griseofulvin,ultramicrosize
Pharmaranks rates Griseofulvin,Ultramicrosize 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Griseofulvin,Ultramicrosize (Griseofulvin, Ultramicrosize) is a medication supplied as a tablet.
Griseofulvin, Ultramicrosize · by Sigmapharm Labs LLC
Generic of Gris-Peg
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Griseofulvin, Ultramicrosize
- Form
- Tablet
- Strength
- GRISEOFULVIN, Ultramicrosize 125MG · GRISEOFULVIN, Ultramicrosize 250MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Sigmapharm Labs LLC
- FDA application
- ANDA202545
What is Griseofulvin,Ultramicrosize?
From the FDA label:Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium . The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is: C 17 H 17 ClO 6 M.W. 352.77 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 ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate. structure
How to use
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 unguium-depending on rate of growth-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. In some forms of athlete's foot, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or monilial infection. Ultramicrosize Griseofulvin Tablets, USP 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 fungal infections more difficult to eradicate, such as tinea…
Side effects
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 ADVERSE REACTIONS, contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Prophylactic Usage - Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established. Serious Skin Reactions Severe skin reactions (e.g, Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section). Hepatotoxicity Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section). Animal Toxicology - 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. Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving grisoefulvin at levels of 2.0%, 1.0% and 0.2% of the diet, and in female rats receiving the two higher dose levels. Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusion 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 reported to have colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals. Usage in Pregnancy - see CONTRAINDICATIONS section. Animal Reproduction Studies - It has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats. Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.
Who should not take Griseofulvin,Ultramicrosize
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.
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Griseofulvin,Ultramicrosize rated?
- pharmaranks gives Griseofulvin,Ultramicrosize a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Griseofulvin,Ultramicrosize?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Griseofulvin,Ultramicrosize. To pay less, Griseofulvin,Ultramicrosize is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Griseofulvin,Ultramicrosize?
- Griseofulvin,Ultramicrosize is marketed by Sigmapharm Labs LLC. You can see Sigmapharm Labs LLC's full profile, rating, and other products on pharmaranks.
- Is Griseofulvin,Ultramicrosize a brand-name or generic drug?
- Griseofulvin,Ultramicrosize is a generic medication; its active ingredient is Griseofulvin, Ultramicrosize. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Griseofulvin,Ultramicrosize available over the counter?
- No. Griseofulvin,Ultramicrosize is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Griseofulvin,Ultramicrosize come in?
- Griseofulvin,Ultramicrosize is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Griseofulvin,Ultramicrosize FDA-registered?
- Griseofulvin,Ultramicrosize is on record with the U.S. FDA under application number ANDA202545. You can verify this on its official FDA label.
- Has Griseofulvin,Ultramicrosize been recalled by the FDA?
- Griseofulvin,Ultramicrosize has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Griseofulvin,Ultramicrosize safe?
- There's no single safe-or-not verdict. pharmaranks gives Griseofulvin,Ultramicrosize a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Griseofulvin,Ultramicrosize?
- Griseofulvin,Ultramicrosize's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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griseofulvin,ultramicrosize
70/100