Rosex cream for external use 30g
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Active ingredients
Metronidazole
Release form
Cream
Composition
Active ingredient: Metronidazole (Metronidazolum) Active ingredient concentration (mg): 7.5
Pharmacological effect
Anti-protozoal. It is believed that the mechanism of action is associated with a violation of the structure of the DNA of sensitive microorganisms. It is active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, as well as obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.). Aerobic microorganisms are resistant to metronidazole ,. pylori Amoxicillin is believed to inhibit the development of metronidazole resistance by Helicobacter pylori.
Pharmacokinetics
Well absorbed after ingestion. Bioavailability is 80%. Distributed in tissues and body fluids. It penetrates the placental barrier and the BBB. Binding to plasma proteins - 20%. Metabolized in the liver by oxidation and binding to glucuronic acid. T1 / 2 is 8 hours. Excreted in the urine (60-80%) and feces (6-15%).
Indications
Rosacea treatment.
Contraindications
Hypersensitivity to the active substance or one of the ingredients of the drug.
Precautionary measures
Metronidazole is used with caution in liver diseases.
Use during pregnancy and lactation
Metronidazole quickly penetrates the placental barrier. In the II and III trimesters of pregnancy, metronidazole is used only for health reasons. Metronidazole is excreted in breast milk. If necessary, use during lactation should decide on the termination of breastfeeding.
Dosage and administration
For external use only. Apply a thin layer of cream on the previously cleaned affected skin twice a day, morning and evening, avoiding the cream getting into the eyes, lips and mucous membranes of the nose. The average duration of treatment is 3-4 months. However, if there are clear indications 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 a clear clinical improvement, treatment should be discontinued. Patients of advanced age do not require dose adjustment. Roex drug is not recommended for use in children due to the lack of safety and efficacy data for patients of this age group.
Side effects
When using Rozex cream, the following spontaneous reports of adverse events were recorded, which within each class of organ systems were categorized 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. Violations of the skin and subcutaneous tissues Often: dry skin, erythema, itching, skin discomfort (burning sensation of the skin, soreness of the skin / tingling), skin irritation, increased manifestations of rosacea Frequency unknown: contact dermatitis, peeling of the skin, swelling of the face. Nervous system disorders. any other side effects that are not listed in the instructions should be noted; you should immediately inform your doctor.
Overdose
Cases of drug overdose Rozeks not described
Interaction with other drugs
When used simultaneously with aluminum hydroxide-containing antacids with Kolestiramine, the absorption of metronidazole from the gastrointestinal tract is slightly reduced. When used simultaneously, metronidazole potentiates the effects of indirect anticoagulants. If you use it simultaneously with disulfiram, acute psychosis and impaired consciousness may develop. increased risk of toxic action when used simultaneously with metronidazole. When used simultaneously with lance prazolom possible glossitis, stomatitis and / or the appearance of dark colored language; with lithium carbonate - possible increase in the concentration of lithium in the blood plasma and the development of symptoms of intoxication; with prednisone - increases the excretion of metronidazole from the body due to the acceleration of its metabolism in the liver under the influence of prednisone. Perhaps a decrease in the effectiveness of metronidazole. When used simultaneously with rifampicin, the clearance of metronidazole is increased from the body; with phenytoin - a slight increase in the concentration of phenytoin in the blood plasma is possible, a case of the development of a toxic effect is described. With simultaneous use with phenobarbital, the excretion of metronidazole from the body increases, apparently due to acceleration of its metabolism in the liver under the influence of phenobarbital.It is possible to decrease the effectiveness of metronidazole. When used simultaneously with fluorouracil, the toxic effect increases, but not the effectiveness of fluorouracil. A case of acute dystonia after taking a single dose of chloroquine in a patient receiving metronidazole is described. When used simultaneously with cimetidine, inhibition of metronidazole metabolism in the liver may occur, which can to slowing its excretion and increase plasma concentrations. When ethanol is used simultaneously in patients receiving metronid ol, development disulfiramopodobnyh reactions.
special instructions
In combination with amoxicillin is not recommended for use in patients younger than 18 years. In the course of treatment, systematic monitoring of the picture of peripheral blood is necessary. During treatment, trichomonas vaginitis in women and trichomonas urethritis in men are recommended to abstain from sex; simultaneous treatment of both partners is mandatory. During the use of metronidazole, darker staining of the urine is observed. During the treatment period with metronidazole, alcohol should be avoided, since acetaldehyde accumulation may occur due to impaired alcohol oxidation. As a result, reactions similar to those characteristic of disulfiram (spastic abdominal pain, nausea, vomiting, headache, sudden flushing of the face) may develop.