Fulvicin P / G

Gris-PEG is a prescription medication used 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)
• tinea unguium (onychomycosis, ringworm of the nails)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 this medicine, 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 this medicine 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 this medicine 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 this medicine 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 this medicine, 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 this medicine. 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• fever
• itching
• joint or muscle pain
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unusual tiredness or weakness

• Confusion
• increased sensitivity of the skin to sunlight
• skin rash, hives, or itching
• soreness or irritation of the mouth or tongue

• Black, tarry stools
• chest pain
• cloudy urine
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• numbness, tingling, pain, or weakness in the hands or feet
• painful or difficult urination
• shortness of breath
• swollen glands
• unusual bleeding or bruising
• yellow eyes or skin

• Abdominal or stomach pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clay-colored stools
• dark urine
• dizziness
• headache
• loss of appetite
• nausea
• unpleasant breath odor
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Hives or welts
• redness of the skin

• Trouble with sleeping

• Heartburn
• pain or discomfort in the chest, upper stomach, or throat
• sleeplessness
• unable to sleep
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to griseofulvin: compounding powder, oral capsule, oral suspension, oral tablet

Hypersensitivity

Hypersensitivity side effects have been reported most commonly. These have included skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema.[Ref]

Dermatologic

Dermatologic side effects have included severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) and erythema multiforme. Fixed-drug eruptions, photosensitivity, exacerbation of systemic lupus erythematosus (SLE), and SLE-like syndromes have been reported. A patient with Hailey-Hailey disease (chronic benign familial pemphigus) experienced a widespread bullous eruption due to griseofulvin (the active ingredient contained in Fulvicin P / G) therapy. Lesions have commonly begun on sun-exposed areas.

Fixed-drug eruptions have been verified by rechallenge.

At least one reported case of toxic epidermal necrolysis resulted in death.

At least one fatal case of SLE exacerbation occurred after ingestion of approximately 1 gram of griseofulvin.

Nervous system

Nervous system side effects have included headache, insomnia, dizziness, and mental confusion. Neuropathy and development of paresthesia of the hands and feet have been reported with long-term use.[Ref]

Neuropathy and paresthesia have been reported in a few cases of long-term griseofulvin therapy. One woman reportedly developed paresthesia in the fingers and feet after 6 months of griseofulvin therapy. Neuropathy progressed for 4 months after the drug was discontinued but resolved 8 months after therapy was discontinued.[Ref]

Hepatic

Hepatic side effects have included hepatotoxicity, jaundice, and elevations in AST, ALT, and bilirubin.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, epigastric/abdominal distress, and oral thrush.[Ref]

Renal

Renal side effects have included interstitial nephritis.[Ref]

One patient developed interstitial nephritis after one year of griseofulvin therapy. The patient presented with renal insufficiency, hematuria, pyuria, eosinophiluria, and anemia. Renal function returned to normal after one year.[Ref]

Genitourinary

Genitourinary side effects have included proteinuria and menstrual irregularities.

Hematologic

Hematologic side effects have included leukopenia.[Ref]

Metabolic

Metabolic side effects have included exacerbation of porphyria.

Other

A disulfiram-like reaction, including flushing, nausea, vomiting, diarrhea and paresthesia of the extremities, occurred in one patient who ingested griseofulvin (the active ingredient contained in Fulvicin P / G) with alcohol.[Ref]

Other side effects have included fever, fatigue, and a disulfiram-like reaction. Impairment of performance of routine activities has been reported occasionally.[Ref]

Musculoskeletal

Musculoskeletal side effects have included at least one case of griseofulvin-induced myositis.

Some side effects of Fulvicin P / G may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Microsize formulation: 500 mg/day orally in single or 2 divided doses

Ultramicrosize formulation: 330 to 375 mg/day orally in single or divided doses

Data not available

The pharmacokinetics of griseofulvin in patients with liver disease have not been studied. Since griseofulvin is primarily metabolized by the liver, caution is advised when it is administered to patients with impaired hepatic function. The use of griseofulvin is contraindicated in patients with hepatocellular failure.