MacMiror Complex suppositories vaginal 8 pieces
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Active ingredients
Nystatin + Nifuratel
Release form
Suppositories
Composition
Nifuratel 500 mg; nystatin 200 thousand IU. Excipients: dimethylpolysiloxane AK 1000 (dimethicone) 960.0 mg. Shell composition: gelatin 351.0 mg, glycerin (glycerol) 171.0 mg, ethyl parahydroxybenzoate 1.8 mg, propyl parahydroxybenzoate 1.0 mg, titanium dioxide 0.4 mg, yellow iron 2.4 mg
Pharmacological effect
Antimicrobial drug for local use. It has antiprotozoal, antifungal and antibacterial effects. Nifuratel is a derivative of nitrofuran that is highly active against a number of bacteria, fungi and protozoa (including Trichomonas vaginalis). Nystatin is an antifungal antibiotic of the polyene group. Binding to the sterols in the cell membrane of fungi, violates its permeability, which leads to cell death. Highly active against Candida albicans. The combination of nifuratel and nystatin allows to achieve a more pronounced antifungal action and significantly expand the spectrum of antimicrobial action. caused by the specific treatment of trichomoniasis. The Complex does not violate the physiological flora, which allows to avoid Vitia dysbiosis and quickly restore normotsenoz vagina.
Pharmacokinetics
Studies have confirmed that with vaginal use in animals (rabbits and dogs) with the re-introduction of a daily dose, which is 30 times higher than the therapeutic dose, the substances that make up the drug do not have a systemic effect. The studies of the pharmacokinetics of the drug in humans also confirm that when used intravaginally, the drug is practically not absorbed from the surface of the vaginal mucosa and has no systemic effect. The concentration of nifuratel in the blood plasma is below the limit quantitation. The maximum concentration (Cmax) 4.54 ng / ml; the time to reach the maximum concentration (Tmax) 8.0 h; integral area under the pharmacokinetic curve concentration-time (AUC) 10.27 ng ml-1 h. Nystatin is not absorbed through the skin and mucous membranes when applied topically.
Indications
Vulvovaginal infections caused by pathogens sensitive to the drug: incl.bacterial vaginitis, vaginal trichomoniasis; vaginitis caused by fungi of the genus Candida, mixed vaginitis.
Contraindications
Hypersensitivity to nifuratel, nystatin or any excipient of the drug; childhood.
Precautionary measures
It is necessary to conduct simultaneous treatment of the sexual partner because of the danger of re-infection. During the period of drug treatment should avoid sexual contact.
Use during pregnancy and lactation
Use of the drug during pregnancy is possible if the potential benefit to the mother outweighs the risk to the fetus or baby. It can be used during breastfeeding, because the drug is practically not absorbed through the mucous membranes, so it does not penetrate into breast milk.
Dosage and administration
Intravaginal: 1 vaginal suppository is administered daily in the evening before bedtime for 8 days or in accordance with the recommendations of the doctor. If necessary, treatment can be repeated after menstruation. To achieve the maximum effect, the suppository is inserted deep into the vagina.
Side effects
Allergic reactions in the form of a skin rash or itching may occur. With the development of allergic reactions, the use of the drug should be discontinued.
Overdose
No cases of drug overdose have been reported.
Interaction with other drugs
The clinically significant interaction of MacMiror Complex with other drugs has not been established.
special instructions
Suppositories are not used for treatment in children, if necessary, use of the drug in this category of patients, it is recommended to use the drug MacMiror Complex in the dosage form vaginal cream, complete with applicator (graduated syringe). The presence of a special nozzle allows you to enter the cream without damaging the hymen. Influence on the ability to drive vehicles, mechanismsThe use of the drug does not affect the ability to drive vehicles and other activities requiring increased attention.