FLAGYL ® is a Metronidazole-based drug
THERAPEUTIC GROUP: Antiprotozoals - Gynecological antiseptic antimicrobials
Indications FLAGYL ® Metronidazole
FLAGYL ® is used in the gynecological field in the treatment of urethritis and vaginitis caused by Trichomonas vaginalis.
Mechanism of action FLAGYL ® Metronidazole
FLAGYL ® is a drug based on Metronidazole, an active ingredient that can be defined as a prodrug as it is activated by the reduction of the nitro group by the target microorganism in an anionic nitroradical.
This new chemical species, highly reactive, is able to interact with the DNA of the microorganism, forming chemical complexes that undermine its integrity, thus compromising the viability of the pathogenic species.
The efficacy of Metronidazole has been demonstrated not only for protozoa such as Trichomonas vaginalis but also against other anaerobic protozoa such as Giardia or Etamoeba rather than against obligate anerobic bacteria such as Bacteroides or microaerophiles such as Campylobacter and Helicobacter.
Both the use in vaginal ovules and in tablets for oral use, allows the active ingredient, following a very high intestinal absorption, to reach intact the lower genital and urinary tracts where, in the presence of the pathogen, it carries out its therapeutic action without altering the normal resident flora, important in protecting the environment from further infection.
Studies carried out and clinical efficacy
STRAINS OF TRICHOMONAS VAGINALIS RESISTANT TO METRONIDAZOLE
Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi. 2012 Jun 30; 30: 210-3.
Mycoplasma hominis symbiosis and Trichomonas vaginalis metronidazoleresistance.
Wang PJ, Xie CB.
Work that denounces the emergence of Trichomonas Vaginalis strains resistant to Metronidazole probably thanks to the onset of new mutations.
These strains could be responsible for particularly serious clinical pictures.
NEW METRONIDAZOLE RELEASE METHODS
Arzneimittelforschung. 2012 Oct; 62: 490-5 ..
Metronidazole immediate release formulations: a fasting randomized open-label crossover bioequivalence study in healthy volunteers.
de Freitas Silva M, Schramm SG, Kano EK, Koono EE, Manfio JL, Porta V, dos Reis Serra CH.
Clinical trial that tests innovative methods of Metronidazole release, able to optimize the pharmacokinetic properties of the active ingredient, thus reducing the doses necessary to reproduce an adequate therapeutic effect.
METRONIDAZOLE ENCEPHALOPATHY
Acta Neurol Taiwan. 2012 Jun; 21: 74-8.
Metronidazole-induced Encephalopathy: Case Report and Review Literature.
Huang YT, Chen LA, Cheng SJ.
Case report that denounces the appearance of some of the most fearful side effects related to the use of Metronidazole, such as encephalopathy, in patients with a previous history of neurological deficits.
These works emphasize the importance of warnings on the use of this drug.
Method of use and dosage
FLAGYL ®
Coated tablets of 250 mg of Metronidazole;
Ovules for vaginal use of 500 mg of Metronidazole.
Although the specific dosage should be defined by the doctor based on the clinical and pathophysiological characteristics of the patient, the maximum oral dose of Metronidazole is that of 2 grams per day divided into at least 4 administrations.
Vaginal ovum therapy, on the other hand, should be prolonged for about 10 days with one vaginal ovum per day.
FLAGYL ® Metronidazole warnings
Although FLAGYL ® therapy is generally well tolerated, in order to ensure maximum safety and maximum efficacy, medical supervision should be sought throughout the treatment.
Particular caution in the use of this drug should be given to patients suffering from liver and kidney diseases, remembering that if it is necessary to prolong the treatment beyond the normal 10 days, the doctor should periodically check the degree of liver function and the haematological picture.
FLAGYL ® in tablets contains lactose, therefore it is contraindicated in patients with lactase enzyme deficiency, glucose-galactose malabsorption syndrome and lactose intolerance.
Any reddish coloring of the urine would be due to the characteristic pigmentation of the active principle.
PREGNANCY AND BREASTFEEDING
Given the ability of Metronidazole to cross both the placental and breast filters, concentrating in pharmacologically active doses, it would be advisable to avoid taking this drug during pregnancy and in the subsequent breastfeeding period.
Interactions
Although Metronidazole has particularly advantageous pharmacokinetic characteristics, such as to minimize possible drug interactions, it would be advisable to avoid the intake of alcohol and lithium during therapy with FLAGYL ® given the increased risk of onset of serious side effects.
Contraindications FLAGYL ® Metronidazole
FLAGYL ® is contraindicated in patients hypersensitive to the active substance or to one of its excipients, during pregnancy and lactation and in subjects with haematological and neurological pathologies.
Undesirable Effects - Side Effects
Metronidazole therapy could lead to headache, nausea, dry mouth, metallic taste, dizziness, convulsions, neuropathies, and hypersensitivity reactions such as itching, vasomotor changes, urticaria and very rarely epidermal necrolysis.
In rare cases, especially in conjunction with alcohol intake, a syndrome known as disulfiram-like, characterized by vomiting, headache and cramping abdominal pain, has been described.
Note
FLAGYL ® is a drug subject to mandatory medical prescription.
The information on FLAGYL ® Metronidazole published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
