Zalain Vaginal

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Zalain Vaginal uses


1 INDICATIONS AND USAGE

Zalain Vaginal® (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 Vaginal 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 Vaginal cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Zalain Vaginal 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 Vaginal 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 Vaginal cream, 2%, contains 17.5 mg of sertaconazole (as Zalain Vaginal, 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 Zalain Vaginal 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 Vaginal® 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 Vaginal® 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 Vaginal 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 Vaginal 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 Zalain Vaginal cream in pregnant women. Zalain Vaginal 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 Vaginal cream. Zalain Vaginal 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 Vaginal 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 Vaginal cream, 2%, to a nursing woman.

8.4 Pediatric Use

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

8.5 Geriatric Use

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

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

Zalain Vaginal 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 Vaginal cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams Zalain Vaginal 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 Vaginal 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 Zalain Vaginal cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at Zalain Vaginal 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 Vaginal was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that Zalain Vaginal 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 Vaginal 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 Vaginal 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

Zalain Vaginal 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

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PATIENT INFORMATION

Zalain Vaginal (er-tack-zo)

(sertaconazole nitrate) cream, 2%


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


What is Zalain Vaginal cream?

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

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

Before using Zalain Vaginal 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 Zalain Vaginal cream?


What are the possible side effects of Zalain Vaginal cream?

The most common side effects of Zalain Vaginal 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 Vaginal 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 Vaginal cream?


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

What are the ingredients in Zalain Vaginal cream?

Active ingredient: Zalain Vaginal

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

Zalain Vaginal®

(sertaconazole nitrate) cream, 2%

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

PRINCIPAL DISPLAY PANEL - 60 g Tube

Zalain Vaginal pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Zalain Vaginal available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Zalain Vaginal destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Zalain Vaginal Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Zalain Vaginal pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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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 Zalain Vaginal?

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

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Zalain Vaginal drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Zalain Vaginal is mentioned below.
Visitors%
Once in a day1
100.0%

One visitor reported doses

What is the dose of Zalain Vaginal drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
201-500mg1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
30-451
100.0%

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

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