FLAGYL ® Metronidazole

FLAGYL ® is a Metronidazole based drug

THERAPEUTIC GROUP: Antiprotozoans - Antimicrobial gynecological antiseptics

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

Indications FLAGYL ® Metronidazole

FLAGYL ® is used in the gynecological field in the treatment of urethritis and vaginitis supported 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 since it is activated by reduction of the nitrogroup by the target microorganism in an anionic nitroradical.

This new highly reactive chemical species 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 for other anaerobic protozoa such as Giardia or Etamoeba rather than towards obligate anerobic bacteria such as Bacteroides or microaerophilic bacteria such as Campylobacter and Helicobacter.

Both use in vaginal ovules and in tablets for oral use, allows the active principle, 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 infections.

Studies carried out and clinical efficacy

METRONIDAZOLE RESISTANT TRICHOMONAS VAGINALIS STRIPS

Zhongguo Ji Sheng Chong Xue Yu Sheng Ji Chong Bing Za Zhi. 2012 Jun 30; 30 (3): 210-3.

Work denouncing the appearance of Metronidazole-resistant Trichomonas Vaginalis strains probably due to the onset of new mutations.

These strains could be responsible for particularly serious clinical pictures.

NEW METHODS OF RELEASING METRONIDAZOLE

Arzneimittelforschung. 2012 Oct; 62 (10): 490-5 ..

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 (2): 74-8.

Case report that reveals the appearance of some of the most feared side effects related to the use of Metronidazole, such as encephalopathy, in patients with a history of neurological deficits.

These works highlight the importance of warnings for the use of this drug.

Method of use and dosage

FLAGYL ®

Metronidazole 250 mg coated tablets;

Eggs for vaginal use of 500 mg of Metronidazole.

Although the specific dosage should be defined by the physician based on the clinical and physiopathological characteristics of the patient, the maximum oral dose of Metronidazole is 2 grams per day divided into at least 4 administrations.

Vaginal ovule therapy, on the other hand, should be prolonged for about 10 days with a vaginal egg a day.

Warnings FLAGYL ® Metronidazole

Although FLAGYL ® therapy is generally well tolerated, in order to guarantee maximum safety and maximum efficacy it would be advisable to request medical supervision during the entire treatment.

Particular caution should be used in the use of this drug for 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 hematological picture.

FLAGYL ® in tablets contains lactose, therefore it is contraindicated in patients with lactase enzyme deficiency, glucose-galactose malabsorption syndrome and lactose intolerance.

The possible reddish colouration of the urine would be due to the characteristic pigmentation of the active ingredient.

PREGNANCY AND BREASTFEEDING

Given the ability of Metronidazole to pass through both placental and mammary 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 the possible drug interactions, it would be advisable to avoid alcohol and lithium intake during FLAGYL ® therapy given the increased risk of serious side effects.

Contraindications FLAGYL ® Metronidazole

FLAGYL ® is contraindicated in patients who are hypersensitive to the active ingredient or to one of its excipients, during pregnancy and lactation and in subjects with haematological and neurological diseases.

Undesirable effects - Side effects

Metronidazole therapy could lead to the appearance of 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 has been described, characterized by vomiting, headache and cramping abdominal pain.