Active ingredient: Sertaconazole Nitrate

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Sertaconazole Nitrate uses


1 INDICATIONS AND USAGE

Sertaconazole Nitrate® (sertaconazole nitrate) cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum [see Clinical Studies (14) ].

Sertaconazole Nitrate cream 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. (1)

2 DOSAGE AND ADMINISTRATION

In the treatment of interdigital tinea pedis, Sertaconazole Nitrate cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Sertaconazole Nitrate cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis.

Not for ophthalmic, oral, or intravaginal use.

Sertaconazole Nitrate cream should be applied to the affected and immediate surrounding area(s) twice daily for 4 weeks. (2)

Not for ophthalmic, oral, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

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

Cream, 2%. (3)

4 CONTRAINDICATIONS

None.

None. (4)

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5 WARNINGS AND PRECAUTIONS

5.1 Local Adverse Reactions

If irritation develops, treatment should be discontinued and appropriate therapy instituted.

Physicians should exercise caution when prescribing Sertaconazole Nitrate cream, 2%, to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.

6 ADVERSE REACTIONS

Most common adverse reactions observed in clinical trials were contact dermatitis, dry skin, burning skin, application site skin tenderness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 drug, and may not reflect the rates observed in practice.

In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Sertaconazole Nitrate® cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.

In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Sertaconazole Nitrate® cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Sertaconazole Nitrate cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In post-marketing surveillance for Sertaconazole Nitrate cream, 2%, the following were reported:

Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies conducted with Sertaconazole Nitrate cream in pregnant women. Sertaconazole Nitrate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Reproduction studies have not been performed with Sertaconazole Nitrate cream. Sertaconazole Nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day Sertaconazole Nitrate in an oral peri- and post-natal development study in rats.

8.3 Nursing Mothers

It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing Sertaconazole Nitrate cream, 2%, to a nursing woman.

8.4 Pediatric Use

The efficacy and safety of Sertaconazole Nitrate cream, 2%, have not been established in pediatric patients below the age of 12 years.

8.5 Geriatric Use

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

11 DESCRIPTION

Sertaconazole Nitrate (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 racemic mixture of equal amounts of R and S enantiomers.

Sertaconazole Nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[b]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is C20H15Cl3N2OS HNO3, and the structural formula is as follows:

Sertaconazole Nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, sparingly soluble in alcohol and in methylene chloride. Each gram of Sertaconazole Nitrate cream, 2%, contains 17.5 mg of sertaconazole (as Sertaconazole Nitrate, 20 mg) in a white cream base of ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, sorbic acid and purified water.

Chemical Structure

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sertaconazole Nitrate cream is an azole antifungal [see Clinical Pharmacology ].

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), Sertaconazole Nitrate cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams Sertaconazole Nitrate per 100 cm2). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.

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. Ergosterol is a key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.

Activity In Vitro and in Clinical Infections :

Sertaconazole Nitrate has been shown to be active against isolates of the following microorganisms in clinical infections [see Indications and Usage (1) ].

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a rat dermal carcinogenicity study, topical administration of Sertaconazole Nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at Sertaconazole Nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).

No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole Nitrate was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that Sertaconazole Nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.

At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), Sertaconazole Nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.

14 CLINICAL STUDIES

In two randomized, double-blind, clinical trials, subjects 12 years and older with interdigital tinea pedis applied either Sertaconazole Nitrate cream, 2%, or vehicle, twice daily for four weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (six weeks after beginning therapy), subjects were evaluated for signs and symptoms related to interdigital tinea pedis.

Treatment outcomes are summarized in the table below.

Trial 1 Trial 2
Sertaconazole Vehicle Sertaconazole Vehicle

Complete Cure Complete Cure – Patients who had complete clearing of signs and symptoms and Mycological Cure. (Primary Efficacy Variable)


13/99 (13.1%)


3/92 (3.3%)


28/103 (27.2%)


5/103 (4.9%)


Effective Treatment Effective Treatment – Patients who had minimal residual signs and symptoms of interdigital tinea pedis and Mycological Cure.


32/99 (32.3%)


11/92 (12.0%)


52/103 (50.5%)


16/103 (15.5%)


Mycological Cure Mycological Cure – Patients who had both negative microscopic KOH preparation and negative fungal culture.


49/99 (49.5%)


18/92 (19.6%)


71/103 (68.9%)


20/103 (19.4%)


In clinical trials, complete cure in sertaconazole treated subjects was achieved in 32 of 160 (20%) subjects with Trichophyton rubrum, in 7 of 28 (25%) subjects with Trichophyton mentagrophytes and in 1 of 13 (15%) subjects with Epidermophyton floccosum.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sertaconazole Nitrate cream, 2%, is white in color and supplied in tubes in the following size:


60-gram tube


NDC 0187-5115-60


Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°-30°C (59°-86°F).

17 PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling (Patient Information)

The patient should be instructed to:


9378100

140248

Rev. 01/14

PATIENT INFORMATION

Sertaconazole Nitrate (er-tack-zo)

(sertaconazole nitrate) cream, 2%


Important information: Sertaconazole Nitrate cream is for use on skin only. Do not use Sertaconazole Nitrate cream in your eyes, mouth, or vagina.


What is Sertaconazole Nitrate cream?

Sertaconazole Nitrate cream is a prescription medicine used on the skin (topical) to treat athlete's foot that is between the toes (interdigital tinea pedis) in people 12 years of age and older with normal immune systems.

It is not known if Sertaconazole Nitrate cream is safe and effective in children under 12 years of age.

What should I tell my healthcare provider before using Sertaconazole Nitrate cream?

Before using Sertaconazole Nitrate cream, tell your healthcare provider about all of your medical conditions, including if you:


Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Sertaconazole Nitrate cream?


What are the possible side effects of Sertaconazole Nitrate cream?

The most common side effects of Sertaconazole Nitrate cream include: redness, itching, dry skin, burning, blistering, swelling, drainage and skin tenderness at the treated skin areas. Tell your healthcare provider if you have any of these skin reactions.

These are not all the possible side effects of Sertaconazole Nitrate cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Sertaconazole Nitrate cream?


General information about the safe and effective use of Sertaconazole Nitrate cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about Sertaconazole Nitrate cream that is written for health professionals. Do not use Sertaconazole Nitrate cream for a condition for which it was not prescribed. Do not give Sertaconazole Nitrate cream to other people, even if they have the same symptoms you have. It may harm them.

What are the ingredients in Sertaconazole Nitrate cream?

Active ingredient: Sertaconazole Nitrate

Inactive ingredients: ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, sorbic acid and purified water

Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Product of Spain

For more information call 1-800-321-4567.

This Patient Information has been approved by the U.S. Food and Drug Administration.

9378100

140248

Rev. 01/14

PRINCIPAL DISPLAY PANEL - 60 g Tube

NDC 0187-5115-60

Sertaconazole Nitrate®

(sertaconazole nitrate) cream, 2%

For Topical Use Only – Not for Oral, Ophthalmic, or Intravaginal Use

PRINCIPAL DISPLAY PANEL - 60 g Tube

Sertaconazole Nitrate available forms, composition, doses:


Indications and Usages:

ATC codes:


ICD-10 codes:


Sertaconazole Nitrate destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Sertaconazole". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Sertaconazole". http://www.drugbank.ca/drugs/DB0115... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Sertaconazole Nitrate?

Depending on the reaction of the Sertaconazole Nitrate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sertaconazole Nitrate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Sertaconazole Nitrate addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Sertaconazole Nitrate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Sertaconazole Nitrate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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