Gris-PEG

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• blood-thinning medications including warfarin, heparin, and dabigatran
• barbiturates including pentobarbital and phenobarbital
• oral contraceptives or birth control
• ranolazine

This is not a complete list of Gris-PEG drug interactions. Ask your doctor or pharmacist for more information.

Take Gris-PEG exactly as prescribed.

Gris-PEG comes in tablet form. It is usually taken once daily, but can be taken up to two times daily.

Gris-PEG tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

Gris-PEG is usually taken for 2 to 4 weeks for skin infections, 4 to 6 weeks for hair and scalp infections, 4 to 8 weeks for foot infections, 3 to 4 months for fingernail infections, and at least 6 months for toenail infections.

Observe quality hygeine while taking Gris-PEG to prevent skin reinfection. Simultaneous use of additional topical drugs is typically reqired for effective treatment of fungal skin infections.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Gris-PEG at the same time.

Store Gris-PEG ® tablets at controlled room temperature 15° - 30°C (59° - 86°F) in tight, light-resistant containers.

Keep this and all medicines out of the reach of children.

You should not use griseofulvin if you are allergic to it, or if you have:

• liver failure;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or
• if you are pregnant.

To make sure you can safely take griseofulvin, tell your doctor if you have any of the following conditions:

• liver disease;
• heart disease;
• lupus; or
• an allergy to penicillin.

FDA pregnancy category C. It is not known whether griseofulvin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether griseofulvin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

You should not use griseofulvin if you are allergic to it, or if you have:

• liver failure;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or

• if you are pregnant or may become pregnant.

To make sure griseofulvin is safe for you, tell your doctor if you have:

• liver disease;

• lupus;

• an allergy to penicillin; or

• if you take a blood thinner such as warfarin (Coumadin, Jantoven).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use griseofulvin if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Griseofulvin may make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking griseofulvin.

It is not known whether griseofulvin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Griseofulvin should not be given to a child younger than 2 years old, or a child who weighs less than 35 pounds.

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.

• It is used to treat fungal infections.

• Tell all of your health care providers that you take Gris-PEG. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Talk with your doctor before you drink alcohol.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Do not use longer than you have been told. A second infection may happen.
• If you have lupus, Gris-PEG can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Gris-PEG.
• If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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 CONTRAINDICATIONSsection.

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.