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Clindamycin (Topical)

Pronunciation

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, 60 g)

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
  • 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: ~10-14 hours (range: 4-24 hours); Vaginal suppository: ~5 hours (range: 1-10 hours)

Half-Life Elimination

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

Use: Labeled Indications

Treatment of bacterial vaginosis (vaginal cream, vaginal suppository); topically in treatment of severe acne

Contraindications

Hypersensitivity to clindamycin, lincomycin, or any component of the formulation; previous CDAD (C. difficile-associated diarrhea), 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 ovule (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 ovule (100 mg) daily at bedtime for 3 days (CDC [Workowski 2015]

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Administration

Intravaginal:

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

Ovule: The foil should be removed; if the applicator is used for insertion, it should be washed for additional 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.

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).

Ovule: Store at room temperature of 25°C (77°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).

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: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD); CDAD has been observed >2 months postantibiotic treatment. Use with caution in patients with a history of gastrointestinal disease. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.

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

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 products: Topical solution (including pledgets) contains 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.

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, back pain, constipation, 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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