Chong Kun Dang Sodium Citicoline Injection 125 mg (mL)

Adult administration

1. Impaired consciousness due to head trauma or brain surgery Adults: Administer 100 ∼ 500 mg of citicoline per dose by intramuscular or 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 an additional 4 weeks. 3. Pancreatitis Administer 1,000 mg of this medicine intravenously once daily for 2 weeks in combination with a protease inhibitor.

This medication is provided as an injectable in a glass ampule, so there is a risk of glass fragments entering when opening the ampule. Therefore, great caution should be exercised when cutting the ampule, particularly when administering to children and elderly patients. This medication should not be used in patients with allergic reactions to this drug or its components. Caution should be taken when administering this medication to patients with a history of drug allergies, or to those with consciousness disturbances following severe head trauma or brain surgery. In these cases, preparations for hemostatic agents or medications to lower intracranial pressure and hypothermia may be necessary. In acute cases of cerebral infarction, it is recommended to start administration within two weeks after a stroke attack. Rarely, shock symptoms may occur when using this drug, so if blood pressure decreases, chest tightness, or difficulty breathing occurs, use should be stopped immediately, and appropriate treatment should be administered. Occasionally, hypersensitivity reactions such as skin rashes may occur, and if such symptoms appear, administration should be discontinued. Psychoneurological side effects, such as insomnia, headaches, dizziness, agitation, and convulsions, may occur rarely, and when used in post-stroke hemiplegic patients, symptoms in the paralyzed areas may worsen. Gastrointestinal symptoms such as nausea or loss of appetite may occur, and abnormalities in liver function tests have also been reported. Temporary symptoms such as diplopia (double vision), heat sensation, changes in blood pressure, and fatigue may occur. When administered to patients with acute severe head trauma or consciousness disturbances following brain surgery, hemostatic agents, antihypertensives, and hypothermia treatment should be performed simultaneously. This drug may enhance the effects of a medication called Levodopa when administered together, so caution is warranted with concomitant use. The safety of this medication has not been established in pregnant women or those with potential for pregnancy, so it should be used only when the benefit of treatment outweighs the risks. Safety in children has also not been established, so care should be exercised when used in pediatric patients. Elderly patients may have decreased physical function, so administration should be performed with caution, including dose reduction. When administered via intramuscular injection, the smallest effective dose should be used while avoiding nerves and blood vessels, and special caution should be taken when administering to newborns, premature infants, toddlers, and children. If there is severe pain at the injection site or blood backs up into the injection needle, the needle should be removed immediately and another site chosen for injection. When administered via intravenous injection, it is advisable to infuse slowly whenever possible.

• shock
• hypotension
• chest tightness
• dyspnea
• rash
• insomnia
• headache
• dizziness
• agitation
• convulsions

This medication should be stored in a sealed container to prevent air or moisture from entering. This will help maintain the efficacy of the medication and prevent deterioration.

Appearance

A brown ampule containing a colorless, transparent liquid for injection

Package unit

10 ampules/box [2 milliliters/ampule*10]