Cerebrolysin Dosing
Based on the available evidence, Cerebrolysin should be administered intravenously at 10-30 mL daily for 21-30 consecutive days, with 10 mL being the most commonly studied and effective dose for acute neurological conditions.
Standard Dosing Regimen
The FDA-approved formulation indicates administration via sublingual spray for adults (spray twice under tongue, three times daily) 1. However, this conflicts with the extensive clinical research demonstrating intravenous administration as the primary route.
For intravenous administration (the clinically studied route):
- Acute ischemic stroke: 15 mL daily via IV infusion for 21 days 2
- Traumatic brain injury with severe disability: 10 mL daily IV for 30 consecutive days 3
- Dementia (Alzheimer's disease and vascular dementia): 10-30 mL daily, with higher doses (up to 60 mL) most effective for neuropsychiatric symptoms 4
Dose-Response Considerations
The optimal dose appears to be 2.5-5.0 mL/kg in preclinical models, with clear dose-dependent effects on neurological outcomes 5:
- Doses ≥2.5 mL/kg significantly improved neurological outcomes in stroke models (p < 0.001) 5
- A 5.0 mL/kg dose reduced infarct volume (p = 0.016) 5
- For mild traumatic brain injury, 2.5 mL/kg was identified as the optimal dose when given for 10 consecutive days 6
Treatment Duration
Treatment should continue for 21-30 consecutive days based on the clinical evidence:
- The 30-day regimen in TBI patients showed improved functional recovery at 3 months (p = 0.017) and 6 months (p = 0.009) 3
- Effects persist for several months after treatment cessation, suggesting disease-modifying rather than purely symptomatic benefits 4
Timing of Initiation
Begin treatment as early as possible after the acute event:
- In preclinical stroke models, treatment initiated 4 hours post-injury demonstrated significant benefit 5
- For TBI, administration beginning in patients with severe disability at 1 month post-trauma still showed efficacy 3
Important Safety Considerations
Seizure risk is a significant concern, particularly in traumatic brain injury:
- Cerebrolysin was associated with higher seizure rates in TBI patients (p = 0.042) 3
- Patients with post-traumatic seizures should be excluded from treatment 3
- Active meningitis or current infections are contraindications 3
Route of Administration Discrepancy
There is a notable discrepancy between the FDA label (sublingual spray) 1 and all clinical research (intravenous infusion) 2, 3, 4, 5, 6. The intravenous route has the strongest evidence base for neuroprotective effects and should be prioritized for acute neurological conditions.