Generic Name: dalteparin (DAL-te-PAR-in)
Brand Name: Fragmin
Tell your doctor you use Fragmin before you have any type of spinal or epidural procedure. Patients who have these procedures while they use Fragmin are at risk for developing bleeding around your spine. This could result in long-term or permanent paralysis.
The risk is increased in patients who have an indwelling epidural catheter. It is also increased in patients with a history of traumatic or repeated epidural or spinal puncture, a deformed spine, or spinal surgery. It is also increased in patients who use medicines that may affect blood clotting, such as other anticoagulants (eg, warfarin), aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen).
If you have a spinal or epidural procedure while you use Fragmin, tell your doctor at once if you notice any symptoms of nerve problems (eg, back pain; numbness or tingling, especially in the legs and feet; muscle weakness; paralysis; loss of bladder or bowel control).
Talk with your doctor if you have recently had or will be having a spinal or epidural procedure. Some time may need to pass between the use of Fragmin and your procedure. Discuss any questions or concerns with your doctor.
Fragmin is used for:
Preventing blood clots in patients who have certain illnesses or who will be having certain types of surgeries. It is also used along with aspirin to prevent certain problems caused by heart attacks or unstable angina (chest pain). It is also used to reduce the recurrence of blood clots in cancer patients. It may also be used for other conditions as determined by your doctor.
Fragmin is a low molecular weight heparin (LMWH). It works by blocking the formation of blood clots.
Do NOT use Fragmin if:
- you are allergic to any ingredient in Fragmin
- you are allergic to heparin, benzyl alcohol, or pork products
- you have active severe high blood pressure, major bleeding, or a history of low platelets or blood clots due to the use of a heparin
- you are receiving Fragmin for unstable chest pain, a heart attack, or prolonged blood clot prevention and will be receiving local anesthesia
Contact your doctor or health care provider right away if any of these apply to you.
Before using Fragmin:
Some medical conditions may interact with Fragmin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney problems, liver problems, stomach or intestinal problems (eg, ulcers), a stroke, or vision problems caused by diabetes or high blood pressure
- if you have inflammation of the heart due to a bacterial infection or severe, uncontrolled high blood pressure
- if you have a bleeding disorder, a history of brain bleeding or blood conditions, or von Willebrand disease
- if you have recently had or are scheduled to have brain, spine, or eye surgery, an epidural catheter, or a spinal puncture
- if you are taking medicines that affect platelets (eg, aspirin, clopidogrel, ticlopidine)
Some MEDICINES MAY INTERACT with Fragmin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Activated protein C, anticoagulants (eg, warfarin), dextran, dipyridamole, direct factor XA inhibitors (eg, rivaroxaban), direct thrombin inhibitors (eg, dabigatran), injectable cephalosporins (eg, cefazolin), injectable penicillins (eg, ampicillin), NSAIDs (eg, ibuprofen, ketorolac, naproxen), platelet inhibitors (eg, clopidogrel, ticlopidine), salicylates (eg, aspirin), sulfinpyrazone, or thrombolytics (eg, streptokinase) because the risk of side effects, such as bleeding, may be increased
- Nitrates (eg, nitroglycerin) because they may decrease the effectiveness of Fragmin
This may not be a complete list of all interactions that may occur. Ask your health care provider if Fragmin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Fragmin:
Use Fragmin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fragmin is usually administered as an injection at your doctor's office, hospital, or clinic. If you will be using Fragmin at home, a health care provider will teach you how to use it. Be sure you understand how to use Fragmin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Fragmin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Fragmin should be given while sitting or lying down.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- Fragmin may be injected in a U-shape around the navel, the upper outer thigh, or the upper outer section of the buttock. The injection site should be changed daily. When injection around the navel or thigh is used, a fold of skin must be held by the thumb and forefinger while the injection is given. The entire needle should be injected at a 45- to 90-degree angle.
- Fixed dose syringes - To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area. Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. The needle guard will not be activated unless the entire dose has been given. Remove the needle from the patient. Let go of the plunger and allow the syringe to move up inside the device until the entire needle is guarded. Discard the assembly in approved containers.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Fragmin, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Fragmin.
Important safety information:
- Fragmin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Tell your doctor or dentist that you take Fragmin before you receive any medical or dental care, emergency care, or surgery.
- Before you begin taking any new prescription or nonprescription medicine, check the label to see if it has aspirin, ibuprofen, or naproxen in it. If it does or you are not sure, contact your doctor or pharmacist.
- If you have ever had an allergic reaction to benzyl alcohol, ask your doctor or pharmacist if your medicine has benzyl alcohol in it.
- Fragmin may affect certain lab tests, including liver enzyme. Be sure your doctor and lab personnel know you are using Fragmin.
- Lab tests, including complete blood cell counts (eg, platelet counts), blood chemistry, and tests for blood in the stool, may be performed while you use Fragmin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Fragmin with caution in the ELDERLY; they may be more sensitive to its effects, especially bleeding.
- Some forms of Fragmin contain benzyl alcohol. Do not use medicine with benzyl alcohol in NEWBORNS or INFANTS. It may cause serious and sometimes fatal side effects. If you have questions, check with your doctor or pharmacist.
- Fragmin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Fragmin may contain the preservative benzyl alcohol, which can cause harm to the fetus. If you become pregnant, use a formulation without this preservative. Discuss any questions or concerns with your doctor or pharmacist. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fragmin while you are pregnant. Fragmin is found in breast milk. If you are or will be breast-feeding while you are using Fragmin, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Fragmin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Mild bleeding, bruising, irritation, pain, redness, or swelling at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; dark red spots under the skin; difficulty walking; fainting; fever; pink or red urine; severe or persistent dizziness or weakness; tingling, numbness (especially in the legs and feet), and muscle weakness; unusual bruising or bleeding; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual bleeding or bruising (eg, nosebleeds, easy bruising, bloody urine or stools).Proper storage of Fragmin:
Store Fragmin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Fragmin out of the reach of children and away from pets.
- If you have any questions about Fragmin, please talk with your doctor, pharmacist, or other health care provider.
- Fragmin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Fragmin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fragmin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fragmin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Fragmin.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.