Sishuning Ciprofol Injection

Brand Name: 思舒宁 ®(Sishuning®)
Generic Name: Ciprofol
Strength: 50 mg per 20 mL ampoule, 5 ampoules per box
Manufacturer: Liaoning Haisi Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Liaoning Haisi Pharmaceutical Co., Ltd.
Approval Date in China: January 13, 2020
Registration Number: 国药准字H20200013
Storage: Store sealed, protected from light at room temperature. Refer to the full package insert for detailed storage specifications.

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1. Indications and Usage
Ciprofol injection is indicated for the induction and maintenance of general anesthesia in adult patients undergoing surgery or diagnostic procedures.
2. Dosage and Administration
Induction: Administered intravenously. The initial dose is typically titrated based on the patient’s age, weight, and clinical condition.
Maintenance: Can be used as a continuous infusion or repeated bolus doses.
Administration: Strictly for intravenous use. It must be administered by trained anesthesia professionals under continuous monitoring.
3. Mechanism of Action
Ciprofol is a short-acting anesthetic agent that acts primarily as a positive allosteric modulator of the GABA_A receptors in the central nervous system. It enhances the inhibitory neurotransmission of GABA, leading to sedative, hypnotic, and amnesic effects.
4. Safety and Warnings
Respiratory Depression: Dose-dependent respiratory depression and apnea can occur, particularly during induction. Airway patency and ventilation must be monitored closely.
Hypotension: A transient decrease in blood pressure is common immediately after induction.
Injection Site Pain: Pain at the injection site may occur, though it is generally less severe than with propofol.
Allergic Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include respiratory depression, hypotension, bradycardia, and injection site pain.
Clinical Research: Clinical trials have demonstrated that ciprofol provides effective induction and maintenance of anesthesia with favorable recovery profiles compared to traditional anesthetics.
6. Drug Interactions
CNS Depressants: Concomitant use with opioids, benzodiazepines, or other sedatives may potentiate the effects, leading to increased respiratory depression and hypotension.
CYP3A4 Inhibitors/Inducers: Drugs that affect the CYP3A4 metabolic pathway may alter the clearance and duration of action of ciprofol.
7. Pharmaceutical Information
Composition: The active ingredient is Ciprofol.
Appearance: White to off-white uniform emulsion.
Storage: Store at controlled room temperature and protect from light.

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