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Cerebrolysin


Brand Names: International
  • Cerabin-C (KR)
  • Cerebrolysin (AT, BG, CN, CZ, EG, HK, KR, LB, LT, LV, PH, PL, RO, TH, VN)
  • Renacenz (AR, CL, MX)
Pharmacologic Category
  • Nootropic
Dosing: Adult
Note: A treatment-free period, equal in length to the therapy course, should be allowed between successive therapy courses.
Dementia: IV, IM: 1.076 g to 4.3 g (5 to 20 mL) once daily to 2 to 3 times a week for 10 to 20 days or until no further benefit is achieved. Doses and frequency may be increased or decreased based on symptoms and age.
Head Trauma: IV, IM: 2.15 g to 10.76 g (10 to 50 mL) once daily to 2 to 3 times a week for 10 to 20 days or until no further benefit is achieved. Doses and frequency may be increased or decreased based on symptoms and age.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Severe impairment: Use is contraindicated.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Pediatric
Note: A treatment-free period, equal in length to the therapy course, should be allowed between successive therapy courses.
Head Trauma: Children: IV, IM: Initial: 215.2 mg to 430.4 mg (1 to 2 mL) once daily to 2 to 3 times a week for 10 to 20 days or until no further benefit is achieved. Doses and frequency may be increased or decreased based on symptoms and age.
Dosing: Renal Impairment: Pediatric
Children:
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Severe impairment: Use is contraindicated.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Use: Labeled Indications
Note: Not approved in the US and/or Canada
Dementia: Symptomatic treatment of dementias including senile, Alzheimer disease, and post-stroke cognitive dysfunction.
Head trauma: Symptomatic treatment of cognitive dysfunction due to head trauma including cerebral concussion or contusion, or post-operative trauma.
Administration: IM
Administer up to 5 mL via intramuscular injection.
Administration: IV
Administer ≤10 mL as IV bolus injection undiluted. For >10 mL, administer slowly as undiluted infusion over 60 minutes.
Storage/Stability
Store below 25°C (77°F).
Preparation for Administration
For IV infusion: Dilute with NS, lactated ringer solution, D5W, or dextran 40
Medication Safety Issues
International issues:
Contraindications
Hypersensitivity to cerebrolysin or any component of the formulation; epilepsy/tonic-clonic seizures; severe renal impairment; severe coagulation disorder; intramuscular injection in patients taking oral anticoagulants
Warnings/Precautions
Concerns related to adverse effects:
• Infusion reaction: Burning sensation, chills, dizziness, palpitation, and arrhythmia may occur due to bolus intravenous injection.
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies.
Breast-Feeding Considerations
It is not known if cerebrolysin is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Adverse Reactions
>10%:
Cardiovascular: Localized phlebitis, shock (shock like symptoms)
Central nervous system: Aggressive behavior, chills, confusion, depression, dizziness, fatigue, headache, hypotonia, insomnia, localized burning (at injection site), malaise, stupor
Dermatologic: Allergic skin reaction, injection site pruritus, skin rubor
Gastrointestinal: Anorexia, constipation, diarrhea, dyspepsia, nausea, vomiting
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Limb Pain, lower back pain, neck pain, tremor
Respiratory: Flu-like symptoms, hyperventilation (including hyperpnea catatonia), respiratory distress
Miscellaneous: Fever
<1%, postmarketing, and/or case reports: Convulsions, tonic-clonic seizures
Drug Interactions: Avoid Concomitant Use
There are no known interactions where it is recommended to avoid concomitant use.
Drug Interactions: Decreased Effect
There are no known significant interactions involving a decrease in effect.
Drug Interactions: Increased Effect/Toxicity
Cerebrolysin may increase the levels/effects of: Monoamine Oxidase Inhibitors
Drug Interactions: Metabolism/Transport Effects
None known.
Dosage Forms: International
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Note: Availability of specific dosage forms may vary by country/region.
Solution, Injection: 215.2 mg/mL
Mechanism of Action
Cerebrolysin, produced from porcine brain tissues, is a mixture of 80% low-molecular-weight peptides and 20% free amino acids, with neurotrophic and neuroprotective activity (Ziganshina 2016).
References: International
Cerebrolysin injection [KR product information]. Available at: http://drug.mfds.go.kr/html/bxsSearchDrugProduct.jsp?item_Seq=199504347. Accessed December 14, 2016.
Ziganshina LE, Abakumova T, Vernay L. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2016;5:12CD007026.

This monograph is adopted from Lexicomp, Nov. 8, 2018