milk
Other medical problems, especially a history of antibiotic-associated colitis, ulcerative colitis, or regional enteritis

Proper use of this medication
Before applying, washing affected areas with warm water and soap, rinsing, and patting dry

» Importance of applying medication to entire affected area

Avoiding too frequent washing of affected areas

» Compliance with full course of therapy, which may take months or longer

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

For topical solution only
Waiting 30 minutes after washing or shaving before applying

» Not using near heat, near open flame, or while smoking

Proper administration technique for applicator-tip bottle:

» Avoiding contact with eyes, nose, mouth, or other mucous membranes

Not using more often than prescribed

For topical suspension only
» Shaking well before using

Precautions while using this medication
Checking with physician or pharmacist if no improvement within about 6 weeks

Applying other medications at different times

Checking with physician if treated skin becomes excessively dry (for topical solution only)

» For severe diarrhea, checking with physician before taking any antidiarrheals; for mild diarrhea, taking attapulgite-containing, but not other, antidiarrheals; checking with physician or pharmacist if mild diarrhea continues or worsens

Using only ``water-base'' cosmetics; not applying too heavily or too often


Side/adverse effects
Signs of potential side effects, especially hypersensitivity reactions and pseudomembranous colitis


General Dosing Information
Use of topical antibacterials may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical or systemic use of the medication.

In the treatment of acne with topical clindamycin, noticeable improvement is usually seen after about 6 weeks in most patients. However, 8 to 12 weeks of treatment may be required before maximum benefit is seen.

For treatment of adverse effects
Some patients may develop antibiotic-associated pseudomembranous colitis (AAPMC), caused by Clostridium difficile toxin, during or following administration of topical clindamycin. Mild cases may respond to discontinuation of the drug alone. Moderate to severe cases may require fluid, electrolyte, and protein replacement.

In cases not responding to the above measures or in more severe cases, oral vancomycin, oral bacitracin, or oral metronidazole may be used. Oral vancomycin is effective in doses of 125 to 500 mg every 6 hours for 7 to 10 days. {06} {13} Recurrences may be treated with a second course of these medications.

Cholestyramine and colestipol resins have been shown to bind C. difficile toxin in vitro . If cholestyramine or colestipol resin is administered in conjunction with oral vancomycin, the medications should be administered several hours apart since the resins have been shown to bind oral vancomycin also.

In addition, AAPMC may result in severe watery diarrhea, which may occur during antibiotic therapy or up to several weeks after therapy is discontinued. If diarrhea occurs, administration of antiperistaltic antidiarrheals (e.g., opiates, diphenoxylate and atropine combination, loperamide) is not recommended since they may delay the removal of toxins from the colon, thereby prolonging and/or worsening the condition.


Topical Dosage Forms

CLINDAMYCIN PHOSPHATE GEL USP

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, a thin film applied two times a day to the affected areas. {06} {16} {20} {21} {26}


Usual pediatric dose
Children up to 12 years of age—Safety and efficacy have not been established. {16} {21}

Strength(s) usually available
U.S.—
{02}{06}

1% (base) (Rx) [Cleocin T Gel (methylparaben) ( propylene glycol) ( sodium hydroxide)]{03}{06}{16}{18}{21}{26}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. {06} Store in a tight container. {16} {18} Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medicine for full time of treatment.

Additional information:
Clindamycin phosphate gel is an aqueous, nonalcoholic, nondrying formulation.


CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, two times a day to the affected areas. {06} {16} {20} {23} {25} {27} {28}


Note: Solutions have been used one to four times a day.


Usual pediatric dose
See Clindamycin Phosphate Gel USP. {16} {23}

Strength(s) usually available
U.S.—
{06}{27}{28}

1% (base) (Rx) [Cleocin T Topical Solution] [Clinda-Derm (isopropyl alcohol 50%) (propylene glycol)][Generic]{06}{16}{23}{26}

Canada—


1% (base) (Rx) [Dalacin T Topical Solution (isopropyl alcohol 50%) (propylene glycol){17}{24}{25}{29}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. {16} {18} Protect from freezing. {06}

Auxiliary labeling:
   • For external use only.
   • Continue medicine for full time of treatment.
   • Keep container tightly closed.
   • Flammable—Keep away from heat and flame.


CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION USP

Usual adult and adolescent dose
Antiacne agent (topical)
See Clindamycin Phosphate Topical Solution USP. {16} {20} {22}


Usual pediatric dose
See Clindamycin Phosphate Topical Solution USP. {16} {22}

Strength(s) usually available
U.S.—


1% (base) (Rx) [Cleocin T Lotion (cetostearyl alcohol 2.5%) (isostearyl alcohol 2.5%){16}]{18}{20}{22}{26}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. {16} {18} Protect from freezing.

Auxiliary labeling:
   • Shake well. {16} {20}
   • For external use only.
   • Continue medicine for full time of treatment.



Revised: 02/22/94



References
  1. Indications Index review, 1986.
  1. PDR Physicians' desk reference. 40th ed. 1986. Oradell, NJ: Medical Economics Company, 1986: 1831–2.
  1. Cleocin-T package insert (Upjohn—US), Rev 10/86, Rec 4/27/87.
  1. Manufacturer comment, 07/30/87.
  1. USP DI 1989, VA Medication Classification System: 2472.
  1. Physicians' desk reference. 43rd ed. 1989. Oradell, NJ: Medical Economics Company, 1989: 2153.
  1. Fleeger CA, editor. USAN 1993. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc. 1989: 136.
  1. OPEN
  1. OPEN
  1. OPEN
  1. Manufacturer, 7/30/87.
  1. OPEN
  1. DICP. Jan 1985; 19: 28.
  1. Tucker SB, Tausend R, Cochran R, Flannigan SA. Comparison of topical clindamycin phosphate, benzoyl peroxide, and a combination of the two for the treatment of acne vulgaris. Br J Derm 1984; 110: 487-92.
  1. Rietschel R, Duncan SH. Clindamycin phosphate used combination with tretinoin in the treatment of acne. Int J Derm 1983; 22: 41-3.
  1. PDR Physicians' desk reference. 44th ed. 1990. Oradell, NJ: Medical Economics Company, 1990: 2216; 2218.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 24th ed. Ottawa: Canadian Pharmaceutical Association, 1989: G3.
  1. USP/NF 1990, Supplement 2: Clindamycin Gel and Topical Suspension have been added as USP products.
  1. OPEN
  1. Cleocin T package insert (Upjohn—US), Issued 4/90.
  1. PDR Physicians' desk reference. 45th ed. 1991. Oradell, NJ: Medical Economics Data, 1991: 2222.
  1. PDR Physicians' desk reference. 45th ed. 1991. Oradell, NJ: Medical Economics Data, 1991: 2222.
  1. PDR Physicians' desk reference. 45th ed. 1991. Oradell, NJ: Medical Economics Data, 1991: 2222.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, 1989: G3.
  1. Dalacin T topical solution 1% (Upjohn—US), New product 4/91.
  1. Cleocin T package insert (Upjohn—US), Rev 10/92, Rec 8/93.
  1. Clinda-Derm package insert (Paddock Lab—US), Rev 8/92, Rec 7/93.
  1. Clindamycin Phosphate Topical Solution package insert (Lemmon Co—US), Rev 11/87, Rec 6/93.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 315-6.
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