Zalain

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Zalain uses

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Zalain reviews

1 INDICATIONS AND USAGE

Zalain^® (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) ].

Zalain 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, Zalain cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Zalain 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.

Zalain 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 Zalain cream, 2%, contains 17.5 mg of sertaconazole (as Zalain, 20 mg) in a white cream base.

Cream, 2%. (3)

4 CONTRAINDICATIONS

None.

None. (4)

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 Zalain 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 Zalain^® 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 Zalain^® 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 Zalain 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 Zalain cream, 2%, the following were reported:

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

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies conducted with Zalain cream in pregnant women. Zalain 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 Zalain cream. Zalain 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 Zalain 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 Zalain cream, 2%, to a nursing woman.

8.4 Pediatric Use

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

8.5 Geriatric Use

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

11 DESCRIPTION

Zalain (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, Zalain. Zalain contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.

Zalain 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:

Zalain 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 Zalain cream, 2%, contains 17.5 mg of sertaconazole (as Zalain, 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

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Zalain 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), Zalain cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams Zalain 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 :

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

• Trichophyton rubrum
• Trichophyton mentagrophytes
• Epidermophyton floccosum

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a rat dermal carcinogenicity study, topical administration of Zalain cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at Zalain 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. Zalain was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that Zalain 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), Zalain 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 Zalain 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.

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

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

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:

• Use Zalain cream, 2%, as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, mouth, vagina and other mucous membranes. Zalain cream, 2%, is for external use only.
• Dry the affected area(s) thoroughly before application, if you wish to use Zalain cream, 2%, after bathing.
• Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved.
• Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling or oozing.
• Avoid the use of occlusive dressings unless otherwise directed by the physician.
• Do not use this medication for any disorder other than that for which it was prescribed.

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PATIENT INFORMATION

Zalain (er-tack-zo)

(sertaconazole nitrate) cream, 2%

What is Zalain cream?

Zalain 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 Zalain cream is safe and effective in children under 12 years of age.

What should I tell my healthcare provider before using Zalain cream?

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

• have any allergies
• are pregnant or plan to become pregnant. It is not known if Zalain cream will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Zalain cream passes into your breast milk.

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 Zalain cream?

• Use Zalain cream exactly as your healthcare provider tells you to use it.
• Use Zalain cream for the full treatment time, even if your symptoms improve.
• If you take a bath or shower, dry the affected skin areas well before you apply Zalain cream.
• Apply Zalain cream 2 times a day for 4 weeks to the affected skin areas between your toes and to the healthy skin around the affected areas.
• Wash your hands after you apply Zalain cream
• Do not cover the treated skin areas with bandages unless your healthcare provider tells you to.

What are the possible side effects of Zalain cream?

The most common side effects of Zalain 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 Zalain 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 Zalain cream?

• Store Zalain cream at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep Zalain cream and all medicines out of the reach of children.

General information about the safe and effective use of Zalain 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 Zalain cream that is written for health professionals. Do not use Zalain cream for a condition for which it was not prescribed. Do not give Zalain cream to other people, even if they have the same symptoms you have. It may harm them.

What are the ingredients in Zalain cream?

Active ingredient: Zalain

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.

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PRINCIPAL DISPLAY PANEL - 60 g Tube

NDC 0187-5115-60

Zalain^®

(sertaconazole nitrate) cream, 2%

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

PRINCIPAL DISPLAY PANEL - 60 g Tube

Zalain pharmaceutical active ingredients containing related brand and generic drugs:

• Sertaconazole Nitrate

Zalain available forms, composition, doses:

• Cream; Topical; Sertaconazole Nitrate 2%
• Suppositories; Vaginal; Sertaconazole Nitrate 300 mg

Zalain destination | category:

• Human:
• Preparations for vaginal conditions
• Topical antifungals and antiparasites

Zalain Anatomical Therapeutic Chemical codes:

• D01AC14 - Sertaconazole
• G01AG - Triazole derivatives

Zalain pharmaceutical companies:

• Andromaco Laboratorios
• Cantabria
• DKSH
• Edward Keller
• Egis
• Ferrer Farma
• Ferrer Internacional
• Geymonat
• GlaxoSmithKline
• Laphal Industrie
• Mayrhofer Pharmazeutika
• Metro Drug Distribution
• Metro Pharma Philippines
• Pfizer
• Pharmacon, Singapore
• Temis Lostalo Laboratorios
• Trommsdorff Arzneimittel
• Wellmex

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

Depending on the reaction of the Zalain after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Zalain 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.

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