Butoconazole 2%

Butoconazole 2% Uses, Dosage, Side Effects, Food Interaction and all others data.

The exact mechanism of the antifungal action of butoconazole is unknown, however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. Imidazoles generally inhibit the conversion of lanosterol to ergosterol via the inhibition of the enzyme cytochrome P450 14α-demethylase, resulting in a change in fungal cell membrane lipid composition. This structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell.

Butoconazole 2% is an imidazole derivative that has fungicidal activity in vitro against Candida spp. and has been demonstrated to be clinically effective against vaginal infections due to Candida albicans. Candida albicans has been identified as the predominant species responsible for vulvovaginal candidasis.

Trade Name Butoconazole 2%
Generic Butoconazole
Butoconazole Other Names Butoconazol, Butoconazole, Butoconazolum
Type
Formula C19H17Cl3N2S
Weight Average: 411.776
Monoisotopic: 410.017802365
Groups Approved
Therapeutic Class Drugs used in Vaginal and Vulval condition
Manufacturer
Available Country Egypt
Last Updated: September 19, 2023 at 7:00 am
Butoconazole 2%
Butoconazole 2%

Uses

Butoconazole 2% vaginal cream is used for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures. Butoconazole 2% vaginal cream is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established.

Butoconazole 2% is also used to associated treatment for these conditions: Vulvovaginal Candidiasis

How Butoconazole 2% works

The exact mechanism of the antifungal action of butoconazole is unknown, however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. Imidazoles generally inhibit the conversion of lanosterol to ergosterol via the inhibition of the enzyme cytochrome P450 14α-demethylase, resulting in a change in fungal cell membrane lipid composition. This structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell.

Dosage

Butoconazole 2% dosage

The recommended dose of Butoconazole 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of butoconazole nitrate.

Side Effects

Of the 314 patients treated with Butoconazole 2% for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.

Toxicity

Oral, rat: LD50 = >1720 mg/kg.

Precaution

If clinical symptoms persist, tests should be repeated to rule out pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.

Food Interaction

No interactions found.

Elimination Route

Following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1.7% (range 1.3-2.2%) of the dose was absorbed on average.

Pregnancy & Breastfeeding use

Pregnancy Category C. In pregnant rats administered 6 mg/kg/day of butoconazole nitrate intravaginally during the period of organogenesis, there was an increase in resorption rate and decrease in litter size; however, no teratogenicity was noted. This dose represents a 130- to 353-fold margin of safety based on serum levels achieved in rats following intravaginal administration compared to the serum levels achieved in humans following intravaginal administration of the recommended therapeutic dose of butoconazole nitrate.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when butoconazole nitrate is administered to a nursing woman

Contraindication

Butoconazole 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.

Special Warning

Pediatric Use: Safety and effectiveness in children have not been established

Storage Condition

Store at 25°C

Innovators Monograph

You find simplified version here Butoconazole 2%

Butoconazole 2% contains Butoconazole see full prescribing information from innovator Butoconazole 2% Monograph, Butoconazole 2% MSDS, Butoconazole 2% FDA label

*** Taking medicines without doctor's advice can cause long-term problems.
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