Methylene blue (Solution) Instructions for Use

Marketing Authorization Holder

Genel RD, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

ATC Code

V03AB17 (Methylthioninium chloride)

Active Substance

Methylthioninium chloride (Rec.INN registered by WHO)

Dosage Form

Methylene blue

Solution for topical and external use (aqueous) 1%: 25 ml, 50 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Solution for topical and external use transparent, dark blue in color.

Excipients: purified water up to 1000 ml.

25 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
25 ml – bottles – group packaging.
50 ml – bottles – group packaging.
100 ml – bottles – group packaging.

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic agent, the bacteriostatic effect is exerted by interacting with mucopolysaccharides and proteins of microorganisms.

Indications

Use for antiseptic treatment of skin and mucous membranes affected by bacterial infections and inflammatory conditions.

• Treat superficial skin infections, including pyoderma and folliculitis.
• Apply to thermal injuries such as burns to prevent secondary infection.
• Employ for irrigation in urinary tract infections, specifically cystitis and urethritis.

ICD codes

Dosage Regimen

Apply externally or topically for all age groups, including children from birth.

For skin conditions, use a tampon or glass rod to apply the 1% solution directly to the affected areas 2-3 times daily. Continue application until clinical signs of the infection resolve.

For urinary tract irrigation in cystitis and urethritis, use a diluted solution of 1:5000 (0.02%). Perform cavity washing with this dilution 1-2 times per day as directed.

Adverse Reactions

Adverse effects are generally mild and infrequent. The most common reaction is local skin irritation at the application site.

Monitor for signs of allergic reactions, including pruritus, erythema, or urticaria. Individual intolerance to the components may occur.

Discontinue use immediately and consult a healthcare professional if any adverse reactions manifest.

Contraindications

• Do not use in patients with a known hypersensitivity or history of allergic reaction to methylthioninium chloride or any of the excipients in the formulation.
• Avoid application on extensive areas of severely compromised skin barrier or on deep, penetrating wounds without medical supervision.
• Contraindicated for ophthalmic use; do not apply to the eyes or conjunctival mucosa.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding.

Pediatric Use

Used in children from birth.

Special Precautions

Effect of the medicinal product for medical use on the ability to drive vehicles, mechanisms

No effect.

Overdose

Systemic absorption from topical application is minimal; overdose is unlikely. Accidental ingestion may cause gastrointestinal irritation, nausea, and vomiting.

Extensive application to large body surface areas, especially on broken skin, might theoretically lead to systemic effects. In case of suspected overdose, discontinue use and seek medical attention for symptomatic and supportive care.

Drug Interactions

Formal interaction studies have not been conducted. Due to low systemic absorption from topical use, clinically significant drug interactions are not anticipated.

Exercise caution when using on skin areas concurrently treated with other topical medications, as the vehicle or occlusive effect might alter absorption. Do not mix with strong oxidizing or reducing agents in the same preparation.

Storage Conditions

In a place protected from light. Keep out of reach of children.

Shelf Life

Shelf life – 1 year

Dispensing Status

Without a prescription.

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.