What is Flenox?
Flenox is a drug that reduces blood clotting (anticoagulant). Its main active ingredient is enoxaparin. It works by inhibiting prothrombinase (a complex of clotting factors), and more specifically, it acts on factor Xa (a component of the prothrombin activator protein). This substance also reduces platelet aggregation (sticking together), increases vascular permeability, activates fibrinolysis (breakdown of fibrin clot) and improves coronary and renal blood flow.
This drug is used to treat and prevent deep vein thrombosis (DVT), which can lead to the formation of blood clots in the lungs (pulmonary embolism), and it is also used for embolism and thrombosis of blood vessels in the brain, lungs, and eyes.
Flenox may be used to prevent blood vessel complications in people with certain types of angina (chest pain) or heart attack.
Use of the drug Flenox
1 mg (0.01 ml) of enoxaparin sodium corresponds to approximately 100 units of anti-Xa ME activity. Flenox should be administered subcutaneously for prophylactic and therapeutic use and intravenously for anticoagulation during hemodialysis. Flenox cannot be administered intramuscularly! The drug is recommended for use only in adults. Technique of subcutaneous administration The syringes filled by the manufacturer are ready for immediate use. There is no need to remove air bubbles from the syringe before injection to avoid loss of drug when using prefilled 20 and 40 mg syringes. When using calibrated prefilled 60 and 80 mg syringes, the volume to be injected must be accurately measured. Flenox subcutaneous injection should be performed alternately into the left or right outer side of the abdominal wall, using different sites for each injection. Do not rub the injection site after administration. The needle should be inserted to its full length vertically into the thickness of the skin fold, made carefully with the thumb and forefinger. The skin fold must be maintained throughout the administration of the drug. Prevention of venous thrombosis During surgical interventions in adults with a moderate risk of thrombus formation (for example, in abdominal surgery) and in patients without a high risk of thromboembolism, the drug is administered subcutaneously at a dose of 20 mg (0.2 ml; 2000 anti-Xa IU) 1 time per day . For adult patients with a high risk of thromboembolism (surgeries on the hip, knee joints; operations in cancer patients), Flenox is administered subcutaneously at a dose of 40 mg (0.4 ml; 4000 anti-Xa) once a day. In general surgery, the first dose should be administered 2 hours, in orthopedic surgery - 12 hours before surgery. The duration of preventive treatment is on average 7–10 days. In orthopedics, the effectiveness of using enoxaparin sodium at a dose of 40 mg (0.4 ml; 4000 anti-Xa) once a day for 4 weeks has been proven. Prevention of venous thromboembolic complications in medical patients on bed rest The recommended dose of Flenox is 40 mg (0.4 ml; 4000 anti-Xa IU) 1 time per day subcutaneously. Flenox is prescribed for a minimum of 6 days, the maximum duration of treatment is no more than 14 days. Prevention of thrombus formation in extracorporeal circulation during hemodialysis The recommended dose for adults is 1 mg/kg of the patient’s body weight. Flenox is injected into the arterial line of the circuit at the beginning of the dialysis session. The anticoagulant effect of this dose is usually sufficient for a 4-hour hemodialysis session; If fibrin rings are detected, an additional dose of the drug can be administered - 5-10 mg/kg. For patients at high risk of bleeding, the dose of enoxaparin sodium should be reduced to 0.5 mg/kg with dual vascular access and to 0.75 mg/kg with single vascular access. When fibrin rings appear, an additional dose of 0.5 mg/kg to 1 mg/kg is administered. Treatment of deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism, Flenox is prescribed subcutaneously once a day at a dose of 1.5 mg/kg or 2 times a day at a single dose of 1 mg/kg (every 12 hours). The duration of treatment is on average 10 days. If necessary, oral anticoagulants are simultaneously prescribed. Treatment is continued until the therapeutic anticoagulant effect of these drugs is achieved (international normalized ratio (INR) value - 2:3). Treatment of unstable angina and non-Q wave myocardial infarction The recommended single dose of Flenox is 1 mg/kg subcutaneously every 12 hours; At the same time, acetylsalicylic acid is prescribed orally (at a dose of 100–325 mg 1 time per day). Duration of treatment - minimum 2 days, maximum - 8 days. Use in special groups of patients There is no need to reduce the dose of the drug in elderly people with preserved renal function. For patients with renal failure (creatinine clearance ≤30 ml/min), dose adjustment of the drug is necessary, since the effect of enoxaparin sodium is significantly enhanced in this patient population. The following dose adjustment is recommended: when used for prophylactic purposes - 20 mg (0.2 ml) 1 time per day; when used for therapeutic purposes - 1 mg/kg 1 time per day. Administration of the drug to patients with liver failure requires careful medical supervision.
What you need to know before you start taking Flenox
If you have an individual intolerance to the components that make up this product, you should stop using it. It is also not recommended to take Flenox if you are allergic to heparin, benzyl alcohol or pork products.
The main contraindications to the use of the drug Flenox:
- active or uncontrolled bleeding;
- thrombocytopenia (reduced number of platelets in the blood);
- a genetic or disease-induced bleeding disorder (such as hemophilia);
- hemorrhagic stroke (bleeding in the brain);
- bacterial endocarditis (infection of the inner lining of the heart);
- gastrointestinal ulcer or active gastric bleeding;
- recent surgery on the brain, spine, or eyes.
Caution should be exercised when taking Flenox for people who have a history of conditions such as:
- liver and kidney diseases;
- uncontrolled high blood pressure;
- eye problems caused by diabetes;
- low platelet count after taking heparin.
If you require surgery or any dental work, you should notify your doctor that you are taking Flenox.
Flenox solution 6000 anti-Xa IU/0.6 ml No. 10
Compound
active ingredient: enoxaparin sodium
1 ml 10,000 anti-Xa IU, which is equivalent to 100 mg enoxaparin sodium
2000 anti-Xa IU/0.2 ml, equivalent to enoxaparin sodium 20 mg
4000 anti-Xa IU/0.4 ml, equivalent to enoxaparin sodium 40 mg
6000 anti-Xa IU/0.6 ml, equivalent to enoxaparin sodium 60 mg
8000 anti-Xa IU/0.8 ml, equivalent to enoxaparin sodium 80 mg
excipients: water for injection.
Indications
— prevention of venous thromboembolism during surgical interventions accompanied by moderate and high thrombogenic risk;
- prevention of deep vein thrombosis in patients on bed rest due to acute therapeutic diseases: NYHA class III or IV heart failure, acute respiratory failure, acute infectious or rheumatic disease, in the presence of at least one other risk factor for venous thromboembolism
- prevention of thrombus formation in the extracorporeal circulation circuit during hemodialysis (the procedure lasts on average up to approximately 4:00)
- treatment of diagnosed deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism and does not have severe clinical symptoms, with the exception of pulmonary embolism, which requires treatment with thrombolytic agents or surgical intervention
- treatment of unstable angina and acute myocardial infarction without a Q wave in combination with acetylsalicylic acid
treatment of acute myocardial infarction with ST segment elevation/elevation in combination with a thrombolytic agent in patients who can undergo further coronary angioplasty, as well as in patients who do not undergo this procedure.
Contraindications.
This medicine is generally not recommended in the following cases:
Hypersensitivity to enoxaparin, heparin or its derivatives, including other low molecular weight heparins.
A history of severe heparin-induced thrombocytopenia (HIT) type II, which was caused by unfractionated heparin or low molecular weight heparin (see section "Peculiarities of use").
Bleeding or tendency to bleed associated with impaired hemostasis (a possible exception to this contraindication may be DIC, if it is not associated with heparin therapy (see Section “Peculiarities of Application”).
Organic lesions that can cause bleeding.
Active clinically significant bleeding.
In addition, this drug is generally not recommended for use in prophylactic doses in patients over 65 years of age in combination with the following drugs (see section "Interactions with other drugs and other types of interactions"):
Acetylsalicylic acid in analgesic, antipyretic and anti-inflammatory doses. Nonsteroidal anti-inflammatory drugs (NSAIDs) (systemic use). Dextran 40 (parenteral use).
Directions for use and doses
1 mg (0.01 ml) of enoxaparin sodium corresponds to approximately 100 units of anti-Xa ME activity. Flenox® should be administered subcutaneously for prophylactic and therapeutic use, except in the following cases:
- use of the drug for anticoagulation in hemodialysis practice;
- treatment of patients with myocardial infarction with ST segment elevation who require intravenous bolus administration.
Children.
Due to the lack of relevant data, the use of LMWH in pediatric practice is not recommended.
Contraindications to the use of the drug Flenox
Flenox should not be taken in the following cases:
- you have a genetic defect of the spine;
- history of spinal surgery or repeated spinal punctures;
- if you are taking other medications that affect blood clotting (antiplatelet agents, some NSAIDs).
Flenox can cause a very serious blood clot to form around the spinal cord if you have had a spinal tap or received a spinal anesthetic (epidural). This type of blood clot can cause long-term or irreversible paralysis.
Be careful! If you experience symptoms such as back pain, numbness and muscle weakness in the lower body, and urinary and fecal incontinence while using Flenox, this may indicate a blood clot in the spinal cord. In this case, immediate hospitalization in a medical facility is required.
Flenox should not be used by pregnant women or women planning to conceive, and this medicine should not be used during breastfeeding, but if there is an urgent need for its use, then strictly as prescribed by the doctor.
Flenox is used only in adults and the elderly.
Special instructions for the use of the drug Flenox
Enoxaparin sodium can be prescribed to pregnant women only if there are strict indications and under strict medical supervision. Due to the lack of information on adequate dosing, efficacy and safety of administration in such cases, enoxaparin sodium is not recommended for use in pregnant women with prosthetic heart valves. During treatment with enoxaparin sodium, breastfeeding should be discontinued. The use of enoxaparin sodium in children is contraindicated. When using enoxaparin sodium, monitoring of patients with a history of heparin-induced thrombocytopenia with or without thrombosis is necessary. Monitoring the number of platelets in peripheral blood is necessary regardless of the indications for which the drug is prescribed and its dosage regimen. It is recommended to determine the platelet count before and throughout the course of treatment. If the platelet count decreases by 30–50% from the initial level, treatment should be stopped immediately. Low molecular weight heparins are not clinically interchangeable. Enoxaparin sodium, like other anticoagulants, should be used with caution in patients with the following conditions: hemostasis disorders, a history of gastric and intestinal ulcers, recent stroke, uncontrolled hypertension (arterial hypertension), diabetic retinopathy, recent neurosurgical or ophthalmological surgery. Enoxaparin sodium should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia (including low molecular weight heparins) with or without thrombosis. The risk of heparin-induced thrombocytopenia may persist for several years. At doses used for the prevention of venous thromboembolism, enoxaparin sodium does not significantly affect bleeding time and other blood parameters, including platelet aggregation or fibrinogen binding to platelets. When using the drug in higher doses, the APTT and ABC (activated clot formation time) may increase. However, the increase in these indicators is not directly dependent on the increase in the antithrombotic activity of enoxaparin sodium and does not require monitoring the activity of the drug. When using the drug prophylactically in elderly patients, there was no increase in the tendency to bleeding. When used in therapeutic doses, there may be a risk of hemorrhagic complications, which requires regular clinical monitoring. In patients with impaired renal function, the release of enoxaparin sodium is slowed down, which increases the risk of bleeding. In patients with severe renal impairment (creatinine clearance ≤30 ml/min), dose adjustment of the drug is recommended. For patients with mild to moderate kidney damage, no dose adjustment is required, but regular monitoring of the patient's condition is necessary. When treating patients with low body weight (≤45 kg in women and ≤57 kg in men), the risk of hemorrhagic complications increases, which requires constant monitoring of the patient. In order to reduce the risk of bleeding after instrumental interventions for the treatment of unstable angina (PTCA), the catheter that provides vascular access should be removed no earlier than 6-8 hours after subcutaneous administration of enoxaparin sodium. The next dose of enoxaparin sodium can be administered only 6–8 hours after removal of the catheter. When performing spinal or epidural anesthesia while using enoxaparin sodium, cases of the development of neuraxial hematomas were noted, which could lead to prolonged or permanent paralysis. When using enoxaparin sodium at a dose of 40 mg 1 time per day or lower, such cases were rarely detected. The risk of developing such complications increases with the use of enoxaparin sodium in higher doses, the use of permanent postoperative epidural catheters, or the simultaneous use of drugs that affect hemostasis, in particular NSAIDs, during traumatic or repeated neuraxial punctures. When combined with spinal or epidural anesthesia using enoxaparin sodium, it is best to install and remove the catheter before administering enoxaparin. Insertion and removal of a catheter for epidural or spinal anesthesia is best performed when the anticoagulant effect of enoxaparin sodium is low: 10–12 hours after administration of 40 mg or lower daily doses of enoxaparin sodium or 24 hours after administration of the drug in high doses (1 mg/kg 2 times a day or 1.5 mg/kg 1 time a day). Subsequent administration of enoxaparin sodium should be carried out no earlier than 2 hours after removal of the catheter. Regular monitoring of the patient's neurological status is necessary. If you suspect signs of a spinal hematoma, you must immediately begin appropriate treatment (if necessary, perform spinal cord decompression). The use of the drug does not affect the speed of psychomotor reactions when driving vehicles or operating other mechanisms.
How to take Flenox?
Flenox is available in injectable form for administration under the skin or intravenously (IV). It is not intended for intramuscular (IM) administration.
When injected under the skin, an injection is most often made into the fatty fold of the abdomen. Do not inject the drug into the same place two times in a row.
Each disposable prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine inside.
After opening the bottle, Flenox must be used within 28 days.
Note! Flenox must be used following the clear instructions of your doctor; you should not stop taking the drug on your own, even if your health has improved.
Flenox drug overdose, symptoms and treatment
Oral administration of enoxaparin sodium (no such cases have been reported) should not lead to serious consequences, given the very low absorption of the drug in the gastrointestinal tract. Accidental overdose after intravenous, extracorporeal or subcutaneous administration of high doses of enoxaparin sodium can lead to hemorrhagic complications due to the anticoagulant activity of the drug. This effect can be largely counteracted by slow intravenous administration of protamine. Care should be taken to avoid overdose of protamine, since even with high doses of protamine, the anti-Xa activity of enoxaparin sodium may persist and the anticoagulant activity will be neutralized. The dose of protamine should correspond to the dose of enoxaparin sodium administered: 1 mg or 100 antiheparin units of protamine to neutralize the anti-IIa activity generated by 1 mg (100 IU anti-Xa activity) of enoxaparin sodium. However, the anti-Xa activity of enoxaparin sodium is never completely neutralized even by a high dose of protamine (maximum effect - 60%). Since neutralization may be temporary (due to the absorption kinetics of low molecular weight heparins), the dose of protamine must be divided into several injections (from 2 to 4 injections over 24 hours).
Directions for use and dosage of Flenox
Usual Adult Dose for Deep Vein Thrombosis.
1 mg/kg subcutaneously every 12 hours or 1.5 mg/kg subcutaneously once daily at the same time every day.
The duration of therapy is at least 5 days until the therapeutic effect of the oral anticoagulant is achieved. The average duration is 7 days.
Usual adult dose for angina, myocardial infarction, and acute coronary syndrome.
1 mg/kg subcutaneously every 12 hours, usually in combination with oral aspirin therapy (100 to 325 mg once daily).
The duration of therapy is at least 2 days until clinical stabilization. The usual duration is from 2 to 8 days.
Usual geriatric dose for myocardial infarction.
75 years and older: Initial dose 0.75 mg/kg subcutaneously every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg for remaining doses).
Usual adult dose for prophylaxis of deep vein thrombosis.
30-40 mg subcutaneously once a day every 12 hours.
The duration of use is usually from 6 to 11 days.
Pharmacological properties of the drug Flenox
Pharmacodynamics. Enoxaparin sodium is a low molecular weight heparin (average molecular weight 4500 daltons) that shares the antithrombotic and anticoagulant activities of standard heparin. Enoxaparin sodium has high anti-Xa activity (100 IU/ml) and low anti-IIa or antithrombin activity (28 IU/ml). When used in recommended doses for various indicators, enoxaparin sodium does not increase bleeding time. In prophylactic doses, enoxaparin sodium does not lead to significant changes in the activated partial thromboplastin time (aPTT), and also does not affect platelet aggregation and fibrinogen binding to platelets. Pharmacokinetics. The pharmacokinetic parameters of the drug are assessed by changes in anti-Xa and anti-IIa activity in blood plasma over time in the recommended dose range. After subcutaneous administration, enoxaparin sodium is quickly and completely absorbed. The absolute bioavailability of enoxaparin sodium after subcutaneous administration is more than 90%. Maximum activity in blood plasma is observed after 3 hours; it averages 1.6 μg/ml after injection at a dose of 20 mg and 3.8 μg/ml after injection at a dose of 40 mg. The elimination of enoxaparin sodium (based on anti-Xa activity levels) is characterized by a half-life of approximately 4.4 hours for a 40 mg dose. The study found that when used in higher doses - from 73.8 to 132.6 mg, the level of anti-Xa activity shows a first half-life of approximately 5 hours and a second half-life of about 9 hours. When used at a dose of 40 mg of anti-Xa, Xa activity can persist in the blood plasma for 24 hours. The elimination of enoxaparin sodium when used in prophylactic doses is not significantly affected in patients with renal failure. It is slightly reduced in older people (half-life - 6-7 hours). These changes do not require adjustment of the dose or frequency of administration of the drug, since accumulation of the drug in the blood plasma in elderly people was not observed. Enoxaparin sodium does not penetrate the placental barrier during the second trimester of pregnancy. The metabolism of enoxaparin sodium occurs in the liver by desulfation and depolymerization. Renal clearance of active metabolites is 10%, total renal excretion is 40% of the drug dose.
What should you not do while taking Flenox?
While using Flenox, you should avoid activities that may increase the risk of bleeding or injury. Also, when shaving or brushing your teeth, you need to be especially careful to avoid cuts to avoid bleeding, which will be difficult to stop.
It is prohibited to consume alcoholic beverages while using Flenox, since alcohol impairs blood clotting, which can be especially dangerous when receiving open injuries with bleeding.
What are the side effects of Flenox?
Among the common side effects while taking the medication Flenox are the following:
- nausea, diarrhea;
- anemia;
- confusion;
- pain, bruising, redness, or irritation at the injection site.
When using Flenox, rare side effects , in the event of which a visit to an ambulance is required, including the following:
- unusual bleeding or any bleeding that does not stop;
- easy bruising, purple or red spots under the skin;
- nosebleeds, bleeding gums;
- abnormal vaginal bleeding, blood in urine or stool;
- coughing up blood or vomit that looks like coffee grounds;
- signs of bleeding in the brain - sudden weakness (especially on one side of the body), sudden severe headache, problems with speech or vision;
- low red blood cell count (anemia)—pale skin, unusual tiredness, feeling dizzy or short of breath, cold hands and feet.
All of the above side effects from taking Flenox are not exhaustive; for more detailed information, you should contact a medical specialist.
Side effects of the drug Flenox
Reactions at the injection site (from mild irritation to pain, bruising at injection sites, hematomas, in exceptional cases - skin necrosis; bullous skin rashes or systemic allergic reactions, including anaphylactoid). If these side effects occur, treatment with the drug must be stopped. Bleeding in the presence of associated risk factors (organic lesions leading to bleeding, invasive procedures or use of drugs affecting hemostasis); there have been reports of isolated cases of significant hemorrhages, in particular retroperitoneal and intracranial; some of these cases were fatal. Thrombocytopenia (mild, transient, asymptomatic in the first days of therapy; immunoallergic thrombocytopenia with thrombosis is possible, which in some cases was complicated by organ infarction or limb ischemia). With long-term treatment (more than 5 weeks), early development of osteoporosis is possible; increased activity of transaminases in blood serum; cases of neuraxial hematomas when using enoxaparin during epidural or spinal anesthesia can lead to varying degrees of neurological disorders, including the formation of long-term or permanent paralysis. Isolated cases of hypersensitivity with cutaneous vasculitis have been reported; asymptomatic and reversible increase in platelet count and liver enzyme levels.
Symptoms and consequences of overdose with Flenox
If the dosage regimen and use of Flenox are not followed, an overdose of this medication may occur, which includes such health changes as:
- bleeding of any etiology (from nasal to cerebral hemorrhage);
- nausea and dark, thick vomit (may indicate stomach bleeding);
- decreased red blood cells in laboratory blood tests (erythropenia);
- hemorrhagic stroke (bleeding in the brain).
If you have such conditions, you need to immediately contact an ambulance to receive prompt, qualified medical care.
Interaction of Flenox with other drugs and substances
Flenox has its own drug interactions, in which case the therapeutic effect of Flenox may be enhanced or weakened.
List of medications that interact with Flenox:
- any drugs used to treat or prevent the formation of blood clots (antiplatelet agents, thrombolytics and other drugs from the group of anticoagulants) - the effect of reducing blood clotting is enhanced;
- non-steroidal anti-inflammatory drugs (NSAIDs) - increases the risk of bleeding;
- Potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor inhibitors - may contribute to the development of hyperkalemia (increased potassium levels in the blood).
The above list is not complete; there are other joint interactions of Flenox with other drugs. For more detailed information, you should consult your doctor.
