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Generic Name: dalteparin (Subcutaneous route)

dal-te-PAR-in

Subcutaneous route(Solution)

Epidural or spinal hematomas, which may result in long-term or permanent paralysis, may occur in patients who are anticoagulated with low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. Factors that can increase the risk of developing these hematomas include: use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis such as NSAIDs, platelet inhibitors, or other anticoagulants, or history of traumatic or repeated epidural or spinal puncture, spinal deformity, or spinal surgery. Monitor patients frequently for neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider risks/benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

Commonly used brand name(s)

In the U.S.

  • Fragmin

Available Dosage Forms:

  • Solution
  • Injectable

Therapeutic Class: Anticoagulant

Pharmacologic Class: Low Molecular Weight Heparin

Uses For Fragmin

Dalteparin 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 prevents blood clots from forming in blood vessels of patients with unstable angina or heart attack. Dalteparin is used for several days after abdominal surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. Dalteparin also may be used for other conditions as determined by your doctor.

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

Before Using Fragmin

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 dalteparin 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 dalteparin in the elderly. However, elderly patients may require an adjustment in the dose, especially those who are at risk of bleeding or those who have kidney disease.

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

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 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
  • Anistreplase
  • Antithrombin, Recombinant
  • Apixaban
  • Argatroban
  • Aspirin
  • Bivalirudin
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Choline Salicylate
  • Citalopram
  • Clonixin
  • Clopidogrel
  • Collagenase, Clostridium histolyticum
  • Dabigatran Etexilate
  • Danaparoid
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Drotrecogin Alfa
  • Enoxaparin
  • Eptifibatide
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenofibrate
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Heparin
  • Ibuprofen
  • Ibuprofen Lysine
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lepirudin
  • Levomilnacipran
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Paroxetine
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Reteplase, Recombinant
  • Rivaroxaban
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sodium Salicylate
  • Streptokinase
  • Sulindac
  • Tenecteplase
  • Tenoxicam
  • Tiaprofenic Acid
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Urokinase
  • Valdecoxib
  • Vorapaxar
  • Vortioxetine
  • Warfarin

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.

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:

  • Bleeding, active or
  • Regional anesthesia or
  • Thrombocytopenia (low platelet count in the blood), heparin-induced, or history of—Should not be used in patients with these conditions.
  • Bleeding problems or
  • Catheter insertion in your spine or
  • Eye problems caused by diabetes or high blood pressure or
  • Heart infection or
  • Hypertension (high blood pressure), severe and uncontrolled or
  • Kidney disease or
  • Liver disease or
  • Stomach or intestinal ulcer or bleeding, active or recent or
  • Stroke or
  • Surgery (e.g., surgery of the eye, brain, or spine), recent or history of or
  • Thrombocytopenia—Use with caution. The risk of bleeding may be increased.

Proper Use of Fragmin

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin (usually in the abdomen, buttocks, or thighs).

If you are using dalteparin 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.

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 from the injections.

If the medicine in the vial (glass container) or prefilled syringe has changed color, or if you see particles in it, do not use it.

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

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 deep venous thrombosis (leg clots) and pulmonary embolism (lung clots):
      • Adults—The dose will be determined by your doctor, based on your condition.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of blood clots after unstable angina (chest pain) or non–Q-wave myocardial infarction (a type of heart attack):
      • Adults—120 International Units (IU) per kilogram (kg) of body weight injected under the skin (but not more than 10,000 IU) given every 12 hours for 5 to 8 days. Unless your doctor recommends otherwise, aspirin should be given 75 to 165 milligrams (mg) daily.
      • 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 14 days after the first shot. Throw away the unused medicine in the bottle after 14 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 Fragmin

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may 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 may increase your chance of bleeding or bruising. This risk is higher if you have a catheter in your back for pain medicine or anesthetics. This is sometimes called an "epidural". 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.

Stop using this medicine and call your doctor right away if you start having pain in chest, groin, or legs, especially the calves; difficulty with breathing; severe, sudden headache; slurred speech; sudden, unexplained shortness of breath; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; or vision changes. These may be symptoms of thromboembolism.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

This medicine contains benzyl alcohol which may cause serious reactions to newborn or premature infants. Discuss this with your doctor if you are concerned.

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.

Fragmin 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
  • Deep, dark purple bruise, pain, or swelling at the place of injection
Less common
  • Bleeding of 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
  • shortness of breath
  • unexplained pain, swelling, or discomfort, especially in the chest, abdomen or stomach, joints, or muscles
  • unusual bruising
  • vomiting of blood or material that looks like coffee grounds
  • weakness
Rare
  • Back pain
  • bleeding from mucous membranes
  • bluish or black discoloration, flushing, or redness of the skin
  • burning, pricking, tickling, or tingling sensation
  • coughing
  • feeling faint
  • fever
  • leg weakness
  • numbness
  • problems with bowel or bladder function
  • skin rash (which may consist of pinpoint, purple-red spots), hives, or itching
  • sloughing of the skin at place of injection
  • swelling of the eyelids, face, or lips
  • tightness in the chest or wheezing

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.

See also: Side effects (in more detail)

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