Actovegin 400 mg, 10 ml. (5 ampoules)

Description

ACTOVEGIN® 40 mg/mL Solution for Injection (10 mL Ampoules, 5-pack)

INN: Actovegin (deproteinized hemoderivative of calf blood)

Form: Sterile solution for injection, 40 mg/mL concentration, 10 mL ampoules.

Pack size: 5 ampoules per carton. Tamper-evident seals and patient leaflet included.

Indications

Intravenous, intra‑arterial or intramuscular administration is indicated in the following conditions:

• Acute or chronic metabolic and vascular cerebral disorders (e.g., cerebral insufficiency syndromes, ischemic stroke, traumatic brain injury).
• Peripheral arterial and venous circulation disorders including angiopathy, leg ulcers, trophic lesions.
• Burns (thermal/chemical), radiation-induced skin and mucous membrane injury.
• Hypoxic or ischemic organ and tissue injuries requiring metabolic and microcirculatory support.

Contraindications

• Pulmonary edema, oliguria, anuria, fluid overload conditions.
• Decompensated heart failure (particularly for infusion form).
• Known hypersensitivity to Actovegin or any excipient.

Dosage & Administration

Route and dose depend on clinical indication and severity:

• Cerebral/metabolic disorders: 10 mL IV or IA daily for 2 weeks, then 5–10 mL IV several times weekly for 4 additional weeks.
• Ischemic stroke: 20–50 mL diluted in 200–300 mL saline or 5% dextrose infusion daily (or several times per week) over 2–3 weeks.
• Arterial angiopathy: 20–50 mL diluted infusion daily or several times weekly; typical 4-week course.
• Trophic ulcers/burns: 10 mL IV or 5 mL IM daily; may inject multiple times daily alongside topical therapy.
• Radiation injury (skin/mucosa): 5 mL IV daily during radiotherapy intervals.
• Radiation cystitis: 10 mL (400 mg) intravesically plus antibacterial therapy.

Important: IM injections max 5 mL per site; infusion rate 2 mL/min; compatible with 0.9% NaCl or 5% glucose solution.

Pharmacodynamics & Mechanism

Actovegin is a highly purified ultrafiltrate from calf blood. It enhances oxygen and glucose uptake at the cellular level, improving ATP generation under hypoxic stress. It exerts neuroprotective action via NF‑κB modulation, PARP inhibition, and caspase‑3 attenuation. Vascular effects include capillary dilation, improved erythrocyte deformability, and stimulation of endothelial nitric oxide synthase.

Clinical Evidence

Post‑stroke cognitive impairment: The ARTEMIDA trial (A Guekht et al., NCT01582854) demonstrated that IV Actovegin 2,000 mg/day followed by oral maintenance significantly improved ADAS‑Cog+ scores at 6 months compared to placebo (Δ –2.3 points; P=0.005). Safety profile was comparable between arms. PMID: 28432265.

Diabetic peripheral neuropathy: In a multicenter RCT of 567 patients (AV‑007‑IM), daily IV Actovegin 2,000 mg for 20 days followed by 1,800 mg/day orally for ~140 days improved Total Symptom Score and vibration perception vs placebo. PMID: 16076938. [oai_citation:1‡Diabetes Journals]

Ischemic stroke outcomes (systematic review): A 2022 PLoS ONE review of 5 controlled trials (>3,800 patients) found limited evidence for improved survival, functional outcomes, or quality of life; some studies indicated a potential increase in recurrent stroke events. Benefit-risk remains uncertain. PMID: 35771887.

Actovegin 400 mg in sports

Actovegin 40 mg/ml (10 ml injections) is utilized in sports medicine for its ability to enhance cellular oxygen uptake and energy metabolism. By promoting glucose transport and increasing oxygen utilization in hypoxic muscle tissue, it helps sustain high-performance output during intense physical activity. Athletes and trainers have reported reduced fatigue, improved endurance, and faster muscle recovery, especially during altitude training or after soft tissue injuries.

Studies have shown that Actovegin injections can improve microcirculation and capillary density, accelerating healing in damaged tissues and reducing downtime between training sessions. It is often incorporated into recovery protocols for overuse injuries, strains, or ischemic conditions. While not classified as doping, its use remains under clinical supervision to optimize recovery and metabolic efficiency in elite sports.
DOI: 10.1097/JSM.0000000000000566.

Safety & Adverse Reactions

Generally well tolerated. Rare allergic responses include urticaria, flush, fever. Extremely rare anaphylaxis reported. Incidence of recurrent stroke may be slightly higher in treated groups; blood pressure and signs of fluid overload should be monitored.

No serious drug interactions identified to date. Use with caution in fluid imbalance or heart failure.

Patient Guidance

• Follow prescribed dosing schedule closely; do not discontinue prematurely.
• IV therapy requires medical supervision; monitor hydration and cardiovascular status.
• Report any allergic symptoms (rash, swelling, difficulty breathing) immediately.
• Inform provider of other medications or medical conditions.
• Not a doping agent; verify compatibility with anti-doping policies if used in sports.

Storage Instructions

Store between 2–25 °C. Keep ampoules sealed until use. Protect from light and moisture. Do not reuse opened ampoules. Shelf life: 3 years. Keep out of reach of children.

Discussion and patient experiences are available on our Discussion Page.