What Are the Best Enoxaparin Injection Sites?

Enoxaparin sodium injection, indications are 2000Axa IU and 4000 Axa IU injection: prevention of venous thromboembolic disease (prevention of intravenous thrombosis), especially thrombosis related to orthopedics or general surgery. 6000 Axa IU, 8000 Axa IU, and 10000 Axa IU injections: for the treatment of deep vein embolism that has developed, with or without pulmonary embolism. Treatment of unstable angina pectoris and non-Q wave myocardial infarction, with aspirin. Used in extracorporeal circulation of hemodialysis to prevent thrombosis.

Drug Name: Enoxaparin Sodium Injection

Drug type: prescription

Cautions for Enoxaparin Sodium Injection

Intraspinal hematoma. When performing spinal anesthesia (spinal and epidural anesthesia) or spinal puncture, it should be noted that patients who use low-molecular-weight heparin or heparin to prevent thrombotic complications may cause spinal hematomas, leading to long-term or permanent Sexual paralysis, the above incidents rarely occur. Placing an epidural catheter or repeated epidural puncture, combined with drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants, may increase the incidence of hematomas. In this case, the symptoms and signs of nerve damage in the patient should be detected, and if it is found that the nerve may be damaged, it should be treated urgently. Physicians should weigh the pros and cons when performing intravascular intervention (anaesthesia or puncture) on such patients.

Enoxaparin sodium injection ingredients

Chemical name: Enoxaparin sodium (low molecular weight heparin sodium).
Molecular structure formula:

Molecular weight: 3500-5500 Dalton excipients; water for injection

Characteristics of Enoxaparin Sodium Injection

This product is colorless or pale yellow clear liquid.

Indications of Enoxaparin Sodium Injection

2000Axa IU and 4000 Axa IU injections:
Prevention of venous thromboembolic diseases (prevention of venous thrombosis), especially those related to orthopaedics or general surgery.
6000 Axa IU, 8000 Axa IU and 10000 Axa IU injections:
Treatment of established deep vein embolism with or without pulmonary embolism.
Treatment of unstable angina pectoris and non-Q wave myocardial infarction, with aspirin.
Used in extracorporeal circulation of hemodialysis to prevent thrombosis.

Enoxaparin sodium injection specifications

(1) 0.2ml; 2000AxaIU; (2) 0.4ml; 4000AxaIU (3) 0.6ml; 6000AxaIU; (4) 0.8ml; 8000AxaIU (5) 1.0ml; 10000AxaIU

Enoxaparin sodium injection dosage

Prevention of venous thromboembolic diseases, treatment of deep vein embolism, treatment of unstable angina pectoris and non-Q-wave myocardial infarction should be given deep subcutaneous injection of enoxaparin; during hemodialysis extracorporeal circulation, intravascular route; for ST segment For severe acute myocardial infarction, the initial treatment is intravenous injection, followed by subcutaneous injection.
This product is for adult use. Intramuscular injection is forbidden to contain 10,000 Axa IU per milliliter of injection, which is equivalent to 100mg of low molecular weight heparin sodium. Each milligram (0.01ml) of low molecular weight heparin sodium is approximately equal to 100 AxaIU.
Subcutaneous injection technique:
The injection dose of enoxaparin can be adjusted according to the weight of the patient. The excess should be discharged before the injection, and the air bubbles in the syringe need not be discharged before the injection.
Pre-filled syringes are ready for immediate use. The injection should be performed after the patient is lying flat. The needle should be alternately injected into the anterior-lateral or posterolateral subcutaneous tissue of the left and right abdominal walls. The needle should pierce the skin vertically instead of at an angle. During the entire injection process, pinch the skin with your thumb and index finger, and pierce the needle all the way. Inject into skin wrinkles.
Intravenous injection technique only for the treatment of ST segment elevation acute myocardial infarction;
Enoxaparin is administered through an intravenous route and cannot be mixed with other drugs or injected at the same time. In order to avoid mixing enoxaparin with other drugs, venous channels should be flushed with a sufficient amount of normal saline or glucose solution before and after administration of enoxaparin to clear other drugs. Enoxaparin is used in combination with 0.9% saline or 5% glucose solution. Is safe.
Intravenous administration of initial 3000AxaIU For initial intravenous administration of 3000AxaIU, prefilled enoxaparin was used, 3000AxaIU (0.3ml) was retained in the syringe, and excess fluid was drained. A dose of 3000 AxaIU can be injected directly into a vein.
Additional venous loading doses for coronary angioplasty. If the last subcutaneous dose is more than 8 hours before balloon dilation, patients with coronary angioplasty will need an additional 30AxaIU / kg intravenously. To ensure the accuracy of this small injection volume, it is recommended to dilute the drug to 300AxalU / ml. In order to obtain a 300AxaIU solution, use 6000AxaIU of pre-filled enoxaparin sodium injection. It is recommended to use a 50ml infusion bag [using, for example, physiological saline (0.9%) or 5% glucose solution]. Take the following operation to remove 30ml solution from the infusion bag with a syringe. Discard. Inject all 6000 AxaIU Enoxaparin sodium pre-filled injection into the remaining 20 ml solution infusion bag. Gently mix the drugs in the infusion bag. Use a syringe to draw the required dilution for intravenous injection. After the dilution is complete, calculate the [diluted volume ml = patient weight kg * ol] according to the following formula or use the following table to obtain the volume of the required injection solution. It is recommended to prepare a diluent before use.

It is generally recommended that platelet counts be routinely measured during treatment because heparin is at risk for inducing thrombocytopenia (HIT).
The recommended dosage should be strictly followed or as directed by your doctor.
Prevent venous thromboembolic disease in surgical patients. When patients are at risk of moderate thrombosis (such as abdominal surgery), the recommended dose of this product is 2000 AxaIU (0.2 ml) or 4000 Axa IU (0.4 ml) once daily subcutaneously. In general surgery, the first subcutaneous injection should be given 2 hours before surgery. When the patient has a high tendency to thrombosis (such as orthopedic surgery), the recommended dose of this product is 12 hours before surgery, once a day 4000 Axa IU (0.4 ml) was injected subcutaneously.
In subarachnoid / epidural anesthesia and percutaneous coronary angioplasty, special attention should be paid to the dosing interval, see special warnings.
Low-molecular-weight heparin treatment should generally last 7 to 10 days. Some patients are suitable for longer treatment cycles. If the patient has a tendency for venous embolism, the treatment should be extended until the risk of venous thromboembolism is eliminated and the patient does not need to stay in bed. In orthopedic surgery, it is beneficial to administer 4000 AxaIU once a day for 3 consecutive weeks.
Prevention of venous thromboembolic disease in medically treated patients. The recommended low-molecular-weight heparin sodium dose is 4000 Axa IU (0.4 ml) once daily subcutaneously. Low-molecular-weight heparin sodium treatment should be a minimum of 6 days until the patient does not need to stay in bed, and a maximum of 14 days.
Treatment of deep vein thrombosis with or without pulmonary embolism, clinical symptoms are not serious, and any uncertain deep vein thrombosis should be diagnosed as soon as possible by appropriate examination.
Usage and dosage Enoxaparin sodium can be used for subcutaneous injection of 150 AxaIU / kg once daily or 100 AxaIU / kg twice daily. When patients are embolic, it is recommended to administer 100 AxaIU / kg twice daily.
No dose of enoxaparin has been evaluated in patients weighing more than 100 kg or less than 40 kg. For patients weighing 100 kg, the efficacy of enoxaparin may be slightly reduced. For patients weighing less than 40 kg, the risk of bleeding may increase. Special clinical monitoring is necessary for these patients.
During deep vein thrombosis treatment:
Unless contraindicated, enoxaparin sodium should be replaced with oral anticoagulants as soon as possible. Enoxaparin treatment should not exceed 10 days, including the time required to achieve the effect of oral anticoagulant therapy, unless the purpose cannot be achieved (see section 4.4 Precautions for use: platelet monitoring). Therefore, oral anticoagulants should be used as soon as possible.
Treatment of unstable angina pectoris and non-Q wave MI.
The recommended dose of low molecular weight heparin sodium for subcutaneous injection is 100 AxaIU / kg each time, once every 12 hours. It should be used with aspirin (100 to 325 mg orally once daily).
The general course of treatment is 2 to 8 days until the clinical symptoms are stable.
Used in extracorporeal circulation of hemodialysis to prevent thrombosis.
The recommended dose is 100 AxaIU / kg. For hemodialysis patients with a high bleeding tendency, the dose should be reduced to 50 Axa IU / kg of low molecular weight heparin or 75 AxaIU / kg of unilateral vascular access. Low molecular weight heparin sodium should be given at the beginning of hemodialysis in the arterial vascular access. The action time of the above-mentioned dose of drugs is generally 4 hours. However, when fibrin loops appear, an additional dose of 50 to 100 AxaIU / kg should be given.
Used in combination with thrombolytic agents or concurrently with percutaneous coronary intervention (PCI) to treat acute ST-elevation myocardial infarction. 100AxaIU / kg is administered subcutaneously 15 minutes after the initial intravenous 3000AxaIU, followed by 12 Subcutaneous injection of 100AxaIU / kg once per hour (maximum initial subcutaneous injection dose is 10000AxaIU)
The first dose of enoxaparin should be administered 15 minutes before thrombolytic therapy and 30 minutes after thrombolytic therapy (with or without fibrin specificity).
The recommended course of treatment is 8 days, or use until discharge (less than 8 days).
Concomitant use: Aspirin should be given as soon as possible after symptoms appear. The maintenance dose is 75 to 325 mg orally daily for at least 30 days, unless otherwise indicated.
Patients undergoing coronary angioplasty do not need to be re-administered if the last subcutaneous injection of enoxaparin was less than 8 hours before balloon dilation.
If the last subcutaneous injection of enoxaparin was more than 8 hours before balloon dilation, enoxaparin should be administered intravenously at a dose of 30 AxaIU / kg. In order to improve the accuracy of the dosage, it is recommended to dilute the drug to 300AxaIU / ml (see the description of the intravenous injection technique only for ST-segment elevation acute myocardial infarction).
Description of intravenous injection technique for ST-segment elevation acute myocardial infarction).
Patients 75 years of age or older should not be given a venous load dose in the treatment of ST-elevation acute myocardial infarction. Because of the 75AxaIU / kg subcutaneous injection every 12 hours (the maximum dose of the first two injections is 7500AxaIU).

Adverse reactions of enoxaparin sodium injection

Enoxaparin has been evaluated in more than 15,000 patients who have received enoxaparin in clinical studies. Includes prevention of deep vein thrombosis in 1776 patients with orthopaedic or abdominal surgery at risk for thromboembolic complications; prevention of deep vein thrombosis in 1169 patients with severe medical illness with severe restricted activity; and 559 for treatment Of the patients with deep venous thrombosis accompanied by pulmonary embolism, 1579 were used to treat unstable angina pectoris and non-Q Boxingen (MI) patients; 10176 were used to treat patients with acute myocardial infarction with CT segment elevation.
During these clinical trials, the amount of enoxaparin sodium used varies according to the indication. Patients with acute medical disease after surgery or severely restricted mobility should be treated with enoxaparin sodium for the prevention of deep vein thrombosis at a dose of 40 mg subcutaneously once daily. In the treatment of deep vein thrombosis (DVT) with or without pulmonary embolism (PE), patients receive 1 mg / kg subcutaneous injection of enoxaparin every 12 hours, or 1.5 mg / kg subcutaneous injection once daily Enoxaparin. In clinical studies of unstable angina pectoris and non-Q-wave myocardial infarction, the dose of enoxaparin sodium is subcutaneously administered every 12 hours. Enoxaparin sodium was given as a 30 mg intravenous fast dose followed by a 1 mg / kg subcutaneous injection every 12 hours.
The adverse reactions observed in these clinical studies and reported after marketing experience are as follows:

*: Such as hematoma, bruising outside the injection site, wound hematoma, hematuria, epistaxis, and gastrointestinal bleeding.
Additional post-marketing experience:
In surgical patients, thromboembolic complications are considered severe; (1) if the bleeding has caused a significant clinical event, or (2) if there is a concomitant decrease in hemoglobin or infusion of 2 or more blood products. Retroperitoneal and intracranial hemorrhage have always been considered the most severe.
Thrombocytopenia and Thrombocytosis

Additional listing experience:
Rare: Cases of immune-allergic thrombocytopenia with thrombosis: In some cases, thrombosis is associated with organ infarction or limb ischemia (see [Note]: Monitoring of platelet counts).
Other clinically relevant adverse reactions are in descending order according to system organ category, incidence classification, and severity. The following table includes adverse reactions for all indications:

In addition to market experience, skin and subcutaneous tissue abnormalities are rare;
Skin vasculitis and skin necrosis usually occur at the injection site (purpura or erythema, infiltration, and pain usually precede these phenomena). Enoxaparin treatment must be stopped.
Injection site nodules (inflammatory nodules, wrapped with non-enoxaparin).
Can subside after a few days and should not cause treatment to stop.

Enoxaparin sodium contraindications

This product is forbidden to be allergic to enoxaparin, heparin or its derivatives, including other low molecular weight heparin.
Hemorrhage or bleeding associated with severe coagulopathy (except for diffuse intravascular coagulation not associated with heparin treatment).
Have a history of severe type II heparin-induced thrombocytopenia, whether or not caused by unfractionated heparin or low-molecular-weight heparin (previously there was a significant decrease in platelet counts).
Active gastrointestinal ulcer or bleeding-prone organ damage.
Clinically significant active bleeding.
Cerebral hemorrhage.
Due to lack of relevant data, except for special cases requiring dialysis, patients with severe renal failure (weight measurement, according to the Cockcroft formula, creatinine clearance of about 30ml / min (see [Caution])
Patients with severe renal failure should use unfractionated heparin in patients receiving therapeutic low-molecular-weight heparin. Subarachnoid or epidural anesthesia cannot be performed. This product is not recommended for the following cases of acute large-scale ischemic stroke with or without If the stroke with consciousness is caused by embolism, enoxaparin cannot be injected within the hour of the event. Whether it is the infarct size of the stroke or the clinical severity of enoxaparin and other low-molecular-weight heparin, the therapeutic effect has not yet been established. Degree renal impairment (creatinine clearance at -ml / min)
Acute infective endocarditis with difficult-to-control arterial hypertension (except for some embolic heart diseases).
In addition, this product should be used with caution when combined with drugs (see [Drug Interactions])
If you have any questions, please consult a physician or pharmacist

Notes on Enoxaparin Sodium Injection

Precautions for the use of this product should be used carefully in the following cases: patients with hemostatic disorders, liver and kidney dysfunction, a history of peptic ulcers, or a history of bleeding-prone organ damage, recent hemorrhagic stroke, severe hypertension that is difficult to control, Diabetic retinopathy; recently underwent neurological or ophthalmic surgery and subarachnoid / epidural anesthesia (see [Precautions]). When combined with all anticoagulants, bleeding will occur (see Adverse Reactions). The cause of bleeding should be immediately identified and appropriate intervention given. In elderly patients, especially] elderly patients, no prophylactic dose of low-molecular-weight heparin caused an increase in bleeding events and a therapeutic dose. It can cause bleeding complications when it is recommended to closely observe patients with renal insufficiency:
Before applying low-molecular-weight heparin treatment, renal function needs to be evaluated, especially the elderly and older. The Cockcroft formula and recently measured body weight are used to determine creatinine clearance (Clcr) to evaluate male patients. Clcr = (-age) × weight / (. × serum Creatine) Here the age unit is "years" and the weight is kg. The serum creatinine is µmol / l. For female patients, the result of this formula must be multiplied. When the serum creatinine unit is mg / ml, this value must be multiplied.
In patients with impaired renal function, increased exposure to low-molecular-weight heparin leads to an increased risk of bleeding. Therefore, in patients with severe renal insufficiency (creatinine clearance rate is about ml / min), the dosage should be adjusted. The recommended dose is to prevent daily AxaIU_, treatment. AxaIU / kg once daily
Patients with moderate and mild renal insufficiency are advised to monitor closely during treatment.
Patients with liver dysfunction should be given special attention to low-weight patients (women [45 kg men [57 kg]). Increased exposure to low-molecular-weight heparin at prophylactic doses increases the risk of bleeding and should be closely monitored.
. Laboratory platelet monitoring for heparin-induced thrombocytopenia (HIT)
Risk of severe, sometimes thrombotic heparin-induced thrombocytopenia during treatment (mainly reported as uncommon heparin and low molecular weight heparin) This is mainly immunogenic and is called type II HIT
Because of the risk of thrombocytopenia, platelet count monitoring should be performed regardless of the indication or dose used. Platelet counts need to be taken before administration or within hours after initial treatment and monitored twice a week during treatment. When the platelet count is less than 100,000 / mm ² and / or thrombocytopenia decreased by%-% between two consecutive counts, it should be suspected that heparin-induced thrombocytopenia mainly occurred at hepatic disorder treatment days (about the peak period after treatment days)
If there is a previous history of heparin-induced thrombocytopenia, it may occur earlier, and there are a few reports that occur after the treatment day.Therefore, before starting treatment, you need to ask the patient's relevant medical history in detail and systematically, and when heparin is used again, platelets recur. The risk of reduced disease may persist for years or even long-term The occurrence of heparin-induced thrombocytopenia in all cases is an emergency and requires expert advice A significant decrease in platelet count (%-% of baseline value) is a warning even if the previous platelet count Reaching the critical level, if a decrease in platelet count is observed, all cases need to be checked 1. Immediately confirm the platelet count 2. If it is confirmed that the platelet count has decreased or even the platelet decrease has increased Heparin treatment should be discontinued in the absence of other clear causes in order to Platelet aggregation rate testing and immunological tests in vitro. Samples were collected using citrate test tubes, but the immediate measures in this case were not based on the results of in vitro platelet aggregation rate or immunological tests because only some special laboratories can routinely perform these tests and Most ideally Results were obtained after a few hours. However, these tests are necessary to assist in the diagnosis of complications because the risk of thrombosis is high if heparin therapy is continued. 3. Prevention and treatment of heparin-induced thrombocytopenia-related thromboembolic complications. If necessary, heparin must be replaced with other types of anticoagulant drugs such as danaparin sodium or hirudin, but individualized heparin must be replaced with oral anticoagulant for clinical or prophylactic doses. Clinical observations and laboratory tests will strengthen oral anticoagulants. Monitoring of curative effect.
Because oral anticoagulation therapy has a period of time before it achieves the best effect, heparin therapy should continue to be treated at a fixed dose, with the goal of maintaining the international normalized ratio (INR) value within the expected treatment range during two consecutive examinations. Anti-Xa factor Monitoring of activity.
As many clinical studies have shown that adjusting the dose of low-molecular-weight hepatic dysfunction based on weight has not yet been established in laboratory tests, but laboratory tests such as monitoring of anti-Factor Xa activity may have an impact on the risk of bleeding when there is a risk of overdose in some clinical settings. Management has a role.
These situations occur mainly when the following patients are given low-molecular-weight heparin:
1) Patients with mild to moderate renal failure. Because low-molecular-weight heparin is different from ordinary heparin, it is mainly eliminated by the kidney. Any kidney failure disease can cause relative overdose ([Contraindications])
2) Overweight or underweight (wasting or even cachexia, obesity);
3) Bleeding due to insensitivity.
Conversely, if low-molecular-weight heparin treatment follows treatment recommendations (especially the course of treatment), laboratory testing may not be recommended during prophylactic or hemodialysis.
The cumulative effect of heparin treatment may not be determined after repeated dosing. It is recommended that blood samples be collected at peak plasma concentrations (based on collected data) if possible, for example, two subcutaneous injections per day, about 4 hours after the third injection .
By repeating factor Xa activity to determine the heparin level, such as checking every 2 to 3 days, you need to consider adjusting the low-molecular-weight heparin dose according to the individual situation and the previous measurement results.
The average value of the anti-Xa activity measurement during the clinical trial was determined using a fluorescence method (aminoacyl decomposition method).
Activated partial thromboplastin time (aPTT)
Some low-molecular-weight heparin moderately increases aPTT. As no clinical relevance has been established, it is not meaningful to use this test to monitor the effect of treatment.
The following conditions need to be monitored for treatment: 1) liver dysfunction, 2) gastrointestinal ulcer or any other organ that may have bleeding damage.
3) Choroidal retinal vascular disease 4) After brain or spinal surgery 5) Lumbar puncture, mainly considering the possible risk of spinal hemorrhage, so postpone it as much as possible 6) Combination with drugs that affect blood coagulation (see [Drug Interactions])
Special warnings should be strictly followed in all cases:
Do not place intramuscular medication away from children

Enoxaparin sodium injection for pregnant and lactating women

Animal studies in pregnancy have shown no evidence of teratogenicity with enoxaparin.
Since there is no teratogenicity in animals, no similar effects are expected in humans. At present, comparative studies between the two seats found that substances that have teratogenic effects on humans have been confirmed to have teratogenic effects on animals.
At present, there is not enough clinical research data to determine whether enoxaparin can be administered at home during pregnancy and that it may be teratogenic or have fetal toxicity.
It is currently not recommended to prevent subarachnoid or extra-membrane anesthesia during pregnancy.
In humans, there is no evidence that this product can pass through the placental barrier, and pregnant women should use it only when deemed necessary by a physician.
Breastfeeding Since neonatal gastrointestinal absorption of this product is not possible in principle, there is no contraindication to the treatment of enoxaparin in breastfeeding women.
However, breastfeeding women should stop breastfeeding when receiving this product.

Enoxaparin sodium injection for children

Because no relevant data on children's medications are available, low molecular weight heparin is not recommended for children.

Enoxaparin sodium injection for the elderly

No dosage adjustment is required for elderly patients when used for prevention. Anti-Xa activity should be measured when used for treatment.

Drug Interactions of Enoxaparin Sodium Injection

To avoid possible interactions between drugs, the doctor or pharmacist must be informed of the drugs being used.
The following drugs are not recommended in combination (combination can increase bleeding tendency):
Acetylsalicylic acid (and its derivatives) for antipyretic and analgesic use, non-steroidal anti-inflammatory drugs (systemic drugs), ketorolac, dextran 40 (parenteral use). When this product is used together with the following drugs, you should pay attention to: oral anticoagulants, thrombolytic agents, acetylsalicylic acid for antiplatelet aggregation (for the treatment of unstable angina pectoris and non-Q wave myocardial infarction), sugar Corticosteroids (systemic medication).

Enoxaparin sodium injection overdose

Accidental overdose of low molecular weight heparin may cause bleeding complications.
If bleeding, some patients may need protamine sulfate treatment, but the following factors need to be considered;
Its curative effect is far lower than that when it is used for unfractionated heparin.
Due to adverse reactions (especially anaphylactic shock), the benefit / risk ratio of protamine sulfate should be evaluated in detail before use.
Protamine dose depends on:
Heparin injection time after heparin injection;
If more than 8 hours after enoxaparin sodium administration or when protamine is required to be injected again, protonin 50 antiheparin units will be administered for every 100 AxaIU of enoxaparin sodium.
If more than 12 hours after enoxaparin sodium injection, protamine injection is not required.
These recommendations are primarily for patients with normal renal function who receive repeated dosing.
Neutralization is achieved by slow intravenous injection of protamine (sulfate or hydrochloride). But anti-Xa activity cannot be completely neutralized. Moreover, due to the pharmacokinetic characteristics of low-molecular-weight heparin, the neutralization effect is transient, so it may be necessary to inject the calculated total protamine dose into multiple injections (2 to 4 times) within 24 hours.
In principle, even large doses of low-molecular-weight heparin will not have severe results after taking it (no incidents have been reported), mainly due to the very low absorption of low-molecular-weight heparin through the gastrointestinal tract.
Physicians should be advised to prevent overdose or toxic reactions.

Clinical trial of enoxaparin sodium injection

Combined with thrombolytic agents or concurrently with percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction In a large multicenter study, 20,479 patients with ST-segment elevation acute myocardial infarction received After thrombolytic therapy, randomly received: enoxaparin 3000AxaIU was given intravenously immediately after subcutaneous injection of 100AxaIU / kg, followed by 75AxaIU / kg subcutaneously every 12 hours, without the need for initial intravenous injection.
In the study, 4716 (23%) patients underwent coronary angioplasty with test drugs in an anti-thrombotic treatment. If the last subcutaneous injection of enoxaparin before the balloon dilation did not exceed 8 hours, the patient does not need additional administration, and if the last subcutaneous injection of enoxaparin before the balloon expansion exceeds 8 hours, the patient does not need additional administration. If the last subcutaneous injection of enoxaparin is more than 8 hours before balloon dilation, an additional 30 AxaIU / kg intravenous dose is required.
Enoxaparin significantly reduced the incidence of primary endpoint events (combined endpoint events included recurrence of myocardial infarction and all events that occurred within 30 days of enrollment); 9.9% in the enoxaparin group and 12.% in the unfractionated heparin group (relative risk The decrease rate was 17% (p less than 0.001). The recurrence rate of myocardial infarction was significantly reduced in the enoxaparin group (3.4% vs. 5%, p <0.001, and the relative risk reduction was 31%). The death rate was reduced in the enoxaparin group, and there was no significant statistical difference between the two groups (6.9% vs. 7.5%, p = 0.11).
The efficacy of enoxaparin was consistent with respect to the primary endpoint, regardless of subgroup: age, gender, site of myocardial infarction, history of diabetes or myocardial infarction, type of thrombolytic injections, and first clinical symptoms and time to start treatment interval.
Enoxaparin compared to unfractionated heparin in the main efficacy standard, patients who underwent coronary angioplasty within 30 days of enrollment (10.8% vs. 13.9%, relative risk reduction rate was 23%) and did not receive coronary angioplasty Of patients (9.7% vs. 11.4%, relative risk reduction ratio was 15%) showed significant efficacy.
In the 30-day experiment, the incidence of major bleeding in the enoxaparin group (2.1%) was significantly higher (P <0.0001) than in the unfractionated heparin group (1.4%), compared to the unfractionated heparin group (0.1%). The incidence of intestinal bleeding was higher (0.5%), and the incidence of intracranial hemorrhage was similar in the two groups (0.8% in the enoxaparin group and 0.7% in the unfractionated heparin group).
The combined standard analysis statistics of the entire clinical effect show that the enoxaparin group has a significant advantage over the unfractionated heparin group (p <0.0001): major criteria including death, recurrence of myocardial infarction, or major bleeding within 30 days (TIMI standard) The relative risk reduction rate of enoxaparin was 14%, and the composite risk index including death, recurrence of myocardial infarction, or intracranial hemorrhage within 30 days, the relative risk reduction rate was 17% (10.1% vs 12.2%).

Pharmacology and Toxicology of Enoxaparin Sodium Injection

Classification of pharmacological treatment: antithrombotic drugs.
Enoxaparin is a low-molecular-weight heparin that separates the antithrombotic and anticoagulant activities of standard heparin. The main feature is that its anti-Xa activity is higher than that of anti-thrombin factor IIa or antithrombin activity. For enoxaparin, the ratio of these two activities is 3.6
Prophylactic dose, which does not significantly affect aPTT.
The therapeutic dose, at peak activity, can extend aPTT time by 1.5 to 2.2 times compared to control time. Prolonged aPTT time reflects residual antithrombin activity.
No long-term studies in animals have shown the potential carcinogenicity of enoxaparin.
In the Ames test, the mouse lymphoma cell forward mutation test, the human lymphocyte chromosome aberration test and other in vitro experiments, and the rat bone marrow chromosome aberration test and other in vivo tests, no enoxaparin was found to have a mutagenic effect.
Subcutaneous administration of up to 20 mg / kg of enoxaparin daily does not affect fertility and reproduction in male and female rats. Teratogenicity studies of enoxaparin were administered subcutaneously in pregnant rats and rabbits up to 30 mg / kg daily, and no teratogenic effects or fetal toxicity were found.
Toxicity studies in rats and dogs with 15 mg / kg enoxaparin daily for 13 weeks, and in rats and monkeys with 10 mg / kg enoxaparin daily for 26 weeks for subcutaneous and intravenous toxicity Except for the anticoagulant effect, no adverse reactions were found in the study.

Pharmacokinetics of Enoxaparin Sodium Injection

The pharmacokinetic parameters of enoxaparin were evaluated by measuring the anti-Xa and anti-Ha activity of plasma at the time of single and repeated subcutaneous injections of the recommended dose and the subsequent single intravenous injection of the recommended dose.
Bioavailable transdermal enoxaparin is quickly and almost completely absorbed (almost 100%). Peak plasma activity is between 3 and 4 hours after dosing. The peak plasma activity (expressed in Axa IU units) was 0.18 plus 0.04 (after administration of 2000 AxaIU) and 0.43 ± 0.11 (after administration of 4000 AxaIU) at the preventive dose, and the therapeutic dose was 1.01 ± 0.14 (after administration of 10,000 AxaIU).
After intravenous injection of 3000AxaIU, followed by subcutaneous injection of 100AxaIU / kg every 12 hours, the first peak anti-Xa factor level was 1.16AxaIU / ml (n = 16), and the average exposure level was close to 88% of steady state. Steady-state levels were reached on the second day of treatment.
Enoxaparin pharmacokinetic properties show that it reaches steady state levels of about 15% within the recommended dose range. A single dose of pharmacokinetics can predict the level of enoxaparin activity at steady state. Repeated subcutaneous injections of 100AxaIU twice a day reached steady-state levels on day 2 after dosing, and the average enoxaparin activity was about 15% higher than the steady-state levels achieved after a single dose. A single dose of pharmacokinetics can predict the level of enoxaparin activity at steady state. Based on the pharmacokinetic characteristics of enoxaparin sodium, differences in steady state and differences in treatment range can be estimated. After subcutaneous injection, plasma anti-IIa activity was 10 times lower than anti-Xa activity. The average maximum anti-IIa activity was about 3 to 4 hours after subcutaneous injection, and the activity was 0.13AIIaIU / ml after repeated subcutaneous injections of 100AxaIU / kg twice a day.
When enoxaparin was combined with thrombolytic drugs, no pharmacokinetic interactions were found.
distributed:
Enoxaparin anti-Xa activity distribution volume is about 5 liters, which is close to blood volume.
metabolism:
This product is mainly metabolized in the liver.
Clear:
When administered subcutaneously, low-molecular-weight heparin exhibits higher anti-Xa activity clearance half-life than unfractionated heparin. Enoxaparin clearance is one-way, with a half-life of about 4 hours after a single subcutaneous injection and a half-life of about 7 hours after repeated administration.
In low-molecular-weight heparin, the anti-IIa activity plasma was attenuated by the anti-Xa activity.
Enoxaparin and its metabolites are cleared through the kidney (unsaturation mechanism) and the bile pathway.
Kidney clearance including anti-Xa active molecules accounts for 10% of the administered dose, and the total active and inactive component excretion rate of the kidney accounts for 40% of the administered dose

Storage of Enoxaparin Sodium Injection

Store below 25 ° C and unpack when needed. Transport as prescribed.

Enoxaparin sodium injection packaging

Syringes, 2 pcs / box

Validity of Enoxaparin Sodium Injection

24 months

Enoxaparin sodium injection standard

Import drug registration standard JX20000267 ^[1]