Griseofulvin tablets 0.125 (Tablets) Instructions for Use

Marketing Authorization Holder

STI-Med-Sorb, PJSC (Russia)

ATC Code

D01BA01 (Griseofulvin)

Active Substance

Griseofulvin (Rec.INN WHO registered)

Dosage Form

Griseofulvin tablets 0.125

Tablets 125 mg: 20, 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are white with a creamy tint, with a bitter taste and no odor.

10 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs.
100 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Antifungal antibiotic

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent. It has a fungistatic effect on various types of dermatophytes.

It inhibits the cell division of fungal cells in metaphase, disrupting the structure of the mitotic spindle.

Griseofulvin accumulates to varying degrees in the cells of the skin, hair, and nails, which are precursors of keratin, making the keratin resistant to fungal invasion.

As the infected keratin is shed, it is replaced by healthy tissue.

Pharmacokinetics

When taken simultaneously with fatty foods, absorption is significantly enhanced.

It accumulates in various concentrations in the keratin layer of the skin, hair, and nails.

A small amount of griseofulvin after oral administration is distributed in body tissues and fluids.

It is metabolized in the liver to form the main metabolites 6-methylgriseofulvin and a glucuronide compound.

T_1/2 is 24 hours. It is excreted by the kidneys. Less than 1% is excreted unchanged in the urine, and 36% in the feces.

Indications

Dermatomycoses, tinea cruris, epidermophytosis of the skin, hair, and nails caused by pathogens of the genera Trichophyton, Microsporum, Epidermophyton.

ICD codes

Dosage Regimen

Adults (including elderly patients) are usually prescribed a daily dose of 250-500 mg every 12 hours.

Children are prescribed a daily dose of 10 mg/kg.

Griseofulvin should be taken after meals, once or in several doses.

The duration of treatment depends on the clinical situation.

For mycoses that are difficult to treat, the course of therapy can last up to 12 months.

Adverse Reactions

From the digestive system hepatitis, nausea, vomiting, diarrhea, epigastric pain.

Allergic reactions urticaria, skin rash, erythema multiforme, toxic epidermal necrolysis.

From the CNS and peripheral nervous system peripheral neuropathy, dizziness, confusion.

From the hematopoietic system granulocytopenia, leukopenia.

Effects due to chemotherapeutic action candidal stomatitis.

Other photosensitivity, lupus-like syndrome.

Contraindications

Porphyria, systemic lupus erythematosus, lupus-like syndrome, organic diseases of the liver and kidneys, hepatic insufficiency, pregnancy, children under 3 years of age, hypersensitivity to griseofulvin.

Use in Pregnancy and Lactation

Griseofulvin is contraindicated for use during pregnancy, as it has been established to have teratogenic and embryotoxic effects.

It is not known whether Griseofulvin is excreted in breast milk. Therefore, if it is necessary to use it during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency and in organic liver diseases.

Use in Renal Impairment

Contraindicated in organic kidney diseases.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Geriatric Use

There are no specific restrictions for use. In this category of patients, the state of liver and kidney function should be taken into account.

Special Precautions

Alcohol consumption should be avoided during treatment with griseofulvin.

Effect on ability to drive vehicles and operate machinery.

Patients taking Griseofulvin should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of griseofulvin with coumarin or indandione derivatives, a decrease in the anticoagulant effect is noted, due to the acceleration of their metabolism as a result of stimulation of liver microsomal enzymes.

With simultaneous use with estrogen-containing oral hormonal contraceptives, due to stimulation of liver microsomal enzymes by griseofulvin, a decrease in the effectiveness of contraceptives is noted.

With simultaneous use with barbiturates or primidone, the antifungal effect of griseofulvin may weaken due to impaired absorption and a decrease in plasma concentration.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.