Sertaconazole
Glenmark
914 Items
2019-09-19
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Clinical Pharmacology
Sertamicol - antifungal agent for external and local use. Sertaconazole is an imidazole and benzothiophene derivative with a broad spectrum of activity against pathogenic fungi Candida spp. (Including Candida albicans, Candida tropicalis), other pathogenic fungi (Pityrosporum orbiculare, Malassezia spp.), Dermatophytes (Trichophyton and Microsporum), Gram-positive bacteria (Streptococcus spp., Staphylococcus spp.), As well as Gardnerella vaginalis, Enterococcus faecalis, Bacteroides spp., Trichomonas vaginalis.
Sertaconazole does not inhibit the viability of Lactobacillus spp. in vitro.
In therapeutic doses has a fungicidal and fungistatic effect. The mechanism of action of sertaconazole is to suppress the synthesis of ergosterol, the main component of the membranes of fungal cells and in competitive antagonism with another component of the cell wall, tryptophan. This leads to disorganization and increase in the permeability of the cell membrane, destruction and destruction of the pathogenic microorganism.
Indications
Superficial mycoses of the skin - dermatophytosis, incl. Stop(Tinea pedis), torso(Tinea corporis), beards(Tinea barbae); candidiasis, versicolor versicolor.
Composition
1 ml of solution contains:
Active substance: sertaconazole nitrate.
Sertaconazole is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Sertamicol | Glenmark | India | solution |
| Sertamicol | Glenmark | India | cream |
| Zalain | Egis | Hungary | suppositories |
| Zalain | Egis | Hungary | cream |
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Dosage and Administration
Intravaginally, once.
Before using the drug, it is necessary to wash the external genitals with neutral or alkaline soap.
One vaginal suppository is inserted deep into the vagina, lying on its back, before bedtime.
If clinical symptoms persist, the suppository may be reintroduced after 7 days.
Adverse reactions
Rarely: burning sensation, itching in the vagina, which pass independently during treatment and do not require discontinuation of the drug. These side effects are classic for topical preparations and reflect the effectiveness of the drug. Allergic reactions are possible.
Contraindications
Hypersensitivity to imidazole derivatives, benzothiophene and other components of the drug.
Pregnancy and Lactation
There are no sufficient data on the use of sertaconazole during pregnancy and lactation. However, taking into account the method of use of the drug (single injection), as well as the lack of systemic absorption of the drug after intravaginal administration, the use of sertaconazole during pregnancy and lactation is possible if the potential benefit to the mother outweighs the possible risk to the fetus or child .
- Brand name: Sertamicol
- Active ingredient: Sertaconazole
- Dosage form: Solution for external use
- Manufacturer: Glenmark
- Country of Origin: India
Studies and clinical trials of Sertaconazole (Click to expand)
- Effect of cyclodextrins on the solubility and antimycotic activity of sertaconazole: Experimental and computational studies
- Determination of sertaconazole nitrate, a new imidazole antifungal, by high-performance liquid chromatography
- Determination of sertaconazole in pharmaceutical preparations by capillary zone electrophoresis
- A validated LC–MS/MS method for determination of sertaconazole nitrate in human plasma
- Anti-inflammatory and anti-itch activity of sertaconazole nitrate
- Sertaconazole-HPβCD-pluronic F127 solid inclusion complexes: characterization and effect on drug solubility
- Sertaconazole 2% cream vs. miconazole 2% cream for cutaneous mycoses: a double-blind clinical trial
- Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis
- Allergic contact dermatitis from sertaconazole with cross-sensitivity to miconazole and econazole
- Anti-Inflammatory Activity of Sertaconazole Nitrate Is Mediated via Activation of a p38–COX-2–PGE2 Pathway
- Alterations Produced by Sertaconazole on the Morphology and Ultrastructure of Candida albicans: Sertaconazol-bedingte Veranderungen der Morphologie und Ultrastruktur von Candida albicans
- The anti-Malassezia furfur activity in vitro and in experimental dermatitis of six imidazole antifungal agents: bifonazole, clotrimazole, flutrimazole, ketoconazole, miconazole and sertaconazole : Die Aktivität von sechs Imidazol-Antimykotika (Bifonazol, Clotrimazol, Flutrimazol, Ketoconazol, Miconazol und Sertaconazol) gegen Malassezia furfur in vitro und bei experimenteller Dermatitis
- Ocular tolerance of sertaconazole gel : Augenverträglichkeit von Sertaconazol-Gel
- Tolerance and kinetic behaviour after single and repeated vaginal administration of sertaconazole cream and tablets in healthy volunteers
- Sertaconazole in the treatment of pediatric patients with cutaneous dermatophyte infections
- Review of in vitro activity of sertaconazole nitrate in the treatment of superficial fungal infections
- Effects of sertaconazole nitrate on T-cell activation, irritant dermatitis, and contact hypersensitivity
- Sertaconazole nitrate has a broad spectrum of activity in vitro
- Sertaconazole nitrate rapidly achieves high concentrations inthe stratum corneum with prolonged rentention time
- Novel anti-inflammatory activity of sertaconazole nitrate is mediated via activation of a p38/COX-2/PGE2 pathway
- Sertaconazole nitrate 2% in the treatment of tinea pedis in patients with coexisting onychomycosis
- Sertaconazole nitrate mediates its antiitch activity by inducing PDG2 via the p38 MAPK pathway
- An open-label study of the safety and efficacy of sertaconazole nitrate in the treatment of seborrheic dermatitis
- Efficacy of once-daily treatment of interdigital tinea pedis with sertaconazole 2% cream
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