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

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 to pH 5, 0 ± 0.2, purified water - up to 100.0 g.

Description:

White, slightly opalescent, homogeneous cream.

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.

The drug is active against 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.

The drug is 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 1 g Rosex^® cream on the face is in average 32.9 ng / ml (range 14.8-54.4 ng / ml). This amount does not exceed 0.5%, 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 serum after the skin application of Rosex® cream 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:

Hypersensitivity 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 been shown to be carcinogenic, Rosec® cream should be used during pregnancy only when presence of clear indications after consultation with the 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 the cream on the previously cleaned affected skin areas twice a day in the morning and in the evening, avoiding 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 obvious signs of the benefits of therapy, the treating physician may consider the continuation of the patient's treatment for an additional 3-4 months, depending on the severity of the condition. If there is no apparent clinical improvement, treatment should be discontinued.

To patients of advanced age correction of the dose is not required.

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

Side effects:

When applying Rosec cream^® 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

Often: 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, peeling of the skin, 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 indicated in the manual are aggravated, or any other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

Overdose:

Cases of overdose are not described.

Interaction:

When using Rosec® cream, no cases of interaction with other drugs have been reported.

The caution warning when concomitantly prescribing metronidazole with warfarin or other indirect anticoagulants due to a possible increase in prothrombin time refers only to the oral form of metronidazole.

Special instructions:

If there are signs of skin irritation due to the use of Rosec® cream, the frequency of its application should be reduced, the drug should be temporarily suspended or finally discontinued and, if necessary, consulted with the doctor.

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

After application of the drug, it is possible to use cosmetics, not possessing 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 inactive metabolite, so its effectiveness is significantly reduced.

Avoid excessive and prolonged use of the drug.

Metronidazole is a derivative of nitroimidazole and it 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:Cream 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 / 02

Date of registration:04.05.2008

Expiration Date:Unlimited

The owner of the registration certificate:Galderma LaboratoriesGalderma Laboratories France

Manufacturer: & nbsp

Laboratoires GALDERMA France

Representation: & nbspGALDERMA, LLCGALDERMA, LLCRussia

Information update date: & nbsp19.09.2016

Illustrated instructions

Instructions

Rosex® (Rozex®)