VAGILEN ® Metronidazole

VAGILEN ® is a drug based on Metronidazole

THERAPEUTIC GROUP: Gynecological anti-infectives and antiseptics - imidazole derivatives

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications VAGILEN ® Metronidazole

VAGILEN ® is a drug intended for the treatment of symptoms caused by infections of Trichomonas vaginalis in both men and women.

Mechanism of action VAGILEN ® Metronidazole

Metronidazole, the active ingredient of VAGILEN ®, is an imidazole derivative known for its strong antibacterial activity directed against Gram negative and Gram positive anaerobic bacteria and especially towards different protozoa such as Trichomonas Vaginalis.

Its antimicrobial chemotherapy activity is due to its ability, once metabolized by pathogenic microorganisms, to interact with DNA, thanks to its marked reactivity, forming functionally inactive nitroradical complexes and thus compromising the replicative and synthetic capacities of the pathogen.

This activity is also facilitated by the excellent pharmacokinetic properties that allow the drug taken orally to be absorbed intensively at the intestinal level, with an excellent bioavailability, and with the consequent excretion at the renal level.

The same activity is also observed following local applications of Metronidazole, which, although drastically reducing the amount of systemically absorbed drug, are able to guarantee a high therapeutic effect concentrated in the application site.

Studies carried out and clinical efficacy

METRONIDAZOLE: FIRST CHOICE DRUG IN THE TREATMENT OF PROTOZOARY INFECTIONS

Clin Infect Dis. 2010 Jan 1; 50 Suppl 1: S16-23.

Work demonstrating that Metronidazole is still the drug of first choice for over 35 years in the treatment of gynecological infections sustained by anaerobic microorganisms rather than by Protozoa.

METRONIDAZOLE IN THE TREATMENT OF TRICHOMONIASIS IN POSITIVE HIV PATIENTS

J Acquir Immune Defic Syndr. 2010 Dec 15; 55 (5): 565-71.

Clinical trial demonstrating that treatment with Metronidazole for 7 days is more effective than the single dose in the control of Trichomonas vaginalis infections in HIV-infected patients.

METRONIDAZOLE RESISTANCE MECHANISMS

Iran J Parasitol. 2012; 7 (3): 24-30.

Molecular study demonstrating that the Metronidazole resistance mechanisms of T.vaginalis are not so much associated with point genetic variations, but rather with the modulation of different bacterial metabolic pathways such as to avoid transformation into active metabolites.

Method of use and dosage

VAGILEN ®

Ovum for vaginal use of 500 mg of Metronidazole;

Metronidazole 250 mg oral capsules.

The expected therapeutic pattern of Trichomoniasis varies according to the sex of the patient and the severity of the clinical picture.

In women it is possible to resort to the use of vaginal ovules, generally 1 or 2 per day, while in men the oral use of 1 or 2 daily capsules can be used.

In both cases it would be advisable to maintain the overall dosage within 2 grams of Metronidazole per day.

Warnings VAGILEN ® Metronidazole

Although the use of VAGILEN ® is generally safe and free of clinically relevant side effects, it would be advisable to consult your doctor rather than the gynecologist before starting therapy.

Particular caution in the use of this drug should be reserved for patients suffering from liver, kidney, hematologic and tumor diseases.

It is also important to remember the photosensitizing effect of Metronidazole which could increase the risk of burns or burns in patients being treated exposed to ultraviolet radiation.

PREGNANCY AND BREASTFEEDING

The ability of Metronidazole, taken both orally and vaginally, to cross the blood-placental barrier and the breast filter, exposing itself to the fetus in pharmacologically active concentrations, inevitably extends the contraindications also to pregnancy and the subsequent period of breastfeeding.

Interactions

Although the pharmacokinetic properties of Metronidazole are such as to limit potential pharmacologically active interactions, it would be advisable to avoid the simultaneous alcohol intake given the risk of developing gastro-intestinal and urogenital symptoms known as disulfiram-like syndrome.

Contraindications VAGILEN ® Metronidazole

The use of VAGILEN ® is contraindicated in patients who are hypersensitive to Metronidazole or to any of its excipients contained in the drug, during pregnancy and lactation.

Undesirable effects - Side effects

The use of VAGILEN ® could cause the appearance of nausea, diarrhea, abdominal cramps, headache and only rarely alterations in the hematological picture.

The topical use of Metronidazole, on the other hand, is often associated with the appearance of local symptoms such as dry skin, erythema, itching and only rarely incontinence.