ERTACZO Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

0187-5115

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1. Indications and Usage

ERTACZO cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, ...

2. Dosage and Administration

Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin. Use ERTACZO ...

3. Dosage Forms and Strengths

Cream, 2%. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Local Adverse Reactions If irritation develops, discontinue treatment and institute appropriate therapy. Physicians should exercise caution when prescribing ERTACZO cream, 2%, to patients known to ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...

8.1. Pregnancy

Risk Summary There are no available data on ERTACZO cream, 2% use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In ...

8.2. Lactation

Risk Summary There are no data available on the presence of sertaconazole in human or animal milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits ...

8.4. Pediatric Use

The safety and effectiveness of ERTACZO cream, 2%, have not been established in pediatric patients younger than 12 years of age.

8.5. Geriatric Use

Clinical trials of ERTACZO cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

11. Description

ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a ...

12.1. Mechanism of Action

Sertaconazole nitrate is an azole antifungal [see Clinical Pharmacology (12.4)].

12.3. Pharmacokinetics

In a multiple-dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42-140 cm²; mean, 93 cm²), ERTACZO cream, 2%, was topically applied every 12 ...

12.4. Microbiology

Mechanism of Action Sertaconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate ...

14. Clinical Studies

In two randomized, double-blind clinical trials, subjects 12 years and older with interdigital tinea pedis applied either ERTACZO cream, 2%, or vehicle, twice daily for 4 weeks. Subjects with moccasin-type ...

16.1. How Supplied

ERTACZO cream, 2%, is white in color and supplied in tubes in the following size: 60-gram tube NDC 0187-5115-60. Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807, USA Manufactured ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct the patient of the following: Administration Instructions ERTACZO cream, 2% is for topical use only. ...