Gris-PEG

Gris-PEG is a prescription medication used to treat several different types of fungal skin infections including jock itch, athlete's foot, and ringworm as well as fungal infections of the fingernails, and toenails. This medication belongs to a group of drugs called antifungals. These work by inhibiting the growth of certain fungi that can cause infections.

Gris-PEG comes in tablet form. It is usually taken once daily, but can be taken up to two times daily. Although symptoms may get better in a few days, Gris-PEG may be taken anywhere from 2 weeks to 6 months, depending on where the infection is located on the body.

Common side effects include skin rashes, swelling of extremities, and diarrhea. 

Gris-PEG can also cause dizziness. Do not drive or operate heavy machinery until you know how Gris-PEG affects you.

Gris-PEG is a prescription medication used to treat 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.

• Pedinol Pharmacal, Inc.

Serious side effects have been reported with Gris-PEG. See the “Gris-PEG Precautions” section.

Common side effects of Gris-PEG include:

• skin rash
• swelling of extremeties
• oral thrush
• nausea
• vomiting
• diarrhea
• headache
• fatigue
• dizziness
• insomnia
• mental confusion
• impairment of performance of routine activities

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

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

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.

Serious side effects have been reported with Gris-PEG including the following:

• Severe skin reactions. Discontinue taking Gris-PEG if you develop any unusual rashes and seek medical attention right away.
• Liver toxicity. Your physician will monitor your liver function if you are taking Gris-PEG for an extended period of time.

Gris-PEG can also cause dizziness. Do not drive or operate heavy machinery until you know how Gris-PEG affects you.

Do not take Gris-PEG if you:

• are allergic to Gris-PEG or to any of its ingredients
• have porphyria
• have liver failure

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gris-PEG, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Gris-PEG, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Gris-PEG or to any of its ingredients
• have porphyria
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Gris-PEG falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Gris-PEG crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Gris-PEG.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Gris-PEG for the treatment of fungal skin, fingernail, and/or toenail infections is 375mg to 750 mg per day in adults and for children:

• Children weighing 35-60 pounds - 125 mg to 187.5 mg daily.
• Children weighing over 60 pounds - 187.5 mg to 375 mg daily.

If you take too much Gris-PEG, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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.