Griseofulvin

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To make swallowing easier, you may crush the Gris-PEG tablet and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Use this medicine for the full prescribed length of time. It may take up several weeks before your symptoms improve. Nail infections can take several months to clear completely.

Griseofulvin will not treat a bacterial or fungal infection, or a viral infection such as the flu or a common cold.

If you use this medicine long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

No information provided.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Griseofulvin is part of the drug class:

• ANTIFUNGALS FOR SYSTEMIC USE

Griseofulvin is an antifungal antibiotic that fights infections caused by fungus.

Griseofulvin is used to treat infections such as ringworm, athlete's foot, jock itch, and fungal infections of the scalp, fingernails, or toenails.

Griseofulvin may also be used for purposes not listed in this medication guide.

Your pharmacist can provide more information about griseofulvin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Griseofulvin is an antifungal medication that fights infections caused by fungus.

Griseofulvin is used to treat infections such as ringworm, athlete's foot, jock itch, and fungal infections of the scalp, fingernails, or toenails.

Griseofulvin may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Absorption

Bioavailability

Absorption of microsize griseofulvin is variable125 and unpredictable and ranges from 25–70% of an oral dose;a peak serum concentrations attained 4 hours after a dose.125

Ultramicrosize griseofulvin is almost completely absorbed following oral administration.a

Food

Absorption of microsize griseofulvin may be enhanced by administration after a high-fat meal.125 a

Distribution

Extent

Following oral absorption, griseofulvin is concentrated in skin, hair, nails, liver, fat, and skeletal muscles.a The drug can be detected in the outer layers of the stratum corneum soon after ingestion.a

Griseofulvin is deposited in keratin precursor cells and has greater affinity for diseased tissue.104 The drug is tightly bound to new keratin.104

Griseofulvin concentrations in skin are higher in warm climates than in cold, possibly because the drug is dissolved in perspiration and deposited in the horny layer of skin when perspiration evaporates.a This explanation has also been used to account for the reversed concentration gradient of the drug in skin; highest concentrations are found in the outermost horny layer, while concentrations are much lower in deeper layers.a

Elimination

Metabolism

Oxidatively demethylated and conjugated with glucuronic acid, principally in the liver.a The major metabolite, 6-desmethylgriseofulvin, is microbiologically inactive.a

Elimination Route

About 30% of a single oral dose of microsize griseofulvin is excreted in urine within 24 hours as 6-desmethylgriseofulvin and its glucuronide conjugate; 50% of the dose is excreted in urine within 5 days.a Unchanged griseofulvin in the urine accounts for <1% of the administered drug.a Approximately one-third of a single dose of microsize griseofulvin is excreted in feces within 5 days.a Griseofulvin also is excreted in perspiration.a

Half-life

9–24 hours.a

In the U.S.

• Fulvicin P/G
• Fulvicin-U/F
• Grifulvin V
• Gris-PEG

Available Dosage Forms:

• Tablet
• Capsule
• Suspension

Therapeutic Class: Antifungal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For griseofulvin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to griseofulvin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of griseofulvin in children. However, safety and efficacy have not been established in children up to 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of griseofulvin in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking griseofulvin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using griseofulvin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Levonorgestrel
• Mestranol
• Norethindrone
• Norgestimate
• Norgestrel
• Ulipristal

Using griseofulvin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aminolevulinic Acid
• Phenobarbital
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using griseofulvin with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use griseofulvin, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of griseofulvin. Make sure you tell your doctor if you have any other medical problems, especially:

• Actinomycosis (bacterial infection) or
• Blastomycosis (Gilchrist’s disease) or
• Candidiasis (yeast infection) or
• Histoplasmosis (Darling’s disease) or
• Other infections (e.g., bacteria) or
• Sporotrichosis (Rose gardener's disease) or
• Tinea versicolor (Tinea flava)—Griseofulvin will not work in patients with these conditions.

• Liver failure or
• Porphyria (enzyme problem)—Should not be used in patients with these conditions.

• Lupus erythematosus or lupus-like diseases—Use with caution. May make this condition worse.

Griseofulvin oral suspension is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:

Tinea corporis

Tinea pedis

Tinea cruris

Tinea barbae

Tinea capitis

Tinea unguium when caused by one or more of the following species of fungi:

Epidermophyton floccosum

Microsporum audouinii

Microsporum canis

Microsporum gypseum

Trichophyton crateriformis

Trichophyton gallinae

Trichophyton interdigitalis

Trichophyton megnini

Trichophyton mentagrophytes

Trichophyton rubrum

Trichophyton schoenleini

Trichophyton sulphureum

Trichophyton tonsurans

Trichophyton verrucosum

Note:Prior to therapy, a dermatophyte should be identified as responsible for the infection.

Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.

Griseofulvin is noteffective in the following:

The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.

Griseofulvin Oral Suspension USP (microsize) 125mg/5mL Label Text

NDC 0093-7102-12

Griseofulvin

Oral Suspension USP

(microsize)

125 mg/5 mL

Each 5 mL (one teaspoonful) contains125 mg

Griseofulvin USP (microsize) in a pink to orange colored,

uniform suspension.

This product is protected by a tamper-resistant seal

around the neck opening. If the seal has been broken or is

removed, do not use the product. Return the product to

place of purchase.

Rx only

4 fl oz (120 mL)

TEVA

• Antifungal Agent, Oral

Dermatophyte infections: Treatment of the following dermatophyte infections of the skin, hair, and nails not adequately treated by topical therapy: Tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following species 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.

Limitations of use: Use for the prophylaxis of fungal infections has not been established; not effective for the treatment of tinea versicolor.