Ultramicrosize Griseofulvin

Griseofulvin

Chartwell Rx, Llc.
Human Prescription Drug
NDC 62135-495

Ultramicrosize Griseofulvin also known as Griseofulvin is a human prescription drug labeled by 'Chartwell Rx, Llc.'. National Drug Code (NDC) number for Ultramicrosize Griseofulvin is 62135-495. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Ultramicrosize Griseofulvin drug includes Griseofulvin - 250 mg/1 . The currest status of Ultramicrosize Griseofulvin drug is Active.

Drug Information:

Drug NDC:	62135-495
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:	Ultramicrosize Griseofulvin
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:	Griseofulvin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Chartwell Rx, Llc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	GRISEOFULVIN - 250 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
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:	06 Apr, 1982
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
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:	ANDA061996
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:	Chartwell RX, LLC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	239239 242831
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.
UPC:	0362135494308 0362135495305 0362135494018
UPC stands for Universal Product Code.
NUI:	N0000008732 N0000175085 N0000175848
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	32HRV3E3D5
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 EPC:	Tubulin Inhibiting Agent [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Decreased Mitosis [PE] Microtubule Inhibition [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Decreased Mitosis [PE] Microtubule Inhibition [PE] Tubulin Inhibiting Agent [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
62135-495-01	100 TABLET in 1 BOTTLE, PLASTIC (62135-495-01)	30 Nov, 2020	N/A	No
62135-495-30	30 TABLET in 1 BOTTLE, PLASTIC (62135-495-30)	30 Nov, 2020	N/A	No
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

Griseofulvin Microsize

Ultramicrosize Griseofulvin

Griseofulvin

Tablet
Chartwell RX, LLC.
NDC: 62135-495

Griseofulvin

Tablet
Rising Pharmaceuticals, Inc
NDC: 64980-184

Griseofulvin

Suspension
Actavis Pharma, Inc.
NDC: 0472-0013

Griseofulvin

Tablet
Rising Pharmaceuticals Inc.
NDC: 64980-186

Product Elements:

Ultramicrosize griseofulvin griseofulvin starch, corn anhydrous lactose magnesium stearate polyethylene glycol 8000 sodium lauryl sulfate griseofulvin griseofulvin ce;3 ultramicrosize griseofulvin griseofulvin starch, corn anhydrous lactose magnesium stearate polyethylene glycol 8000 sodium lauryl sulfate griseofulvin griseofulvin ce;4

Indications and Usage:

Indications and usage ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athleteâs foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barberâs itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: trichophyton rubrum , trichophyton tonsurans, trichophyton mentagrophytes, trichophyton interdigitalis,trichophyton verrucosum, trichophyton megnini, trichophyton gallinae, trichophyton crateriform, trichophyton sulphureum, trichophyton schoenleini, microsporum audouini, microsporum canis, microsporum gypseum and epidermophyton floccosum. note: prior to therapy, the type of fungi responsible for the infection should be identified. the use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. griseofulv Read more...

in is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, north american blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.

Warnings:

Warnings prophylactic usage: safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.

Dosage and Administration:

Dosage and administration accurate diagnosis of infecting organism is essential. identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguiumâdepending on rate of growthâfingernails, at least 4 months; toenails, at least 6 months. general measures in regard to hygiene should be observed to control sources of infection or reinfection. concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. in some forms of athleteâs foot, yeasts and bacteria may be involved as well as fungi. griseofulvin will not eradicate the bacterial or Read more...

monilial infection. ultramicrosize griseofulvin tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing. adults: daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. for those fungus infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended. pediatric use : approximately 7.3 mg per kg of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. on this basis, the following dosage schedule is suggested: 16-27 kg: 125 mg to 187.5 mg daily. over 27 kg: 187.5 mg to 375 mg daily children and infants 2 years of age and youngerâdosage has not been established. clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

Contraindications:

Contraindications two cases of conjoined twins have been reported since 1977 in patients taking griseofulvin during the first trimester of pregnancy. griseofulvin should not be prescribed to pregnant patients. if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. this drug is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin.

Adverse Reactions:

Adverse reactions there have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see warnings section). when adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. paresthesia of the hands and feet have been reported after extended therapy. other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities. proteinuria and leukopenia have been reported rarely. administration of the drug should be discontinued if granulocytopenia occurs. when rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both. to report suspected Read more...

adverse reactions, contact chartwell rx, llc., at 845-232-1683 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Description:

Description ultramicrosize griseofulvin tablets, usp contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of penicilliu m. griseofulvin crystals are partly dissolved in polyethylene glycol 8000 and partly dispersed throughout the tablet matrix. the chemical name of griseofulvin, usp is 7-chloro-2â,4,6-trimethoxy-6âÎ²-methylspiro[benzofuran-2( 3h ),1â-[2]cyclohexene]-3,4â-dione. its structural formula is: griseofulvin, usp occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. each ultramicrosize griseofulvin tablet contains 125 mg or 250 mg griseofulvin ultramicrosize. the inactive ingredients for ultramicrosize griseofulvin tablets, 125 mg or 250 mg, include: corn starch, lactose anhydrous, magnesium stearate, polyethylene glycol 8000, and sodium lauryl sulfate. structural formula

Clinical Pharmacology:

Clinical pharmacology microbiology - griseofulvin is fungistatic with in vitro activity against various species of microsporum, epidermophyton, and trichophyto n. it has no effect on bacteria or other genera of fungi. pharmacokinetics â following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. the drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. the efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. this factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. however, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy. in a bioequivalence study conducted in healthy volunteers (n=24) in the fasted state, 250 m Read more...

g ultramicrocrystalline griseofulvin tablets were compared with 250 mg ultramicrocrystalline griseofulvin tablets that were physically altered (crushed) and administered with applesauce. the 250 mg ultramicrocrystalline griseofulvin tablets were found to be bioequivalent to the physically altered (crushed) 250 mg ultramicro-crystalline griseofulvin tablets (see table 1 ). table 1: mean (Â±sd) of the pharmacokinetic parameters for griseofulvin administered in applesauce as a single-dose of ultramicrocrystalline griseofulvin tablets 250-mg uncrushed and crushed to fasted healthy volunteers (n=24) 250 mg ultramicrocrystalline griseofulvin tablets unaltered 250 mg ultramicrocrystalline griseofulvin tablets physically altered (crushed and i n applesauce) c max (ng/ml) 600.61 (Â± 167.6) 672.61 (Â± 146.2) t max (hr) 4.04 (Â± 2.2) 3.08 (Â± 1.02) auc (ng.hr/ml) 8,618.89 (Â± 1,907.2) 9,023.71 (Â± 1,911.5)

Pharmacokinetics:

Pharmacokinetics â following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. the drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. the efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. this factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. however, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy. in a bioequivalence study conducted in healthy volunteers (n=24) in the fasted state, 250 mg ultramicrocrystalline griseofulvin tablets were compared with 250 mg ultramicrocrystalline griseofulvin tablets that were physically altered (crushed) and administered with applesauce. the 250 mg ultramicrocrystallin Read more...

e griseofulvin tablets were found to be bioequivalent to the physically altered (crushed) 250 mg ultramicro-crystalline griseofulvin tablets (see table 1 ). table 1: mean (Â±sd) of the pharmacokinetic parameters for griseofulvin administered in applesauce as a single-dose of ultramicrocrystalline griseofulvin tablets 250-mg uncrushed and crushed to fasted healthy volunteers (n=24) 250 mg ultramicrocrystalline griseofulvin tablets unaltered 250 mg ultramicrocrystalline griseofulvin tablets physically altered (crushed and i n applesauce) c max (ng/ml) 600.61 (Â± 167.6) 672.61 (Â± 146.2) t max (hr) 4.04 (Â± 2.2) 3.08 (Â± 1.02) auc (ng.hr/ml) 8,618.89 (Â± 1,907.2) 9,023.71 (Â± 1,911.5)

How Supplied:

How supplied ultramicrosize griseofulvin tablets, usp 125 mg, are supplied as off white, round tablets debossed with âceâ over â3â on one side and a functional score on the other side. they are available as follows: bottles of 30 ndc 62135-494-30. bottles of 100 ndc 62135-494-01. ultramicrosize griseofulvin tablets, usp 250 mg, are supplied as off white, round tablets debossed with âceâ over â4â on one side and a functional score on the other side. they are available as follows: bottles of 30 ndc 62135-495-30. bottles of 100 ndc 62135-495-01.

Package Label Principal Display Panel:

Principal display panel ndc 62135-494-01 ultramicrosize griseofulvin tablets, usp 125 mg rx only 100 tablets chartwell rx ndc 62135-494-01 ultramicrosize griseofulvin tablets, usp 125 mg rx only 100 tablets chartwell rx

Principal display panel ndc 62135-494-30 ultramicrosize griseofulvin tablets, usp 125 mg rx only 30 tablets chartwell rx ndc 62135-494-30 ultramicrosize griseofulvin tablets, usp 125 mg rx only 30 tablets chartwell rx

Principal display panel ndc 62135-495-01 ultramicrosize griseofulvin tablets, usp 250 mg rx only 100 tablets chartwell rx ndc 62135-495-01 ultramicrosize griseofulvin tablets, usp 250 mg rx only 100 tablets chartwell rx

Principal display panel ndc 62135-495-30 ultramicrosize griseofulvin tablets, usp 250 mg rx only 30 tablets chartwell rx ndc 62135-495-30 ultramicrosize griseofulvin tablets, usp 250 mg rx only 30 tablets chartwell rx

Comments/ Reviews:

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