Grifulvin V

Contraindications

Hypersensitivity

Porphyria

Hepatocellular failure

Pregnancy

Cautions

Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme reported, some resulting in hospitalization or death; discontinue if severe skin reaction occurs

Elevations in AST, ALT, bilirubin, and jaundice reported, some resulting in hospitalization or death; discontinue if jaundice occurs

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

Pregnancy category: X; no adequate and well-controlled studies in pregnant women, but animal studies have shown embryotoxic and teratogenic effects

Lactation: Excretion in milk unknown; avoid use because of potential tumorigenicity

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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.

• Fungal Nails
• Information on Birth Control Pills

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.

In the U.S.

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

Available Dosage Forms:

• Tablet
• Capsule
• Suspension

Therapeutic Class: Antifungal

• If you have an allergy to griseofulvin or any other part of Grifulvin V (griseofulvin microsize tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Liver disease or porphyria.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Grifulvin V.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Grifulvin V. 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, Grifulvin V 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 Grifulvin V.
• 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.

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

Along with its needed effects, griseofulvin (the active ingredient contained in Grifulvin V) 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 while taking griseofulvin:

• 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 of griseofulvin 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