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enoxaparin (Subcutaneous route, Injection route)

ee-nox-a-PAR-in

Subcutaneous routeSolution

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurologic compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters; by the concomitant use of drugs affecting hemostasis such as NSAIDs, platelet inhibitors, or other anticoagulants; or by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment .

Commonly used brand name(s):

In the U.S.

Lovenox

Available Dosage Forms:

Solution
Injectable

Therapeutic Class: Anticoagulant

Pharmacologic Class: Low Molecular Weight Heparin

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Uses For enoxaparin

Enoxaparin 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. enoxaparin is used for several days after hip or knee replacement surgery, and in some cases following abdominal surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. Enoxaparin 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 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.

Enoxaparin is available only with your doctor's prescription.

Before Using enoxaparin

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 enoxaparin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to enoxaparin 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 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 in the elderly. However, elderly patients are more likely to have bleeding problems and age-related kidney disease, which may require an adjustment of dosage in patients receiving enoxaparin, especially those who weigh less than 45 kilograms (99 lbs).

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

Using enoxaparin 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
Alclofenac
Alteplase, Recombinant
Ancrod
Anisindione
Anistreplase
Antithrombin, Recombinant
Antithrombin III Human
Apazone
Ardeparin
Argatroban
Benoxaprofen
Bivalirudin
Bromfenac
Bufexamac
Carprofen
Certoparin
Citalopram
Clometacin
Clonixin
Clopidogrel
Dalteparin
Danaparoid
Defibrotide
Dermatan Sulfate
Desirudin
Dexketoprofen
Diclofenac
Dicumarol
Diflunisal
Dipyrone
Droxicam
Duloxetine
Enoxaparin
Eptifibatide
Escitalopram
Etodolac
Etofenamate
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Heparin
Ibuprofen
Indomethacin
Indoprofen
Isoxicam
Ketoprofen
Ketorolac
Lamifiban
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Nabumetone
Nadroparin
Naproxen
Niflumic Acid
Nimesulide
Oxaprozin
Oxyphenbutazone
Parnaparin
Paroxetine
Pentosan Polysulfate Sodium
Phenindione
Phenprocoumon
Phenylbutazone
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Reteplase, Recombinant
Reviparin
Sertraline
Sibrafiban
Streptokinase
Sulindac
Suprofen
Tenecteplase
Tenidap
Tenoxicam
Tiaprofenic Acid
Tinzaparin
Tirofiban
Tolmetin
Urokinase
Warfarin
Xemilofiban
Zomepirac

Using enoxaparin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aspirin
Benorilate
Choline Salicylate
Magnesium Salicylate
Mesalamine
Olsalazine
Salicylamide
Salicylic Acid
Salsalate
Sodium Salicylate
Sodium Thiosalicylate
Trolamine Salicylate

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of enoxaparin

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

If you are using enoxaparin at home, your doctor will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your doctor if you have any problems using the medicine.

Put used syringes in a puncture-resistant, disposable container, or dispose of them as directed by your doctor.

Dosing

The dose of enoxaparin 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 enoxaparin. 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 certain types of chest pain and heart attack:
  - Adults—Dose is based on body weight and must be determined by your doctor. However, the recommended dose is 1 milligram (mg) per kilogram (kg) of body weight injected under the skin every twelve hours for two to eight days. The dose is 1 mg per kg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (abdominal surgery):
  - Adults—40 milligrams (mg) injected under the skin once a day for seven to ten days. The first dose should be given 2 hours before the surgery. However, the dose is 30 mg once a day if you have a poorly performing kidney.
  - 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 twelve hours for seven to ten days. Alternatively, for hip replacement surgery, the dose may be 40 mg injected under the skin once a day for three weeks. The dose is 30 mg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (in patients with a serious illness who cannot get out of bed):
  - Adults—40 milligrams (mg) injected under the skin once a day for six to eleven days. The dose is 30 mg once a day if you have a poorly performing kidney.
  - 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 recommended dose is 1 milligram (mg) per kilogram (kg) of body weight every 12 hours injected under the skin for about seven days. The dose is 1 mg per kg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For treatment of certain types of chest pain and heart attack:
  - Adults—Dose is based on body weight and must be determined by your doctor. However, the recommended dose is 1 milligram (mg) per kilogram (kg) of body weight every 12 hours injected under the skin for two to eight days. Aspirin 100 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 enoxaparin, 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 While Using enoxaparin

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

You may bleed and bruise more easily while you are using enoxaparin. 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. Avoid nose picking and forceful nose blowing.

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

Patients requiring certain procedures (such as epidural/spinal anesthesia or spinal puncture) while being treated with enoxaparin are at risk of having a blood clot in or around the spine. This condition may result in long-term or permanent paralysis.

enoxaparin may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

Make sure your doctor knows if you have received enoxaparin or heparin before and had a reaction called thrombocytopenia. Tell your doctor if new blood clots formed while you were receiving the medicine.

Tell your doctor if you have recently given birth, fallen or suffered a blow to the body or head, or had medical or dental surgery. These events may increase the risk of serious bleeding while you are taking enoxaparin.

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.

enoxaparin 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 in 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
shortness of breath

Less common

Bruising
chest discomfort
collection of blood under the skin
confusion
continuing bleeding or oozing from the nose and/or mouth, or surgical wound
convulsions (seizures)
fever
irritability
lightheadedness
lower back pain
pain or burning while urinating
swelling of the hands or feet
tightness in the chest
uncontrolled bleeding at the site of injection
wheezing
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 from a lying or sitting position suddenly
extreme fatigue
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
troubled breathing
weight gain

Incidence not known

Abdominal pain
deep, dark purple bruise
hives or welts
irregular heartbeat
itching, pain, redness, or swelling
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
skin rash
unusual tiredness or weakness
weakness or heaviness of 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
irritation, pain, or redness at the place of injection

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

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