Expiration date: 02/2025

Structure and Composition:

Vaginal Tablets. 1 tablet contain:

Metronidazole 100 mg

miconazole nitrate 100 mg

Excipients: Sodium lauryl sulfate Colloidal silicon dioxide magnesium stearate, povidone, sodium hydrogencarbonate tartaric acid sodium carboxymethylstarch (type A), crospovidone, lactose monohydrate hypromellose

contour bezgyachakova packing 10 pcs. In the paper cartons 1 pack.

Description pharmaceutical form:

Lenticular vaginal tablets oval with a pointed tip, almost white, engraved with "100" on one side.

Pharmacokinetics:

Metronidazole. In intravaginal application is absorbed into the systemic circulation. Cmax in the blood is determined 6-12 hours and approximately 50% of the Cmax, which is achieved (1-3 hours) after a single dose equivalent dose metronidazole inside.

Miconazole. Systemic absorption of miconazole nitrate after intravaginal application is limited. After 8 h after drug application miconazole 90% is still present in the vagina. Unmodified miconazole or undetectable in plasma or in urine.

Description of the pharmacological actions:

The mechanism of action of metronidazole is in biochemical restoration of 5-nitro intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5-nitro interacts with DNA microbial cells by inhibiting the synthesis of nucleic acids, which leads to the death of microorganisms.

Metronidazole - antimicrobial and protivoprotozoynoe broad spectrum of action. It is active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis and against obligate anaerobes (sporo- and asporogenous) - Bacteroides spp. (Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Eubacterium sensitive strains. Metronidazole-insensitive aerobic microorganisms and facultative anaerobes.

Miconazole has antifungal activity relative to the normal dermatophytes, yeasts and fungi and various other antibacterial activity against certain Gram-positive bacteria.

Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of the other components in the lipid membrane, which leads to the death of the fungal cells. Quickly removes itching often accompanies the infection caused by dermatophytes and yeasts. It does not change the composition of flora and vaginal pH.

Indications:

• Trichomonas, Candida and nonspecific vaginitis (topical treatment).
  

Contraindications:

• Hypersensitivity to the drug's components (including other nitroimidazole derivatives)
  
• blood diseases, leukopenia (including history)
  
• incoordination, organic CNS (including epilepsy)
  
• hepatic insufficiency (in the case of the appointment of large doses)
  
• pregnancy
  
• during breastfeeding.
  

Carefully:

• diabetes
  
• microcirculation disturbance.
  

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effect:

Local: itching, burning, pain and irritation in the vagina thick, white, mucous discharge from the vagina, odorless or with a faint odor, frequent urination burning sensation or irritation of the penis in the sexual partner.

From the digestive tract: nausea, change in taste, "metallic" taste and dry mouth, decreased appetite, cramping abdominal pain vomiting, constipation or diarrhea.

Allergic reactions: rash, itching, skin rash.

From the nervous system: headache, dizziness.

Other: leukopenia or leukocytosis. In rare cases - urine staining in red-brown color (due to the presence of water-soluble pigment produced in the metabolism of metronidazole).

Drug Interactions:

As disulfiram causes intolerance of ethanol. Concomitant use with disulfiram may lead to the development of various mental disorders, depression of consciousness.

It enhances the effect of indirect anticoagulants (warfarin, etc.), Which leads to increased formation of prothrombin time.

Do not combine with non-depolarizing muscle relaxants (vecuronium bromide).

Co-administration with barbiturates may accelerate the elimination of metronidazole, resulting in reduced its effect.

Metronidazole, cimetidine inhibits metabolism, which may lead to an increase in its concentration in the serum and an increased risk of side effects.

When concomitantly with drugs lithium may increase the concentration of the latter in plasma.

Dosage and administration:

Intravaginal (deep), pre-moistened with water pill.

Trichomonas vaginitis - 1 table. per day for 10 days in combination with taking into metronidazole.

The nonspecific vaginitis or Candida vaginitis - 1 table. Two times a day for 10 days, optionally in combination with metronidazole reception inside.

metronidazole treatment should not last more than 10 days and recur more often than 2-3 times a year.

Special instructions:

To the simultaneous treatment of the sexual partner, no matter if they have any symptoms of disease.

During the period of treatment should refrain from sexual intercourse.

When specifying a history of changes in the peripheral blood, as well as when using the drug in high doses and / or long-term use it is necessary to monitor blood count.

Metronidazole can be immobilized Treponema, which leads to false positive test Nelson.

Be wary of during the drivers of vehicles and people skills relate to the high concentration of attention (may cause dizziness associated with taking the drug).