Enoxaparin (intravenous route, subcutaneous route, injection route)


    Brand Name

    US Brand Name

    Lovenox


    Description

    Enoxaparin injection is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used for several days after hip or knee replacement surgery, and in some cases following abdominal or stomach surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. It is also used if you are unable to get out of bed because of a serious illness. In addition, enoxaparin is used to prevent blood clots from forming in the arteries of the heart during certain types of chest pain and heart attacks.

    Enoxaparin injection is used together with warfarin to treat acute deep vein thrombosis with or without pulmonary embolism. It is also used to treat certain types of acute heart attacks.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of enoxaparin injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of enoxaparin injection in the elderly. However, elderly patients are more likely to have bleeding problems and age-related kidney disease, which may require an adjustment in the dose for patients receiving enoxaparin injection, especially those who weigh less than 45 kilograms (kg).

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Defibrotide

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Alipogene Tiparvovec
    • Alteplase, Recombinant
    • Amtolmetin Guacil
    • Anagrelide
    • Anistreplase
    • Antithrombin, Recombinant
    • Apixaban
    • Argatroban
    • Aspirin
    • Bemiparin
    • Betrixaban
    • Bivalirudin
    • Bromfenac
    • Bufexamac
    • Caplacizumab-yhdp
    • Celecoxib
    • Choline Salicylate
    • Citalopram
    • Clonixin
    • Clopidogrel
    • Collagenase, Clostridium histolyticum
    • Curcumin
    • Dabigatran Etexilate
    • Dalteparin
    • Danaparoid
    • Desvenlafaxine
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Dipyridamole
    • Dipyrone
    • Drotrecogin Alfa
    • Droxicam
    • Edoxaban
    • Eptifibatide

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergy to benzyl alcohol, heparin, or pork products or
    • Major bleeding, active or
    • Thrombocytopenia (low platelet count in the blood), history of—Should not use in patients with these conditions.
    • Blood disease or bleeding problems or
    • Blood vessel problems or
    • Catheter insertion in the spine or
    • Diabetic retinopathy (eye problem) or
    • Heart infection or
    • Heart valves, prosthetic or
    • Hypertension (high blood pressure), uncontrolled or
    • Septic shock or
    • Stomach or intestinal ulcer or bleeding, active or
    • Stroke, recent or history of or
    • Surgery (eg, eye, brain, or spine), recent or history of or
    • Thrombocytopenia, heparin-induced, or history of or
    • Threatened miscarriage or
    • Weight of less than 99 pounds in women or 126 pounds in men—Use with caution. The risk of bleeding may be increased.
    • Kidney disease—Use with caution. The effects may be increased because of slower removal from the body.

    Proper Use

    A nurse or other trained health professional will usually give you this medicine in the hospital. This medicine is given as a shot under your skin or into a vein.

    It may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

    If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

    Do not inject into skin areas that are bruised or have scars.

    Check the liquid in the vial or prefilled syringe. It should be clear and colorless or pale yellow. Do not use it if it is cloudy, discolored, or if you see particles in it.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For injection dosage form:
      • For prevention of blood clots after unstable angina (chest pain) or non–Q-wave myocardial infarction (a type of heart attack):
        • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight injected under the skin every 12 hours together with aspirin 100 to 325 mg once a day for 2 to 8 days.
        • Children—Use and dose must be determined by your doctor.
      • For prevention of deep venous thrombosis (abdominal or stomach surgery):
        • Adults—40 milligrams (mg) injected under the skin once a day for 7 to 10 days. The first dose should be given 2 hours before the surgery.
        • Children—Use and dose must be determined by your doctor.
      • For prevention of deep venous thrombosis (hip or knee replacement surgery):
        • Adults—30 milligrams (mg) injected under the skin every 12 hours for 7 to 10 days. Alternatively, for hip replacement surgery, the dose may be 40 mg injected under the skin once a day for 3 weeks.
        • Children—Use and dose must be determined by your doctor.
      • For prevention of deep venous thrombosis (in patients with a serious illness):
        • Adults—40 milligrams (mg) injected under the skin once a day for 6 to 11 days.
        • Children—Use and dose must be determined by your doctor.
      • For treatment of acute deep vein thrombosis with or without pulmonary embolism:
        • Adults—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 1 milligram (mg) per kilogram (kg) of body weight every 12 hours injected under the skin for 7 days.
        • Children—Use and dose must be determined by your doctor.
      • For treatment of certain type of acute heart attack
        • Adults—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 30 milligrams (mg) injected into your vein and 1 milligram (mg) per kilogram (kg) of body weight injected under the skin followed by 1 mg per kg every 12 hours injected under the skin for 8 days. Aspirin 75 to 325 mg orally once a day may also be given.
        • Older adults—Dose is based on body weight and must be determined by your doctor. However, the starting dose is 0.75 mg per kg of body weight injected under the skin every 12 hours for 8 days. Aspirin 75 to 325 mg orally once a day may also be given.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    If you were given a bottle of medicine to use with your syringes, you must use the medicine within 28 days after the first shot. Throw away the unused medicine in the bottle after 28 days.

    Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments.

    Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

    This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

    Enoxaparin may cause bleeding problems. This risk is higher if you have a catheter in your back for pain medicine or anesthesia (sometimes called an "epidural"), or if you have kidney problems. The risk of bleeding increases if your kidney problems get worse. Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, bleeding gums, blood in the urine or stools, tingling, numbness, or weakness of the lower legs, or pinpoint red spots on your skin.

    Lovenox® multiple-dose vials contain benzyl alcohol as a preservative. Tell your doctor right away if you are pregnant or have had an allergic reaction to benzyl alcohol.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Bleeding gums
    • coughing up blood
    • difficulty with breathing or swallowing
    • dizziness
    • headache
    • increased menstrual flow or vaginal bleeding
    • nosebleeds
    • paralysis
    • prolonged bleeding from cuts
    • red or black, tarry stools
    • red or dark brown urine
    • trouble breathing

    Less common

    • Bruising
    • chest discomfort or tightness
    • collection of blood under the skin
    • confusion
    • continuing bleeding or oozing from the nose or mouth, or surgical wound
    • fever
    • irritability
    • lightheadedness
    • lower back pain
    • pain or burning while urinating
    • seizures
    • swelling of the hands or feet
    • uncontrolled bleeding at the site of injection
    • vomiting of blood or material that looks like coffee grounds

    Rare

    • Back pain
    • burning, pricking, tickling, or tingling sensation
    • chest pain
    • chills
    • cough
    • decreased urine output
    • dilated neck veins
    • dizziness or lightheadedness when getting up suddenly from a lying or sitting position
    • fainting
    • fast or irregular heartbeat
    • general feeling of discomfort or illness
    • irregular breathing
    • leg weakness
    • problems with bowel or bladder function
    • skin rash or hives
    • sneezing
    • sore throat
    • sudden fainting
    • swelling of the face, fingers, feet, genitals, mouth, or tongue
    • thickening of the bronchial secretions
    • unusual tiredness or weakness
    • weight gain

    Incidence not known

    • Deep, dark purple bruise
    • hives or welts, skin rash
    • irregular heartbeat
    • itching, pain, redness, or swelling at the injection site
    • large, flat, blue, or purplish patches in the skin
    • nausea or vomiting
    • nervousness
    • numbness or tingling in the hands, feet, or lips
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • redness of the skin
    • stomach pain
    • weakness or heaviness of the legs

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Less common

    • Diarrhea

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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