What Is a Prescription Card?

The main ingredient of this product is levobupivacaine hydrochloride. Its chemical name is S-(-)-1-butyl-N- (2,6-dimethylphenyl) -2-piperidinecarboxamide hydrochloride salt.
Its structural formula is:

Molecular formula: C ₁₈ H ₂₈ N ₂ O · HCL
Molecular weight: 324.94

Soka (Levobupivacaine Hydrochloride Injection), the indication is mainly used for surgical epidural anesthesia.

Drug Name

Speed Card

Drug type

Prescription drugs, medicines for medical workers' injuries

The main ingredient of this product is levobupivacaine hydrochloride. Its chemical name is S-(-)-1-butyl-N- (2,6-dimethylphenyl) -2-piperidinecarboxamide hydrochloride. salt.
Its structural formula is:

Molecular formula: C ₁₈ H ₂₈ N ₂ O · HCL
Molecular weight: 324.94

This product is a colorless or almost colorless clear liquid.

It is mainly used for surgical epidural anesthesia.

5ml: 37.5mg

Adults are used for nerve block or infiltration anesthesia with a maximum dose of 150 mg at a time. The concentration of the drug solution is formulated as: surgical epidural block: 0.5% to 0.75% (10 to 20ml containing 50 to 150mg) moderate to total motion block.

Hypotension, nausea, postoperative pain, fever, vomiting, anemia, pruritus, pain, headache, constipation, dizziness, fetal distress, etc., occasionally asthma, edema, dyskinesia, involuntary muscle contraction, spasm, tremor, syncope, Arrhythmia, extrasystole, atrial fibrillation, cardiac arrest, intestinal obstruction, elevated bilirubin, blurred consciousness, suffocation, bronchospasm, dyspnea, pulmonary edema, respiratory insufficiency, sweating, skin discoloration, etc.

1. Severe liver and kidney dysfunction, hypoproteinemia, patients who are allergic to this product or those who are allergic to amide local anesthetics are prohibited.
2. If this product is mixed with epinephrine hydrochloride, it should not be used in patients with toxic goiter, severe heart disease or taking tricyclic antidepressants.
3. This product is not used for subarachnoid block because there is no clinical application data so far.
4. This product is not used in children under 12 years of age, and its safety needs to be confirmed.

1. Do not use too much when using it, which can cause hypotension, convulsions, cardiac arrest, respiratory depression and convulsions.
2. If severe hypotension or bradycardia occurs, ephedrine or atropine can be injected intravenously.
3. Barbiturates can be given if muscle tremors and cramps occur.
4. After giving the local anesthetic injection, the cardiovascular and respiratory changes and the patient's state of consciousness must be closely observed. The following symptoms of the patient may be signs of poisoning: restlessness, anxiety, incoherence, numbness and tingling in the lips, metal odor, tinnitus , Dizziness, blurred vision, muscle tremors, depression, or lethargy.
5. Amide local anesthetics, such as this product is metabolized by the liver. Therefore, caution should be exercised in patients with liver disease when administering such drugs, especially in multiple doses.
6. This product is not suitable for intravenous injection, so in the injection administration, the blood is drawn back to confirm that it is not necessary for intravascular injection.
7. The solution of levobupivacaine injection should not be used for block anesthesia of obstetric para-uterine tissue. Because there is no data to date to support this use and there is a risk of fetal bradycardia or lethality.

Most local anaesthetics can be excreted into the mother's milk. Care should be taken when using this product in nursing women. Whether levobupivacaine or other metabolites are excreted from milk has not been confirmed. Rat studies have shown that a small amount of levobupivacaine was detected in babies born to lactating rats.
There is still no research on the effects of pregnant women using this product on fetal development, and the advantages and disadvantages should be weighed.

There is no research data on the safety and effectiveness of this product for children.

Of the clinical studies of levobupivacaine, 16% were over 65 years old and 8% were over 75 years old. The safety and effectiveness of these patients and young patients were basically the same. No other clinical reports were found. obviously different. However, high sensitivity cannot be ruled out in some individual elderly patients.

In vitro experiments show that morphine, fentanyl, clonidine, and sufentanil have no inhibitory effect on the oxidative metabolism of levobupivacaine. However, none of these drugs are inhibitors of CYP3A4 or CYP1A2 isoforms. Although clinical studies have not been conducted, it is possible that the metabolic mechanism of levobupivacaine is affected by known CYP3A4 inducers (such as phenytoin, phenobarbine (Bital, rifampicin, etc.), CYP3A4 inhibitors, CYP1A2 inducers (omeprazole, etc.), and CYP1A2 inhibitors.

Focusing on prevention, it is best to inject levobupivacaine in divided doses. After each injection or during the infusion, closely observe the patient's life indicator and consciousness. Once there is a change, oxygen inhalation should be given in time.
In the event of inadequate pulmonary ventilation or respiratory arrest caused by an incorrect intrathecal injection of a drug, an artificial airway should be established or the airway should be kept open, with 100% oxygen to control ventilation or assist ventilation.
If convulsions occur, barbiturate hydrochloride, anticonvulsants or muscle relaxants should be administered intravenously to stop the convulsions, but these drugs should be used under the guidance of an experienced doctor. While ensuring effective lung ventilation, quickly estimate the circulatory function. In the case of circulatory failure, fluid should be injected intravenously, and if necessary, blood pressure increasing drugs should be used.
There are special difficulties in rescuing term pregnant women who are poisoned by local anesthetics. The enlarged uterus will compress the inferior vena cava and aggravate circulatory failure. At this time, the pregnant woman should be placed on the left side, or the uterus should be moved to the left to relieve the pressure on the vena cava. Maternal resuscitation is more difficult than other patients. Cardiac compression is often ineffective, and the fetus should be delivered or removed as soon as possible to make the recovery easier.

Pharmacological effects: Levobupivacaine is an amide local anesthetic. Local anesthetics block the generation and conduction of nerve stimulation by increasing the threshold of nerve electrical stimulation, slowing the propagation of nerve stimulation and reducing the rate of increase of action potential. Generally, anesthesia is performed with the diameter of nerve fibers, myelin formation, and conduction velocity. Clinically, the order of neurological loss is 1) pain, 2) temperature, 3) touch, 4) proprioception and position, and 5) skeletal muscle strength.

The plasma concentration reached a peak about 30 minutes after the epidural administration, and the average (Cmax) reached 1.2 g / ml at a dose of 150 mg. At a blood concentration of 0.1 to 1 g / ml, about 97% of the product was associated with plasma proteins. Binding, 0.01% to 0.1 g / ml and human blood cells bound to 0% to 2%, when the blood drug concentration was 10 g / ml, the binding to blood cells increased to 32%. After intravenous administration, the volume of levobupivacaine distribution was 67 liters. Levobupivacaine is metabolically degraded in the liver, making it difficult to find prototype drugs in urine and stool. The biological half-life in the body is 3.3 hours, the plasma clearance is 39 liters / hour, and the plasma elimination half-life is 1.3 hours.

Store at room temperature (10-30 ° C).

Glass ampoules, 5 pieces / box.

24 months

WS-706 (X-518) -2002

National Medicine Standard H20020570

Jiangsu Hengrui Pharmaceutical Co., Ltd.

April 30, 2007