BC Choline Injection 500 mg (Sodium Citicoline)

Adult administration

1. Impaired consciousness due to head trauma or brain surgery Adults: Administer 100 ∼ 500 mg of citicoline per dose intramuscularly or by intravenous infusion 1 ∼ 2 times daily. 2. Hemiplegia following stroke Administer 1,000 mg of this medicine intravenously once daily for 4 consecutive weeks. Alternatively, administer 250 mg intravenously once daily for 4 weeks. If improvement is observed, continue injections for another 4 weeks. 3. Pancreatitis In combination with a protease inhibitor, administer 1,000 mg of this medicine intravenously once daily for 2 weeks.

This medication is provided in a glass ampule form, so care must be taken to avoid glass fragments when opening the ampule. Extra caution is particularly necessary when used in children or elderly patients. Patients who have had allergic reactions to this medication or its components should not use it. Patients with a history of drug allergic reactions or those with consciousness disorders following severe head trauma or brain surgery should use this medication with special caution. In such cases, it must be administered after preparing necessary measures such as haemostatic agents, medications to lower intracranial pressure, and induced hypothermia. For patients with consciousness disorders during the acute phase of cerebral infarction, it is recommended to start administration within 2 weeks after a stroke event. Rarely, serious side effects such as shock may occur when using this medication, so if symptoms like hypotension, chest tightness, or shortness of breath appear, administration should be immediately stopped, and appropriate medical treatment must be undertaken. If hypersensitivity reactions such as skin rashes occur, administration should be discontinued, and symptoms of neurological disturbances such as insomnia, headache, dizziness, agitation, and convulsions may occur. When used in patients with hemiparesis after a stroke, there may be sensory abnormalities or worsening in the paralyzed area, so caution is advised. Gastrointestinal symptoms such as nausea and loss of appetite may occur, and liver function test values may show transient abnormalities. Transient visual disturbances may appear, and other symptoms like warmth sensation, blood pressure changes, and malaise might also be experienced. In patients with significant head trauma or consciousness disorders due to brain surgery, it is necessary to use this medication in conjunction with haemostatic agents, blood pressure stabilizers, and hypothermia treatment. Co-administration with the drug Levodopa may enhance Levodopa's effect, so caution is advised when using both medications together. The safety of this medication in pregnant women or women of childbearing potential has not been sufficiently confirmed, hence it should only be administered when the benefits of treatment are deemed greater than the risks. Safety has not been established in children, so caution is required when used in pediatric patients. Elderly patients often have declining bodily functions, requiring careful attention such as dosage adjustments when using this medication. When administered as an intramuscular injection, it must be injected avoiding nerves or blood vessels with the minimum necessary dosage, and extra care is required for neonates and young children. If there is severe pain at the injection site or blood reflux, the needle should be removed immediately and injected at another site. When administered as an intravenous injection, it is safer to do so as slowly as possible.

• Shock
• hypotension
• chest tightness
• shortness of breath
• rash
• insomnia
• headache
• dizziness
• agitation
• convulsions

This medication should be stored in a sealed container to avoid exposure to air, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way can maintain the effectiveness of the medication over a longer period.

Appearance

A transparent colorless solution contained in a colorless ampule.

Package unit

For domestic use - 50 ampules/box [(2 mL/1 ampule)], For export - 10 ampules/box [(2 mL/1 ampule)], For export - 10 ampules/box [(4 mL/1 ampule)]