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Griseofulvin [Grifulvin 250mg]

Drug Approvals

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(British Approved Name, rINN)

Synonyms: Curling Factor; Griseofulviini; Griseofulvin; Griseofulvina; Griseofulvinum; Grizeofulvin; Grizeofulvinas
INN: Griseofulvin [rINN (en)]
INN: Griseofulvina [rINN (es)]
INN: Griséofulvine [rINN (fr)]
INN: Griseofulvinum [rINN (la)]
INN: Гризеофульвин [rINN (ru)]
Chemical name: (2S,4´R)-7-Chloro-2´,4,6-trimethoxy-4´-methylspiro[benzofuran-2(3H),3´-cyclohexene]-3,6´-dione
Molecular formula: C17H17ClO6 =352.8
CAS: 126-07-8
ATC code: D01AA08; D01BA01
Read code: y02UD

Pharmacopoeias. In China, Europe, International, Japan, US

European Pharmacopoeia, 6th ed. (Griseofulvin). An antifungal substance produced by the growth of certain strains of Perdcillium griseofulvum, or by any other means. It is a white or yellowish-white powder. The particles of the powder are generally up to 5 micrometres in maximum dimension, though larger particles, which may occasionally exceed 30 micrometres, may be present. It contains 97 to 102% of C17H17CIO6, calculated on the dried substance. Practically insoluble in water slightly soluble in dehydrated alcohol and in methyl alcohol freely soluble in dimethylformamide and in tetrachloroethane.

The United States Pharmacopeia 31, 2008(Griseofulvin). A white to creamy-white, odourless powder, in which particles of the order of 4 micrometres in diameter predominate. It has a potency of not less than 900 micrograms of C17H17CIO6 per mg. Very slightly soluble in water sparingly soluble in alcohol soluble in acetone, in chloroform, and in dimethylformamide. Store in airtight containers.

Adverse Effects

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Adverse effects are usually mild and transient and consist of headache, skin rashes and urticaria, dry mouth, an altered sensation of taste, and gastrointestinal disturbances. Angioedema, erythema multiforme, toxic epidermal necrolysis, proteinuria, leucopenia and other blood dyscrasias, oral candidiasis, peripheral neuropathy, photosensitisation, and severe headache have been reported occasionally. Depression, confusion, dizziness, impaired coordination, insomnia, and fatigue have also been reported. Griseofulvin may precipitate or aggravate systemic lupus erythematosus.

There have been a few reports of hepatotoxicity attributed to griseofulvin.

Effects on the skin. Fatal toxic epidermal necrolysis in a 19-year-old woman was attributed to griseofulvin that she had taken for 6 days she had also taken metronidazole for 1 day. There are also reports’ of erythema multiforme in 4 patients occurring within 10 days of starting griseofulvin. The precipitation or aggravation of systemic lupus erythematosus is a known complication of griseofulvin. Most cases are said to be characterised by prominent skin manifestations and absence of renal disease although the nephrotic syndrome has been described in a 16-year-old male after 2 single doses of griseofulvin taken 3 weeks apart.

Hypersensitivity. A serum sickness-like reaction has been reported in a 5-year-old child being treated for tinea capitis with griseofulvin. About 3 weeks after starting treatment the child developed fever, rash on his legs and back, swelling of his toes and fingers, and leg pain. Symptoms resolved after griseofulvin was stopped.

Precautions

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Griseofulvin is contra-indicated in patients with severe liver disease or systemic lupus erythematosus.

Griseofulvin is embryotoxic and teratogenic in rats and there have been isolated cases of conjoined twins after its use during the first trimester of pregnancy. It is therefore contra-indicated in pregnancy and women should not become pregnant during, or within 1 month of stopping therapy. Griseofulvin may reduce the effectiveness of oral contraceptives and additional contraceptive precautions should be used during treatment. Data from in-vitro and in-vivo studies using mammalian cells, which showed aneuploidy, have led to the warning that men taking griseofulvin should not father children within 6 months of treatment.

Griseofulvin may impair the ability to drive or operate machinery and has been reported to enhance the effects of alcohol.

Porphyria. Griseofulvin has been associated with acute attacks of porphyria and is considered unsafe in porphyric patients.

Interactions

Phenobarbital has been reported to decrease the gastrointestinal absorption of griseofulvin. Plasma concentrations of griseofulvin have also been reported to be reduced by drugs that induce metabolising enzymes.

Griseofulvin may increase the rate of metabolism and diminish the effects of some drugs such as coumarin anticoagulants and oral contraceptives.

Griseofulvin may enhance the effects of alcohol.

Alcohol. In addition to reports of griseofulvin enhancing the effects of alcohol, a severe disulfiram-like reaction to alcohol has been reported in a patient taking griseofulvin.

Bromocriptine. For a report that griseofulvin can block the response to bromocriptine.

Salicylates. Griseofulvin has been reported to reduce plasma concentrations of salicylate in a patient taking aspirin.

Antimicrobial Action

Griseofulvin is a fungistatic antibiotic that inhibits fungal cell division by disruption of the mitotic spindle structure. It may also interfere with DNA production. It is active against the common dermatophytes, including some species of‘ Epidermophyton, Microsporum, or Trichophyton.

Pharmacokinetics

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Absorption of griseofulvin from the gastrointestinal tract is variable and incomplete, but is enhanced by reducing the particle size or when given with a fatty meal. Peak plasma concentrations are reached within 4 hours and are maintained for 10 to 20 hours.

Griseofulvin is about 84% bound to plasma proteins. It is deposited in keratin precursor cells and is concentrated in the stratum corneum of the skin and in the nails and hair, thus preventing fungal invasion of newly formed cells. Concentrations of 12 to 25 micrograms/g are maintained in skin during long-term use, while plasma concentrations remain at about 1 to 2 micrograms/mL. Griseofulvin has an elimination half-life of 9 to 24 hours, and is metabolised by the liver mainly to 6-demethylgriseofulvin and its glucuro-nide conjugate which are excreted in the urine. A large amount of a dose of griseofulvin of reduced particle size appears unchanged in the faeces less than 1% is excreted unchanged in the urine some is excreted in the sweat.

Uses and Administration

Griseofulvin is an antifungal used orally in the treatment of dermatophyte infections. It is generally given when such infections involve the scalp, hair, nails, and skin and do not respond to topical treatment (see Skin Infections, p.521) infections ofthe soles ofthe feet, the palms ofthe hands, and the nails respond slowly.

The usual dose of griseofulvin has been 0.5 to 1 g daily in single or divided doses children have been given 10 mg/kg daily. These doses are for preparations of griseofulvin of reduced particle size, sometimes known as microcrystalline or microsize griseofulvin. Doses have been reduced by about one-quarter when preparations, available in some countries, containing ultramicrocrys-talline or ultramicrosize griseofulvin are used. Griseofulvin should be given with or after meals.

The duration of treatment depends on the thickness of the keratin layer: 2 to 8 weeks for infections ofthe hair and skin, up to 6 months for infections of the fingernails, and 12 months or more for infections ofthe toe-nails.

Griseofulvin is also used as a 1% topical spray in tinea pedis.

Non-infective skin disorders. Lichen planus is usually treated with corticosteroids or retinoids but griseofulvin has been suggested as an alternative to topical corticosteroids in erosive disease. However, some researchers have found it to be of no value.

Dramatic responses of pigmented purpuric dermatoses to griseofulvin 500 to 750 mg daily have been reported in 5 patients.

Preparations

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British Pharmacopoeia 2008: Griseofulvin Tablets

The United States Pharmacopeia 31, 2008: Griseofulvin Capsules Griseofulvin Oral Suspension Griseofulvin Tablets Ultramicrosize Griseofulvin Tablets.

Proprietary Preparations

 

Argentina: Grisovin

Australia: Griseostatin † Grisovin

Austria: Griseomed † Grisovin

Brazil: Fulcin Sporostatin

Canada: Fulvicin †

Chile: Fulvistatin P/G †

France: Grisefuline

Germany: Fulcin S Gricin Griseo Likuden M

India: Grisactin Walavin

Indonesia: Fulcin Fungistop Griseofort Mycostop

Ireland: Fulcin †

Israel: Grifulin

Italy: Fulcin Grisovina FP

Malaysia: Grisuvin Grivin Krisovin Medofulvini Myconili

Mexico: Fulcin Fulsivin Fulvina † Grisovin

Philippines: Grisovin

Portugal: Fulcin † Grisomicon † Grisovin

Singapore: Grivin † Krisovin Medofulvin

Spain: Fulcin Greosin †

Switzerland: Grisol †

Thailand: Aofen Grifulvin Grisflavin Grivin Neofulvin Trivanex

Turkey: Gefulvin Grisovin

United Kingdom: Grisol Grisovin

USA: Gris-PEG

 

Multi-ingredient

Argentina: Griseopius

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Synonyms of Griseofulvin *:

Griseofulvina [INN-Spanish], Griseofulvine [INN-French], Griseofulvinum [INN-Latin]

* Official titles and synonyms used in the British, European, and US Pharmacopoeias. INNs in the other main official languages (French, Latin, and Spanish) have also been included in the list of synonyms where these differ from the English INN.

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Dosage forms of Griseofulvin:

Name, Strength, Form, Route
Griseofulvin Suspension Oral
Griseofulvin Tablet Oral

Therapeutic classes of Griseofulvin:

Antibacterial Agents, Antibiotics, Antifungal

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