Griseofulvin
Griseofulvin (microsize)
Chartwell Rx, Llc.
Human Prescription Drug
NDC 62135-968Griseofulvin also known as Griseofulvin (microsize) is a human prescription drug labeled by 'Chartwell Rx, Llc.'. National Drug Code (NDC) number for Griseofulvin is 62135-968. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Griseofulvin drug includes Griseofulvin - 125 mg/5mL . The currest status of Griseofulvin drug is Active.
Drug Information:
| Drug NDC: | 62135-968 |
| 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: | 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 (microsize) |
| 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: | Suspension |
| 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 - 125 mg/5mL
|
| 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: | 02 Mar, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 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: | ANDA065200 |
| 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: | 239238
|
| 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: | 0362135968410
|
| 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 |
|---|
| 62135-968-41 | 120 mL in 1 BOTTLE (62135-968-41) | 26 Aug, 2021 | 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. |
Product Elements:
Griseofulvin griseofulvin (microsize) alcohol docusate sodium fd&c red no. 40 fd&c yellow no. 6 magnesium aluminum silicate menthol, unspecified form methylparaben propylene glycol propylparaben water saccharin sodium sodium alginate sucrose griseofulvin griseofulvin orange, cream
Indications and Usage:
Indications and usage major indications for griseofulvin oral suspension, usp are: tinea capitis (ringworm of the scalp) tinea corporis (ringworm of the body) tinea pedis (athlete's foot) tinea unguium (onychomycosis; ringworm of the nails) tinea cruris (ringworm of the thigh) tinea barbae (barberâs itch) griseofulvin oral suspension, usp inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: trichophyton rubrum trichophyton tonsurans trichophyton mentagrophytes trichophyton interdigitalis trichophyton verrucosum trichophyton sulphureum trichophyton schoenleini microsporum audouini microsporum canis microsporum gypseum epidermophyton floccosum trichophyton megnini trichophyton gallinae trichophyton crateriform 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 antifungal age
Read more...nts alone. it is not effective in: bacterial infections candidiasis (moniliasis) histoplasmosis actinomycosis sporotrichosis chromoblastomycosis coccidioidomycosis north american blastomycosis cryptococcosis (torulosis) tinea versicolor nocardiosis
Warnings:
Warnings prophylactic usage: safety and efficacy of prophylactic use of this drug has not been established. chronic feeding of griseofulvin, at levels ranging from 0.5-2.5% of the diet, resulted in the development of liver tumors in several strains of mice, particularly in males. smaller particle sizes result in an enhanced effect. lower oral dosage levels have not been tested. subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice. although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusions in this regard. in subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. griseofulvin has been
Read more... reported to have a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals. reports of animal studies in the soviet literature state that a griseofulvin preparation was found to be embryotoxic and teratogenic on oral administration to pregnant wistar rats. rat reproduction studies done in the united states and great britain were inconclusive in this regard. pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. because the potential for adverse effects on the human fetus cannot be ruled out, additional contraceptive precautions should be taken during treatment with griseofulvin and for a month after termination of treatment. griseofulvin oral suspension, usp should not be prescribed to women intending to become pregnant within one month following cessation of therapy. suppression of spermatogenesis has been reported to occur in rats but investigation in man failed to confirm this. griseofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. these effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage. since griseofulvin has demonstrated harmful effects in vitro on the genotype in bacteria, plants, and fungi, males should wait at least six months after completing griseofulvin therapy before fathering a child.
Dosage and Administration:
Dosage and administration accurate diagnosis of the 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 unguium â depending on rate of growth â fingernails, 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 since in some forms of athlete's foot, yeasts and bacteria may be involved. griseofulvin will not eradicate the bacterial or monilial
Read more...infection. adults: a daily dose of 500 mg 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 daily dose of 1 gram is recommended. children: approximately 5 mg per pound of body weight per day is an effective dose for most children. on this basis the following dosage schedule for children is suggested: children weighing 30 to 50 pounds - 125 mg to 250 mg daily. children weighing over 50 pounds - 250 mg to 500 mg daily.
Contraindications:
Contraindications this drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. two cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy. griseofulvin should not be prescribed to pregnant patients.
Adverse Reactions:
Adverse reactions when adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria and rarely, angioneurotic edema or erythema multiforme-like drug reaction, and may necessitate withdrawal of therapy and appropriate countermeasures. paresthesias of the hands and feet have been reported rarely 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.
Description:
Description griseofulvin is an antibiotic derived from a species of penicillium. each 5 ml of griseofulvin oral suspension, usp contains 125 mg of griseofulvin (microsize) and also contains alcohol (0.2%), docusate sodium, fd&c red no. 40, fd&c yellow no. 6, magnesium aluminum silicate, menthol, methylparaben, orange cream flavors, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sodium alginate and sucrose.
Clinical Pharmacology:
Clinical pharmacology griseofulvin oral suspension, usp acts systemically to inhibit the growth of trichophyton, microsporum, and epidermophyton genera of fungi. fungistatic amounts are deposited in the keratin, which is gradually exfoliated and replaced by noninfected tissue. griseofulvin absorption from the gastrointestinal tract varies considerably among individuals, mainly because of insolubility of the drug in aqueous media of the upper g.i. tract. the peak serum level found in fasting adults given 0.5 gm occurs at about four hours and ranges between 0.5 and 2.0 mcg/ml. it should be noted that some individuals are consistently "poor absorbers" and tend to attain lower blood levels at all times. this may explain unsatisfactory therapeutic results in some patients. better blood levels can probably be attained in most patients if griseofulvin is administered after a meal with a high fat content.
How Supplied:
How supplied griseofulvin oral suspension, usp (microsize) 125 mg per 5 ml is available as follows: 4 fl oz (120 ml) bottle (ndc 62135-968-41) dispense griseofulvin oral suspension, usp in a tight, light-resistant container as defined in the usp. storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. manufactured by: chartwell pharmaceuticals, llc. congers, ny 10920 manufactured for: chartwell rx, llc. congers, ny 10920 l70567 rev: 08/2021
Package Label Principal Display Panel:
Principal display panel griseofulvin oral suspension, usp (microsize) 125 mg/5 ml - ndc 62135-968-41 - label griseofulvin oral suspension, usp 25 mg/5 ml - ndc 62135-968-41 - label