luliconazole (Rx)

Brand and Other Names:Luzu
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream

  • 1%
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Tinea Corporis & Tinea Cruris

Indicated for the treatment of tinea corporis nad corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum

Apply cream to affected area and ~1-inch surrounding area(s) qDay for 1 week

Tinea Pedis

Indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum

Apply cream to affected area and ~1-inch surrounding area(s) qDay for 2 weeks

<18 years: Safety and efficacy not established

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Adverse Effects

<1%

Application site reactions

Postmarketing Reports

Contact dermatitis

Cellulitis

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Warnings

Contraindications

None

Cautions

For topical use only; not for ophthalmic or intravaginal administration

May inhibit CYP2C19 and CYP3A4 isoenzymes; particularly when treating large surface areas (ie, moderate-to-severe tinea cruris) that result in increased luliconazole systemic exposure

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Pregnancy & Lactation

Pregnancy

There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; in animal reproduction studies with pregnant rats and rabbits, there were no adverse developmental effects observed with subcutaneous administration of luliconazole during organogenesis at doses up to 3 and 24 times, respectively, the maximum recommended human dose (MRHD)

Lactation

There is no information available on presence in human milk, effects of drug on breastfed infant, or effects of drug on milk production after topical application to women who are breastfeeding; lack of clinical data during lactation precludes a clear determination of risk to an infant during lactation; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Imidazole antifungal that alters the fungal cell membrane; interacts with 14-alpha demethylase (an enzyme necessary for conversion of lanosterol to ergosterol), inhibiting the synthesis of ergosterol which is an essential component of the membrane; increases cell permeability causing leakage of cellular contents

Absorption

Tinea pedis

  • Peak plasma concentration: 0.4 ng/mL (first dose); 0.93 ng/mL (final dose)
  • Peak plasma time: 16.9 hr (first dose); 5.8 hr (final dose)
  • AUC: 6.88 ng•hr/mL (first dose); 18.74 ng•hr/mL (final dose)

Tinea cruris

  • Peak plasma time: 21 hr (first dose); 6.5 hr (final dose)
  • Peak plasma concentration: 4.91 ng/mL (first dose); 7.36 ng/mL (final dose)
  • AUC: 85.1 ng•hr/mL (first dose); 121.74 ng•hr/mL (final dose)

Distribution

Protein bound: >99%

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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