Rozex® (Cream, Gel) Instructions for Use
ATC Code
D06BX01 (Metronidazole)
Active Substance
Metronidazole (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antiprotozoal drug with antibacterial activity for external use
Pharmacotherapeutic Group
Antimicrobial and antiprotozoal agent
Pharmacological Action
An antiprotozoal agent with broad-spectrum antibacterial activity from the imidazole group.
It is active against anaerobes (Bacteroides spp., Fusobacterium spp., Mobiluncus spp., Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Eubacterium spp., Bacteroides fragilis, Prevotella spp.) and protozoa (Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica).
When applied topically, it has an anti-acne effect, the mechanism of which is not precisely known (it is not associated with an effect on the Demodex folliculorum mite, found in hair follicles and sebaceous gland secretion, or any influence on the production of this secretion).
Topically applied Metronidazole may possess antioxidant activity. It has been established that it significantly reduces the production of reactive oxygen species, hydroxyl radicals, and hydrogen peroxide by neutrophils, which are potential oxidants capable of causing tissue damage at the site of inflammation. Topically applied Metronidazole is not effective against telangiectasias observed in rosacea.
Pharmacokinetics
With topical application, absorption is minimal; only trace amounts of the drug are detected in blood plasma. Absorbed Metronidazole crosses the placental barrier and the blood-brain barrier. Cmax in blood is up to 66 ng/ml.
Indications
Rosacea (including post-steroid); acne vulgaris; oily seborrhea, seborrheic dermatitis; trophic ulcers of the lower extremities (against the background of varicose veins, diabetes mellitus); poorly healing wounds; bedsores; hemorrhoids, anal fissures.
ICD codes
| ICD-10 code | Indication |
| E10.5 | Insulin-dependent diabetes mellitus with peripheral circulatory complications (including ulcer, gangrene) |
| E11.5 | Non-insulin-dependent diabetes mellitus with peripheral circulatory complications (including ulcer, gangrene) |
| I83.2 | Varicose veins of lower extremities with ulcer and inflammation |
| K60 | Fissure and fistula of anus and rectum |
| K64 | Hemorrhoids and perianal venous thrombosis |
| L21 | Seborrheic dermatitis |
| L70 | Acne |
| L71.9 | Rosacea, unspecified (Acne rosacea) |
| L89 | Decubitus ulcer and pressure area |
| L98.4 | Chronic skin ulcer, not elsewhere classified |
| T79.3 | Posttraumatic wound infection, not elsewhere classified |
| ICD-11 code | Indication |
| 5A10 | Type 1 diabetes mellitus |
| 5A11 | Type 2 diabetes mellitus |
| BD74.Z | Chronic venous insufficiency of lower extremities, unspecified |
| DB50.Z | Fissure or fistula of anal region, unspecified |
| DB6Z | Hemorrhoids or perianal venous diseases, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| EA40 | Tropical phagedenic ulcer |
| EA81.Z | Seborrheic dermatitis, unspecified |
| ED80.Z | Acne, unspecified |
| EF60 | Ischemic ulceration of the skin |
| EH90.Z | Pressure ulcer of unspecified degree |
| EM0Z | Unspecified skin disorder |
| ME60.2 | Ulcerative skin lesion of unspecified nature |
| NF0A.3 | Posttraumatic wound infection, not elsewhere classified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Apply a thin layer of Rozex Cream or Gel to the affected skin areas twice daily, in the morning and evening.
Before application, thoroughly cleanse and dry the skin area. Wash hands before and after use.
The standard treatment duration is 3 to 9 weeks. For rosacea, continue therapy for up to 3 to 4 months as directed.
The initial therapeutic effect is typically observed after approximately 3 weeks of consistent use.
For trophic ulcers, bedsores, and poorly healing wounds, apply the preparation to the cleansed affected area and cover with a sterile dressing.
For hemorrhoids and anal fissures, apply a thin layer to the affected perianal area after hygiene procedures.
Avoid contact with eyes, mucous membranes, and open wounds. If contact occurs, rinse immediately with copious water.
If excessive skin dryness, irritation, or burning occurs, reduce application frequency to once daily or temporarily discontinue use.
If no clinical improvement is seen after 3 weeks, consult a physician for re-evaluation.
Do not use for longer than the prescribed period. Do not apply occlusive dressings unless directed by a physician.
Adverse Reactions
Allergic reactions rarely – urticaria, skin rash.
From the skin and subcutaneous tissue rarely – hyperemia, peeling, mild dryness and burning of the skin, lacrimation (when applied close to the eyes).
Contraindications
Hypersensitivity to metronidazole.
Use in Pregnancy and Lactation
Use with caution in the first trimester of pregnancy and during breastfeeding.
Geriatric Use
There are currently no indications for restricting the topical use of metronidazole in elderly patients.
Special Precautions
Avoid contact with eyes. If a preparation containing Metronidazole gets into the eyes, they should be rinsed immediately with plenty of water.
Drug Interactions
Should be used with caution concurrently with warfarin and other indirect anticoagulants (increases prothrombin time).
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Cream for external use 0.75%: tubes 5 g, 15 g, 30 g or 50 g
Marketing Authorization Holder
Laboratoires Galderma (France)
Dosage Form
 |
Rozex® | Cream for external use 0.75%: tubes 5 g, 15 g, 30 g or 50 g |
Dosage Form, Packaging, and Composition
Cream for external use 0.75% shiny, homogeneous, from white to light yellow in color.
| 100 g | |
| Metronidazole | 750 mg |
Excipients : benzyl alcohol – 2.2 g, isopropyl myristate – 2 g, glycerol – 4 g, sorbitol 70% non-crystalline – 5 g, emulsifying wax – 12.5 mg, lactic acid or sodium hydroxide – to pH 5.0±0.2, purified water – up to 100 g.
5 g – aluminum tubes (1) – cardboard boxes.
15 g – aluminum tubes (1) – cardboard boxes.
30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
Gel for external use 0.75%: tubes 5 g, 15 g, 30 g or 50 g
Marketing Authorization Holder
Laboratoires Galderma (France)
Dosage Form
|
Rozex® | Gel for external use 0.75%: tubes 5 g, 15 g, 30 g or 50 g |
Dosage Form, Packaging, and Composition
| Gel for external use 0.75% | 1 g |
| Metronidazole | 7.5 mg |
5 g – aluminum tubes (1) – cardboard boxes.
15 g – aluminum tubes (1) – cardboard boxes.
30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
![Rozex® [Cream, Gel] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Rozex® [Cream, Gel] 2")