sertaconazole
Regulatory sources consulted
Approved indications
- Dermatophyte skin infections, cutaneous candidiasis, and tinea versicolor.
Contraindications
Absolute
- Hypersensitivity to sertaconazole, other imidazoles, or any excipient.
Clinical warnings
- For external use only; avoid eyes and mucosae, do not use occlusive dressings, and stop for persistent irritation. — CIMA DERMOFIX 20 mg/g crema, registro 59078
- Withdraw any topical corticosteroid at least 2 weeks before starting sertaconazole. — CIMA DERMOFIX 20 mg/g crema, registro 59078
- Uncommon reactions include erythema, burning sensation, itching and disseminated or application-site vesicles; they are usually mild and transient. — CIMA DERMOFIX 20 mg/g crema, registro 59078
- Sorbic acid may cause local skin reactions, such as contact dermatitis. Methyl parahydroxybenzoate (methylparaben) may cause allergic reactions, possibly delayed. — https://cima.aemps.es/cima/dochtml/ft/59078/FT_59078.html
Pregnancy and lactation
During pregnancy, use only if needed. Breastfeeding is not contraindicated, but do not apply to the nipple.
Recent literature (PubMed)
A rising number of researchers are interested in thiophene-based analogs as they have wide possibilities of biological potential in the largely developing chemical world of the heterocyclic moiety. It also occupies a central position in synthetic organic chemistry and is of the highest theoretical and practical importance. It became an important moiety for researchers to discover combinatorial libraries and implement the efforts in search of the lead entity. Moreover, it helps medicinal chemists to improve sophisticated molecules with a broad range of pharmacological activities. Thiophene and its synthetic derivatives are a prominent heterocyclic compound class with intriguing uses in medical chemistry. It has been manifesting to be an effective drug in current respective diseases scenario. It has been discovered that thiophene had an extensive spectrum of pharmacological potential with numerous applications in academic interest, in the pharmaceutical industry, material science, and medicinal chemistry. Antimitotic, antimicrobial, anti-inflammatory, anticonvulsant, antipsychotic, antiarrhythmic, anti-anxiety, antifungal, antioxidant, estrogen receptor regulating, and anti-cancer are one of the pharmacological and physiological activities of thiophene moiety. However, there are some marketed formulations available such as Thiophenfurin, Teniposide, Cefoxitin, Ticaconazole, Sertaconazole, Suprofen, ketotifen, Brinzolamide, Dorzolamide, Tiotropium which contain thiophene nucleus. Thus, in brief, gathering recent data is necessary to comprehend the present scenario of thiophene moiety for scientific research purposes and highlights a broad view of the biological potential of compounds having a thiophene nucleus.
High worldwide prevalence and significant morbidity of vulvovaginal candidiasis (VVC) requires better therapeutic approaches to improve quality of life of affected women. Although treatment of acute episodes is often straightforward, complicated and recurrent vulvovaginal candidiasis (RVVC) presents medical challenges. This review focuses on therapy of VVC particularly by topical antifungals , especially imidazoles, compared to oral treatment with fluconazole, itraconazole, ibrexafungerp, or oteseconazole. Candidiasis by non-Candida albicans, VVC in pregnant women and RVVC are complex challenges . Current treatment, alternatives, and roles played by topical azoles in VVC are highlighted. VVC requires personalized treatment considering whether the woman is pregnant or not, concomitant treatments, clinical presentations (acute or recurrent) and the Candida species involved. Although therapeutic tools are increasing, the usefulness of topical drugs, such as clotrimazole and miconazole, is very relevant. In addition, we it is also necessary to expand the therapeutic tools with new antifungals and formulations, and repurposing current drugs against fluconazole-resistant species of Candida.
Facial seborrhoeic dermatitis (FSD) is a chronic inflammatory skin disorder characterized by remission and exacerbation episodes. In most cases, FSD requires long-term treatment. To compare the efficacy and safety of pimecrolimus and sertaconazole in patients with FSD. In total, 60 patients with FSD were enrolled in this double-blind, active-controlled, randomized trial, and instructed to topically apply either pimecrolimus 1% cream (30 patients) or sertaconazole 2% cream (30 patients) twice daily for 4 weeks. Assessment of disease severity was performed using the Scoring Index (SI) at baseline, on Days 14 and 28, and at 4 weeks after treatment cessation. The levels of satisfaction from treatment and any adverse effects (AEs) were also assessed in both groups. Although the severity of disease reduced upon treatment in both groups, application of pimecrolimus caused a significantly better improvement than sertaconazole on Days 14 and 28 (P < 0.01 and P < 0.001, respectively). The rate of relapse was significantly lower in the pimecrolimus compared with the sertaconazole group at 4 weeks after treatment cessation (P = 0.01). The highest level of satisfaction (46.7%) was observed on Day 28 in the pimecrolimus group. Both topical treatments had acceptable safety profiles; however, pimecrolimus 1% cream was significantly (P < 0.01) less irritating than sertaconazole 2% cream. Pimecrolimus is associated with faster response and fewer AEs than sertaconazole in patients with FSD.
Vaginal candidiasis (VC) commonly affects pregnant women. Traditionally, clotrimazole vaginal tablets (CLO) have been the cornerstone of management. However, sertaconazole ovules (SER) offer a novel topical antimycotic option. This double-blinded, randomized trial evaluated the efficacy of single-dose SER and CLO in treating acute VC during pregnancy. From June 2020 to May 2021, this trial recruited pregnant women aged ≥ 18 years with VC symptoms (abnormal vaginal discharge and/or vulvar/vaginal itching) confirmed by microscopy. Participants with ≥ 4 VC episodes in the prior year, immunocompromised status, or imidazole contraindications and those who were absent at the 2-week follow-up were excluded. Participants were randomized to receive either 300 mg SER or 500 mg CLO. Evaluations 2 weeks after the initial medication administration included clinical cure (self-reported resolution of all symptoms), microscopic cure (pseudohyphal absence), patient satisfaction, side effects, and time to clinical cure. Participants with persistent VC received weekly SER doses until delivery. Assessments of recurrence and pregnancy outcomes were done. The analysis included 96 participants (48 per group, mean age 27.4 ± 7.4 years, gestational age at diagnosis 22.9 ± 6.4 weeks). Without statistical significance, SER achieved a higher clinical cure rate (62.5% vs 50%, p = 0.217; a mean difference of 12.5%, 95%CI: -17.5% to 42.5%; and a rate ratio of 1.25, 95%CI: 0.71 to 2.23) and a lower microscopic cure (47.9% vs. 62.5%, p = 0.151; a mean difference of -14.6%, 95%CI: -44.3% to 15.1%; and a rate ratio of 0.77, 95%CI: 0.43 to 1.37). The two groups had comparable times to clinical cure (SER: 3.1 ± 1.8 days, CLO: 3.4 ± 2.7 days; p = 0.848) and substantial satisfaction rates (SER: 66.7%, CLO: 60.4%; p = 0.753). No side effects were reported. Of 60 participants who gave birth at Siriraj Hospital, there were no significant differences in pregnancy outcomes. Repeated SER dosing eradicated symp