Gynomax®
Embil Pharmaceutical
833 Items
2019-09-19
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Clinical Pharmacology
After a single injection of 300 mg of thioconazole in the form of a vaginal suppository of patients with vaginal candidiasis, the average concentration of the drug in plasma was 21.2 ng / ml after 8 hours of administration, and a day later it was below the detection limit.
The average concentration in the vaginal secretion was 21.4 mg / l through
24 h after injection.
The average concentration of thioconazole (91.4 mcg / ml) in the vaginal secretion was in the MIK90 range (1-64 mcg / ml) for the absolute majority of fungal and bacterial pathogens within 72 hours after a single injection of 300 mg of thioconazole.
When administered intravaginally, only 10% of tinidazole was subjected to systemic absorption (compared with oral administration).
T1 / 2 tinidazole -14.0 -14.7 h, and the total clearance - 40.3-47.6 ml / min.
With intravaginal use, both thioconazole and itinidazole are slightly absorbed. Thus, the absorption of dvuhpreparatov in combination should be low.
Pharmacodynamics
The drug Gaynomaks®, vaginal suppositories is a combination of thioconazole itinidazole.
Thioconazole is a synthetic antifungal agent with a high activity against yeast-like and other fungi (dermatophytes). It is also effective against bacterial pathogens: Trichomonas vaginalis, Gardnerellavaginalis, Bacteroides spp., Some gram-positive bacteria (including Staphylococcus and Symptocrosis, which is a replication of the Symphocytosis spp., Some gram-positive bacteria (including Staphylococcus Syrottocrosis, 4).
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 violates the intracellular ionic balance, which leads to cell death.
Tichodos .).
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 through 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, as a rule, is characteristic of the group of 5-nitroimidazoles, 65-70% of the strains of metronidazole high-resistant to Trichomonas vaginalis are hypersensitive to ctinidazole.
The effectiveness of the combination of thioconazole with tinidazole and intravaginal administration is 90-100%, while the recovery by microbiological criterion is 85%.
Indications
- treatment of vaginitis caused by Candida, Trichomonas and Gardnerella genera
- treatment of vaginitis of mixed infectious etiology
Composition
1 suppository contains
active substances: thioconazole 100.00 mg, tinidazole 150.00 mg,
excipient - witepsol S55.
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Dosage and Administration
Intravaginally.
The drug is prescribed 1 vaginal suppository at night for 7 days. Alternative regimen: 1 vaginal suppository 2 times a day (in the morning and at night) for 3 days.
Vaginal suppositories should be inserted deep into the vagina using disposable fingertips contained in the package.
Adverse reactions
Side effects according to the results of clinical studies. In clinical studies, the combination of 150 mg tinidazole with 100 mg thioconazole in the form of a cream or vaginal tablets, clinical and microbiological indicators were evaluated in total in 348 patients, both regimens were evaluated (3 or 7 days).
According to research results, the safety of this combination was rated 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 mild, only 0.75% of patients discontinued treatment due to allergic reactions.
Post-marketing application experience.
In the post-marketing practice of using the drug, the following adverse events were additionally reported:
Local reactions: rarely - edema, irritation of the mucous membrane of the vagina.
CNS and peripheral nervous system: rarely - headache,
fatigue .
On the part of the urinary system: rarely - dark urine.
Allergic reactions: rarely - skin rash, urticaria, in some cases - angioedema.
Although intravaginal use of the combination of thioconazole with tinidazole showed no cases of transient leukopenia, cases of this symptom associated with neurological or gastrointestinal symptoms associated with the systemic use of tinidazole have been described.
Contraindications
- organic diseases of the nervous system at the present time or in history;
- leukemia, disorders of hemopoiesis;
- I trimester of pregnancy, lactation;
- virginity, age up to 18 years;
- hypersensitivity to the active components or their derivatives, other components of the drug.
Drug interactions
The simultaneous intake of alcohol and tinidazole in the dosage form for systemic action can cause intestinal colic, nausea and vomiting, redness of the skin.
Despite the fact that the use of tinidazole in the composition of vaginal suppositories minimizes the flow of the drug into the systemic circulation, the interaction with alcohol must be considered when prescribing the drug.
Pregnancy and Lactation
Tinidazole penetrates the placental barrier as well as 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. At the time of treatment of drugs Gaynomaks should stop breastfeeding. Use of the drug Gainomax in the third trimester of pregnancy should be evaluated by the attending physician from the position of the ratio of the potential benefits to the mother and the possible risks to the fetus.
Special instructions
Despite the fact that in clinical studies there were no persistent hematological disorders during the use of the drug, tinidazole should not be taken in patients with diseases of the hematopoietic system (leukemia, disorders of hemopoiesis) at present or in history.
The drug Gainomax should not be used simultaneously with the means of mechanical contraception (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 administration of the drug, as well as within 2 days after the last dose. The drug should not be stored in the refrigerator.
Influence on ability to drive motor transport and control mechanisms
Taking the drug Gainomax does not affect the ability to drive vehicles and mechanisms.
Overdosage
In case of accidental ingestion of a large amount of the drug, the stomach is being washed. Specific antidote does not exist, spend symptomatic therapy.
- Brand name: Gynomax
- Active ingredient: Tinidazole, Thioconazole
- Dosage form: Vaginal suppositories.
- Manufacturer: Embil Pharmaceutical
- Country of Origin: Turkey
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