Rozamet cream 1% 25g tube

Description

Composition
Active substance:
1 g of cream contains: Metronidazole 10.00 mg ;.
Excipients:
Glycerol, liquid paraffin, emulsifier Lanette SX [cetostearyl alcohol, sodium lauryl sulfate, purified water], propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.
Description:
Uniform cream white and odorless.
Product form:
Cream for external use 1%.
25 g in the aluminum tube coated with a protective varnish twice with soldered hole, a protective membrane and a plastic cap, equipped with the cone-shaped device to puncture a protective membrane. The tube together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to the active substance or one of the formulation ingredients.
Dosage
1 %
Indications
Treatment of rosacea and acne.
If necessary, please consult your physician before using the drug.
Interaction with other drugs
When applying the cream Rozamet not been reported cases of interaction with other drugs. Warning: be careful while appointing metronidazole with warfarin or other indirect anticoagulants due to a possible increase in prothrombin time refers only to the form of oral metronidazole.
Overdose
Overdose cases are not marked.
pharmachologic effect
Pharmacological group:
Antimicrobial and protivoprotozoynoe means.
Pharmacodynamics:
Metronidazole possesses antimicrobial and antiparasitic properties and is active against many pathogenic microorganisms. Metronidazole possesses anti-acne activity and is particularly effective against papulo-pustular inflammatory elements rosacea.
The mechanism of action apparently also includes anti-inflammatory effect. The drug is active against gram-negative aerobic microorganisms: Helicobacter pylori; anaerobic bacteria: Bacteroides fragilis, Bifidobacterium, Bilophila, Clostridium, Clostridium difficile, Clostridium perfringens, Eubacterium, Fusobacterium, Peptostreptococus, Prevotella, Prophyromonas, Veillonella; protozoa: Entamoeba histolytica, Glardia intestinalis, Trichomonas vaginalis.
Pharmacokinetics:
Maximum concentration of metronidazole in serum with topical application 1 g of cream on the skin Rozamet averages 32.9 ng / mL (range 14.8 to 54.4 ng / ml). This amount does not exceed 0.5% of the average maximum serum concentration after oral administration of metronidazole 250 mg of metronidazole in the form of tablets. Peak metronidazole concentrations in blood serum after dermal application of the cream Rozamet observed after 6-24 hours. When applied topically the drug concentration at the site of application are significantly higher than in blood plasma.
Pregnancy and breast-feeding
Pregnancy.
Data on the use of metronidazole are absent in pregnant women. Rozamet cream should be used during pregnancy only when there are clear indications after consulting your doctor.
During breastfeeding.
After oral administration, metronidazole is excreted in breast milk in concentrations similar to those found in the blood plasma. Despite the fact that after topical application of the cream Rozamet breastfeeding women its level in the blood is significantly lower than after administration of metronidazole into the decision on the termination of breastfeeding or terminating the application of the drug should be made based on an assessment of the importance of the drug to the mother and the risk for child.
Conditions of supply of pharmacies
Without recipe.
side effects
When applying the cream Rozamet have been reported following spontaneous adverse event reports that within each class divided by the frequency of occurrence of organ systems with the use of the following categories:
Very common (> 1/10)
Often (> 1/100 to
special instructions
If signs of skin irritation due to application of a cream Rozamet should reduce its rate of application, to suspend or completely cancel the drug and, if necessary, to consult with a physician.
cream should avoid contact with the eyes and mucous membranes. In case of contact thoroughly wash them with warm water.
After application of the drug is possible to use cosmetic products that do not have comedogenic and astringent properties.
During treatment should avoid exposure to UV radiation (sunlight, tanning, sun lamps). Under the action of UV radiation metronidazole becomes inactive metabolite, so its efficiency significantly decreases.
Avoid excessive and prolonged use of the drug.
Metronidazole is a derivative of nitroimidazole and should be used with caution in patients with blood disorders.
Carefully read the manual before you start using the product. Keep these instructions, it may be needed again. If you have any questions, consult your doctor. Medicines that you are being treated meant to you personally, and should not be transferred to other persons as it may harm them even if you have the same symptoms that you have.
Effects on ability to drive vehicles and working with machinery.
The drug has no effect on the ability to drive vehicles and mechanisms.
Storage conditions
At temperatures above 25 C, the reach of children.
Dosing and Administration
For external use only.
Cream Rozamet applied thinly on precleaned affected skin and lightly rubbed twice a day, morning and evening, avoiding contact with the eyes, lips, and mucous membranes of the nose. Between skin cleansing and applying the cream is recommended to make a break of 15 – 20 minutes. The average duration of treatment is 3 – 4 months. However, if there are clear signs of good therapy, your doctor may be considered to continue treating a patient for an additional 3 – 4 months, depending on the severity of the condition.
Elderly patients No dose adjustment is required. The drug Rosa met is not recommended for use in children due to lack of data on the safety and efficacy of the drug in patients in this age category.
If after treatment there is no improvement or there are new symptoms, you should consult with your doctor.
Use drug only according to the application and in those doses which are specified in the instruction. If necessary, please consult your physician before using the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist