Get your patient on Ultramicrosize Griseofulvin - Ultramicrosize Griseofulvin tablet (Ultramicrosize Griseofulvin)

Ultramicrosize griseofulvin tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton verrucosum, Trichophyton megninii, Trichophyton gallinae,  Trichophyton crateriforme, Trichophyton sulphureum, Trichophyton schoenieinii, 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 this 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.

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 – 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.

Adults: Daily administration of 330 mg (as a single dose or in divided amounts) 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 daily dosage of 660 mg is recommended.

Children: Approximately 3.3 mg per pound of body weight per day is an effective dose for most children. On this basis, the following dosage schedule is suggested: Children weighing 30 to 50 pounds- 82.5 mg to 165 mg daily. Children weighing over 50 pounds – 165 mg to 330 mg daily.

Children 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.

This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin.

Rare 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 or to women contemplating pregnancy.

When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes and urticaria, and rarely, angioneurotic edema and epidermal necrolysis (Lyell’s syndrome), 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, nephrosis, leukopenia, hepatic toxicity, GI bleeding, and menstrual irregularities 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.

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 label matrix.

Each Ultramicrosize Griseofulvin Tablet, USP contains 165 mg ultramicrosize griseofulvin, USP.

The inactive ingredients for Ultramicrosize Griseofulvin Tablets, USP include: corn starch, lactose anhydrous, magnesium stearate, polyethylene glycol 8000, and sodium lauryl sulfate.

ACTIONS Microbiology Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton , and Trichophyton . It has no effect on bacteria or on other genera of fungi.

Human Pharmacology 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.

Ultramicrosize Griseofulvin Tablets, USP 165 mg, Off-white, oval shaped tablets debossed with “ C ” above bisect and “ E ” below bisect on one side and “ 269 ” on the other side; bottle of 30 (NDC 73308-435-30).

Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

Manufactured for:

Ayurax, LLC

Fairhope, AL 36532

Distributed by:

Solubiomix, LLC

Madisonville, LA 70447

L72531

Rev. 01/2025