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Sophorae japonicae tinctura (Tincture) Instructions for Use

Marketing Authorization Holder

Krasnodar Pharmaceutical Factory, PJSC (Russia)

ATC Code

D11AX (Other drugs used in dermatology)

Active Substance

Sophorae japonicae fructus (Grouping name)

Dosage Form

Bottle Rx Icon Sophorae japonicae tinctura Tincture: bottle 25 or 100 ml

Dosage Form, Packaging, and Composition

Tincture 1 L
Japanese pagoda tree fruits 500 g

25 ml – dark glass bottles.
100 ml – dark glass bottles.

Clinical-Pharmacological Group

A drug with antimicrobial, anti-inflammatory, and tissue regeneration-improving action for external use

Pharmacotherapeutic Group

Antiseptic of plant origin

Pharmacological Action

A herbal product. Contains rutin, kaempferol-3-sophoroside, quercetin-3-rutinoside, genistein-4-sophorabioside, flavone glycosides.

It exerts an antimicrobial action and stimulates regeneration.

Indications

  • For the topical treatment of purulent inflammatory skin processes.
  • Apply for the management of infected wounds, burns, and trophic ulcers to exert antimicrobial effects and stimulate tissue regeneration.

ICD codes

ICD-10 code Indication
I83.2 Varicose veins of lower extremities with ulcer and inflammation
L98.4 Chronic skin ulcer, not elsewhere classified
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
EA40 Tropical phagedenic ulcer
EF60 Ischemic ulceration of the skin
EM0Z Unspecified skin disorder
ME60.2 Ulcerative skin lesion of unspecified nature
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 topically only. Use for irrigation, washing, and the application of wet dressings to the affected skin areas.

Do not use orally or on mucous membranes. The frequency and duration of application are determined by the physician based on the severity of the condition and the rate of healing.

Adverse Reactions

Allergic reactions are possible, including localized skin rash, pruritus, erythema, or urticaria at the application site.

Discontinue use immediately and consult a physician if any signs of hypersensitivity appear. The benefit-risk ratio should be re-evaluated.

Drug Interactions

Formal studies of drug interactions have not been conducted. No specific interactions with other topically applied medicinal products are currently known.

Exercise caution when applying to large areas concurrently with other topical agents, as the potential for systemic absorption and interaction, though low, cannot be entirely ruled out.

Contraindications

  • Hypersensitivity to the herbal product or any of its components.
  • Do not use in patients with a known history of allergic reactions to Sophora japonica (Japanese pagoda tree) or related plants.

Overdose

Overdose from topical application is unlikely. Systemic effects are not anticipated due to limited absorption.

In case of accidental ingestion, seek medical attention immediately. Symptoms may be related to the ethanol content of the tincture and require supportive care.

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

Rx Only

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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