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Griseofulvin 250 mg Tablets (Grifulvin)

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Griseofulvin is an antifungal antibiotic derived from a number of Penicillium species. It was the first oral drug for treatment of dermatophytosis.

Mechanism of action

Griseofulvin is a fungistatic drug which binds to microtubular proteins and inhibits fungal cell mitosis. It also acts as an inhibitor of nucleic acid synthesis.

Griseofulvin: Spectrum of action

Griseofulvin has a limited spectrum of action which is almost restricted to the dermatophytes (Epidermophyton floccosum, Microsporum species and Trichophyton species). Its clinical use is limited to these infections. It is ineffective in cutaneous candidosis and pityriasis versicolor.

Acquired resistance

Treatment failure attributable to the development of griseofulvin resistance is an uncommon problem in patients with dermatophytoses.

Pharmacokinetics of Griseofulvin 250 mg (Grifulvin 250 mg)

Absorption of griseofulvin from the gastrointestinal tract is dependent on drug formulation. Administration of the drug with a high fat meal will increase the rate and extent of absorption, but individual patients tend to achieve consistently high or low serum concentrations. Four hours after a single 1000-mg dose, blood levels in the region of 0-3.75 mg/1 can be anticipated.

Griseofulvin appears in the stratum corneum within 4-8 h of oral administration, as a result of drug secretion in perspiration. However, levels begin to fall soon after the drug is discontinued and within 48-72 h it can no longer be detected. The mechanisms by which griseofulvin is delivered to the hair and nails are not well understood: deposition in newly formed cells is thought to be the major factor.

Metabolism of Griseofulvin 250 mg (Grifulvin 250 mg)

Griseofulvin is metabolized by the liver to 6-desmethyl griseofulvin which is excreted in the urine. The drug has an elimination half-life from 9 to 21 h. Less than 1% of a given dose appears in the urine in unchanged form.

Pharmaceutics of Griseofulvin 250 mg

Griseofulvin is available as oral tablets and oral suspension.

Therapeutic use of Griseofulvin 250 mg

Griseofulvin is indicated in moderate to severe dermatophytoses of the skin, scalp hair, or nails where topical treatment is considered inappropriate or has failed.

Griseofulvin: Mode of administration

It is important to adjust the dose to the weight of the patient. The adult dose can range from 500 to 1000 mg either as a single or divided doses; not less than 10 mg/kg should be given. The dose for children under 25kg is 10 mg/kg and 250-500 mg for children over 25 kg. It should be taken after meals.

The duration of treatment will differ from patient to patient and depend upon the nature and extent of the infection. For hair or skin at least 4 weeks of treatment is required. Long courses (usually 6-12 months) and high doses may be needed for nail infections. Long-term relapse rates are high; between 40 and 70% for toenails, but somewhat lower for fingernails.

Adverse reactions of Griseofulvin 250 mg (Grifulvin 250 mg)

In most cases, prolonged courses and high doses are well tolerated. Patients have complained of headaches, nausea, vomiting and abdominal discomfort. Urticarial reactions and erythematous rashes occur in occasional patients.

The drug is contraindicated in patients with liver disease as hepatic function may deteriorate and the risk of other side-effects is increased.

Drug interactions of Griseofulvin 250 mg

Griseofulvin has been shown to stimulate the metabolism of warfarin, thus reducing its anticoagulant effect. Absorption is reduced in patients receiving concomitant treatment with phenobarbitone, but the effect can be reduced by administration of griseofulvin with food. Failure of contraception has been reported in patients taking griseofulvin and oral contraceptive steroids.

Griseofulvin: Organs and Systems

Nervous system

Headache is the most common adverse effect of griseofulvin. It occurs in about 50% of patients and can be severe. Drowsiness, dizziness, fatigue, confusion, depression, irritability, and insomnia have also been observed. Impaired co-ordination and unsteadiness while walking have been reported in some cases when there was confusion. Peripheral neuritis has been attributed to griseofulvin, but with little proof of a causal relation.

Sensory systems

Eyes

Blurring of vision has been reported with griseofulvin.

Taste

Griseofulvin can cause dysgeusia; both taste and smell disturbances may occur more frequently than has been realized.

Psychological, psychiatric

The psychiatric effects of griseofulvin can be very disturbing and are aggravated by alcohol.

Endocrine

An estrogen-type effect has been reported in children, affecting the genitals and the breasts. Griseofulvin interferes with porphyrin metabolism. In man, transient increases in erythrocyte protoporphyrin concentrations have been demonstrated, and the production and excretion of porphyrins is increased. Acute intermittent porphyria is an absolute contraindication to griseofulvin. In patients with other forms of porphyria it should also be avoided, in view of the many alternatives.

Hematologic

There is no evidence that griseofulvin can cause serious blood disorders. However, leukopenia, neutropenia, and monocytosis have been reported.

Gastrointestinal

Anorexia, a feeling of bloating, mild nausea, and mild diarrhea are common. Vomiting, abdominal cramps, and more severe diarrhea are rare. Black, furry tongue, glossodynia, angular stomatitis, and taste disturbances have been described.

Liver

While there have been anecdotal reports of hepatitis and cholestasis, a causal relation has never been shown.

Skin

Dermatological adverse effects are not uncommon with griseofulvin and are of considerable variety. The following have been described: urticaria, photosensitivity eruptions, erythema multiforme, morbilliform rashes, serum sickness-like reactions, fixed drug eruption, Stevens-Johnson syndrome, vasculitis, toxic epidermal necrolysis, and lupus erythematosus.

A 40-year-old woman had a burning sensation and erythema of the lips, buccal mucosa, palate, and vulva, which recurred within 4 hours of oral rechallenge with griseofulvin 125 mg.

The risk of serious skin disorders has been estimated in 61 858 users, aged 20-79 years, of oral antifungal drugs identified in the UK General Practice Research Database. They had received at least one prescription for oral fluconazole, griseofulvin, itraconazole, ketoconazole, or terbinafine. The background rate of serious cutaneous adverse reactions (corresponding to non-use of oral antifungal drugs) was 3.9 per 10 000 person-years (95% CI = 2.9). Incidence rates for current use were 15 per 10 000 person-years (1 for itraconazole, 11.1 (3 for terbinafine, 10 (1 for fluconazole, and 4.6 (0 for griseofulvin. Cutaneous disorders associated with the use of oral antifungal drugs in this study were all mild.

Immunologic

The triggering of a lupus-like syndrome by griseofulvin, by way of an allergic reaction, has been described, but is rare.

Griseofulvin: Side Effects

Griseofulvin was originally isolated in 1939 as a natural product of Penicillium griseofulvum. It interferes with fungal microtubule formation, disrupting the cell’s mitotic spindle formation and arresting the metaphase of cell division. Griseofulvin is a fungistatic compound and is active against Trichophyton, Microsporon, and Epidermophyton species. With the development of newer safer azoles and the introduction of terbinafine, all of which are easy to administer, the indications for griseofulvin have dwindled.

Pharmacokinetics

Griseofulvin is commercially available for oral administration as griseofulvin microsize (4 |j,m particle size) and griseofulvin ultramicrosize (1 m particle size). The oral availability of the micronized formulation is variable, 25-70%; ultramicronized griseofulvin, in contrast, is almost completely absorbed. Peak plasma concentrations occur about 4 hours after dosing.

Griseofulvin distributes to keratin precursor cells and is concentrated in skin, hair, nails, liver, adipose tissue, and skeletal muscle. In skin, a concentration gradient is established over time, with the highest concentrations in the outermost stratum corneum. However, within 48-72 hours after withdrawal, plasma concentrations of griseofulvin are markedly reduced and it is no longer detectable in the stratum corneum. The half-life of griseofulvin is 9-21 hours. It is oxidatively demethylated and conjugated with glucuronic acid, primarily in the liver; its major metabolite, 6-desmethylgriseofulvin, is microbiologically inactive.

Within 5 days, about one-third of a single dose of micronized griseofulvin is excreted in the feces, and 50% in the urine, predominantly as glucuronidated 6-desmethylgriseofulvin. The slow penetration rate of griseofulvin into tissues may explain difficulties and delays in eradication of infection in nails.

General adverse effects

The more common adverse effects of griseofulvin include headache and a variety of gastrointestinal symptoms. Griseofulvin can cause photosensitivity and exacerbate lupus and porphyria. Cases of erythema multiforme-like reactions, toxic epidermal necrolysis, and a reaction resembling serum sickness have been reported. Proteinuria, nephrosis, hepatotoxicity, leukopenia, menstrual irregularities, estrogen-like effects, and reversible impairment of hearing have been reported rarely. Griseofulvin is teratogenic in animals and has mutagenic and carcinogenic potential, but the significance of these observations for humans is unclear.

Griseofulvin: Organs and Systems

Second-Generation Effects

Pregnancy

Embryotoxicity and mutagenicity have been shown in animal experiments with high doses of griseofulvin. Although for this reason most handbooks and drug formularies warn against the use of griseofulvin during pregnancy, there are no reports of any adverse effects on the human fetus, despite the fact that griseofulvin has been on the market since the early 1960s and has been used extensively and, no doubt, during many pregnancies (19,45)

Susceptibility Factors

Patients with porphyria are at risk; acute intermittent porphyria is an absolute contraindication to griseofulvin.

Exposure to intense natural or artificial sunlight should be avoided during treatment with griseofulvin.

Patients with pre-existing systemic lupus erythematosus may be more susceptible to the development of skin manifestations from griseofulvin.

Drug-Drug Interactions

Alcohol

The effects of alcohol are potentiated by griseofulvin, and the use of alcohol increases the risk and severity of psychiatric disturbances.

Ciclosporin

Ciclosporin blood concentrations halved in a patient who took griseofulvin 500 mg/day, despite an increase in ciclosporin dose by 70%. When griseofulvin was withdrawn, the ciclosporin concentration rose. This interaction is attributable to induction of cytochrome P450 by griseofulvin.

Coumarin anticoagulants

Griseofulvin is a potent inducer of cytochrome P450 and has a significant effect on P450 expression in hepatocytes. It therefore increases the rate of metabolism of coumarin anticoagulants. However, both increases and decreases in prothrombin time have been reported.

Oral contraceptives

The combination of griseofulvin with oral contraceptives can lead to oligomenorrhea, amenorrhea, and breakthrough bleeding; unintended pregnancies have been reported. In a case of oligomenorrhea after treatment with griseofulvin, the use of a higher estrogen oral contraceptive restored regularity of the menstrual cycle. The fact that griseofulvin has an estrogen-like effect in children suggests that it may affect the rate of estrogen metabolism.

Phenobarbital

The concomitant use of phenobarbital reduces griseofulvin concentrations, an effect that has been attributed to induction of liver enzymes by phenobarbital.

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