Rosex cream, 30 g

Rosacea treatment.

For external use only.
Apply the cream in a thin layer on previously cleansed affected skin areas twice a day in the morning and in the evening, avoiding getting the cream in the eyes, on the lips and mucous membranes of the nose.

The average duration of treatment is 3-4 months.
However, in the presence of clear signs of the benefits of therapy, the attending physician may consider continuing the patient's treatment for an additional 3 to 4 months, depending on the severity of the condition. In the absence of obvious clinical improvement, treatment should be discontinued.

Elderly patients do not need dose adjustment.

The drug Rozeks Ѓ is not recommended for use in children due to the lack of data on the safety and efficacy of the drug in patients of this age category.

100 g of cream contains:
Active ingredient: metronidazole - 0.75 g.
Excipients: benzyl alcohol - 2.2 g, isopropyl palmitate - 2.0 g, glycerol - 4.0 g, sorbitol 70% non-crystalline - 5.0 g , emulsion wax - 12.5 g, lactic acid or sodium hydroxide - up to pH 5.0 Б} 0.2, purified water - up to 100.0 g.

Hypersensitivity to the active substance or one of the ingredients of the drug.

Tradename:

Rozex Ѓ

International non-proprietary name:

metronidazole.

Dosage form:

cream for external use.

Composition:

100 g of cream contains:
Active ingredient: metronidazole - 0.75 g.
Excipients: benzyl alcohol - 2.2 g, isopropyl palmitate - 2.0 g, glycerol - 4.0 g, sorbitol 70% non-crystalline - 5.0 g , emulsion wax - 12.5 g, lactic acid or sodium hydroxide - up to pH 5.0 Б} 0.2, purified water - up to 100.0 g.

Description

White slightly opalescent homogeneous cream.

Pharmacotherapeutic group:

Antimicrobial and antiprotozoal agent.

ATX code: (D 06BX 01).

Pharmacological properties

Pharmacodynamics

Metronidazole has antiparasitic and antimicrobial properties and is active against many pathogenic microorganisms. Metronidazole is especially effective against the papulopustular inflammatory elements of rosacea. The mechanism of action also appears to include an anti-inflammatory effect.

The drug is active against 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.

Resistant to the drug: gram-positive aerobic microorganisms - Actinomyces; anaerobic - Mobiluncus, Propionibacterium acnes.

Pharmacokinetics

The maximum concentration of the active substance in the blood serum with external application of 1 g of Rosex Ѓ cream on the face is on average 32.9 ng / ml (range 14.8-54.4 ng / ml). This amount does not exceed 0.5% of the average maximum concentration of metronidazole in the blood serum after oral administration of 250 mg of metronidazole in the form of tablets. The peak concentration of the active substance in the blood serum after the cutaneous application of Rosex Ѓ cream is observed after 6-24 hours.
When applied externally, the concentration of the drug at the site of application is significantly higher than in blood plasma.

Indications for use:

Rosacea treatment.

Contraindications

Hypersensitivity to the active substance or one of the ingredients of the drug.

Application during pregnancy and during breastfeeding

Pregnancy There is no
clinical experience with the external use of metronidazole during pregnancy. In the case of oral administration, metronidazole crosses the placental barrier and quickly enters the fetal bloodstream. After oral administration of metronidazole to rats or mice, no signs of fetal toxicity were observed. However, since reproductive toxicity studies in animals do not always predict a response in humans, and since oral administration of metronidazole has demonstrated its carcinogenic properties in some rodents, Rozex Ѓ cream should be used during pregnancy only if there are clear indications after consultation with a doctor.

Breastfeeding period
After oral administration, metronidazole passes into breast milk in concentrations similar to those found in blood plasma. Despite the fact that after external use of the drug Rozex Ѓ in women who are breastfeeding, its blood level is significantly lower than after taking metronidazole orally, the decision to stop breastfeeding or to stop using the drug should be made taking into account the importance of using the drug for the mother and the risk for the fetus.

Method of administration and dosage:

For external use only.
Apply the cream in a thin layer on previously cleansed affected skin areas twice a day in the morning and in the evening, avoiding getting the cream in the eyes, on the lips and mucous membranes of the nose.

The average duration of treatment is 3-4 months.
However, in the presence of clear signs of the benefits of therapy, the attending physician may consider continuing the patient's treatment for an additional 3 to 4 months, depending on the severity of the condition. In the absence of obvious clinical improvement, treatment should be discontinued.

Elderly patients do not need dose adjustment.

The drug Rozeks Ѓ is not recommended for use in children due to the lack of data on the safety and efficacy of the drug in patients of this age category.

Side effect

When using Rosex Ѓ cream, the following spontaneous reports of adverse events were recorded, which, within each class of organ systems, were subdivided according to the frequency of occurrence using the following categories:
Very often (? 1/10)
Often (? 1/100 to Uncommon (? 1 / 1,000 to Rarely (? 1/10,000 to Very rare ( Disorders of the skin and subcutaneous tissues
Often: dry skin, erythema, itching, skin discomfort (burning sensation of the skin, skin soreness / tingling), skin irritation, increased manifestations of rosacea
Frequency unknown: contact dermatitis, flaky skin, facial swelling

Nervous system disorders
Uncommon: hypesthesia, paresthesia, dysgeusia (metallic taste in the mouth)

Gastrointestinal disorders
Uncommon: nausea

If any of the side effects indicated in the instructions are aggravated, or any other side effects not indicated in the instructions are noted, you should immediately inform your doctor about it.

Interaction with other medicinal products

When using RozexЃ cream, there were no cases of interaction with other drugs.

The warning to be careful while prescribing metronidazole with warfarin or other indirect anticoagulants due to a possible increase in prothrombin time applies only to the oral form of metronidazole.

special instructions

If signs of skin irritation appear due to the use of RosexЃ cream, you should reduce the frequency of its application, temporarily suspend or permanently cancel the use of the drug and, if necessary, consult a doctor.

Avoid getting the cream in the eyes and mucous membranes. In case of accidental contact, rinse thoroughly with warm water.

After applying the drug, it is possible to use cosmetics that do not have comedogenic and astringent properties.

During treatment, exposure to UV radiation (direct sunlight, tanning beds, sunlight lamps) should be avoided. Under the influence of UV radiation, metronidazole passes into an inactive metabolite, therefore its effectiveness is significantly reduced.

Avoid excessive and prolonged use of the drug. Metronidazole is a derivative of nitroimidazole and its

should be used with caution in patients with blood disorders.

Influence on the ability to drive vehicles and work with mechanisms

Based on the pharmacodynamic profile and clinical experience of using the drug, it is not expected that the ability to drive vehicles and work with mechanisms is impaired.

Overdose

Overdose cases are not described.

Release form:

Cream for external use 0.75% 5g, 15g, 30g and 50g in an aluminum tube, with an internal epoxyphenol coating, with an aluminum membrane and a tightly screwed polypropylene cap with a punch.
1 tube with instructions for use is placed in a cardboard box.

Shelf life:

3 years.
Do not use after the expiration date.

Storage conditions:

At a temperature not exceeding 25 ? C. Do not freeze.
Keep out of the reach of children.

Terms of dispensing from pharmacies:

Without recipe.