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Clotrimazole (Topical)

Pronunciation

Pronunciation

(kloe TRIM a zole)

Dosage Forms

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

Cream, External:

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

Desenex: 1% (15 g [DSC], 30 g)

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

Lotrimin AF: 1% (24 g) [contains benzyl alcohol, cetyl alcohol]

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)

Brand Names: U.S.

  • 3 Day Vaginal [OTC]
  • Alevazol [OTC]
  • Clotrimazole 3 Day [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]

Pharmacologic Category

  • Antifungal Agent, Imidazole Derivative
  • Antifungal Agent, Oral Nonabsorbed/Partially Absorbed
  • Antifungal Agent, Topical
  • Antifungal Agent, Vaginal

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

Use: Labeled Indications

Topical cream and solution: Topical treatment of candidiasis due to Candida albicans and tinea versicolor caused by Malassezia furfur

OTC labeling: Topical treatment of tinea pedis, tinea cruris, and tinea corporis

Topical ointment: OTC labeling: Topical treatment of tinea cruris, C. albicans, tinea corporis, and tinea pedis

Vaginal cream: Treatment of vaginal yeast infections and relief of associated external vulvar itching and irritation

Contraindications

Hypersensitivity to clotrimazole or any component of the formulation.

OTC labeling: When used for self-medication, do not use vaginal cream if you have never had a vaginal yeast infection diagnosed by a doctor.

Documentation of allergenic cross-reactivity for imidazole antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Cutaneous candidiasis: Topical:

Cream, solution: Apply to affected area twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis.

Ointment (OTC labeling): Apply to affected area twice daily for 2 weeks.

Tinea corporis, tinea cruris, tinea pedis (OTC labeling): Topical: Cream, ointment, solution: Apply to affected area twice daily for 2 weeks (tinea cruris) or 4 weeks (tinea corporis, tinea pedis).

Tinea versicolor: Topical: Cream, solution: Apply to affected area 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 (at bedtime) for 7 consecutive days. Note: Guidelines recommend a duration of 7 to 14 days (CDC [Workowski 2015]). May also apply externally twice daily for 7 days as needed for itching and irritation.

Cream (2%): Insert 1 applicatorful of 2% vaginal cream daily (preferably at bedtime) for 3 consecutive days. May also apply externally twice daily for 7 days as needed for itching and irritation.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Cutaneous candidiasis:

Children and Adolescents: Topical: Cream, solution: Refer to adult dosing.

Children ≥2 years and Adolescents: Topical: Ointment (OTC labeling): Refer to adult dosing.

Tinea corporis, tinea cruris, and tinea pedis: Topical: Cream, ointment, solution: Children ≥2 years and Adolescents: Refer to adult dosing.

Vulvovaginal candidiasis: Intravaginal: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Administration

Intravaginal: For vaginal use only; may also apply externally for itching and irritation of surrounding areas. Do not use tampons, douches, spermicides, or other vaginal products or have vaginal intercourse during treatment.

Topical: For external use only; avoid contact with eyes and application to severely cracked or irritated areas. Cleanse and thoroughly dry area prior to application. Apply a thin layer to affected area. For treatment of athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once a day.

Storage

Store between 20°C and 25°C (68°F and 77°F).

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

Concerns related to adverse effects:

• Local irritation: If irritation/sensitivity develops, discontinue therapy and institute appropriate alternative therapy.

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.

Other warnings/precautions:

• Appropriate use: Topical: For external use only; avoid contact with the eyes. Not effective for treatment of scalp or nails. When used for self-medication, discontinue use and contact a healthcare provider if there is no improvement in 2 weeks (jock itch) or 4 weeks (athlete's foot, ringworm).

• Self-medication (OTC use): Vaginal: When used for self-medication (OTC), consult a health care provider before use if experiencing vaginal itching and discomfort for the first time, frequent vaginal yeast infections (eg, monthly, 3 in 6 months), or exposure to HIV. A mild increase in vaginal itching, burning, or irritation may occur with use; a health care provider should be consulted before switching to another agent if patient does not experience complete relief. Discontinue use and contact a health care provider if symptoms do not improve in 3 days or last more than 7 days, or if symptoms of a more serious condition occur (eg, abdominal pain, back/shoulder pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge). For vaginal use only; do not use tampons, douches, spermicides, or other vaginal products or have vaginal intercourse during treatment.

Pregnancy Risk Factor

B

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]).

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 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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