Gainomax suppositories 150 + 100mg, No. 7
Russian Pharmacy name:
Гайномакс суппозитории 150+100мг, №7
Intravaginally.
The drug is prescribed for 1 vaginal suppository at night for 7 days. Alternative regimen: 1 vaginal suppository 2 times a day (morning and night) for 3 days.
Vaginal suppositories should be inserted deep into the vagina using the disposable fingertips provided in the package.
Elderly patients
When prescribing the drug to elderly patients (over 65 years of age), changes in the dosage regimen are not required.
Vaginal suppositories are yellowish, flat with a rounded end in the form of a truncated ellipse.
1 supp.
thioconazole 100 mg
tinidazole 150 mg
Excipients: witepsol 2250.0 mg.
organic diseases of the nervous system at present or in history;
leukemia, hematopoietic disorders;
I trimester of pregnancy, lactation period;
virginity, age up to 18 years;
hypersensitivity to active ingredients or their derivatives, other components of the drug.
pharmachologic effect
Gainomax is a combination of thioconazole and tinidazole. Thioconazole 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 thioconazole is to increase the permeability of the cell membrane of the fungus 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. In clinical studies, it was shown that thioconazole is more effective than miconazole both in clinical terms (98% and 78%, respectively) and microbiologically (eradication of the pathogen in 76% and 67% of cases, respectively). In addition, the administration of thioconazole in comparison with 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, Pacteroides spp., Clostridium spp., Clostridium spp., Clostridium spp. spp.).
The mechanism of action of tinidazole is not fully understood. The 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 is more active in anaerobes than in aerobes, although tinidazole penetrates the cell membranes of both. During the reduction reaction, active intermediate substances 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 hypersensitive to tinidazole.
According to clinical studies, the effectiveness of the combination of thioconazole with tinidazole with intravaginal administration is 90-100%, while the recovery according to the microbiological criterion is 85%.
Pharmacokinetics
With intravaginal use, both thioconazole and tinidazole are not significantly absorbed. Thus, the absorption of the two drugs in combination should be low.
Side effect
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 a cream or vaginal tablets, clinical and microbiological parameters were evaluated in a total of 348 patients, both dosage regimens were evaluated (3 or 7 days).
According to the research 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 discontinued treatment due to allergic reactions.
Post-marketing experience of application.
In the post-marketing practice of using the drug, the following adverse events were additionally reported:
Local reactions: rarely - edema, irritation of the vaginal mucosa.
From the side of the central nervous system and peripheral nervous system: rarely - headache,
fatigue. ...
From the urinary system: rarely - darkening of the urine.
Allergic reactions: rarely - skin rash, urticaria, in some cases - angioedema.
Although no cases of transient leukopenia were observed with intravaginal use of a combination of thioconazole with tinidazole, cases of this symptom associated with neurological or gastrointestinal symptoms associated with systemic use of tinidazole have been described.
Application during pregnancy and lactation
Tinidazole crosses 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 the drug Gainomax is contraindicated in the first trimester of pregnancy. During treatment with Gainomax, breastfeeding should be discontinued. The use of the drug Gainomax in the third trimester of pregnancy should be assessed by the attending physician from the standpoint of the ratio of the potential benefits to the mother and the possible risks to the fetus.
Application in children
Contraindicated in children under 18 years of age, virgins.
Use in elderly patients
When prescribing the drug to elderly patients (over 65 years of age), changes in the dosage regimen are not required.
special instructions
Despite the fact that clinical studies did not reveal persistent hematological disorders during the use of the drug, tinidazole should not be taken by patients with diseases of the hematopoietic system (leukemia, hematopoietic disorders) at the present time or in history.
Gainomax should not be used simultaneously with mechanical contraceptives (condoms, contraceptive caps or diaphragms), because the suppository base may react with the latex base of these agents.
Alcohol intake should be excluded during the drug intake, as well as within 2 days after taking the last dose. The drug should not be stored in the refrigerator.
Influence on the ability to drive vehicles and use mechanisms
Taking the drug Gainomax does not affect the ability to drive vehicles and mechanisms.
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 performed.
Drug interactions
The simultaneous intake 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 in the composition 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.