Розекс

General characteristics. Structure:

Active ingredient: metronidazole of 0,75 g.
 
Excipients: dinatrium эдетат, carbomer 940 (карбопол 980®), propylene glycol, methylparahydroxybenzoate, пропилпарагидроксибензоат, sodium hydroxide, the water purified.

Pharmacological properties:

Pharmacodynamics. Metronidazole has antiparasitic and antimicrobic properties and is active concerning many pathogenic microorganisms. Metronidazole is especially effective concerning papulo-pustular inflammatory elements of a rozatse. The action mechanism, apparently, includes also antiinflammatory effect.
Drug is active concerning gram-negative aerobic microorganisms: Helicobacter pylori; anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium, Bilophila, Clostridium, Clostridium difficile, Clostridium perfringens, Eubacterium, Fusobacterium, Peptostreptococus, Prevotella, Prophyromonas, Veillonella; protozoa: Entamoeba histolytica, Glardia intestinalis, Trichomonas vaginalis.
Are steady against drug: gram-positive aerobic microorganisms - Actinomyces; anaerobic - Mobiluncus, Propionibacterium acnes.

Pharmacokinetics. The maximum concentration of active ingredient in blood serum at external use of 1 g of Rozeks of gel on face skin averages 32,9 ng/ml (range 14,8-54,4¡ú/ml). This quantity does not exceed 1% of average maximum concentration of metronidazole in blood serum after oral administration of 250 mg of metronidazole in the form of tablets. The peak of concentration of active ingredient after cutaneous use of Rozeks® of gel is observed in 6-24 hours.
At external use concentration of drug in a site of application is much higher, than in a blood plasma.

Indications to use:

Treatment of a rozatse.

Route of administration and doses:

Outwardly. To apply gel with a thin layer on previously cleared affected areas of skin twice a day in the morning and in the evening, avoiding hit of gel on mucous membranes of eyes, lips and a nose.

The average duration of treatment makes 3-4 months.

Features of use:

Use of Rozeks® gel should be suspended temporarily or to cancel finally in case of development of the undesirable phenomena.
It is necessary to avoid hit of gel on mucous membranes. At accidental hit it is necessary to wash out carefully them warm water.
During treatment it is necessary to avoid solar or artificial ultra-violet radiation.

Side effects:

At use of Rozeks® gel only the local undesirable phenomena in the form of irritation of skin (burning sensation, an itch, a pricking, reddening) were noted.

As propylene glycol, methylparahydroxybenzoate and пропилпарагидроксибензоат are a part of drug, there is a risk of development of allergic reactions (urticaria, allergic contact dermatitis).

Interaction with other medicines:

At use of Rozeks® gel interaction cases with other medicines were not registered.

The prevention to be careful at co-administration of metronidazole with warfarin or other indirect anticoagulants because of possible increase in a prothrombin time belongs only to a peroral form of metronidazole.

Contraindications:

Hypersensitivity to one of drug ingredients.

Pregnancy and breastfeeding
Controlled clinical tests of use of drug at pregnancy and a lactation it was not carried out. By researches on animals it was established that drug has no toxic effect on a fruit and does not cause malformations.

Розекс® gel does not get into breast milk.

Use of Rozeks® gel at pregnancy and feeding by breast milk is possible when the estimated advantage for mother exceeds potential risk for a fruit.

Overdose:

Cases of overdose are not described.

Storage conditions:

At a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Gel for external use of 0,75% on 5 g, 15 g, ZOG and 50 g in an aluminum tuba, with an internal epoxyphenolic covering, with an aluminum membrane and densely screwing up polypropylene cover with a punch. On 1 tuba with the application instruction place in a cardboard pack.