Cortexin: Practical Research and Usage Guide

This guide provides practical information for working with Cortexin, drawing from Russian clinical protocols and prescribing information. Understanding the preparation's specific handling requirements and dosing regimens is essential for effective research use. Cortexin is supplied as a lyophilized powder in sealed glass vials, typically containing 5 mg or 10 mg of active substance per vial. The powder is white or white with yellowish tint and requires reconstitution before intramuscular injection. Each vial also contains the stabilizer glycine (6 mg in the 5 mg vial, 12 mg in the 10 mg vial). Reconstitution is performed by adding 1 to 2 ml of sterile water for injection or 0.9 percent sodium chloride solution to the vial. The recommended diluent volume for adult doses is 1 to 2 ml, producing a concentrated solution suitable for IM injection. Direct the diluent gently down the inside wall of the vial to minimize foaming. Allow the lyophilized cake to dissolve by gentle swirling—do not shake vigorously. The resulting solution should be clear or slightly opalescent. Do not use if the solution is turbid or contains visible particles. The standard adult dosing regimen is 10 mg intramuscularly once daily for 10 consecutive days. This treatment course can be repeated at intervals of 3 to 6 months depending on clinical response. For acute neurological conditions (stroke, TBI), treatment is typically initiated as early as possible after the acute event. For chronic cognitive conditions, treatment courses are scheduled at regular intervals as maintenance therapy. Pediatric dosing follows weight-based guidelines. For children weighing less than 20 kg, the dose is 0.5 mg per kg of body weight per day. For children weighing 20 kg or more, the adult dose of 10 mg per day is used. Pediatric treatment courses also last 10 days, with repeat courses at 3 to 6 month intervals. For newborns and infants with perinatal encephalopathy, some protocols use 5 mg per day for 10 days. Intramuscular injection technique follows standard IM injection procedures. The primary injection site for adults is the upper outer quadrant of the gluteus maximus muscle. For children, the anterolateral thigh (vastus lateralis) is preferred due to better muscle development at this site in pediatric patients. Clean the injection site with an alcohol swab and allow to dry. Insert the needle at a 90-degree angle to the skin, aspirate to confirm absence of blood return, then inject slowly over 15 to 30 seconds. Apply gentle pressure after needle withdrawal. Rotate injection sites systematically between left and right sides to minimize local tissue irritation. A simple alternating pattern (right gluteal on odd days, left gluteal on even days) is commonly used. Treatment course design for specific indications follows established Russian clinical protocols. For acute ischemic stroke, Cortexin 10 mg IM daily for 10 days, ideally initiated within the first 6 to 24 hours. A second 10-day course may be administered after a 10-day rest period for persistent deficits. For rehabilitation, courses are repeated every 3 to 6 months. For traumatic brain injury, the same 10 mg daily for 10 days protocol applies during the acute and subacute phases. Multiple courses may be administered during rehabilitation with 3 to 6 month intervals. For cognitive disorders and cognitive enhancement in elderly patients, 10 mg daily for 10 days, repeated every 6 months. Some protocols employ two consecutive 10-day courses separated by a 10-day break for more intensive treatment. For pediatric neurodevelopmental conditions, weight-adjusted dosing for 10 days, repeated every 3 to 6 months. Some pediatric neurologists employ longer initial courses of 20 days (two consecutive 10-day courses with a brief break) for more severe conditions. The timing of daily injections is recommended in the morning or first half of the day, as Cortexin has mild activating properties that could potentially interfere with sleep if administered late in the day. Storage of lyophilized Cortexin vials requires protection from light at temperatures of 2 to 20 degrees Celsius. The manufacturer recommends refrigerated storage (2 to 8 degrees Celsius) for optimal stability, with a shelf life of 3 years from manufacture when properly stored. Reconstituted Cortexin should be used immediately and cannot be stored—any unused reconstituted solution must be discarded. The safety of Cortexin is well-established through extensive clinical use. The most common adverse effect is injection site pain, reported in approximately 5 to 10 percent of patients. This can be minimized by slow injection technique and appropriate site rotation. Systemic adverse effects are uncommon and include transient headache, mild dizziness, brief psychomotor agitation, and rare allergic reactions manifesting as skin rash or urticaria. No serious adverse events or fatalities attributable to Cortexin have been reported in published literature. Contraindications include known hypersensitivity to Cortexin or any component of the formulation, known allergy to animal-derived proteins (bovine or porcine origin), and pregnancy and breastfeeding (due to insufficient safety data). Unlike Cerebrolysin, Cortexin is not specifically contraindicated in epilepsy, though monitoring is recommended as with any CNS-active agent. Drug interactions have not been systematically studied, but clinical experience suggests good compatibility with standard neurological medications including antiplatelet agents, anticoagulants, antihypertensives, and other neuroprotective agents. Cortexin is frequently used in combination with piracetam, citicoline, and other nootropics in Russian clinical practice without reported adverse interactions. Quality assurance for Cortexin relies on the manufacturer's GMP-compliant production process. Each batch is tested for peptide content, amino acid composition, sterility, pyrogen levels, and biological activity. For researchers obtaining Cortexin through non-standard channels, verification of product authenticity is essential, as counterfeit pharmaceutical products have been documented in some markets.