Gynocaps - instructions for use, doses, side effects, contraindications

Excipients: lecithin purified - 45 mg, beeswax - 144 mg, purified water - 108 mg, sunflower oil - sufficient amount to obtain the contents of a capsule weighing 1800 mg.

Composition of gelatin capsule shell: gelatin 268 mg, glycerol 134 mg, purified water 35 mg, methyl parahydroxybenzoate E-218 0.5 mg, propyl parahydroxybenzoate E-216 0.13 mg, titanium dioxide E-171 1.8 mg, dye: sunset "yellow E-110 - 0.026 mg.

Description:

Capsules soft gelatinous ovoid shape with a pointed end, with a seam, elastic, opaque, light brown in color.

The contents of capsules are an oil suspension from light yellow to dark yellow with inclusions of white color and an odorless odor. During storage, it is possible to exfoliate the mixture.

Pharmacotherapeutic group:Antimicrobial agent combined (antimicrobial and antiprotozoal agent + antifungal agent)

ATX: & nbsp

G.01.A.F Imidazole derivatives

G.01.A.F.20 Combinations of imidazole derivatives

Pharmacodynamics:

Combination drug for intravaginal use, containing metronidazole and miconazole.

Metronidazole - antimicrobial and antiprotozoal drug, a derivative of 5-nitroimidazole. 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 restored 5-nitro group of metronidazole interacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria and protozoa.

Active with respect to Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, as well as obligate anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Eubacter spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). MPK for these strains is 0.125-6.25 μg / ml.

Metronidazole is insensitive to aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against aerobes.

Miconazole - an effective antimycotic agent that exerts its effect, primarily on dermatophytes and yeast fungi. When intravaginal application is active mainly in relation to Candida albicans.

Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, which leads to the death of fungal cells. Miconazole does not change the composition of normal microflora and pH of the vagina.

Pharmacokinetics:

With intravaginal application metronidazole absorbed into the systemic circulation. The maximum concentration of metronidazole in the blood is determined after 6-12 hours and is approximately 50% of the maximum concentration that is reached (in 1-3 hours) after a single dose of equivalent dose of metronidazole inside. Metronidazole penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. The connection with plasma proteins is less than 20%.

Metabolized in the liver by hydroxylation, oxidation and glucuronation. The activity of the main metabolite (2-hydroxymethonidazole) is 30% of the original connection.

It is excreted by the kidneys - 60-80% of the dose of the systemic action drug (20% of this quantity in unchanged form). Metronidazole Metabolite, 2-oximetronidazole, stains urine in a reddish-brown color, due to the presence of a water-soluble pigment formed as a result of metronidazole metabolism. The intestine displays 6-15% of the dose of the systemic drug.

System Absorption miconazole after intravaginal application low.

Rapidly destroyed in the liver. Histohematetic barriers overcome badly. In 8 hours after application of the preparation, 90% of miconazole is still present in the vagina. Unaltered miconazole is not found either in plasma or in urine.

Indications:

Local treatment of mixed etiologies of vaginitis caused simultaneously Trichomonas spp. and Candida spp.

Contraindications:

- Increased individual sensitivity to the components of the drug and other azoles;

- pregnancy (I trimester);

- lactation period;

- leukopenia (including in the anamnesis);

- organic lesions of the central nervous system (including epilepsy);

- liver failure;

- children's age (up to 12 years).

Carefully:FROMdiabetes mellitus, disorders of microcirculation.

Pregnancy and lactation:

Pregnancy

Gynocapsus is contraindicated for use in the first trimester of pregnancy.The use of the drug in the II and III trimesters is possible only in cases where the potential benefit to the mother exceeds the risk to the fetus.

Lactation period

Ginocaps penetrates into breast milk. If you need to use the drug should stop breastfeeding. During the period of breastfeeding, the use of the drug is contraindicated.

Dosing and Administration:

Intravaginal.

1 capsule vaginal is injected deep into the vagina in the evening before going to bed for 10 days in conjunction with taking metronidazole inside.

Side effects:

Local reactions: itching, burning, pain, irritation of the vaginal mucosa; thick, white, mucous discharge from the vagina without smell or with a faint odor, frequent urination; sensation of burning or irritation of the penis in the sexual partner;

From the digestive system: nausea, vomiting, changes in taste, metallic taste in the mouth, decreased appetite, abdominal pain of a spastic nature, diarrhea, diarrhea, constipation;

Allergic reactions: urticaria, itching of the skin, rash;

From the side of the central nervous system: headache, dizziness;

From the hematopoietic system: leukopenia or leukocytosis;

From the genitourinary system: staining the urine in a reddish-brown color causes 2-oxymetronidazole (water-soluble pigment, formed as a result of metabolism of metronidazole).

Overdose:

Data on overdose with intravaginal application of metronidazole are not available. However, with simultaneous use with metronidazole inside, systemic effects can develop.

Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy, leukopenia, darkening of urine. Symptoms of an overdose of miconazole not identified.

Treatment: with the occasional ingestion of a large number of capsules of vaginal gynocaps, if necessary, gastric lavage, the introduction of activated carbon, and hemodialysis may be performed. Metronidazole does not have a specific antidote. Metronidazole and its metabolites are eliminated in hemodialysis.

When any symptoms of an overdose occur, symptomatic and supportive therapy is recommended.

Interaction:

Since systemic absorption of miconazole is low, interaction with other drugs is caused by metronidazole.

Metronidazole compatible with sulfonamides and antibiotics.

With the simultaneous use of alcohol causes reactions like disulfiram (cramping pain in the abdomen, nausea, vomiting, headache, skin hyperemia). It is inadmissible to use together with disulfiram (additive effect, can cause confusion).

The drug may increase the effect of indirect anticoagulants. Prothrombin time can increase, so correction of the dose of indirect anticoagulants is necessary.

It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

Inducers of microsomal oxidation enzymes in the liver (eg, phenytoin, phenobarbital) can accelerate the elimination of metronidazole, which will lead to a decrease in its concentration in the blood plasma.

Cimetidine suppresses the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of side effects.

The concentration of lithium in the blood can increase during the course of treatment with metronidazole,so before using Gynocapsa, you need to reduce the dose of lithium or stop taking it for the duration of treatment.

Special instructions:

The use of alcoholic drinks during the course of therapy with gynocaps is strictly prohibited.

During treatment with Gynocapsus, it is recommended to abstain from sexual intercourse.

Simultaneous treatment of sexual partners is recommended.

When using the drug, minor leukopenia can be observed, so it is advisable to monitor the blood picture (the number of white blood cells) at the beginning and at the end of therapy.

Metronidazole can immobilize treponema, which leads to a false positive TPI test (Treponema Pallidum Immobilization test or Nelson's treponemal test).

Effect on the ability to drive transp. cf. and fur:

When there are side effects from the central nervous system, one should refrain from managing motor vehicles and working with potentially dangerous mechanisms.

Form release / dosage:

Vaginal capsules, 100 mg + 100 mg.

Packaging:

5 capsules per contour squeeze box (blister) made of polyvinylchloride film and aluminum foil printed lacquered.

2 contour squeeze packs (blisters), together with instructions for use, are placed in packs of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

1 year and 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004061

Date of registration:29.12.2016

Expiration Date:29.12.2021

The owner of the registration certificate:MINSKINTERKAPS, UP MINSKINTERKAPS, UP Republic of Belarus

Manufacturer: & nbsp

MINSKINTERKAPS, UP Republic of Belarus

Representation: & nbspMINSKINTERKAPS MINSKINTERKAPS Republic of Belarus

Information update date: & nbsp28.01.2017

Illustrated instructions

Instructions

Gynocaps (Ginocaps)