Citicoline (Citisaph) 250mg/ml (1g/4ml) Solution for Injection (IM/IV) 4ml x 10 Ampoules

Here is the detailed information for Citicoline (Citisaph) 250mg/ml (1g/4ml) Solution for Injection (IM/IV) 4ml x 10 Ampoules:

Product Description:

Citicoline (Citisaph) 250mg/ml is a neuroprotective and nootropic medication that helps to improve brain function and repair damaged brain cells. The active ingredient Citicoline, also known as CDP-choline (Cytidine diphosphate choline), is a precursor to the neurotransmitter acetylcholine and plays a crucial role in the synthesis of phosphatidylcholine, a key component of cell membranes.

This medication is formulated as an injectable solution for intramuscular (IM) or intravenous (IV) administration. Each ampoule contains 250mg of Citicoline per milliliter, and the 4ml ampoules are supplied in packs of 10.

Indications:

Citicoline (Citisaph) is indicated for the following conditions:

1. Acute Stroke:

   • It is used as an adjunctive treatment in patients with acute ischemic stroke to support brain recovery and reduce neurological damage.

2. Traumatic Brain Injury (TBI):

   • It is used to treat patients with head trauma to help with the recovery of cognitive functions and reduce brain damage.

3. Cognitive Disorders:

   • Citisaph is indicated for improving cognitive performance and memory in conditions such as Alzheimer's disease, dementia, and other age-related cognitive impairments.

4. Glaucoma:

   • Used in the treatment of glaucoma to improve visual functions and reduce damage to the optic nerve.

5. Other Neurological Disorders:

   • It is used in conditions involving neurological degeneration, such as Parkinson’s disease, multiple sclerosis, and vascular dementia, for its neuroprotective effects.

Dosages:

The dosage of Citicoline (Citisaph) is determined based on the severity of the condition being treated, and it is typically administered intramuscularly (IM) or intravenously (IV). The general dosage recommendations are as follows:

For Acute Stroke and Traumatic Brain Injury:

• Initial dose: 500mg to 1g (2 to 4ml) once daily for the first 7 to 14 days.

• After the initial phase, the dose may be reduced to 250mg to 500mg (1 to 2ml) daily.

For Cognitive Disorders (Dementia, Alzheimer’s Disease):

• 250mg to 500mg (1 to 2ml) once daily as a maintenance dose.

• Treatment may continue for extended periods, depending on the patient’s response.

For Glaucoma:

• 250mg to 500mg (1 to 2ml) daily, depending on the severity of the condition.

For Other Neurological Disorders:

• 250mg to 500mg (1 to 2ml) once or twice daily, depending on the severity of the condition.

Administration:

• Intravenous (IV) administration is typically done over 10 to 20 minutes to avoid sudden changes in blood pressure.

• Intramuscular (IM) injections are generally performed into large muscle masses, such as the gluteus maximus or the deltoid muscle.

Side Effects:

Citicoline (Citisaph) is generally well tolerated, but side effects can occur in some individuals. Common and severe side effects include:

Common Side Effects:

1. Headache: A mild to moderate headache may occur during the administration.

2. Gastrointestinal Issues:

   • Nausea, vomiting, or diarrhea may occur in some cases.

3. Insomnia: Difficulty sleeping or disrupted sleep patterns.

4. Dizziness: Feeling lightheaded or dizzy, especially after intravenous administration.

5. Flushing: Redness or warmth of the skin, especially in the upper body.

6. Mild allergic reactions: Such as itching or rash.

Serious Side Effects:

1. Severe Allergic Reactions (Anaphylaxis):

   • Rare but possible, including symptoms like difficulty breathing, swelling of the face, lips, tongue, or throat, which can lead to anaphylaxis. Immediate medical attention is required.

2. Hypotension:

   • Low blood pressure (especially after IV administration) can occur in some cases.

3. Tachycardia:

   • Rapid heart rate may occur in rare cases.

4. Severe Gastrointestinal Reactions:

   • More severe gastrointestinal symptoms such as stomach cramps, bloody stools, or persistent diarrhea.

5. Severe headaches or migraines: Persistent or severe headaches that may require medical evaluation.

Contraindications:

Citicoline (Citisaph) should be used with caution or avoided in certain situations. It is contraindicated in the following:

1. Hypersensitivity to Citicoline or any of the ingredients:

   • Individuals with known allergy to Citicoline or any excipients in the formulation should avoid this medication.

2. Severe Renal Impairment:

   • Use with caution in patients with severe renal impairment as renal function may affect the drug's elimination.

3. Severe Hepatic Impairment:

   • Caution should be exercised when administering Citicoline to patients with severe liver disease.

4. Pregnancy:

   • Category C: Citicoline should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is recommended to consult a healthcare provider before using it during pregnancy.

5. Breastfeeding:

   • Citicoline is not known to be excreted in breast milk, but as a precaution, it is recommended to consult a healthcare provider before using Citicoline while breastfeeding.

6. Infants and Neonates:

   • There is limited safety data on the use of Citicoline in infants or neonates. It should only be administered to these groups if absolutely necessary and under medical supervision.

Precautions:

1. Renal and Hepatic Function:

   • Regular monitoring of renal and hepatic function is advised during prolonged use of Citicoline in patients with mild to moderate renal or hepatic impairment.

2. Pregnancy and Breastfeeding:

   • Consult with a healthcare provider before use in pregnant or breastfeeding women to ensure the safety of both mother and child.

3. Drug Interactions:

   • Citicoline may interact with other central nervous system (CNS) medications. Always inform the healthcare provider about any other medications being taken.

4. Injection Site Reactions:

   • Ensure proper administration technique to minimize the risk of injection site reactions, such as swelling or pain at the injection site.

5. Use with Other Nootropic or Neuroprotective Drugs:

   • If Citicoline is being used alongside other neuroprotective or nootropic drugs, close monitoring may be required to assess effectiveness and avoid potential side effects or interactions.

Summary:

Citicoline (Citisaph) 250mg/ml Solution for Injection is used to treat neurological conditions, including acute stroke, traumatic brain injury, cognitive impairments, and glaucoma. It works as a neuroprotective and nootropic agent, supporting brain cell repair and improving cognitive function.

Typical dosages range from 250mg to 1000mg daily, depending on the severity of the condition. Side effects are generally mild, including headache, nausea, and dizziness, but serious reactions such as severe allergic reactions and hypotension are possible.

Contraindications include known allergy to Citicoline, severe renal or hepatic impairment, and pregnancy unless the potential benefits outweigh the risks. Always consult a healthcare provider before starting treatment with Citicoline, especially for pregnant or breastfeeding women.

Always follow your healthcare provider's instructions for use, and do not hesitate to reach out if you experience any adverse reactions or concerns during treatment.