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Ranaveksim (Powder) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

ATC Code

D06BA05 (Sulfanilamide)

Active Substance

Sulfanilamide (Rec.INN registered by WHO)

Dosage Forms

Bottle OTC Icon Ranaveksim Powder for external use 2 g: bottle with dispenser
Powder for external use 5 g: bottle with dispenser
Powder for external use 10 g: bottle with dispenser

Dosage Form, Packaging, and Composition

Powder for external use white or almost white, crystalline.

1 bottle
Sulfanilamide 2 g

Polymer bottles (1) with a dispenser – cardboard packs.


Powder for external use white or almost white, crystalline.

1 bottle
Sulfanilamide 5 g

Polymer bottles (1) with a dispenser – cardboard packs.


Powder for external use white or almost white, crystalline.

1 bottle
Sulfanilamide 10 g

Polymer bottles (1) with a dispenser – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

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

Pharmacological Action

Antimicrobial agent, Sulfanilamide, one of the first representatives of chemotherapeutic agents of the sulfonamide group. It has a bacteriostatic effect.

The mechanism of action is due to competitive antagonism with PABA and competitive inhibition of the enzyme dihydropteroate synthase.

This leads to a disruption in the synthesis of dihydrofolic, and then tetrahydrofolic acid, and as a result, to a disruption in the synthesis of nucleic acids.

It is active against gram-positive and gram-negative cocci, Escherichia coli, Shigella spp., Vibrio cholerae, Haemophilus influenzae, Clostridium spp., Bacillus anthracis, Corynebacterium diphtheriae, Yersinia pestis, as well as against Chlamydia spp., Actinomyces spp., Toxoplasma gondii.

Indications

As part of complex therapy: purulent wounds, infected burns (I-II degree) and other purulent-inflammatory skin processes.

ICD codes

ICD-10 code Indication
L01 Impetigo
L02 Cutaneous abscess, furuncle and carbuncle
L03 Cellulitis
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1B70.1 Streptococcal cellulitis of the skin
1B70.2 Staphylococcal cellulitis of the skin
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0 Bullous impetigo
1B72.1 Nonbullous impetigo
1B72.Z Impetigo, unspecified
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1B7Y Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44 Non-pyogenic bacterial infections of skin
EA50.3 Staphylococcal scarlet fever
EB21 Pyoderma gangrenosum
NE11 Burn of unspecified body region
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 the powder externally onto the affected skin areas or onto a sterile gauze pad.

Use a thin, even layer to cover the entire wound surface.

Apply to mucous membranes with caution, ensuring the area is clean and dry.

Change the wound dressing every 1-2 days or more frequently if significant exudate is present.

Before reapplication, cleanse the wound thoroughly of any residual exudate or previous powder.

The standard course of treatment is 10-14 days.

Do not exceed the recommended treatment duration without medical supervision.

Discontinue use and consult a physician if no improvement is observed within 3-5 days.

Avoid contact with eyes and other sensitive areas.

Wash hands before and after applying the medication.

Adverse Reactions

Allergic reactions skin manifestations.

With long-term use in high doses : systemic action: headache, dizziness, nausea, vomiting, dyspepsia, cyanosis, crystalluria.

Contraindications

Severe renal failure, blood diseases, bone marrow depression, anemia, chronic heart failure, thyrotoxicosis, hepatic failure, azotemia, porphyria, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation, hypersensitivity to sulfonamides.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in renal failure.

Use in Renal Impairment

Contraindicated in severe renal failure, nephrosis, nephritis. Use with caution in patients with impaired renal function. During treatment, it is necessary to increase the volume of fluid consumed.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

Premature discontinuation of treatment may contribute to the development of sulfonamide-resistant strains of microorganisms.

During therapy, plenty of alkaline fluids are recommended.

If necessary, antimicrobial drugs are prescribed simultaneously orally.

If allergic reactions develop, it is necessary to discontinue the drug and prescribe appropriate treatment.

Drug Interactions

Myelotoxic drugs enhance the manifestations of hematotoxicity.

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

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