Cerebrolysin Solu Ing

CEREBROLYSIN SOLU ING by SUN PHARMA LABORATORIES LTD.

Name

• Common Name: Cerebrolysin
• Brand Name: Cerebrolysin (Sun) Injection

Composition

Cerebrolysin Solution for Injection contains a proteolytic peptide fraction from porcine brain protein, also referred to as Cerebrolysin concentrate or Cerebroprotein Hydrolysate. Each ml of solution typically contains 215.2 mg of this active ingredient in an aqueous solution, with sodium hydroxide and water for injection as excipients.

Uses

Cerebrolysin is a neurotrophic peptidergic drug used for the treatment of various central nervous system (CNS) disorders. It is indicated for:

• Memory and concentration disorders.
• Dementia, including Alzheimer's disease, vascular dementia, multi-infarct dementia, and mixed forms of dementia.
• Sequelae of stroke (ischemic and hemorrhagic).
• Craniocerebral trauma (head injury, commotion, and contusion).
• Posttraumatic or postoperative complaints following cerebral injuries or neurosurgery.
• Aprosexia (attention deficiency) in dementia.

Dosage and Administration

Cerebrolysin can be administered intramuscularly, intravenously, or via infusion, with the dosage depending on the patient's condition and age.

• Intramuscular (IM) Injection: Up to 5 ml can be injected slowly over 3 minutes.
• Intravenous (IV) Injection: Up to 10 ml can be injected slowly over 3 minutes.
• Intravenous (IV) Infusion: Doses between 10 ml and up to a maximum of 50 ml are recommended as a slow intravenous infusion, typically diluted with standard infusion solutions (e.g., 0.9% sodium chloride, Ringer's solution, or 5% glucose solution) in a total volume of 100 ml. The infusion duration should be approximately 15 to 60 minutes.
• Treatment courses typically involve daily administration for 10-20 days, and can be repeated with treatment-free intervals. For dementia, typical daily doses range from 5-30 ml, and for post-apoplectic deficits or traumatic brain injury, 10-60 ml.

Side Effects

Common and generally mild side effects include:

• Swelling and pain at the injection site.
• A feeling of warmth at the injection site if injected too quickly.
• Tremors, headache, mild fever.
• Nausea, vertigo, agitation, sweating, flu-like symptoms.
• In isolated cases: palpitation, arrhythmia, reddening of the skin, itching, and burning at the injection site.
• Rarely observed gastrointestinal disturbances include lack of appetite, dyspepsia, diarrhea, constipation, and vomiting.
• Serious, but rare, side effects may include severe allergic reactions (e.g., severe dizziness, difficulty breathing, rash, anxiety).

Precautions

• Contraindications: Hypersensitivity to any component of Cerebrolysin, epilepsy or severe seizure disorders (may increase seizure frequency), and severe renal impairment.
• Pregnancy and Breastfeeding: Not recommended unless absolutely necessary, and only after consulting a doctor to weigh potential benefits against risks, due to lack of clinical data in humans.
• Drug Interactions: Concomitant administration with antidepressants or MAO inhibitors may lead to cumulative effects; dosage reduction of antidepressants may be advisable.
• Incompatibilities: Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion, or with solutions that alter pH (outside 5.0 - 8.0) or contain lipids. It should not be mixed with other drugs (e.g., vitamins, cardiovascular drugs) in the same syringe.
• Administration: Use only clear, amber solutions. Ampoules are for single use, and solutions should be removed immediately before use to maintain sterility.

Storage

Cerebrolysin should be stored at room temperature, typically not exceeding 25°C or 30°C. It must be protected from light, ideally stored in its outer packaging, and should not be frozen. Avoid storing in damp places or near heat sources. After opening, the solution should be used immediately, and any residual content discarded.

Cerebrolysin Solution for Injection, marketed by SUN PHARMA LABORATORIES LTD., is a medication primarily used for its neuroprotective and neurorehabilitative properties. It consists of a proteolytic peptide fraction derived from porcine brain protein.

Here are some frequently asked questions about Cerebrolysin Solution for Injection:

What is Cerebrolysin used for?

Cerebrolysin is indicated for the treatment of various central nervous system disorders, including memory disorders, concentration disorders, and different forms of dementia such as Alzheimer's disease and vascular dementia. It is also used to aid recovery after stroke, traumatic brain injury, and cranial injuries.

How does Cerebrolysin work?

Cerebrolysin is a neurotrophic and neuroprotective agent. It contains biological peptides that enhance nerve repair, promote the survival of nerve cells, and improve communication between them. It increases glucose penetration and consumption in damaged brain regions, reduces cerebral lactate concentration, and stimulates neurogenesis (the formation of new neurons) and oligodendrogenesis. Cerebrolysin's components can cross the blood-brain barrier, allowing it to act directly on brain tissue.

What is the usual dosage for Cerebrolysin?

Cerebrolysin is administered as an injection, either intramuscularly or intravenously, or as an infusion. The dosage and duration of treatment depend on the patient's condition and age. Typically, a course of treatment lasts 10 to 20 days, with daily administration. For specific conditions:

• Cerebral metabolic disturbances (dementia): 5-30 ml per day.
• Post-apoplectic defunctionalization symptoms (stroke) or cranio-cerebral traumata: 10-50 ml per day.
• Children: 1-2 ml per day. Individual doses up to 5 ml can be given intramuscularly, and up to 10 ml can be given as an undiluted intravenous injection, both slowly over 3 minutes. Doses between 10 ml and 50 ml are recommended as a slow intravenous infusion, diluted with standard solutions like 0.9% sodium chloride, Ringer's solution, or 5% glucose, with an infusion duration of approximately 15 to 60 minutes.

What are the possible side effects of Cerebrolysin?

Common side effects are usually mild and transient and may include swelling and pain at the injection site, a feeling of warmth if injected too quickly, tremors, headache, nausea, vertigo, mild fever, agitation, confusion, sweating, fatigue, depression, apathy, or flu-like symptoms. Rarely, palpitations or arrhythmia have been reported, especially with rapid injection.

Is Cerebrolysin safe during pregnancy or breastfeeding?

Animal studies have not shown evidence of teratogenic effects (causing birth defects). However, due to a lack of clinical data in humans, Cerebrolysin should only be used during pregnancy and breastfeeding after a careful assessment of the potential risks versus benefits by a doctor.

Can Cerebrolysin be taken with other medications?

Cerebrolysin can be administered concomitantly with vitamins, cardiac stimulants, or cardiovascular agents, but it should not be mixed with these other drugs in the same syringe or infusion. Caution is advised when Cerebrolysin is used with antidepressants or MAO inhibitors, as additive effects may occur. In such cases, it may be recommended to reduce the dosage of the antidepressant. Cerebrolysin should not be mixed with balanced amino acid solutions or lipid-containing solutions in an infusion.

What precautions should be taken when using Cerebrolysin?

Cerebrolysin is contraindicated in patients with hypersensitivity to its components, epilepsy, or severe renal impairment. Special care should be taken in individuals with allergic diathesis or epileptic conditions, as treatment might increase the frequency of seizures. The solution should be clear and amber, and any open ampoules or residual content should be discarded as it is for single use only. It is recommended to flush intravenous lines with physiological saline solution before and after Cerebrolysin administration.

What happens if a dose of Cerebrolysin is missed?

As Cerebrolysin is typically administered by a qualified healthcare professional in a clinical setting, a missed dose is unlikely. If a dose is somehow missed, it should be taken as soon as remembered. It is important not to skip doses and to complete the full prescribed course of treatment.

How should Cerebrolysin be stored?

Cerebrolysin should be stored at room temperature, not exceeding 25°C or 30°C, in a dry place, and protected from light. It should not be frozen or stored in damp places. Always keep it out of reach of children and do not use it beyond its expiration date.