Reversolut (Cream) Instructions for Use

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

ATC Code

D06BX01 (Metronidazole)

Active Substance

Metronidazole (Rec.INN registered by WHO)

Dosage Form

Reversolut

Cream for external use 10 mg/1 g: tube 25 g

Dosage Form, Packaging, and Composition

Cream for external use white in color, homogeneous, with a characteristic odor, free of lumps, free of agglomerated particles, free of liquid phase separation.

Excipients: emulsifying wax, liquid paraffin, propylene glycol, glycerol (glycerin) (85%), methylparaben, propylparaben, purified water.

25 g – aluminum tubes (1) – cardboard cartons.

Clinical-Pharmacological Group

Antiprotozoal drug with antibacterial activity for external use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antimicrobial agents for topical use; other antimicrobial agents

Pharmacological Action

An antiprotozoal agent with broad-spectrum antibacterial activity from the imidazole group.

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 (not related to an effect on the Demodex folliculorum mite, found in hair follicles and sebaceous gland secretion, or any influence on the production of this secretion).

Topical 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. Topical 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 BBB. C_max in blood – 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

Dosage Regimen

Apply a thin layer of cream to the affected skin areas twice daily, in the morning and evening.

Cleanse and dry the skin thoroughly prior to each application.

For rosacea, the typical treatment duration is 3 to 9 weeks.

For acne vulgaris and seborrheic dermatitis, continue application for up to 3 to 4 months.

The initial therapeutic effect for inflammatory lesions is usually observed after approximately 3 weeks of use.

For trophic ulcers, bedsores, and poorly healing wounds, apply to the cleansed wound surface and surrounding skin.

For hemorrhoids and anal fissures, apply a small amount to the affected perianal area after hygiene procedures.

Avoid contact with eyes. If contact occurs, rinse immediately with copious amounts of water.

Wash hands before and after application unless the hands are the treatment area.

Discontinue use and consult a physician if severe skin irritation, excessive dryness, or signs of an allergic reaction occur.

Adverse Reactions

Allergic reactions rarely – urticaria, skin rash.

Skin and subcutaneous tissue disorders 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, 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. In case of contact of the preparation containing Metronidazole with the eyes, they should be rinsed immediately with plenty of water.

Drug Interactions

Should be used with caution concomitantly 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.