FLEBOTON® IM Injection Ampoules

Carbazochrome 1.5 mg + Troxerutin 150 mg

Medical Description

FLEBOTON® is a combination injectable vascular-protective medicine containing Carbazochrome 1.5 mg and Troxerutin 150 mg. It is used as an adjunctive treatment to reduce capillary fragility, improve microvascular integrity, and manage conditions associated with capillary bleeding, venous insufficiency, and vascular permeability. The combination aims to stabilize capillary walls, reduce edema, and improve venous and lymphatic circulation.

Troxerutin is a semi-synthetic flavonoid derived from rutin with well-documented venoactive, anti-inflammatory, antioxidant, and capillary-protective properties. It improves venous tone, reduces capillary permeability, inhibits leukocyte activation, and enhances microcirculatory blood flow.

Carbazochrome is a capillary stabilizer that has historically been used to reduce bleeding from fragile capillaries by promoting capillary resistance and reducing vascular permeability. Unlike systemic hemostatic agents, carbazochrome does not directly affect blood coagulation or platelet function.

Although troxerutin has supportive evidence from randomized trials and systematic reviews for chronic venous disease, the combination of carbazochrome and troxerutin has limited contemporary high-quality clinical evidence, and its use varies among countries. Current international chronic venous disease guidelines primarily recommend micronized purified flavonoid fraction (MPFF) over other venoactive drugs because of stronger clinical evidence.

Therapeutic Indications

FLEBOTON® may be used as an adjunctive treatment for:

• Chronic venous insufficiency (CVI)
• Chronic venous disease (CVD)
• Varicose veins
• Capillary fragility
• Increased capillary permeability
• Lower limb edema associated with venous disorders
• Venous pain and heaviness
• Hemorrhoidal disease (adjunctive therapy)
• Minor capillary bleeding when appropriate and under physician supervision
• Postoperative or post-traumatic edema (selected patients)

Mechanism of Action

Troxerutin

• Improves venous tone.
• Reduces venous stasis.
• Decreases capillary permeability.
• Increases capillary resistance.
• Improves lymphatic drainage.
• Reduces inflammation by inhibiting leukocyte activation.
• Protects vascular endothelium against oxidative stress.
• Reduces tissue edema.

Carbazochrome

• Stabilizes fragile capillary walls.
• Reduces abnormal capillary permeability.
• Improves capillary resistance.
• Helps decrease minor capillary bleeding.
• Does not significantly alter coagulation factors or platelet aggregation.

Clinical Benefits

Treatment with FLEBOTON® may help:

• Reduce lower limb edema.
• Relieve leg heaviness and discomfort.
• Improve symptoms of chronic venous insufficiency.
• Reduce capillary leakage.
• Improve microcirculatory function.
• Support recovery following vascular injury or surgery (when clinically indicated).
• Complement the management of hemorrhoidal disease.

►Adult Dosage

Intramuscular Administration

• One ampoule administered intramuscularly once daily, or as directed by the treating physician.

The duration of therapy depends on the underlying condition and clinical response.

FLEBOTON® is intended for intramuscular use only unless otherwise specified by the manufacturer or prescribing physician. Administration should be performed by qualified healthcare professionals.

►Pediatric Use

• Safety and efficacy have not been established in children.
• Routine pediatric use is not recommended.

Pregnancy

• Human clinical data are limited.
• Use during pregnancy only if the anticipated benefit outweighs the potential risk, particularly during the first trimester.
• Administration should be based on physician assessment.

Breastfeeding

• It is unknown whether carbazochrome or troxerutin is excreted into breast milk.
• Use during breastfeeding only after consultation with a healthcare professional.

Contraindications

Do not use in patients with:

• Hypersensitivity to carbazochrome, troxerutin, rutin derivatives, or any component of the formulation.
• Known allergy to injectable excipients.

Warnings and Precautions

• Not intended to replace definitive treatment of severe venous disease.
• Compression therapy, regular walking, weight control, and leg elevation remain first-line management for chronic venous insufficiency.
• Persistent bleeding requires medical evaluation to determine the underlying cause.
• Injection-site reactions may occur.
• Use cautiously in patients with severe renal impairment because troxerutin is primarily eliminated by the kidneys.
• Not indicated for the treatment of deep vein thrombosis (DVT) or pulmonary embolism.

Possible Side Effects

Most adverse reactions are mild and self-limiting.

Common

• Injection-site pain
• Injection-site redness
• Mild nausea

Less Common

• Headache
• Dizziness
• Gastrointestinal discomfort
• Skin rash
• Pruritus

Rare

• Hypersensitivity reactions
• Urticaria
• Angioedema
• Anaphylactic reactions (very rare)

Patients should seek immediate medical attention if signs of a severe allergic reaction occur.

Drug Interactions

No clinically significant drug interactions have been consistently reported.

Healthcare providers should be informed of all prescription medications, over-the-counter medicines, herbal products, and dietary supplements before treatment.

Storage

• Store below 25–30°C (according to the manufacturer's labeling).
• Protect from light.
• Do not freeze.
• Keep ampoules in the original package.
• Keep out of the reach of children.

Evidence Summary

Troxerutin has been evaluated in randomized controlled trials and PubMed-indexed studies demonstrating improvements in symptoms of chronic venous disease, including edema, leg pain, and venous discomfort, through enhancement of venous function and microcirculation. Systematic reviews suggest that venoactive drugs such as troxerutin can provide symptomatic relief; however, the evidence is generally less robust than for micronized purified flavonoid fraction (MPFF). Carbazochrome has a long history of clinical use as a capillary stabilizer, but contemporary high-quality randomized trials supporting its efficacy are limited. Consequently, international vascular guidelines primarily recommend MPFF as the preferred oral venoactive agent, while troxerutin remains an accepted option for symptom relief in selected patients.

Key Patient Counseling Points

• The injection should be administered only by a qualified healthcare professional.
• Continue lifestyle measures such as regular walking, leg elevation, and compression therapy if prescribed.
• Report persistent bleeding, severe pain, or worsening swelling to your healthcare provider.
• Inform your physician of any history of allergies to injectable medications.
• Attend scheduled follow-up appointments to assess treatment response.

Patient Disclaimer

This information is intended for educational purposes only and does not replace professional medical advice, diagnosis, or treatment. FLEBOTON® should be administered only under the supervision of a qualified healthcare professional. Seek immediate medical attention if you experience severe allergic reactions, sudden leg swelling, chest pain, difficulty breathing, or persistent unexplained bleeding.

Selected High-Quality References

• European Society for Vascular Surgery (ESVS). 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease.
• Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society. 2023 Clinical Practice Guidelines for Varicose Veins.
• International Union of Phlebology (UIP). Global guidance on chronic venous disease.
• Cochrane Database of Systematic Reviews. Venoactive drugs for chronic venous disease.
• Martinez-Zapata MJ, et al. Interventions for chronic venous insufficiency and venous leg ulcers.
• Belcaro G, et al. Troxerutin in chronic venous insufficiency: clinical efficacy and safety.
• Cesarone MR, et al. Effects of troxerutin on venous microcirculation and edema.
• Reviews on flavonoids and microvascular protection indexed in PubMed.
• UpToDate: Chronic venous disease in adults.
• Merck Manual Professional Edition: Chronic Venous Insufficiency.
• Medscape: Chronic Venous Insufficiency and Varicose Veins.
• NIH National Center for Biotechnology Information (NCBI Bookshelf).