Trexen Duo (Ketoconazole, Clindamycin)

Active Ingredient: Ketoconazole, Clindamycin
Dosage: 100 mg / 400 mg
Route of Administration: Intravaginal
Dosage Form: Suppositories
Quantity per package: 7
Availability: Out of Stock

Why is Trexen Duo Not Used in the USA?

Despite its benefits, Trexen Duo is not used in the USA, largely due to the rigorous FDA approval process that necessitates detailed evidence of safety and efficacy. The U.S. also has a variety of single-agent and combination therapies that have already been extensively studied and approved, making the introduction of a new combination like Trexen Duo less necessary and potentially less economically viable for pharmaceutical companies. Additionally, concerns about resistance development and side effects may also influence regulatory decisions and physician preferences in the U.S. market.

Equivalent Drugs Sold in the USA for Similar Diseases and Symptoms

For Candidiasis and other fungal infections

This drug is used to treat a broad range of antifungal infections in the United States, similar to those treated by Trexen Duo.

What is Trexen Duo?

Trexen Duo is a combination drug containing Tinidazole and Nystatin. It is indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Tinidazole is an antiprotozoal and antibacterial agent effective against anaerobic bacteria and protozoa, and Nystatin is an antifungal medication used to treat fungal infections.

Indications

The drug is indicated in the treatment of bacterial vaginosis caused by Bacteroides spp, Gardnerella vaginalis, Mobiluncus spp, Mycoplasma hominis, as well as other anaerobic germs. Due to its antifungal action, it is indicated in the treatment of vaginal candidiasis and mixed vaginitis.

Where Is Trexen Duo Used?

Trexen Duo is especially popular in countries with higher prevalence rates of fungal infections, particularly in tropical or subtropical regions where such conditions are more common due to the climate. Countries in Latin America, parts of Africa, and some Asian countries might have higher usage rates of this medication.

In all these areas, the combination of Tinidazole and Nystatin provides a comprehensive treatment approach, tackling both protozoal/bacterial and fungal infections simultaneously. This is particularly advantageous in settings where medical diagnosis might be delayed or less precise, allowing for broad-spectrum treatment initiation based on symptoms. Furthermore, the ease of administration (as a single vaginal preparation) can improve patient compliance in regions where healthcare follow-up might be challenging.

Dosage and administration

The dose of Trexen Duo is administered vaginally, once a day, preferably at night at bedtime, for 7 consecutive days in pregnant patients and 5 days in non-pregnant patients unless another scheme is advised by the attending physician.

Contraindications

History of hypersensitivity to clindamycin, lincomycin, ketoconazole, any azolic antifungal and the components of the formula.

Side effects

The administration of Trexen Duo intravaginally has caused some adverse reactions in some cases, although its responsibility has not been fully proven. Patients reported symptomatic cervicitis / vaginitis, candidiasis, vaginal trichomoniasis and vulvar irritation. A few cases of local irritation, pruritus and burning sensation have been reported, especially at the beginning of treatment. Due to the minimal absorption of clindamycin and ketoconazole administered vaginally, no systemic adverse reactions have been observed. It can also cause allergic reactions.

Overdose

Cases of overdose with this product have not been reported.

Interaction

Clindamycin shows cross-resistance with lincomycin and antagonistic effect in vitro with erythromycin.