Usage
- Cerebroprotein Hydrolysate is prescribed for managing various neurological conditions, including stroke, traumatic brain injury (TBI), Alzheimer’s disease, vascular dementia, and other forms of dementia. It is also used to support cognitive function in age-related cognitive decline and to treat attention deficit disorders.
- Pharmacological Classification: Neurotrophic and neuroprotective agent.
- Mechanism of Action: Cerebroprotein Hydrolysate acts on the central nervous system by stimulating the production of neurotrophic factors like brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), which promote the survival, differentiation, and repair of neurons. It also exhibits neuroprotective effects by reducing excitotoxic damage, blocking the overactivation of calcium-dependent proteases, and scavenging free oxygen radicals. It also regulates and improves neuronal metabolism and modulates synaptic plasticity.
Alternate Names
- Cerebrolysin (brand name)
- CEREBROCIP (brand name)
- CEREHENZ (brand name)
- Cerebrogen (brand name)
- Cerebport (brand name)
How It Works
- Pharmacodynamics: Cerebroprotein Hydrolysate’s main effect is to promote neuronal survival, growth, and differentiation, leading to improved cognitive function, nerve repair, and neuroprotection.
- Pharmacokinetics: The drug can be administered orally, intramuscularly (IM), or intravenously (IV). Absorption varies depending on the route of administration. Metabolism and elimination pathways are not fully elucidated, but it is believed to be primarily metabolized in the liver. More research is needed to fully understand the pharmacokinetic profile in humans.
- Mode of Action: Stimulates the production of neurotrophic factors (BDNF and NGF), which promote neuronal survival and differentiation. It also reduces excitotoxic damage, blocks calcium-dependent proteases, and acts as a free radical scavenger. It further regulates neuronal metabolism and modulates synaptic plasticity. These actions contribute to neuronal repair and neuroprotection.
- Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: While its exact mechanism is not fully understood, it modulates several signaling pathways including the Shh/Ptch-1/Gli-1 signaling pathway, which is essential in neuronal development and repair. More research is needed for a comprehensive understanding of its interactions at the cellular and molecular levels.
- Elimination Pathways: The exact elimination pathways have yet to be fully characterized. It is believed to undergo metabolism primarily in the liver.
Dosage
Standard Dosage
Adults:
- IV Infusion: 60-180 mg (calculated by total nitrogen) dissolved in 10-15 ml sterile water for injection, then further diluted in 250 ml normal saline and infused slowly over 60-120 minutes.
- IM Injection: 30 mg reconstituted with 5ml sterile water.
- Oral: 90 - 180mg via capsules or tablets
- Treatment duration is typically 10-20 days of daily administration, followed by a maintenance dose of 30 mg IM injection two to three times a week, depending on the patient’s condition and response. This may be repeated over several treatment cycles for long-term management.
Children:
- Safety and efficacy in children below 18 years have not been fully established. Use only under strict medical supervision and after careful consideration of the benefit-risk ratio. Pediatric dosages should be adjusted based on age and weight, and are generally lower than adult doses.
Special Cases:
- Elderly Patients: Use with caution due to potential increased sensitivity to side effects and possible underlying health conditions. Close monitoring is recommended. Dosage adjustments may be necessary based on individual patient characteristics.
- Patients with Renal Impairment: Contraindicated in severe renal insufficiency. Caution is advised in patients with mild to moderate renal impairment; dosage adjustments may be required.
- Patients with Hepatic Dysfunction: Limited information is available. Use with caution, as the drug is primarily metabolized in the liver. Dosage adjustments may be required.
- Patients with Comorbid Conditions: Use with caution in patients with seizures, epilepsy, high blood pressure, cardiovascular disease, or autoimmune disorders. Dosage adjustments and close monitoring may be necessary.
Clinical Use Cases
The dosage and administration guidelines for specific clinical settings are similar to the standard adult dosage.
- Intubation: No specific dosage adjustments are mentioned.
- Surgical Procedures: No specific dosage adjustments are mentioned.
- Mechanical Ventilation: No specific dosage adjustments are mentioned.
- Intensive Care Unit (ICU) Use: No specific dosage adjustments are mentioned.
- Emergency Situations: No specific dosage adjustments are mentioned for emergency situations.
Dosage Adjustments
- Dosage adjustments may be required based on patient-specific factors like age, weight, renal/hepatic function, and comorbid conditions.
- In patients on antidepressants or MAOIs, consider lowering the antidepressant dose due to potential additive effects.
Side Effects
Common Side Effects
- Headache
- Nausea
- Vertigo/Dizziness
- Increased sweating
- Agitation
- Fever
- Flu-like symptoms
- Injection site reactions (pain, inflammation)
- Gastrointestinal discomfort
Rare but Serious Side Effects
- Hypersensitivity reactions (skin rash, itching, anaphylaxis)
- Seizures (especially in patients with epilepsy)
- Neurological effects (worsening of existing conditions, new neurological symptoms)
- Confusion
- Hallucinations
Long-Term Effects
- Long-term effects have not been fully characterized. Close monitoring is recommended during prolonged use.
Adverse Drug Reactions (ADR)
- Anaphylaxis (rare)
- Status epilepticus (worsening of seizures)
Contraindications
- Hypersensitivity to Cerebroprotein Hydrolysate or any of its components.
- Severe renal insufficiency.
- Status epilepticus (active seizures).
- Heart Disease
Drug Interactions
- Antidepressants (especially SSRIs and MAOIs): May enhance serotonergic activity, potentially leading to serotonin syndrome.
- Monoamine oxidase inhibitors (MAOIs): Similar risk of serotonin syndrome as with SSRIs.
- Anticoagulants and antiplatelet agents: Increased risk of bleeding complications.
- Balanced amino acid solutions: Do not mix in the same infusion.
- Diuretics
- Immunosuppressants.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not established. Data on human pregnancy are limited. Use only if the potential benefits outweigh the risks.
- Fetal Risks: Limited information on fetal risks. Animal studies did not show reproductive toxicity.
- Breastfeeding: Limited information on excretion in breast milk and potential neonatal effects. Use with caution.
Drug Profile Summary
- Mechanism of Action: Neurotrophic and neuroprotective agent, promoting neuronal survival, growth, and repair; modulates several signaling pathways.
- Side Effects: Headache, nausea, vertigo, increased sweating, agitation, fever, confusion, hallucinations, injection site reactions. Rarely, hypersensitivity reactions, seizures, or worsening of neurological conditions.
- Contraindications: Hypersensitivity, severe renal insufficiency, status epilepticus, heart disease.
- Drug Interactions: Antidepressants (SSRIs, MAOIs), anticoagulants, balanced amino acid solutions, diuretics, immunosuppressants.
- Pregnancy & Breastfeeding: Use with caution. Limited human data.
- Dosage: Adults: IV: 60-180 mg/day for 10-20 days; IM: 30 mg; Oral: 90-180 mg/day. Dosage adjustments may be required. Pediatric use: Safety not fully established.
- Monitoring Parameters: Monitor for neurological status, hypersensitivity reactions, and other side effects. Assess renal and hepatic function if necessary.
Popular Combinations
- No specific popular drug combinations are mentioned in the provided texts.
Precautions
- General Precautions: Evaluate for allergies, renal/hepatic impairment, and history of seizures. Monitor for adverse reactions.
- Specific Populations: Use with caution in pregnant or breastfeeding women, children, and the elderly.
- Lifestyle Considerations: Limit alcohol consumption. Consult a doctor regarding driving restrictions as dizziness may occur.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cerebroprotein Hydrolysate?
A: The recommended dosage varies depending on the route of administration and the patient’s condition. The typical IV dosage is 60-180 mg infused slowly over 1-2 hours, once daily for 10-20 days, and oral administration is 90-180 mg per day. The IM dosage is 30 mg. Dosage adjustments may be necessary for children, the elderly, and patients with renal or hepatic impairment.
Q2: What are the common side effects of Cerebroprotein Hydrolysate?
A: Common side effects include headache, nausea, vertigo, increased sweating, agitation, fever, flu-like symptoms, and injection site reactions.
Q3: Is Cerebroprotein Hydrolysate safe to use during pregnancy?
A: Limited information is available on its use during pregnancy. Use only if the potential benefits clearly outweigh the risks.
Q4: How does Cerebroprotein Hydrolysate work?
A: It stimulates neurotrophic factors like BDNF and NGF, which promote neuronal survival and differentiation. It also protects neurons from damage.
Q5: Are there any drug interactions I should be aware of?
A: Yes, Cerebroprotein Hydrolysate may interact with antidepressants (especially SSRIs and MAOIs), anticoagulants, and balanced amino acid solutions. Consult your doctor about potential drug interactions.
Q6: What conditions is Cerebroprotein Hydrolysate used to treat?
A: It’s used to treat stroke, TBI, Alzheimer’s disease, vascular dementia, and other dementias, age-related cognitive decline, and attention deficit disorders.
Q7: Can Cerebroprotein Hydrolysate be administered intramuscularly?
A: Yes, it can be administered intravenously, intramuscularly, or orally.
Q8: What precautions should I take when prescribing Cerebroprotein Hydrolysate?
A: Evaluate the patient for allergies, renal/hepatic impairment, and a history of seizures. Monitor for adverse reactions and consider dosage adjustments for special populations.
Q9: Can I use Cerebroprotein Hydrolysate with antidepressants?
A: Use with caution. It may enhance serotonergic activity. The dosage of the antidepressant may need to be lowered. Close monitoring is recommended.
Q10: Is Cerebroprotein Hydrolysate contraindicated in any specific medical conditions?
A: Yes, it’s contraindicated in severe renal insufficiency, hypersensitivity to the drug, status epilepticus, and heart disease.
