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Clindamycin (Topical)

Pronunciation

(klin da MYE sin)

Index Terms

  • Clindamycin Phosphate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, Vaginal, as phosphate [strength expressed as base]:

Cleocin: 2% (40 g) [contains benzyl alcohol]

Clindesse: 2% (5 g, 5.8 g [DSC]) [contains disodium edta, methylparaben, propylparaben]

Generic: 2% (40 g)

Foam, External, as phosphate [strength expressed as base]:

Evoclin: 1% (50 g, 100 g) [contains cetyl alcohol, propylene glycol]

Generic: 1% (50 g, 100 g)

Gel, External, as phosphate [strength expressed as base]:

Cleocin-T: 1% (30 g, 60 g) [contains methylparaben, propylene glycol]

Clindagel: 1% (40 mL [DSC], 75 mL) [contains methylparaben, polyethylene glycol, propylene glycol]

ClindaMax: 1% (30 g [DSC], 60 g [DSC])

Generic: 1% (30 g, 60 g)

Kit, External, as phosphate [strength expressed as base]:

Clindacin ETZ: 1% [contains cetyl alcohol, isopropyl alcohol, propylene glycol]

Clindacin Pac: 1% [contains cetyl alcohol, isopropyl alcohol, propylene glycol]

Lotion, External, as phosphate [strength expressed as base]:

Cleocin-T: 1% (60 mL) [contains cetostearyl alcohol, methylparaben]

ClindaMax: 1% (60 mL [DSC])

Generic: 1% (60 mL)

Solution, External, as phosphate [strength expressed as base]:

Cleocin-T: 1% (30 mL, 60 mL) [contains isopropyl alcohol, propylene glycol]

Generic: 1% (30 mL, 60 mL)

Suppository, Vaginal, as phosphate [strength expressed as base]:

Cleocin: 100 mg (3 ea)

Swab, External, as phosphate [strength expressed as base]:

Cleocin-T: 1% (60 ea) [contains isopropyl alcohol, propylene glycol]

Clindacin ETZ: 1% (60 ea) [contains isopropyl alcohol, propylene glycol]

Clindacin-P: 1% (69 ea) [contains isopropyl alcohol, propylene glycol]

Generic: 1% (60 ea)

Brand Names: U.S.

  • Cleocin
  • Cleocin-T
  • Clindacin ETZ
  • Clindacin Pac
  • Clindacin-P
  • Clindagel
  • ClindaMax [DSC]
  • Clindesse
  • Evoclin

Pharmacologic Category

  • Antibiotic, Lincosamide
  • Topical Skin Product, Acne

Pharmacology

Reversibly binds to 50S ribosomal subunits preventing peptide bond formation thus inhibiting bacterial protein synthesis; bacteriostatic or bactericidal depending on drug concentration, infection site, and organism

Absorption

Topical solution or foam, phosphate: Minimal; Vaginal cream, phosphate: ~5%; Vaginal suppository, phosphate: ~30%

Metabolism

Hepatic; forms metabolites (variable activity); Clindamycin phosphate is converted to clindamycin HCl (active)

Excretion

Urine (<0.2% with topical foam and solution)

Time to Peak

Vaginal cream: ~10 to 14 hours (range: 4 to 24 hours); Vaginal suppository: ~5 hours (range: 1 to 10 hours)

Half-Life Elimination

Vaginal cream: 1.5 to 2.6 hours following repeated dosing; Vaginal suppository: 11 hours (range: 4 to 35 hours, limited by absorption rate)

Use: Labeled Indications

Acne vulgaris: Treatment of acne vulgaris (topical gel, topical lotion, topical solution)

Bacterial vaginosis: Treatment of bacterial vaginosis (vaginal cream, vaginal suppository)

Off Label Uses

Hidradenitis suppurativa

Data from a limited number of patients studied suggest that topical clindamycin may be beneficial for the treatment of hidradenitis suppurativa [Clemmensen 1983]. Additional data may be necessary to further define the role of topical clindamycin in this condition.

Rosacea

Although limited, trial data suggest that topical clindamycin may be effective in the treatment of rosacea.

Contraindications

Hypersensitivity to clindamycin, lincomycin, or any component of the formulation; history of antibiotic-associated colitis, regional enteritis, ulcerative colitis.

Dosing: Adult

Acne: Topical:

Gel (Cleocin T, ClindaMax), pledget, lotion, solution: Apply a thin film twice daily

Gel (Clindagel), foam (Evoclin): Apply once daily

Bacterial vaginosis: Intravaginal:

Suppositories: Insert one suppository (100 mg clindamycin) daily into vagina at bedtime for 3 days

Cream:

Cleocin: One full applicator inserted intravaginally once daily before bedtime for 3 or 7 consecutive days in nonpregnant patients or for 7 consecutive days in pregnant patients

Clindesse: One full applicator inserted intravaginally as a single dose at anytime during the day in nonpregnant patients

Alternate dosing: Pregnant or non-pregnant patients: Intravaginal:

Cream (preferred): One full applicator (5 g) at bedtime for 7 days (CDC [Workowski 2015])

Suppository (alternative therapy): One suppository (100 mg) daily at bedtime for 3 days (CDC [Workowski 2015]

Hidradenitis suppurativa (off-label use): Topical: Solution: Apply to affected area twice daily (Jemec 2012)

Rosacea (off-label use): Topical: Lotion: Apply twice daily to the face (Wilkin 1993)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acne: Topical: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Intravaginal:

Cream: Insertion with the applicator should be as far as possible into the vagina without causing discomfort.

Suppository: Remove from packaging prior to use; if applicator is used for insertion, wash after each use.

Topical:

Foam: Dispense directly into cap or onto a cool surface; do not dispense directly into hands or face (foam will melt on contact with warm skin). Wash skin with mild soap and allow to fully dry. Apply in small amounts to face using fingertips and gently massage into affected areas until foam disappears. Avoid contact with eyes, mouth, lips, mucous membranes, or broken skin.

Gel: Avoid contact with eyes.

Lotion: Shake well immediately before using.

Solution or pledget: Avoid contact with eyes, mouth or other mucous membranes; solution/pledget contains an alcohol base and if inadvertent contact with mucous membranes occurs, rinse with liberal amounts of water. Remove pledget from foil immediately before use; discard after single use. May use more than one pledget for each application to cover area.

Storage

Cream: Store at room temperature. Protect from freezing.

Foam: Store at room temperature of 20°C to 25°C (68°F to 77°F). Avoid fire, flame, or smoking during or immediately following application.

Gel: Store at room temperature.

Clindagel: Do not store in direct sunlight.

Lotion: Store at room temperature of 20°C to 25°C (68°F to 77°F). Protect from freezing.

Suppository: Store at room temperature of 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Avoid heat >30°C (86°F) and high humidity.

Pledget: Store at room temperature.

Topical solution: Store at room temperature of 20°C to 25°C (68°F to 77°F). Protect from freezing.

Drug Interactions

Erythromycin (Systemic): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Erythromycin (Topical): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Neuromuscular-Blocking Agents: Clindamycin (Topical) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Adverse Reactions

Topical: >10%: Dermatologic: Xeroderma (18% to 23%; gel, lotion, solution), oily skin (gel, lotion: 10% to 18%; solution: 1%), erythema (7% to 16%; gel, lotion, solution), burning sensation of skin (10% to 11%; gel, lotion, solution), exfoliation of skin (7% to 11%; lotion, solution), pruritus (7% to 11%; gel, lotion, solution)

Vaginal:

>10%: Genitourinary: Vaginal moniliasis (≤13%)

1% to 10%:

Dermatologic: Pruritus (≤1% nonapplication site; <1% application site)

Genitourinary: Vulvovaginal disease (3% to 9%), vulvovaginitis (≤7%), vaginal pain (2%), trichomonal vaginitis (≤1%)

Infection: Fungal infection (≤1%)

<1% (Limited to important or life-threatening; all routes): Abdominal pain, bacterial infection, colitis, constipation, contact dermatitis, diarrhea (hemorrhagic or severe), dysgeusia, dyspepsia, dysuria, edema, endometriosis, epistaxis, eye pain, flank pain, folliculitis, folliculitis (gram-negative infection), gastrointestinal disease, hypersensitivity reaction, hyperthyroidism, maculopapular rash, menstrual disease, pseudomembranous colitis, pyelonephritis, severe colitis, upper respiratory infection, urinary tract infection, uterine hemorrhage, vulvovaginal pruritus

Warnings/Precautions

Concerns related to adverse effects:

• Colitis: Use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD); CDAD has been observed >2 months postantibiotic treatment. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.

Special populations:

• Atopic patients: Use with caution in atopic patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Topical foam: Topical foam may cause irritation especially when used with abrasive, desquamating or peeling agents; avoid contact with eyes, mouth, lips, mucous membranes, or broken skin.

• Topical pledget or solution: Topical pledget and topical solution contain an alcohol base and may cause eye irritation or burning. Rinse with cool tap water if product comes in contact with mucous membranes, abraded skin, or eyes. Use caution when applying near mouth (unpleasant taste).

• Vaginal products: May weaken condoms, or contraceptive diaphragms; barrier contraceptives are not recommended concurrently or for 3-5 days (depending on the product) following treatment. Vaginal cream contains ingredients that may cause eye burning and irritation; rinse with cool tap water if product comes in contact with the eyes.

Other warnings/precautions:

• Appropriate use: Acne: American Academy of Dermatology (AAD) acne guidelines recommend clindamycin (topical) be used in conjunction with other therapies (not as monotherapy) due to the risk of bacterial resistance. If given for mild acne, clindamycin (topical) should be used in combination with benzoyl peroxide. If given for moderate to severe acne, it should be used in combination with a topical retinoid or systemic antibiotic agent (AAD [Zaenglein 2016]).

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse effects were not observed in animal reproduction studies. Clindamycin has been shown to cross the placenta following oral and parenteral dosing (Philipson 1973; Weinstein 1976). The amount of clindamycin available systemically is less following topical and vaginal application than with IV or oral administration.

Various clindamycin vaginal products are available for the treatment of bacterial vaginosis. Recommendations for use in pregnant woman vary by product labeling. Current guidelines note that the same oral or vaginal regimens used in nonpregnant women may be used during pregnancy, including oral or vaginal clindamycin (CDC [Workowski 2015]).

If treatment for acne is needed during pregnancy, topical clindamycin may be considered if an antibiotic is needed. To decrease systemic exposure, pregnant women should avoid application to inflamed skin for long periods of time, or to large body surface areas (Kong 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, itching, dry skin, redness, oily skin, or headache. Have patient report immediately to prescriber signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), severe skin irritation, painful urination, difficult urination, vaginitis, or severe vaginal irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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