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Trexen Duo 100-400mg 10 Ovules, Clindamycin Phosphate, Ketoconazole
THIS IS A BRAND MEDICATION
THERAPEUTIC INDICATIONS: Antibiotic and antifungal vaginal.
TREXEN DUO ® for antibiotic action is indicated for the treatment of bacterial vaginosis caused by Bacteroides spp, Gardnerella vaginalis, Mobiluncus spp, Mycoplasma hominis and other anaerobes.
For its antifungal action is indicated for the treatment of vaginal candidiasis and mixed vaginitis. The ovules of TREXEN DUO ® is a soft gelatin capsule, hydrophilic, containing clindamycin and ketoconazole cream, ovules TREXEN DUO ® dissolves with temperature and humidity of the vagina.
Pharmacokinetics in Humans: TREXEN DUO ® is clindamycin plus ketoconazole in a formulation for vaginal ovules with an antibacterial and antifungal action both specially designed for the etiological treatment of vaginal infections more common in women, bacterial vaginosis, candidiasis vaginal and mixed vaginitis.
Clindamycin is a semisynthetic derivative of lincomycin with antibiotic action against various strains of gram positive aerobic organisms such as Gardnerella vaginalis and Streptococcus viridans, microaerophilic gram-negative and anaerobic bacteria such as Bacteroides fragilis, Mobiluncus spp, Fusobacterium, within which the germs are responsible of bacterial vaginosis.
Clindamycin phosphate is inactive until it is hydrolyzed to yield free clindamycin, enzymes, phosphatases, the vaginal mucosa rapidly hydrolyze the drug after topical application.
Clindamycin has bactericidal action since it binds exclusively to the 50S subunit of bacterial ribosomes and suppresses protein synthesis. When administered clindamycin egg formulation reaches systemic absorption averaged 30%, compared with the vaginal cream reaches only 4%.
The distribution and elimination after an intravaginal application have not been fully identified, however, appears to be systemic half-life between 1.5 and 2.6 hours and is eliminated by the self-purifying mechanisms of the vagina.
Ketoconazole is an antifungal azoles group, a synthetic derivative of imidazole, with fungistatic and fungicidal action depending on the dose.
Like others in this group antifungal, ketoconazole inhibits ergosterol synthesis by blocking the demethylase lanosterol 14-alpha-dependent cytochrome P-450 is necessary to convert lanosterol to ergosterol.
Ergosterol is an essential component of the cytoplasmic membrane, by inhibiting its synthesis disrupts the membrane causing increased permeability resulting in a loss of cellular components, producing a fungistatic action.
At higher concentrations, ketoconazole may have direct physicochemical action on the cell membrane miceto, exerting a fungicide. Ketoconazole in vitro, prevents the formation of pseudohyphae in Candida, facilitating the phagocytosis of polymorphonuclear fungus.
Ketoconazole has a broad spectrum of activity including yeasts and dermatophytes.
Yeasts: Candida albicans, C. tropicalis, Malassezia ovale.
Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouinii, M. gypseum and Epidermophyton floccosum.
Ketoconazole applied vaginally has minimal systemic absorption. Plasma concentrations in women receiving 400 mg of ketoconazole ranging from 4 to 20.7 micrograms / ml.
Because ketoconazole applied vaginally hardly reaches the circulation, does not undergo biotransformation and is eliminated by self-cleansing mechanisms of the vagina.
CONTRAINDICATIONS: A history of hypersensitivity to clindamycin, lincomycin, ketoconazole, azole antifungal and any components of the formula.
PRECAUTIONS:
Warnings: Sexual abstinence is recommended during treatment with this product, avoid douching and using tampons.
Use in Pregnancy and Lactation: No adequate and well controlled studies in pregnant women during the first quarter.
Because animal reproduction studies are not always forecast the human response, this drug should not be used during the first trimester of pregnancy unless the physician's judgment absolutely necessary.
Lactation It is not known whether clindamycin or ketoconazole are excreted in human milk after vaginal administration due to low absorption. However, oral or parenteral, has detected the presence of clindamycin and ketoconazole in breast milk.
Hence it is decided to discontinue nursing or treatment.
ADVERSE REACTIONS: The administration of vaginal clindamycin has been associated with the following clinical manifestations, even though there have been found entirely your responsibility.
In genital tract: Cervicitis / vaginitis symptomatic candidiasis, trichomoniasis, vaginal and vulvar irritation.
With the administration of ketoconazole vaginally have reported few cases of local irritation, itching and burning, especially when starting treatment.
For low absorption of clindamycin and ketoconazole administered vaginally have not been observed systemic adverse reactions.
The soft gelatin capsule, ovule TREXEN DUO ® contains red dye no. 6 which can cause allergic reactions.
DRUG INTERACTIONS AND OTHER GENDER: Clindamycin shows cross-resistance to lincomycin and antagonistic effect in vitro with erythromycin.
CHANGES IN RESULTS OF LABORATORY TESTS: There have been demonstrated.
PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: Systemic absorption of clindamycin as much of ketoconazole applied vaginally is minimal.
In vitro studies utililizando ketoconazole and clindamycin have shown that drugs are mutagenic.
It has been reported that ketoconazole and clindamycin administered vaginally are carcinogenic or teratogenic, they have no effect on fertility.
DOSAGE AND ADMINISTRATION:
The dose of TREXEN DUO ® is a vaginal ovule, once daily, preferably at bedtime for 7 consecutive days in pregnant patients and 5 days pregnant patient, except better opinion of the treating physician.
REPRESENTATIONS AND MANAGEMENT Overdosage: There are no reports regarding the presence of overdose with this product.
- Drug Name: Duo Trexen
- Brand comparison: Trexen Duo
- Active ingredient: clindamycin phosphate /
- ketoconazole
- Presentation: Ovules
- Concentration: 100-400mg
- Response time: No
- Laboratory Asofarma, S. A. de CV
- Egg Box with 7 ovules
- Manufactured in: Mexico
