Rozex^® (Cream, Gel) Instructions for Use

Instructions
Dosage forms

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. C_max 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

Open the list of 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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Rozex^® [Laboratoires Galderma (France)]
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.

Rozex^® [Laboratoires Galderma (France)]
Gel for external use 0.75%: tubes 5 g, 15 g, 30 g or 50 g