FORTEGYN

FORTEGIN

 

Dosage form: vaginal suppositories

Composition: One vaginal suppository contains active substances:

metronidazole micronized 300.00 mg;

miconazole nitrate micronized 100.00 mg;

neomycin sulfate 48.80 mg;

polymyxin sulfate 4.40 mg;

Centella asiatica 15.00 mg.

Pharmacotherapeutic group: Combined antimicrobial, antiprotozoal, antifungal and refreshing drug for topical use.

ATX code G01AX.

Pharmacological properties

Metronidazole is a 5-nitroimidazole derivative that has antiprotozoal and antimicrobial effects.
The mechanism of action is the biochemical reduction of the 5-nitro group of metronidazole by 
intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group 
of metronidazole interacts with the DNA of microorganisms, inhibiting its synthesis, which leads to the death of bacteria.

Active against Trichomonas vaginalis, Entamoeba histolytica, as well as obligate anaerobes Bacteroides spp. 
(including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), 
Fusobacterium spp., some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.).

Miconazole nitrate, a derivative of imidazole and triazole, has an antifungal effect: it inhibits the synthesis 
of ergosterol in the cell membrane. Active against dermatophytes, yeast and some other fungi. Shows antimicrobial activity 
against gram-positive microorganisms. Does not change the composition of the microflora and pH of the vagina.

Neomycin sulfate is a broad-spectrum antibiotic from the aminoglycoside group. Has a bactericidal effect against gram-positive 
(Staphylococcus spp., Streptococcus pneumoniae) and gram-negative (Escherichia coli, Shigella dysenteria spp.,
Shigella flexneri spp., Shigella boydii spp., Shigella sonnei spp., Proteus spp.) microorganisms.
The mechanism of the bactericidal action of neomycin is associated with the effect on ribosomes and
 inhibition of protein synthesis in the bacterial cell. Inactive against Streptococcus spp. Resistance of microorganisms to neomycin develops slowly and to a small extent.

Polymyxin sulfate is an antibiotic produced by spore-forming bacteria Bacillus polymixa.
It has a bactericidal effect associated with disruption of the integrity of the microbial cell membrane.
 Absorbed on phospholipids of the membrane, increases its permeability, causes lysis of bacteria.
Active against gram-negative microorganisms: Pseudomonas aeruginosa, Salmonella spp., Shigella spp.,
Escherichia coli, Klebsiella spp., Bordetella pertussis, Haemophilus influenzae, Enterobacter. 
Fusobacteria and bacteroides (Bacteroides fragilis) are moderately sensitive. Does not affect coccal aerobic 
(Staphylococcus spp., Streptococcus spp., including Streptococcus pneumoniae, Neisseria gonorrhoeae, Neisseria meningitidis)
and anaerobic microorganisms, most strains of Proteus spp., Mycobacterium tuberculosis, Corynebacterium diphtheriae and fungi.

Centella asiatica has a wound healing effect, stimulates the process of granulation and collagen formation, and promotes epithelization.

Indications for use:

-vulvitis;

-vaginitis;

-vulvovaginitis;

-cervicovaginitis;

-candidiasis;

-leukorrhea.

Directions for use and dosage:

1 candle per day, before bedtime. Inserted deep into the vagina in a lying position after evening toilet. Duration of treatment is 5–10 days.

Release form

Vaginal suppositories. 6 candles are placed in a contour cell packaging made of polyvinyl chloride film. 
1 blister pack along with instructions for medical use is placed in a cardboard box.

Best before date

3 years.

Should not be used after the expiration date.




Conditions for dispensing from pharmacies

On prescription.




Manufacturer:

Laboratorios Temis Lostaló S.A.

Zepita 3178, C1285ABF, Cuidad Autónoma de Buenos Aires, Argentina.