Gainomax, vaginal suppositories 150mg+100 mg 7 pcs

Mildew (candidiasis), Vaginitis

Indications

treatment of vaginitis caused by pathogens of the genera Candida, Trichomonas and Gardnerella (vaginal candidiasis, Trichomonas vulvovaginitis, Gardnerella vaginitis, nonspecific vaginitis), as well as mixed infection.

Pharmacological effect

Pharmacotherapeutic group: Combined antimicrobial agent (antimicrobial and antiprotozoal agent + antifungal agent)

Pharmacological action

The drug Gaynomax is a combination of tioconazole and tinidazole. Tioconazole is a synthetic antifungal agent with high activity against yeast-like and other fungi (dermatophytes). It is also effective against bacterial pathogens: Gardnerella vaginalis, Bacteroides spp., some gram-positive bacteria (including Staphylococcus and Sreptococcus spp.).

The mechanism of action of tioconazole is to increase the permeability of the fungal cell membrane by inhibiting the synthesis of ergosterol, its main component. An increase in the permeability of the cell membrane disrupts the intracellular ionic balance, which leads to cell death. Clinical studies have shown that tioconazole is more effective than miconazole both clinically (98% and 78%, respectively) and microbiologically (pathogen eradication in 76% and 67% of cases, respectively). In addition, taking tioconazole compared to miconazole was subjectively 2 times more comfortable for patients.

Tinidazole is effective against both protozoal pathogens (Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia) and most anaerobic bacteria (Gardnerella vaginalis, Bacteroides fragilis, Bacteroides melaninogenicus, Bacteroides spp., Clostridium spp., Eubacterium spp., Peptostreptococcus spp. and Veillonella spp.).

The mechanism of action of tinidazole is not fully understood. Reduction of the nitro group is mediated by the ferredoxin system and the low redox potential produced only by anaerobic bacteria. This fact may be the reason that the absorption of tinidazole occurs more actively in anaerobes than in aerobes, although tinidazole penetrates the cell membranes of both. During the reduction reaction, active intermediates are formed and the diffusion gradient increases, which enhances the absorption of tinidazole.

Despite the fact that cross-resistance is usually characteristic of the 5-nitroimidazole group, 65-70% of Trichomonas vaginalis strains highly resistant to metronidazole are hypersensitized to tinidazole.

According to clinical studies, the effectiveness of the combination of tioconazole with tinidazole when administered intravaginally is 90-100%, while recovery according to the microbiological criterion is 85%.

Pharmacokinetics

When administered intravaginally, both tioconazole and tinidazole are only slightly absorbed. Therefore, the absorption of the two drugs in combination should be low.

Special instructions

Despite the fact that in clinical studies no persistent hematological disorders were found during the use of the drug, tinidazole should not be taken by patients with diseases of the hematopoietic system (leukemia, hematopoietic disorders) currently or in history.

The drug Gainomax should not be used simultaneously with mechanical contraception (condoms, contraceptive caps or diaphragms), because The suppository base may react with the latex base of these products.

Alcohol intake should be avoided while taking the drug, as well as for 2 days after taking the last dose. The drug should not be stored in the refrigerator.

Impact on the ability to drive vehicles and machinery

Taking Gainomaxa does not affect the ability to drive vehicles and machines.

Active ingredient

Tinidazole, Tioconazole

Composition

Active substances
tinidazole 150 mg
tioconazole 100 mg
Excipients: solid fat (Vitepsol S55) – 2250 mg.

Pregnancy

Tinidazole penetrates the fetoplacental barrier and also into breast milk. The effects of the components of this drug on the development of the fetus and newborn are not known.

Taking Gainomax is contraindicated in the first trimester of pregnancy. During treatment with Gainomax, breastfeeding should be stopped. The use of Gaynomax in the third trimester of pregnancy should be assessed by the attending physician from the perspective of the relationship between potential benefits for the mother and possible risks for the fetus.

Contraindications

organic diseases of the nervous system currently or in history;
leukemia, hematopoiesis disorders;
I trimester of pregnancy, lactation period;
virginity, age under 18;
hypersensitivity to the active components or their derivatives, other components of the drug.

Side Effects

Side effects according to the results of clinical studies. In clinical studies of the combination of tinidazole 150 mg with thioconazole 100 mg in the form of cream or vaginal tablets, clinical and microbiological parameters were assessed in a total of 348 patients, both dosage regimens (3 or 7 days) were evaluated.

According to the study results, the safety of this combination was assessed as high. The following side effects were observed: allergic reactions (in 3.3-4.5% of cases), local itching (1.9%) and burning sensation (1.7%). In most cases, side effects were moderate, only 0.75% of patients interrupted treatment due to allergic reactions.

Post-marketing experience of application.

In post-marketing practice of using the drug, the following adverse events were additionally reported:

Local reactions: rarely – swelling, irritation of the vaginal mucosa.

From the central nervous system and peripheral nervous system: rarely – headache,
fatigue. .

From the urinary system: rarely – darkening of urine.

Allergic reactions: rarely – skin rash, urticaria, in some cases – angioedema.

Although no cases of transient leukopenia have been reported with intravaginal use of the combination of tioconazole and tinidazole, cases of this symptom associated with neurological or gastrointestinal symptoms associated with systemic use of tinidazole have been described.

Interaction

The simultaneous use of alcohol and tinidazole in a dosage form for systemic action can cause intestinal colic, nausea and vomiting, and redness of the skin.

Despite the fact that the use of tinidazole as part of vaginal suppositories minimizes the entry of the drug into the systemic circulation, interaction with alcohol must be taken into account when prescribing the drug.

Overdose

In case of accidental ingestion of a large amount of the drug, gastric lavage is performed. There is no specific antidote; symptomatic therapy is carried out.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of the reach of children.

Shelf life

Shelf life – 2 years.

Manufacturer

Exeltis Ilach San. Ve Tik. A.S., Türkiye