Gynofort® [Butoconazole]
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Clinical Pharmacology
Gynofort - antifungal.
Pharmacodynamics
Butoconazole, an imidazole derivative, has fungicidal activity against fungiCandida, Trichophyton, Microsporum, Epidermophyton and some gram-positive bacteria. Most effective for candida. By blocking the formation of ergosterol from lanosterol in the cell membrane, increases the permeability of the membrane, which leads to the lysis of the fungal cell.
Vaginal cream is a water-in-oil emulsion, therefore, the wearer of butoconazole has a bioadhesive property (bioadhesive gives an increase in bioavailability and duration of action of the drug). With intravaginal use, butoconazole is located on the vaginal mucosa for 4–5 days.
Pharmacokinetics
The cream has a high bioadhesive properties. With intravaginal administration, about 1.7% of the administered dose is absorbed. Cmax in blood it is 2–18.6 ng / ml and is reached in 13 hours. Butoconazole is extensively metabolized and partially excreted through the intestines and kidneys.
Indications
Candida albicans vaginal candidiasis.
Composition
1 g of cream contains:
Active substance: butoconazole nitrate 20 mg;
Excipients: sorbitol - 399.78 mg; mineral oil - 80.32 mg; glyceryl monostearate - 27.13 mg; polyglyceryl-3-oleate - 27.13 mg; wax - 4.52 mg; colloidal silicon dioxide - 10.13 mg; disodium edetate - 0.5 mg; methyl parahydroxybenzoate - 1.8 mg; propyl parahydroxybenzoate - 0.5 mg; propylene glycol - 50 mg; water - 378.19 mg
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Dosage and Administration
Gynofort used intravaginally. The treatment consists of a single application of the contents of one applicator (about 5 g), inserted into the vagina at any time of the day. In the case of persisting symptoms of the disease, repeat the microbiological study.
Adverse reactions
Burning, itching, soreness and swelling of the vaginal wall, pain / cramps in the lower abdomen.
Contraindications
- hypersensitivity to any of the components of the drug;
- gestation period;
- lactation;
- children's age up to 18 years (efficiency and safety are not established).
Drug interactions
Cream Gynofort® contains mineral oil, damaging products from latex or rubber (including condoms or intravaginal diaphragms), therefore within 72 hours after using Gynofort® It is not recommended to use the above contraceptives. Other contraceptive methods should be used.
Special instructions
If the clinical signs of infection persist after completion of treatment, a microbiological examination should be repeated to identify the causative agent and confirm the diagnosis.
- Brand name: Gynofort
- Active ingredient: Butoconazole nitrate
- Dosage form: Vaginal cream
- Manufacturer: Gedeon Richter
- Country of Origin: Hungary
Studies and clinical trials of Butoconazole (Click to expand)
- Effect of butoconazole nitrate 2% vaginal cream and miconazole nitrate 2% vaginal cream treatments in patients with vulvovaginal candidiasis
- In vitroactivity of cloconazole, sulconazole, butoconazole, isoconazole, fenticonazole, and five other antifungal agents against clinical isolates ofCandida albicansandCandidaspp.
- Butoconazole nitrate pharmacokinetics studied by capillary electrophoresis
- The synthesis and antifungal activity of the enantiomers of butoconazole nitrate
- Control of Candida albicans vaginitis in mice by short-duration butoconazole treatment in situ : Butoconazol-Kurzzeitbehandlung der Candida albicans-Vaginitis in situ bei Mäusen
- Three-day treatment of patients with vulvovaginal candidiasis: A comparison of butoconazole inserts with econazole ovules
- Butoconazole vaginal cream approved in Singapore
- Butoconazole approved in 15 countries for vulvovaginal candidiasis
- Butoconazole approved in Canada for vaginal yeast infections
- Butoconazole [`Gynazole-1'; KV Pharmaceutical] has received marketing approval in Brazil
- Effect of butoconazole nitrate cream and wax insert on the barrier property of contraceptive devices
- Development of a liquid chromatography-tandem mass spectrometry method for determination of butoconazole nitrate in human plasma and its application to a pharmacokinetic study
- Butoconazole Nitrate
- Butoconazole
- Butoconazole: 3-day treatment effective against vaginal candidosis
- Short course butoconazole may improve compliance in the treatment of vulvovaginal candidiasis
- Butoconazole nitrate: 1% and 2% creams compare well with miconazole nitrate in vaginal candidiasis
- Butoconazole and miconazole in treating vaginal candidiasis.
- xPharm: The Comprehensive Pharmacology Reference || Butoconazole
- A Comparison of Butoconazole Nitrate Cream with Econazole Nitrate Cream for the Treatment of Vulvovaginal Candidiasis
- Vulvovaginal Candidosis: Comparison of 3-Day Treatment with 2% Butoconazole Nitrate Cream and 6-Day Treatment with 1% Clotrimazole Cream
- Development and validation of LC-MS/MS assay for the determination of Butoconazole in human plasma: Evaluation of systemic absorption following topical application in healthy volunteers