Ultramicrosize Griseofulvin 125 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Tubulin Inhibiting Agent class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Griseofulvin is used to treat skin infections such as jock itch, athlete's foot, and ringworm; and fungal infections of the scalp, fingernails, and toenails. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- It really can be — and that's one of the most important things to understand about this medication. Fungal infections of the nails especially can take at least 4 to 6 months to cle...
- How long do I have to take griseofulvin? It seems like a really long time.
- Yes, and specifically with a fatty meal if you can. Studies show that eating something high in fat — like a full meal with dairy or meat — dramatically increases how much of the me...
- It's best to avoid alcohol entirely during treatment. The combination of griseofulvin and alcohol has been reported to cause an unpleasant and potentially dangerous reaction — naus...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Griseofulvin — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.752 | $275.23 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ultramicrosize Griseofulvin 125 mg 00115-1724-01 | Amneal | 100 tablets | $2.752 | AB | Availability likely | — |
| Ultramicrosize Griseofulvin 125 mg 00781-5827-01 | Sandoz | 100 tablets | $2.752 | AB | Availability likely | — |
| Ultramicrosize Griseofulvin 125 mg 23155-0863-01 | Heritage | 100 tablets | $2.752 | AB | Availability likely | — |
| Ultramicrosize Griseofulvin 125 mg 42794-0013-08 | Sigmapharm | 30 tablets | $2.752 | AB | Availability likely | — |
| Ultramicrosize Griseofulvin 125 mgthis 62135-0494-01 | Chartwell | 100 tablets | $2.752 | AB | Availability likely | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62135-0494-01 You're viewing this | 100 TABLET in 1 BOTTLE, PLASTIC (62135-494-01) | $2.75 / ea | $275.23 | 2020-11-30 | Active |
| 62135-0494-30 | 30 TABLET in 1 BOTTLE, PLASTIC (62135-494-30) | $2.75 / ea | $82.57 | 2020-11-30 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($2.75 NADAC).
Pack size FAQ
What quantity is in NDC 62135-0494-01?
What is the difference between NDC 62135-0494-01 and NDC 62135-0494-30?
What NDC number is used to bill for this package of Ultramicrosize Griseofulvin 125 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 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 (athlete’s foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber’s 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. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.
⏱️ 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 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 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 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 younger–dosage 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.
⚠️ Warnings ▾
WARNINGS 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 griseofulvin 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 a 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.
🤒 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 ADVERSE REACTIONS, contact Chartwell RX, LLC., at 845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Microbiology - Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton, and Trichophyton . It has no effect on bacteria or other genera of fungi. Pharmacokinetics - 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 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 (±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 in Applesauce) C max (ng/mL) 600.61 (± 167.6) 672.61 (± 146.2) T max (hr) 4.04 (± 2.2) 3.08 (± 1.02) AUC (ng.hr/mL) 8,618.89 (± 1,907.2) 9,023.71 (± 1,911.5)
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ultramicrosize Griseofulvin Tablets, USP 125 mg, are supplied as off white, round tablets debossed with ‘CE’ over ‘3’ 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 ‘CE’ over ‘4’ 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
📋 Description ▾
DESCRIPTION Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium . 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-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2( 3H ),1’-[2]cyclohexene]-3,4’-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. "Image Description"