Metroseptol - instructions for use, dose, side effects, contraindications

Excipients: propylene glycol, ethanol, disodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carbomer 980, trolamine, purified water.

1 g of cream for external use contains:

Active substance: metronidazole - 10.0 mg;

Excipients: cetyl alcohol, spermaceti, stearic acid, glycerol 99.5%, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description:

Gel - colorless, transparent with opalescence, jelly-like mass.

Cream - a homogeneous mass of white or white with a creamy shade of color.

Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug

ATX: & nbsp

P.01.A.B Nitroimidazole derivatives

P.01.A.B.01 Metronidazole

Pharmacodynamics:

Antiprotozoal and antimicrobial 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 reduced 5-nitro group of metronidazole reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Active in a relationship Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., 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 (Eubacteria spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp., Mobiluncus spp.).

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

With external application also has antioxidant, anti-inflammatory and dermatoprotective effect.

Has anti-acne action, the mechanism of which is precisely unknown (not related to the action on the mite Demodex folliculorum, found in the hair follicles and the secretion of the sebaceous glands, and any influence on the production of this secret).

Antioxidant activity is due to a significant decrease in production by neutrophils, which are potential oxidants, capable of causing tissue damage at the site of inflammation.

Metronidazole for external use is ineffective against telangiectasias seen in rosacea.

Pharmacokinetics:

Absorption is minimal, after external application of the gel or cream in the serum, only trace amounts of the drug are detected. Sucked metronidazole passes through the placenta and the BBB.The maximum concentration when applied to the skin of the face is up to 66 ng / ml (when applying 1 g of gel equivalent to 7.5 mg of metronidazole).

The connection with plasma proteins is less than 20%. Metabolized in the liver by hydroxylation, oxidation and glucuronation. Activity of the main metabolite (2-hydroxymethonidazole) - 30% of the activity of the starting compound.

The drug is excreted in the urine in unchanged form, as well as in the form of hydroxyl and conjugated metabolites.

Indications:

Pink acne (including post-steroids), acne vulgaris, infectious skin diseases, perioral dermatitis, pressure ulcers, trophic ulcers, burns, seborrhoeic eczema, oily seborrhea, seborrheic dermatitis, trophic ulcers of the lower extremities (against varicose veins, diabetes mellitus ), flaccid wounds, hemorrhoids, fissures of the anus.

Contraindications:

Hypersensitivity.

Pregnancy and lactation:

With caution in pregnancy (I trimester), and during lactation.

Dosing and Administration:

Apply to the pre-cleaned affected skin a thin layer 2 times in the morning, and in the evening, for 3-9 weeks. If necessary, an occlusive bandage is applied.The pronounced therapeutic effect is usually observed after 3 weeks. treatment.

Cream and gel should be used alternately after 12 hours. If necessary, you can re-treat.

With vulgar acne the drug can be prescribed against the background of taking antibiotics.

In the treatment of wounds the dosage regimen is set individually.

Side effects:

Allergic reactions (urticaria, skin rash); hyperemia, peeling and burning of the skin, lacrimation when applied in the eye area.

Overdose:

Due to the lack of systemic absorption, an overdose is unlikely.

Interaction:

When external application of the drug is unlikely, the interaction associated with systemic absorption of metronidazole.

However, when the drug is administered to persons receiving anticoagulants, it should be remembered that metronidazole can enhance the anticoagulant effect of warfarin and other indirect antigoagulants (increases prothrombin time).

Metroseptol can be combined with sulfonamides and antibiotics.

Special instructions:

For external use only!

Avoid contact with Metroseptol in the eye (may cause lacrimation).In case of contact with the gel or cream in the eyes, they should be washed immediately with a large amount of water.

It is important to apply the drug to the entire affected area.

When applied to extensive surfaces and / or long-term use, systemic side effects can not be ruled out, so the drug should be administered with caution to patients with impaired hematopoiesis. When local reactions appear, the drug should be used less often or temporarily discontinued.

After applying Metroseptol, you can use makeup.

Use in children - not recommended

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

The drug does not limit psychophysical activity, ability to drive vehicles and service moving mechanisms.

Form release / dosage:Cream or gel for external use, 1%.

Packaging:

For 15 grams in aluminum inside lacquered lithographed tubes.

Tubes, together with instructions for the use of the drug, are placed in individual lithographed cardboard packs.

Storage conditions:

At a temperature of no higher than 25 ° C, do not freeze.

In a place inaccessible to children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N011513 / 02

Date of registration:09.12.2005 / 16.02.2010

Expiration Date:09.12.2010

The owner of the registration certificate:Pharmaceutical plant Elfa AO, PolandPharmaceutical plant Elfa AO, Poland Poland

Manufacturer: & nbsp

ELFA PHARMACEUTICAL COMPANY, S.A. Poland

Representation: & nbspPharmaceutical plant ELPHA A.O. Pharmaceutical plant ELPHA A.O. Poland

Information update date: & nbsp25.04.2018

Illustrated instructions

Instructions

Metroseptol (Metroseptol)