Griseofulvin is an antibiotic derived from a species of Penicillium. Each GRIFULVIN V Tablet contains either 250 mg or 500 mg of griseofulvin microsize, and also contains calcium stearate, colloidal silicon dioxide, starch, and wheat gluten. Additionally, the 250 mg tablet also contains dibasic calcium phosphate. Each 5 mL of GRIFULVIN V Suspension contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water.

Major indications for GRIFULVIN V are:

Tinea capitis (ringworm of the scalp)
Tinea corporis (ringworm of the body)
Tinea pedis (athlete's foot)
Tinea unguium (onychomycosis; ringworm of the nails)
Tinea cruris (ringworm of the thigh)
Tinea barbae (barber's itch)

GRIFULVIN V inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as:

Trichophyton rubrum
Trichophyton tonsurans
Trichophyton mentagrophytes
Trichophyton interdigitalis
Trichophyton verrucosum
Trichophyton sulphureum
Trichophyton schoenleini
Microsporum audouini
Microsporum canis
Microsporum gypseum
Epidermophyton floccosum
Trichophyton megnini
Trichophyton gallinae
Trichophyton crateriform

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 anti-fungal agents alone.

It is not effective in:

Bacterial infections
Candidiasism (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
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, 2to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium - depending on rate of growth - fingernails, at least 4 months; toenails, at least 6months.

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 since in some forms of athlete's foot, yeasts and bacteria may be involved. Griseofulvin will not eradicate the bacterial or monilial infection.

Adults: A daily dose of 500 mg 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 daily dose of 1.0 gram is recommended.

Children:Approximately 5 mg per pound of body weight per day is an effective dose for most children. On this basis the following dosage schedule for children is suggested:

Children weighing 30 to 50 pounds - 125 mg to 250 mg daily.

Children weighing over 50 pounds - 250mg to 500 mg daily.

GRIFULVIN V 250 mg Tablets in bottles of 100 (NDC 0062-0211-60) (white, scored, imprinted "ORTHO 211").

GRIFULVIN V 500 mg Tablets in bottles of 100 (NDC 0062-0214-60) and 500 (NDC 0062-0214-70) (white, scored, imprinted "ORTHO 214").

Dispense GRIFULVIN V Tablets in a tight container as defined in the USP.

GRIFULVIN V Suspension 125 mg per 5 mL in bottles of 4 fl oz (120 mL) (NDC 0062-0206-04).

Dispense GRIFULVIN V Suspension in a tight, light-resistant container as defined in the USP.

STORE AT ROOM TEMPERATURE

DERMATOLOGICAL DIVISION, ORTHO PHARMACEUTICAL CORPORATION, Raritan, New Jersey 08869. Revised January 1997. FDA Rev date: n/a

When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria and rarely, angioneurotic edema or erythema multiforme-like drug reaction, 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 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.

Patients on warfarin-type anticoagulant therapy may require dosage adjustment of the anticoagulant during and after griseofulvin therapy. Concomitant use of barbiturates usually depresses griseofulvin activity and may necessitate raising the dosage.

The concomitant administration of griseofulvin has been reported to reduce the efficacy of oral contraceptives and to increase the incidence of breakthrough bleeding.

Prophylactic Usage: Safety and efficacy of prophylactic use of this drug has not been established.

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. Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusions 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.

Reports of animal studies in the Soviet literature state that a griseofulvin preparation was found to be embryotoxic and teratogenic on oral administration to pregnant Wistar rats. Rat reproduction studies done in the United States and Great Britain were inconclusive in this regard. Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. Because the potential for adverse effects on the human fetus cannot be ruled out, additional contraceptive precautions should be taken during treatment with griseofulvin and for a month after termination of treatment. GRIFULVIN V should not be prescribed to women intending to become pregnant within one month following cessation of therapy.

Suppression of spermatogenesis has been reported to occur in rats but investigation in man failed to confirm this. Griseofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage.

Since griseofulvin has demonstrated harmful effects in vitro on the genotype in bacteria, plants, and fungi, males should wait at least six months after completing griseofulvin therapy before fathering a child.

Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hemopoietic, should be done.

Since griseofulvin is derived from species of penicillin, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty.

Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Should a photosensitivity reaction occur, lupus erythematosus may be aggravated.

No information provided.

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

Two 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.

GRIFULVIN V acts systemically to inhibit the growth of Trichophyton, Microsporum, and Epidermophyton genera of fungi. Fungistatic amounts are deposited in the keratin, which is gradually exfoliated and replaced by noninfected tissue.

Griseofulvin absorption from the gastrointestinal tract varies considerably among individuals, mainly because of insolubility of the drug in aqueous media of the upper G.I. tract. The peak serum level found in fasting adults given 0.5 gm occurs at about four hours and ranges between 0.5 and 2.0 mcg/mL.

It should be noted that some individuals are consistently "poor absorbers" and tend to attain lower blood levels at all times. This may explain unsatisfactory therapeutic results in some patients. Better blood levels can probably be attained in most patients if the tablets are administered after a meal with a high fat content.

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

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

GRISEOFULVIN - ORAL TABLET

(GRISS-ee-oh-FULL-vin)

COMMON BRAND NAME(S): Fulvicin, Grifulvin V, Gris-Peg, Grisactin

USES: This medication is used to treat fungal infections of the skin, hair, and nails that do not respond to creams/lotions. Clearing such infections will get rid of symptoms such as itching, red/peeling/scaly skin, and discolored nails. This medication works by stopping the growth of fungi. It does not treat infections due to bacteria or yeast.

HOW TO USE: Take this medication by mouth as directed by your doctor. For the best absorption, it is best taken with or after a meal containing a moderate amount of fat. Talk to your doctor or pharmacist about specific dietary instructions, especially if you are on a low-fat diet.

The dosage is based on your medical condition and response to therapy. In children, dosage is also based on weight. The length of treatment depends on the type of infection you have. It may take several weeks to months to complete treatment for infections of the scalp, feet, and body. Nail infections may require several months to a year or longer to treat.

Antifungal medications work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication for the full prescribed length of treatment even if symptoms improve after a few days. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Headache, nausea, vomiting, diarrhea, stomach upset, tiredness, dizziness, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of the hands/feet, mental/mood changes (e.g., confusion, trouble doing normal activities), sunburn-like rash, hearing changes, butterfly-shaped facial rash (around the nose and cheeks), joint/muscle pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark/frothy urine, change in the amount of urine, signs of infection (e.g., fever, persistent sore throat).

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking griseofulvin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain blood disorder (porphyria), severe liver disease (liver failure).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lupus.

This drug may make you dizzy or less alert. Do not engage in activities requiring alertness such as driving or using machinery until you know how this drug affects you and that you can safely perform these activities.

Avoid alcoholic beverages while you are taking this drug unless your doctor gives permission. Drinking alcohol during treatment with this drug could result in a fast heartbeat and flushing of the skin.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss delaying griseofulvin treatment. Use of reliable form(s) of birth control is recommended during treatment and for 1 month after the drug is stopped. If you are planning to become pregnant within 1 month after treatment, the manufacturer recommends avoiding this drug. (See also Drug Interactions.)

The effects of this drug on human sperm are unknown. However, based on animal cell studies, the manufacturer recommends waiting for a period of time after completing griseofulvin treatment before trying to father a child. Discuss the risks and benefits with your doctor, and ask how long to wait after your last dose before trying to father a child.

It is not known if this drug passes into breast milk. Due to the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: barbiturates (e.g., phenobarbital), warfarin.

This medication may decrease the effectiveness of birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., kidney and liver function, complete blood count) should be performed periodically to check for side effects with prolonged treatment. Consult your doctor for more details.

Ask your doctor or pharmacist about ways to control the infection and to prevent re-infection. Fungus spreads easily in warm, moist areas. Follow good hygiene (e.g., wash and dry the infected area completely, and do not share articles of clothing or objects that come in contact with the infected area).

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.