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Miconazole (Topical)


General


Pronunciation

(mi KON a zole)


Brand Names: U.S.

  • Aloe Vesta Antifungal [OTC]
  • Aloe Vesta Clear Antifungal [OTC]
  • Antifungal [OTC]
  • Azolen Tincture [OTC]
  • Baza Antifungal [OTC]
  • Carrington Antifungal [OTC]
  • Critic-Aid Clear AF [OTC]
  • Cruex Prescription Strength [OTC]
  • DermaFungal [OTC]
  • Desenex Jock Itch [OTC]
  • Desenex Spray [OTC]
  • Desenex [OTC]
  • Fungoid Tincture [OTC]
  • Lotrimin AF Deodorant Powder [OTC]
  • Lotrimin AF Jock Itch Powder [OTC]
  • Lotrimin AF Powder [OTC]
  • Lotrimin AF [OTC]
  • Micaderm [OTC]
  • Micatin [OTC]
  • Miconazole 3
  • Miconazole 3 Combo Pack [OTC]
  • Miconazole 7 [OTC]
  • Micro Guard [OTC]
  • Miranel AF [OTC]
  • Mitrazol [OTC] [DSC]
  • Podactin [OTC]
  • Remedy Antifungal Clear [OTC]
  • Remedy Antifungal [OTC]
  • Remedy Phytoplex Antifungal [OTC]
  • Secura Antifungal Extra Thick [OTC]
  • Secura Antifungal [OTC]
  • Soothe & Cool INZO Antifungal [OTC]
  • Triple Paste AF [OTC]
  • Vagistat-3 [OTC]
  • Zeasorb-AF [OTC]

Indications


Use: Labeled Indications

Treatment of vulvovaginal candidiasis and a variety of skin and mucous membrane fungal infections


Contraindications


Hypersensitivity to miconazole or any component of the formulation


Dosing and Administration


Dosing: Adult

Tinea corporis: Topical: Apply twice daily for 4 weeks

Tinea pedis: Topical: Apply twice daily for 4 weeks

Effervescent tablet: Dissolve 1 tablet in ~1 gallon of water; soak feet for 15 to 30 minutes; pat dry

Tinea cruris: Topical: Apply twice daily for 2 weeks

Vulvovaginal candidiasis: Intravaginal:

Cream, 2%: Insert 1 applicatorful at bedtime for 7 days

Cream, 4%: Insert 1 applicatorful at bedtime for 3 days

Suppository, 100 mg: Insert 1 suppository at bedtime for 7 days

Suppository, 200 mg: Insert 1 suppository at bedtime for 3 days

Suppository, 1,200 mg: Insert 1 suppository (a one-time dose); may be used at bedtime or during the day

Note: Many products are available as a combination pack, with a suppository for vaginal instillation and cream to relieve external symptoms. External cream may be used twice daily, as needed, for up to 7 days.


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Tinea corporis, tinea pedis, tinea cruris: Topical: Note: Not for OTC use in children <2 years: Refer to adult dosing.

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


Storage

Store at room temperature.


Dosage Forms/Strengths


Dosage Forms

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

Aerosol, External, as nitrate:

Desenex Spray: 2% (133 g)

Lotrimin AF: 2% (150 g)

Aerosol Powder, External, as nitrate:

Cruex Prescription Strength: 2% (85 g)

Desenex Jock Itch: 2% (113 g)

Desenex Spray: 2% (113 g)

Lotrimin AF Deodorant Powder: 2% (133 g)

Lotrimin AF Jock Itch Powder: 2% (133 g)

Lotrimin AF Powder: 2% (133 g)

Cream, External, as nitrate:

Antifungal: 2% (14 g, 28 g, 42.5 g) [contains benzoic acid]

Antifungal: 2% (113 g, 198 g) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]

Baza Antifungal: 2% (4 g, 57 g, 142 g)

Carrington Antifungal: 2% (141 g) [contains disodium edta, methylparaben, propylene glycol, propylparaben]

Micaderm: 2% (30 g)

Micatin: 2% (14 g) [contains benzoic acid]

Micro Guard: 2% (57 g)

Podactin: 2% (28.35 g) [contains benzoic acid]

Remedy Antifungal: 2% (118 mL) [contains methylparaben, propylparaben, trolamine (triethanolamine)]

Secura Antifungal: 2% (57 g) [contains cetearyl alcohol, methylparaben, propylparaben]

Secura Antifungal Extra Thick: 2% (92 g) [contains cetearyl alcohol, methylparaben, propylparaben]

Soothe & Cool INZO Antifungal: 2% (56.7 g, 141.7 g)

Generic: 2% (15 g, 28.4 g, 30 g)

Cream, Vaginal, as nitrate:

Miconazole 7: 2% (45 g) [contains benzoic acid]

Generic: 2% (45 g)

Kit, External, as nitrate:

Fungoid Tincture: 2% [contains benzyl alcohol]

Kit, Vaginal, as nitrate:

Miconazole 3 Combo Pack: Cream, topical: 2% (9 g) and Suppository, vaginal: 200 mg (3s)

Miconazole 3 Combo Pack: Cream, topical: 2% (9 g) and Suppository, vaginal: 200 mg (3s) [contains benzoic acid]

Vagistat-3: Cream, topical: 2% (9 g) and Suppository, vaginal: 200 mg (3s) [contains benzoic acid]

Lotion, External, as nitrate:

Zeasorb-AF: 2% (56 g) [contains alcohol, usp]

Ointment, External, as nitrate:

Aloe Vesta Antifungal: 2% (56 g, 141 g)

Aloe Vesta Clear Antifungal: 2% (56 g) [dye free, fragrance free]

Critic-Aid Clear AF: 2% (4 g, 57 g, 142 g)

DermaFungal: 2% (113 g)

Remedy Antifungal Clear: 2% (71 g) [contains soybean oil]

Triple Paste AF: 2% (56.7 g) [contains polysorbate 80]

Powder, External, as nitrate:

Desenex: 2% (43 g, 85 g)

Lotrimin AF: 2% (90 g)

Micro Guard: 2% (85 g)

Mitrazol: 2% (30 g [DSC])

Remedy Antifungal: 2% (85 g)

Remedy Antifungal: 2% (85 g) [talc free; contains methylparaben]

Remedy Phytoplex Antifungal: 2% (85 g) [paraben free; contains sodium benzoate, soy protein]

Zeasorb-AF: 2% (71 g)

Zeasorb-AF: 2% (71 g) [starch free]

Solution, External, as nitrate:

Azolen Tincture: 2% (29.57 mL) [contains benzyl alcohol, isopropyl alcohol]

Fungoid Tincture: 2% (29.57 mL) [contains benzyl alcohol]

Miranel AF: 2% (28 g) [contains disodium edta, menthol, propylene glycol, sd alcohol 40b]

Suppository, Vaginal, as nitrate:

Miconazole 7: 100 mg (7 ea)

Miconazole 3: 200 mg (3 ea)

Generic: 100 mg (7 ea)


Drug Interactions

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

Vitamin K Antagonists (eg, warfarin): Miconazole (Topical) may increase the serum concentration of Vitamin K Antagonists. Consider therapy modification


Adverse Reactions


Frequency not defined.

Topical: Allergic contact dermatitis, burning, maceration

Vaginal: Abdominal cramps, burning, irritation, itching


Warnings/Precautions


Concerns related to adverse effects:

- Irritation: Discontinue if sensitivity or irritation occurs.

Special populations:

- Pediatric: Topical products are not for self-medication (OTC use) in children <2 years of age; vaginal products are not for OTC use in children <12 years of age.

Dosage form specific issues:

- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of 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 and/or benzyl alcohol derivative with caution in neonates. See manufacturer 's labeling.

- Fungoid tincture: Patients with diabetes, circulatory problems, renal or hepatic dysfunction should contact healthcare provider prior to self-medication (OTC use).

- Petrolatum-based: Vaginal products are petrolatum-based and may damage rubber or latex condoms or diaphragms; separate use by 3 days.

- Vaginal products: Consult with healthcare provider prior to self-medication (OTC use) if experiencing vaginal itching/discomfort, lower abdominal pain, back or shoulder pain, chills, nausea, vomiting, foul-smelling discharge, if this is the first vaginal yeast infection, or if exposed to HIV. Contact healthcare provider if symptoms do not begin to improve after 3 days or last longer than 7 days. May damage condoms or diaphragms.

Other warnings/precautions:

- Appropriate use: For topical use only; avoid contact with eyes.


Pregnancy Considerations

Following vaginal administration, small amounts are absorbed systemically (Stevens 2002). Adverse fetal events have not been observed (Czeizel 2004). 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

Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients


Absorption

Topical: Negligible; Vaginal: Small amount absorbed systemically


Distribution

Into body tissues, joints, and fluids; poor penetration into sputum, saliva, urine, and CSF


Metabolism

In the liver


Excretion

Feces (~50%); urine (<1%, unchanged)


Half-Life Elimination

Multiphasic degradation: Alpha: 40 minutes; Beta: 126 minutes; Terminal: 24 hours


Protein Binding

91% to 93%


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?)

- Patient may experience burning, abdominal cramps, or application site irritation. Have patient report immediately to prescriber severe skin irritation, severe vaginal irritation, severe abdominal pain, nausea, vomiting, or foul-smelling vaginal discharge (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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