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  4. Gynazole 1

Gynazole 1

Butoconazole Nitrate


Padagis Israel Pharmaceuticals Ltd
Human Prescription Drug
NDC 45802-396
Gynazole 1 also known as Butoconazole Nitrate is a human prescription drug labeled by 'Padagis Israel Pharmaceuticals Ltd'. National Drug Code (NDC) number for Gynazole 1 is 45802-396. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Gynazole 1 drug includes Butoconazole Nitrate - 100 mg/5g . The currest status of Gynazole 1 drug is Active.

Drug Information:

Drug NDC: 45802-396
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Gynazole 1
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Butoconazole Nitrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Padagis Israel Pharmaceuticals Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:BUTOCONAZOLE NITRATE - 100 mg/5g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:VAGINAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 29 Apr, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 12 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA200923
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Padagis Israel Pharmaceuticals Ltd
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:890785
890786
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:4805237NP5
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Azole Antifungal [EPC]
Azoles [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
45802-396-011 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR29 Apr, 2015N/ANo
45802-396-021 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR29 Apr, 2015N/AYes
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.
Other medicines with the same generic name

Gynazole 1


Butoconazole Nitrate

Cream
Padagis Israel Pharmaceuticals Ltd
NDC: 45802-396

Product Elements:

Gynazole 1 butoconazole nitrate butoconazole nitrate butoconazole edetate disodium glyceryl isostearate methylparaben mineral oil polyglyceryl-3 oleate propylene glycol propylparaben silicon dioxide sorbitol water microcrystalline wax odorless

Indications and Usage:

Indications and usage gynazole • 1® butoconazole nitrate vaginal cream usp, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by candida ). the diagnosis should be confirmed by koh smears and/or cultures (see clinical studies ). note: gynazole • 1® butoconazole nitrate vaginal cream usp, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see precautions - pregnancy ).

Warnings:

Warnings this cream contains mineral oil. mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with gynazole•1® butoconazole nitrate vaginal cream usp, 2% is not recommended. recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (hiv) in women who are considered at risk for hiv infection.

General Precautions:

General - if clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.

Dosage and Administration:

Dosage and administration the recommended dose of gynazole • 1® butoconazole nitrate vaginal cream usp, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. this amount of cream contains approximately 100 mg of butoconazole nitrate.

Contraindications:

Contraindications gynazole • 1® butoconazole nitrate vaginal cream usp, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.

Adverse Reactions:

Adverse reactions of the 314 patients treated with gynazole • 1® butoconazole nitrate vaginal cream usp, 2% for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. in 3 patients (1%) these complaints were considered treatment-related. five of the 18 patients reporting adverse events discontinued the study because of them.

Use in Pregnancy:

Pregnancy:

Pediatric Use:

Pediatric use - safety and effectiveness in children have not been established.

Description:

Description gynazole • 1® butoconazole nitrate vaginal cream usp, 2% contains butoconazole nitrate 2%, an imidazole derivative with antifungal activity. its chemical name is (±)-1-[4-(p-chlorophenyl)-2- [(2,6-dichlorophenyl) thio]butyl] imidazole mononitrate, and it has the following chemical structure: butoconazole nitrate is a white to off-white crystalline powder with a molecular weight of 474.79. it is sparingly soluble in methanol; slightly soluble in chloroform, methylene chloride, acetone, and ethanol; very slightly soluble in ethyl acetate; and practically insoluble in water. it melts at about 159°c with decomposition. gynazole • 1® butoconazole nitrate vaginal cream usp, 2% contains 2% butoconazole nitrate in a cream of edetate disodium, glyceryl monoisostearate, methylparaben, mineral oil, polyglyceryl-3 oleate, propylene glycol, propylparaben, colloidal silicon dioxide, sorbitol solution, purified water, and microcrystalline wax. chemical structure.jpg

Clinical Pharmacology:

Clinical pharmacology following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1.7% (range 1.3-2.2%) of the dose was absorbed on average. peak plasma levels (13.6-18.6 ng radioequivalents/ml of plasma) of the drug and its metabolites are attained between 12 and 24 hours after vaginal administration. microbiology - the exact mechanism of the antifungal action of butoconazole nitrate is unknown; however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. imidazoles generally inhibit the conversion of lanosterol to ergosterol, resulting in a change in fungal cell membrane lipid composition. this structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell. butoconazole nitrate is an imidazole derivative that has fungicidal activity in vitro against candida spp. and has been demonstrated to be clinically effective against vaginal infections due
to candida albicans . candida albicans has been identified as the predominant species responsible for vulvovaginal candidiasis.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility - carcinogenesis - long term studies in animals have not been performed to evaluate the carcinogenic potential of this drug. mutagenicity - butoconazole nitrate was not mutagenic when tested in the ames bacterial test, yeast, chromosomal aberration assay in cho cells, cho/hgprt point mutation assay, mouse micronucleus, and rat dominant lethal assays. impairment of fertility - no impairment of fertility was seen in rabbits or rats administered butoconazole nitrate in oral doses up to 30 mg/kg/day (5 times the human dose based on mg/m 2 ) or 100 mg/kg/day (10 times the human dose based on mg/m 2 ), respectively.

Clinical Studies:

Clinical studies vulvovaginal candidiasis : two studies were conducted that compared 2% butoconazole nitrate cream with clotrimazole tablets. there were 322 enrolled patients, 161 received 2.0% butoconazole vaginal cream and 161 patients inserted the 500-mg clotrimazole vaginal tablet. at the second follow-up visit (30 days post-therapy), 118 patients in the butoconzole group and 116 in the clotrimazole group were evaluable for efficacy analysis, respectively. all of these patients had infection caused by candida albicans . the efficacy of the study drugs was assessed by evaluating clinical, mycologic and therapeutic cure rates, which are summarized in table 1. the therapeutic cure was defined as complete resolution of signs and symptoms of vaginal candidiasis (clinical cure) along with a negative koh examination and negative culture for candida spp. (microbiologic eradication) at the long term follow-up (30 days). the therapeutic cure rate was 67% in the butoconazole group and 61% in
the clotrimazole group. table 1.jpg

How Supplied:

How supplied gynazole•1® butoconazole nitrate vaginal cream usp, 2% is available in cartons containing one single-dose prefilled disposable applicator (ndc 45802- 396 -01). store at 25°c (77°f); excursions permitted to 15°-30°c (59°-86°f) [see usp controlled room temperature]. avoid heat above 30°c (86°f)

Spl Patient Package Insert:

Patient package insert gynazole•1® butoconazole nitrate vaginal cream usp, 2% in one prefilled disposable applicator using the gynazole•1® butoconazole nitrate vaginal cream usp, 2% prefilled disposable applicator 3 easy steps: step 1: preparing the applicator peel back the protective foil and remove the prefilled applicator. applicator is designed to be used with tip in place. do not remove tip; do not use applicator if tip has been removed. do not warm applicator before using. while holding the applicator firmly, pull the ring back to fully extend the plunger ( see figures 1 and 2 ). step 2: inserting the applicator gently insert the applicator into the vagina as far as it will comfortably go ( see figures 3a and 3b ). step 3: applying the cream push the plunger to release the cream ( see figures 4a, 4b and 4c ). remove the empty applicator from the vagina and throw it away. important instructions • one prefilled applicator of gynazole • 1® butoconazole n
itrate vaginal cream usp, 2% should be administered. • this cream contains mineral oil. mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with gynazole • 1® butoconazole nitrate vaginal cream usp, 2% is not recommended. • there are no adequate and well-controlled studies in pregnant women. gynazole • 1® butoconazole nitrate vaginal cream usp, 2% should be used during pregnancy only under the supervision of a physician. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. rev 11-14 :8f200 rc j1 figure 1 and 2.jpg figure 3a figure 3b.jpg figure 4a figure 4b figure 4c.jpg

Package Label Principal Display Panel:

Package/label principal display panel rx only ndc 45802- 396 -01 gynazole•1® butoconazole nitrate vaginal cream usp, 2% the applicator delivers approximately 5 g cream, containing 100 mg butoconazole nitrate. in one prefilled disposable applicator for vaginal use only. net wt 5.8 g the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. gynazole-1-image serialization


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