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Clotrimazole (Topical)


General


Pronunciation

(kloe TRIM a zole)


Brand Names: U.S.

  • 3 Day Vaginal [OTC]
  • Alevazol [OTC]
  • Clotrimazole 3 Day [OTC]
  • Clotrimazole Anti-Fungal [OTC]
  • Clotrimazole GRx [OTC]
  • Desenex [OTC]
  • Gyne-Lotrimin 3 [OTC]
  • Gyne-Lotrimin [OTC]
  • Lotrimin AF For Her [OTC]
  • Lotrimin AF [OTC]
  • Pro-Ex Antifungal [OTC]
  • Shopko Athletes Foot [OTC]

Indications


Use: Labeled Indications

Treatment of susceptible fungal infections, including dermatophytoses, superficial mycoses, and cutaneous candidiasis, as well as vulvovaginal candidiasis


Contraindications


Hypersensitivity to clotrimazole or any component of the formulation


Dosing and Administration


Dosing: Adult

Dermatophytosis, cutaneous candidiasis: Topical (cream, solution): Apply twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis.

Vulvovaginal candidiasis: Intravaginal:

Cream (1%): Insert 1 applicatorful of 1% vaginal cream daily (preferably at bedtime) for 7 consecutive days. Note: Guidelines recommend a duration of 7 to 14 days (CDC [Workowski 2015]).

Cream (2%): Insert 1 applicatorful of 2% vaginal cream daily (preferably at bedtime) for 3 consecutive days.

Dermatologic infection (superficial): Topical (cream, solution): Apply to affected area twice daily (morning and evening) for 7 consecutive days.


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Vaginal, topical infections: Children >12 years: Refer to adult dosing.


Administration

Topical: Avoid contact with eyes. For external use only. Apply sparingly. Protect hands with latex gloves. Do not use occlusive dressings.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Clotrimazole Anti-Fungal: 1% (14.17 g, 28.35 g) [contains benzyl alcohol, cetyl alcohol]

Clotrimazole GRx: 1% (14 g) [contains benzyl alcohol, cetyl alcohol, polysorbate 80]

Desenex: 1% (15 g, 30 g)

Lotrimin AF: 1% (12 g, 24 g)

Lotrimin AF For Her: 1% (24 g)

Pro-Ex Antifungal: 1% (42 g) [contains cetyl alcohol, edetate trisodium, methylparaben, trolamine (triethanolamine)]

Shopko Athletes Foot: 1% (28.4 g) [contains benzyl alcohol, cetostearyl alcohol]

Generic: 1% (15 g, 30 g, 45 g)

Cream, Vaginal:

3 Day Vaginal: 2% (21 g) [contains benzyl alcohol, cetyl alcohol]

Clotrimazole 3 Day: 2% (22.2 g)

Gyne-Lotrimin: 1% (45 g) [contains benzyl alcohol]

Gyne-Lotrimin 3: 2% (21 g) [contains benzyl alcohol, cetyl alcohol]

Generic: 1% (45 g)

Ointment, External:

Alevazol: 1% (56.7 g)

Solution, External:

Generic: 1% (10 mL, 30 mL)


Drug Interactions

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination

Sirolimus: Clotrimazole (Topical) may increase the serum concentration of Sirolimus. Monitor therapy

Tacrolimus (Systemic): Clotrimazole (Topical) may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy


Adverse Reactions


Vaginal:

1% to 10%: Genitourinary: Vulvovaginal burning

<1% (Limited to important or life-threatening): Burning sensation of the penis (of sexual partner), polyuria, pruritus vulvae, vaginal discharge, vulvar pain, vulvar swelling


Warnings/Precautions


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: When using topical formulation, avoid contact with eyes.


Pregnancy Considerations

Following topical and vaginal administration, small amounts of imidazoles are absorbed systemically (Duhm 1974). Vaginal topical azole products (7-day therapies only) are the preferred treatment of vulvovaginal candidiasis in pregnant women. This product may weaken latex condoms and diaphragms (CDC [Workowski 2015]).


Actions


Pharmacology

Binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements


Absorption

Topical: Negligible through intact skin; Intravaginal: 3% to 10% of dose is absorbed


Time to Peak

Serum: Vaginal cream: ~24 hours


Patient and Family Education


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?)

- Have patient report immediately to prescriber severe skin irritation, severe vaginal irritation, nausea, vomiting, foul-smelling vaginal discharge, or abdominal pain (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 healthcare 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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