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

Excipients: disodium edetate 0.05 g, carbomer 940 (carbopol 980®) 0.65 g, propyl glycol 3.0 g, methyl parahydroxybenzoate 0.08 g, propyl parahydroxybenzoate 0.02 g g, sodium hydroxide 10% - up to pH 4.8-5.2, water

Description:

Transparent, almost colorless or slightly yellowish, homogeneous gel.

Pharmacotherapeutic group:antimicrobial and antiprotozoal agent

ATX: & nbsp

P.01.A.B Nitroimidazole derivatives

P.01.A.B.01 Metronidazole

Pharmacodynamics:

Metronidazole has antiparasitic and antimicrobial properties and is active against many pathogenic microorganisms. Metronidazole especially effective against papulo-pustular inflammatory elements of rosacea. The mechanism of action, apparently, also includes an anti-inflammatory effect.

A drug active for gram-negative aerobic microorganisms: Helicobacter pylori; anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium, Bilophila, Clostridium, Clostridium difficile, Clostridium perfringens, Eubacterium, Fusobacterium, Peptostreptococcus, Prevotella, Porphyromonas, Veillonella; protozoa: Entamoeba histolytica, Giardia intestinalis, Trichomonas vaginalis.

To the preparation are stable: 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® gel on the face skin averages 29.1 ng / ml (range 19.1-42.7 ng / ml). This amount is not exceeds 0.5% of the average maximum concentration 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 after the cutaneous application of Rosex® gel is observed after 6-24 hours.

With external application, the concentration of the drug at the site of application is much higher than in the blood plasma.

Indications:

Treatment of rosacea.

Contraindications:PExcess sensitivity to the active ingredient or one of the ingredients of the drug.

Pregnancy and lactation:

Pregnancy

Clinical experience of external use of metronidazole during pregnancy is absent. In case of oral administration metronidazole penetrates the placental barrier and quickly enters the fetal bloodstream. After oral administration of metronidazole, rats or mice showed no signs of toxicity to the fetus. However, since studies on reproductive toxicity in animals do not always allow predicting a response in humans, and since oral administration of metronidazole to some rodents has demonstrated its carcinogenic properties,the Rosex® gel preparation should be used during pregnancy only if there are clear indications after consulting a doctor.

Breastfeeding period

After oral administration metronidazole penetrates into breast milk in concentrations similar to those found in blood plasma. In spite of the fact that after external application of the drug Rosex ® in breast-feeding women, its blood level is significantly lower than after taking metronidazole inwards, the decision to stop breastfeeding or stop the use of the drug should be made taking into account the evaluation of the importance of the drug for the mother and the risk for the fetus.

Dosing and Administration:

For external use only.

Apply a thin layer of gel on the previously cleaned affected skin areas twice a day in the morning and in the evening, avoiding getting the gel in the eyes, on the lips and mucous membranes of the nose.

The average duration of treatment is 3-4 months. However, if there are obvious signs of the benefit of therapy by the attending physician, the question of continuing the patient's treatment for an additional 3-4 months, depending on the degree of severity of the condition, may be considered.If there is no apparent clinical improvement, treatment should be discontinued.

Patients old age correction of the dose is not required.

Rosec® is not recommended in children due to the lack of data on safety and efficacy of the drug in patients of this age category.

Side effects:

When applying the Rosex gel® The following spontaneous reports of adverse events were recorded, which within each class of organ systems were divided by frequency of occurrence using the following categories:

Very often (≥1 / 10)

Often (≥1 / 100 to <1/10)

Infrequently (≥1 / 1,000 to <1/100)

Rarely (≥1 / 10,000 to <1/1 000)

Very rarely (<1/10 000), including individual messages

Disturbances from the skin and subcutaneous tissues

The privateo: dry skin, erythema, itching, skin discomfort (burning sensation of the skin, soreness of the skin / pricking), skin irritation, increased manifestations of rosacea.

Unknown frequency: contact dermatitis, skin peeling, swelling of the face.

Disturbances from the nervous system

Infrequently: synesthesia, paresthesia, dysgeusia (metallic taste in the mouth).

Disorders from the gastrointestinal tract

Infrequently: nausea.

If any of the side effects listed in the manual are aggravated, or Any other side effects not listed in the instructions should be reported to the doctor immediately.

Overdose:

Cases of overdose are not described.

Interaction:

When using the Rosex® gel, no cases of interaction with other drugs have been reported.

Caution should be exercised when concomitant administration of metronidazole with warfarin or other indirect anticoagulants because of the possible increase in prothrombin time, refers only to the oral form of metronidazole.

Special instructions:

If signs of skin irritation appear due to the use of Rosex® gel, the frequency of its application should be reduced, the drug should be temporarily suspended or permanently discontinued and, if necessary, consulted with a doctor.

Avoid contact with 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 possess comedogenic and astringent properties.

During treatment, exposure to UV radiation (direct sunlight, solarium, sunlight) should be avoided. Under the action of UV radiation metronidazole goes into an inactive metabolite, so its effectiveness is significantly reduced.

Avoid excessive and prolonged use of the drug.

Metronidazole is a derivative of nitroimidazole and should be used with caution in patients with impaired blood.

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

Based on the pharmacodynamic profile and clinical experience of the use of the drug, the ability to drive vehicles and work with mechanisms is not expected to be violated.

Form release / dosage:Gel for external use, 0,75%.

Packaging:

For 5 g, 15 g, 30 g and 50 g in an aluminum tube, with an internal epoxy-phenol coating, with an aluminum membrane and a tightly screwed polypropylene lid with a punch.

One tube with instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013885 / 01

Date of registration:25.12.2008

Expiration Date:Unlimited

Date of cancellation:2017-01-23

The owner of the registration certificate:Galderma LaboratoriesGalderma Laboratories France

Manufacturer: & nbsp

Laboratoires GALDERMA France

Representation: & nbspGALDERMA, LLCGALDERMA, LLCRussia

Information update date: & nbsp23.01.2017

Illustrated instructions

Instructions

Rosex® (Rozex®)