Griseofulvin

352.77

352.77

95226

204-767-4

32HRV3E3D5

755822

DTXSID8020674

C65819

STOUT OCTAHEDRA OR RHOMBS FROM BENZENE|WHITE TO CREAMY POWDER|COLORLESS CRYSTALLINE SOLID

D - Dermatologicals

29419090

71.1

2.2

White to yellow-white Powder

1.45 g/cm³

220 °C

469.04°C (rough estimate)

228.0±29.1 °C

1.4429 (estimate)

Practically insoluble in water

−20°C

3.11E-11mmHg at 25°C

Oral-Rat LD50: 10000 mg/kg; Oral-Mouse LD50: 50000 mg/kg

Combustion produces toxic chloride gas

354 º (c=1, dimethylform)

ODORLESS

178.6 Ų [M+H]+ [CCS Type: TW, Method: calibrated with polyalanine and drug standards]

SUBLIMES WITHOUT DECOMP @ 210 °C

Insoluble in water.

Ethers

GRISEOFULVIN is incompatible with strong oxidizing agents. (NTP, 1992).

UN 1648 3 / PGII

3

60-61-40-43-45

53-22-36/37/39-45

WG9800000

T,Xn

The warehouse is ventilated, low temperature and dry; stored and transported separately from food materials

PREPARATIONS OF GRISEOFULVIN HAVE EXPIRATION DATES OF 2-5 YR FOLLOWING THE DATE OF MFR

P201-P280-P308 + P313

H317-H351-H360

SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.|PRECAUTIONS FOR "CARCINOGENS": There is no universal method of disposal that has been proved satisfactory for all carcinogenic compounds & specific methods of chem destruction ... published have not been tested on all kinds of carcinogen-containing waste. ... summary of avail methods & recommendations ... /given/ must be treated as guide only. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": ... Incineration may be only feasible method for disposal of contaminated laboratory waste from biological expt. However, not all incinerators are suitable for this purpose. The most efficient type ... is probably the gas-fired type, in which a first-stage combustion with a less than stoichiometric air:fuel ratio is followed by a second stage with excess air. Some ... are designed to accept ... aqueous & organic-solvent solutions, otherwise it is necessary ... to absorb soln onto suitable combustible material, such as sawdust. Alternatively, chem destruction may be used, esp when small quantities ... are to be destroyed in laboratory. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": HEPA (high-efficiency particulate arrestor) filters ... can be disposed of by incineration. For spent charcoal filters, the adsorbed material can be stripped off at high temp & carcinogenic wastes generated by this treatment conducted to & burned in an incinerator. ... LIQUID WASTE: ... Disposal should be carried out by incineration at temp that ... ensure complete combustion. SOLID WASTE: Carcasses of lab animals, cage litter & misc solid wastes ... should be disposed of by incineration at temp high enough to ensure destruction of chem carcinogens or their metabolites. /Chemical Carcinogens/|For more Disposal Methods (Complete) data for GRISEOFULVIN (6 total), please visit the HSDB record page.

Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

LIN C, SYMCHOWICZ S; ABSORPTION, DISTRIBUTION, METABOLISM, & EXCRETION OF GRISEOFULVIN IN MAN & ANIMALS; DRUG METAB REV 4(1) 75 (1975). PHARMACOKINETICS, METABOLISM & DISTRIBUTION OF GRISEOFULVIN IN MAN & ANIMALS ARE REVIEWED.|DE MATTEIS F; HEPATIC PORPHYRIAS CAUSED BY 2-ALLYL-2-ISOPROPYLACETAMIDE, 3,5-DIETHOXYCARBONYL-1,4-DIHYDROCOLLIDINE, GRISEOFULVIN & RELATED COMPD; HANDB EXP PHARMAKOL 44 (HEME HEMOPROTEINS) 129 (1978). A REVIEW & DISCUSSION WITH MANY REF OF THE INTERACTIONS OF THE ABOVE WITH LIVER PORPHYRIN METAB.|DAVIES RR; ANTIFUNGAL CHEMOTHERAPY. GRISEOFULVIN; ANTIFUNGAL CHEMOTHER 149 (1980). A REVIEW WITH MANY REF ON THE PHARMACOLOGY AND TOXICOLOGY OF GRISEOFULVIN.

Flash point data for this chemical are not available. It is probably combustible. (NTP, 1992)

|Danger|H317 (93.69%): May cause an allergic skin reaction [Warning Sensitization, Skin]|P201, P202, P261, P272, P280, P281, P302+P352, P308+P313, P321, P333+P313, P363, P405, and P501|Aggregated GHS information provided by 207 companies from 13 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.|H340: May cause genetic defects [Danger Germ cell mutagenicity]|P201, P202, P260, P264, P270, P281, P308+P313, P309+P311, P314, P405, and P501

Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992)

SMALL SPILLS AND LEAKAGE: If a spill of this chemical occurs, FIRST REMOVE ALL SOURCES OF IGNITION, then you should dampen the solid spill material with acetone and transfer the dampened material to a suitable container. Use absorbent paper dampened with acetone to pick up any remaining material. Seal your contaminated clothing and the absorbent paper in a vapor-tight plastic bag for eventual disposal. Solvent wash all contaminated surfaces with acetone followed by washing with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should store this material under ambient temperatures, and keep away from oxidizing materials. (NTP, 1992)

MINIMUM PROTECTIVE CLOTHING: If Tyvek-type disposable protective clothing is not worn during handling of this chemical, wear disposable Tyvek-type sleeves taped to your gloves. RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with a combination filter cartridge, i.e. organic vapor/acid gas/HEPA (specific for organic vapors, HCl, acid gas, SO2 and a high efficiency particulate filter). (NTP, 1992)|PRECAUTIONS FOR "CARCINOGENS": ... Dispensers of liq detergent /should be available./ ... Safety pipettes should be used for all pipetting. ... In animal laboratory, personnel should ... wear protective suits (preferably disposable, one-piece & close-fitting at ankles & wrists), gloves, hair covering & overshoes. ... In chemical laboratory, gloves & gowns should always be worn ... however, gloves should not be assumed to provide full protection. Carefully fitted masks or respirators may be necessary when working with particulates or gases, & disposable plastic aprons might provide addnl protection. ... Gowns ... /should be/ of distinctive color, this is a reminder that they are not to be worn outside the laboratory. /Chemical Carcinogens/

PRECAUTIONS FOR "CARCINOGENS": A high-efficiency particulate arrestor (HEPA) or charcoal filters can be used to minimize amt of carcinogen in exhausted air ventilated safety cabinets, lab hoods, glove boxes or animal rooms ... Filter housing that is designed so that used filters can be transferred into plastic bag without contaminating maintenance staff is avail commercially. Filters should be placed in plastic bags immediately after removal ... The plastic bag should be sealed immediately ... The sealed bag should be labelled properly ... Waste liquids ... should be placed or collected in proper containers for disposal. The lid should be secured & the bottles properly labelled. Once filled, bottles should be placed in plastic bag, so that outer surface ... is not contaminated ... The plastic bag should also be sealed & labelled. ... Broken glassware ... should be decontaminated by solvent extraction, by chemical destruction, or in specially designed incinerators. /Chemical Carcinogens/

PRECAUTIONS FOR "CARCINOGENS": Smoking, drinking, eating, storage of food or of food & beverage containers or utensils, & the application of cosmetics should be prohibited in any laboratory. All personnel should remove gloves, if worn, after completion of procedures in which carcinogens have been used. They should ... wash ... hands, preferably using dispensers of liq detergent, & rinse ... thoroughly. Consideration should be given to appropriate methods for cleaning the skin, depending on nature of the contaminant. No standard procedure can be recommended, but the use of organic solvents should be avoided. Safety pipettes should be used for all pipetting. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": In animal laboratory, personnel should remove their outdoor clothes & wear protective suits (preferably disposable, one-piece & close-fitting at ankles & wrists), gloves, hair covering & overshoes. ... Clothing should be changed daily but ... discarded immediately if obvious contamination occurs ... /also,/ workers should shower immediately. In chemical laboratory, gloves & gowns should always be worn ... however, gloves should not be assumed to provide full protection. Carefully fitted masks or respirators may be necessary when working with particulates or gases, & disposable plastic aprons might provide addnl protection. If gowns are of distinctive color, this is a reminder that they should not be worn outside of lab. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": ... Operations connected with synth & purification ... should be carried out under well-ventilated hood. Analytical procedures ... should be carried out with care & vapors evolved during ... procedures should be removed. ... Expert advice should be obtained before existing fume cupboards are used ... & when new fume cupboards are installed. It is desirable that there be means for decreasing the rate of air extraction, so that carcinogenic powders can be handled without ... powder being blown around the hood. Glove boxes should be kept under negative air pressure. Air changes should be adequate, so that concn of vapors of volatile carcinogens will not occur. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": Vertical laminar-flow biological safety cabinets may be used for containment of in vitro procedures ... provided that the exhaust air flow is sufficient to provide an inward air flow at the face opening of the cabinet, & contaminated air plenums that are under positive pressure are leak-tight. Horizontal laminar-flow hoods or safety cabinets, where filtered air is blown across the working area towards the operator, should never be used ... Each cabinet or fume cupboard to be used ... should be tested before work is begun (eg, with fume bomb) & label fixed to it, giving date of test & avg air-flow measured. This test should be repeated periodically & after any structural changes. /Chemical Carcinogens/|For more Preventive Measures (Complete) data for GRISEOFULVIN (9 total), please visit the HSDB record page.

PRECAUTIONS FOR "CARCINOGENS": Procurement ... of unduly large amt ... should be avoided. To avoid spilling, carcinogens should be transported in securely sealed glass bottles or ampoules, which should themselves be placed inside strong screw-cap or snap-top container that will not open when dropped & will resist attack from the carcinogen. Both bottle & the outside container should be appropriately labelled. ... National post offices, railway companies, road haulage companies & airlines have regulations governing transport of hazardous materials. These authorities should be consulted before ... material is shipped. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": When no regulations exist, the following procedure must be adopted. The carcinogen should be enclosed in a securely sealed, watertight container (primary container), which should be enclosed in a second, unbreakable, leakproof container that will withstand chem attack from the carcinogen (secondary container). The space between primary & secondary container should be filled with absorbent material, which would withstand chem attack from the carcinogen & is sufficient to absorb the entire contents of the primary container in the event of breakage or leakage. Each secondary container should then be enclosed in a strong outer box. The space between the secondary container & the outer box should be filled with an appropriate quantity of shock-absorbent material. Sender should use fastest & most secure form of transport & notify recipient of its departure. If parcel is not received when expected, carrier should be informed so that immediate effort can be made to find it. Traffic schedules should be consulted to avoid ... arrival on weekend or holiday ... /Chemical Carcinogens/

practically nontoxic

Side effects are minor: headaches, gastrointestinal reactions and cutaneous eruptions

Transient mild-to-moderate elevations in serum aminotransferase levels occur in up to 5% of patients treated with griseofulvin, but these abnormalities are usually asymptomatic and resolve even with continuation of the medication. Clinically apparent hepatotoxicity is rare and only isolated case reports have been published. The liver injury is typically cholestatic and usually arises within the first few months of therapy. Signs of hypersensitivity such as fever, rash and eosinophilia are rare but griseofulvin can include hypersensitivity reactions and at least one case of DRESS syndrome accompanied by serum aminotransferase elevations has been reported with its use. Published cases of griseofulvin induced liver injury have all been self-limited, recovery requiring 1 to 3 months. Griseofulvin can increase intrahepatic levels of protoporphyrin and induce acute attacks of porphyria in patients with acute intermittent porphyria in remission.

...METABOLISM /OF GRISEOFULVIN/ IS ACCELERATED BY...PRIMIDONE IN RATS AND MAN...|GRISEOFULVIN ACTED AS A COCARCINOGEN WITH SKIN APPLICATIONS OF 3-METHYLCHOLANTHRENE IN MICE...|Effects may be potentiated when alcohol is used concurrently with griseofulvin; also, concurrent use with griseofulvin may result in tachycardia, diaphoresis, and flushing.|/Coumarin- or indandione-derivative anticoagulants/ effects, may be decreased when these agents are used concurrently with griseofulvin; decrease is thought to be due to accelerated metabolism of anticoagulants secondary to stimulation of hepatic microsomal enzyme activity; prothrombin time should be monitored until a stable level is maintained; dosage adjustments may be necessary during and after griseofulvin therapy.|For more Interactions (Complete) data for GRISEOFULVIN (6 total), please visit the HSDB record page.

For the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, cradle cap or other conditions caused by Trichophyton or Microsporum fungi.|FDA Label

Griseofulvin is a fungistatic agent used to treat superficial fungal skin infections such as tinea capitis and pedis. Griseofulvin therapy can cause transient mild-to-moderate serum aminotransferase elevations and has very rarely been linked to clinically apparent acute drug induced liver injury.

Antifungal Agents

Antibiotics, Antifungal|GRISEOFULVIN IS USED IN THE TREATMENT OF TINEAS (RINGWORM INFECTIONS) OF THE SKIN, HAIR & NAILS--TINEA CORPORIS, TINEA PEDIS, TINEA CRURIS, TINEA BARBAE, TINEA CAPITIS & TINEA UNGUIUM (ONYCHOMYCOSIS) CAUSED BY SUSCEPTIBLE SPECIES OF TRICHOPHYTON, MICROSPORUM, OR EPIDERMOPHYTON.|MEDICATION (VET): DRUG IS USEFUL IN TREATMENT OF SUPERFICIAL FUNGUS INFECTIONS CAUSED BY TRICHOPHYTON MENTAGROPHYTES, RUBRUM, INTERDIGITALE, SCHOENLEINI, SULPHUREUM AND VERRUCOSUM, AND MICROSPORUM AND OVINI, CANIS, AND GYPSEUM...|MEDICATION (VET): TO TREAT RINGWORM OF SKIN OR NAILS ESPECIALLY THOSE AREAS DIFFICULT TO TREAT LOCALLY (EYE, MOUTH, NAIL AREAS), OR THOSE REFRACTORY TO OTHER THERAPY.|For more Therapeutic Uses (Complete) data for GRISEOFULVIN (14 total), please visit the HSDB record page.

ORAL THRUSH DUE TO CANDIDAL OVERGROWTH HAS...OCCURRED.|GRISEOFULVIN...IS CONTRAINDICATED IN PATIENTS WITH ACUTE INTERMITTENT PORPHYRIA OR A HISTORY OF.../IT/, HEPATOCELLULAR FAILURE, AND HYPERSENSITIVITY TO THE DRUG. ... SAFE USE...DURING PREGNANCY HAS NOT BEEN ESTABLISHED.|RARELY, TRANSIENT DIMINUTION OF HEARING HAS OCCURRED...PARESTHESIAS OF HANDS AND FEET HAS FOLLOWED EXTENDED THERAPY... OCCASIONALLY, LARGE DOSES HAVE PRODUCED...PSYCHOTIC SYMPTOMS.|GRISEOFULVIN HAS BEEN REPORTED TO CAUSE TACHYCARDIA AND FLUSHING...|For more Drug Warnings (Complete) data for GRISEOFULVIN (17 total), please visit the HSDB record page.

TRICHOPHYTON, EPIDERMOPHYTON, & MICROSPORUM CAN BE MADE RESISTANT...IN VITRO, & SUCH STRAINS REMAIN FULLY VIRULENT AS INFECTIOUS AGENTS IN ANIMALS. ISOLATES FROM HUMANS RECEIVING THE ANTIBIOTIC APPEAR, WITH A FEW EXCEPTIONS, TO RETAIN THEIR SENSITIVITY TO THE DRUG WHEN EXAMINED IN VITRO. DERMATOPHYTES CONCENTRATE GRISEOFULVIN BY ENERGY-DEPENDENT PROCESS, & SUCH UPTAKE IS CORRELATED WITH THE SENSITIVITY OF THE FUNGI TO THE ANTIBIOTIC.

Griseofulvin is a mycotoxic metabolic product of Penicillium spp. It was the first available oral agent for the treatment of dermatophytoses and has now been used for more than forty years. Griseofulvin is fungistatic with in vitro activity against various species of Microsporum Epidermophyton, and Trichophyton. It has no effect on bacteria or on other genera of fungi. Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. Once the keratin-Griseofulvin complex reaches the skin site of action, it binds to fungal microtubules (tubulin) thus altering fungal mitosis.

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

Poorly absorbed from GI ranging from 25 to 70% of an oral dose. Absorption is significantly enhanced by administration with or after a fatty meal.|IN RATS GIVEN ORAL DOSES OF 100 MG/KG BODY WT (36)CL-GRISEOFULVIN, 10% OF ACTIVITY WAS FOUND IN URINE AFTER 24 HR & 4% DURING 24-48 HR. ...IN ANOTHER STUDY, WITHIN 24-HR PERIOD ONLY 0.14% OF SIMILAR ORAL DOSES IN RATS WAS FOUND IN URINE, & 16% WAS RECOVERED IN FECES. FOLLOWING ITS IV INJECTION GRISEOFULVIN WAS DISTRIBUTED EVENLY THROUGHOUT TISSUES, ALTHOUGH HIGHER LEVELS WERE FOUND IN SKIN & LUNG.|Microsize - variable, ranging from 25 to 70% of an oral dose. Ultramicrosize - Almost completely absorbed. Absorption is significantly enhanced by administration with or after a fatty meal.|Griseofulvin is deposited in varying concentrations in the keratin layer of the skin, hair, and nails. It can be detected in the stratum corneum of the skin within a few hours following administration. Only a very small fraction of an oral dose is distributed in the body fluids and tissues.|Elimination: Renal. less than 1% of a dose is excreted as unchanged drug in the urine. Approximately 36% of griseofulvin is excreted unchanged in the feces.|GRISEOFULVIN IS PROBABLY DEPOSITED IN BASAL CELLS AND IS CARRIED OUTWARDS INTO EPIDERMIS AS NORMAL SKIN GROWTH PROCEEDS. THIS...MAKES FOR LONG LATENCY FROM TIME MEDICATION IS BEGUN UNTIL EVIDENCE OF IMPROVEMENT OCCURS.

Primarily hepatic with major metabolites being 6-methyl-griseofulvin and its glucuronide conjugate.|Griseofulvin is mainly metabolized to 6-dimethylgriseofulvin and its glucuronide.|...IT HAS BEEN REPORTED THAT 6-DEMETHYLGRISEOFULVIN IS THE MAJOR URINARY METABOLITE...IN MAN, THE PREVIOUSLY REPORTED 4-DEMETHYL-GRISEOFULVIN WAS ABSENT. GRISEOFULVIC ACID (7-CHLORO-4,6-DIMETHOXY-6'-METHYLGRISAN-2',3,4'-TRIONE) WAS IDENTIFIED...

9-21 hours|DRUG HAS A HALF-LIFE IN PLASMA OF ABOUT 1 DAY, & APPROX 50% OF ORAL DOSE CAN BE DETECTED IN THE URINE WITHIN 5 DAYS, MOSTLY IN THE FORM OF METABOLITES /SRP: 36% IN THE FECES WITHIN 5 DAYS/.|The half-life of griseofulvin in canine plasma was found to be 47 minutes ... .

Griseofulvin is fungistatic, however the exact mechanism by which it inhibits the growth of dermatophytes is not clear. It is thought to inhibit fungal cell mitosis and nuclear acid synthesis. It also binds to and interferes with the function of spindle and cytoplasmic microtubules by binding to alpha and beta tubulin. It binds to keratin in human cells, then once it reaches the fungal site of action, it binds to fungal microtubes thus altering the fungal process of mitosis.|Fungistatic; griseofulvin inhibits fungal cell mitosis by causing disruption of the mitotic spindle structure, thereby arresting the metaphase of cell division. It is deposited in varying concentrations in the keratin precursor cells of skin, hair, and nails, rendering the keratin resistant to fungal invasion. As the infected keratin is shed, it is replaced with healthy tissue.

SYMPTOMS: Symptoms of exposure to this compound may include urticaria, headaches, confusion, dizziness, nausea, diarrhea, photosensitivity and leukopenia. Other symptoms may include epigastric distress, fever and arthralgia. It may cause renal damage and porphyria. It may also cause peripheral neuritis, syncope and blurred vision. Exposure has caused skin rashes, fatigue, proteinuria and, rarely, angioneurotic edema, paresthesia and lupus erythematosus. Symptoms may include dryness of the mouth, an altered sensation of taste, gastrointestinal disturbances, severe allergic reactions, erythema multiforme, exfoliative dermatitis, candidiasis, depression, irritability and, rarely, hepatitis. Other symptoms reported are oral thrush, vomiting, insomnia, impairment of the performance of routine activities and, rarely, lupus-like syndromes and granulocytopenia. Skin irritation may occur. Exposure can lead to lethargy, vertigo, transient macular edema, augmentation of the effects of alcohol, heartburn, flatulence, angular stomatitis, neutropenia, punctate basophilia, monocytosis, albuminuria, cylindruria and hepatotoxicity. Abnormalities of the sexual organs and breasts have occurred, especially in children. It is contra-indicated in persons with porphyria and liver failure. A case of blurred vision with greenish tint, and papilledema have been reported. ACUTE/CHRONIC HAZARDS: This compound may cause irritation of and be absorbed through the skin. When heated to decomposition it emits toxic fumes of carbon monoxide, carbon dioxide and hydrogen chloride gas. (NTP, 1992)

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. IMMEDIATELY call a hospital or poison control center even if no symptoms (such as redness or irritation) develop. IMMEDIATELY transport the victim to a hospital for treatment after washing the affected areas. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. IMMEDIATELY call a physician and be prepared to transport the victim to a hospital even if no symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. OTHER: Since this chemical is a known or suspected carcinogen you should contact a physician for advice regarding the possible long term health effects and potential recommendation for medical monitoring. Recommendations from the physician will depend upon the specific compound, its chemical, physical and toxicity properties, the exposure level, length of exposure, and the route of exposure. (NTP, 1992)

PHOTOSENSITIVITY & PPT OF DISCOID LUPUS ERYTHEMATOSUS IN 1 PT WITH NO PREVIOUS EVIDENCE OF THE DISEASE; IN ANOTHER PT WITH KNOWN SYSTEMIC LUPUS ERYTHEMATOSUS FEVER & MALAISE AFTER TREATMENT WITH GRISEOFULVIN.|THE OCCURRENCE OF CHOLESTATIC JAUNDICE IN PT RECEIVING GRISEOFULVIN IS DESCRIBED. COMPLETE RECOVERY FOLLOWED DISCONTINUATION OF DRUG ADMIN.

Fulvicin U F

DUSTS 1.5-3.5% WT/WT FOR USE AT 75 LB/ACRE. WETTABLE POWDERS, DISPERSIBLE CONCENTRATES (SOLN IN DIMETHYL FORMAMIDE WITH DISPERSING AGENT). /SRP: NOT APPROVED FOR USE ON CROPS IN US./|GRISEOFULVIN, USP (FULVICIN U/F, GRIFULVIN V, GRISACTIN), IS MARKETED IN CAPSULES CONTAINING 125 OR 250 MG & IN TABLETS CONTAINING 125, 250, OR 500 MG; IT IS ALSO AVAIL AS ORAL SUSPENSION (125 MG/5 ML). ... TABLETS INCORPORATING ULTRAMICROSIZED PREPN (FULVICIN P/G, GRIS-PEG) CONTAIN 125 OR 250 MG OF GRISEOFULVIN (EQUIVALENT TO 250 OR 500 MG OF PREPN...ABOVE).|BIOAVAILABILITY OF A 500 MG MICROSIZE FORMULATION WAS COMPARED TO 2 NEW ULTRAMICROSIZE FORMULATIONS. ONE 330 MG ULTRAMICROSIZE TABLET IS BIOEQUIVALENT TO 2 165 MG ULTRAMICROSIZE TABLETS & EITHER ULTRAMICROSIZE DOSAGE REGIMEN IS BIOEQUIVALENT TO 500 MG OF THE MICROSIZE FORMULATION.|THE BIOAVAILABILITY OF GRISEOFULVIN TABLETS SPRAY DRIED WITH 20% METHYLCELLULOSE WAS DETERMINED IN 10 RABBITS. COMPARED TO REGULAR TABLETS, DRUG ABSORPTION WAS GREATER IN THE SPRAY DRIED PREPN.|Tablet, 250 mg, 500 mg; suspension, 250 mg/ml /Grifulvin V/

NOT APPROVED IN UNITED STATES IN FOOD PRODUCING ANIMALS.

AOAC METHOD NO. 968.49. DETERMINATION IN FEEDS, APPLICABLE TO CONCN GREATER THAN OR EQUAL TO 10 MG/OZ; CHROMATOGRAPHY; SPECTROPHOTOMERY, READING AT 290 & 320 NM.|HIGH PERFORMANCE LIQ CHROMATOGRAPHIC METHOD WAS USED TO DETERMINE THE PURITY OF GRISEOFULVIN IN COMMERCIAL DRUG SUBSTANCE SAMPLES & ANALYZE GRISEOFULVIN & ITS DECOMPOSITION IMPURITIES IN FRESH & AGED POWDERS, CAPSULES & TABLETS. RESULTS SHOWED THAT DECHLOROGRISEOFULVIN WAS THE MAJOR IMPURITY OF ALL BATCHES TESTED & THAT OTHER SIGNIFICANT IMPURITIES WERE ABSENT. METHOD ALLOWED SEPARATION OF DECOMPOSITION IMPURITIES AFTER ACCELERATED DECOMPOSITION STUDIES.

PLASMA, FLUOROMETRIC DETERMINATION; ROWLAND M, RIEGELMAN S, & EPSTEIN WL; ABSORPTION KINETICS OF GRISEOFULVIN IN MAN; J PHARM SCI 57: (984) (1968).|BLOOD, FLUORESCENCE SPECTROSCOPY. UDENFRIEND S, FLUORESCENCE ESSAY IN BIOLOGY & MEDICINE; ACADEMIC PRESS, NEW YORK, NY (1962).|METHOD WAS TESTED IN VITRO & IN RABBITS. REPRODUCIBLE RESULTS OBTAINED WITH HIGH SENSITIVITY & PLASMA CONCN AS LOW AS 50 NG/ML WERE MEASURED.|SERUM WAS ANALYZED BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY WITH SENSITIVITY LESS THAN 0.2 MUG/ML.|SPECIFIC QUANTITATIVE METHOD INVOLVES EXTRACTION WITH ETHER, EVAPORATION, ADDITION OF INTERNAL STD DISSOLVED IN BENZENE, & GLC ANALYSIS USING ELECTRON CAPTURE DETECTOR. SENSITIVITY IS 0.05 UG/ML OF PLASMA.

Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients|Animal Drugs -> FDA Approved Animal Drug Products (Green Book) -> Active Ingredients|Polyketides [PK] -> Aromatic polyketides [PK13] -> Dibenzofurans, griseofulvins, dibenzopyrans and xanthones [PK1306]