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Fragmin

Dalteparin

Fragmin

Fragmin (Dalteparin) is an FDA-approved medication used to treat and prevent blood clots. It treats other conditions such as pulmonary embolism (PE), deep vein thrombosis (DVT) and acute coronary syndrome. It is administered as an injection under the skin or through an IV. The dosage of this drug varies based on the condition being treated and patient characteristics. Common side effects include increased bleeding or bruising. Following the prescribed dosage and consulting a doctor for any concerns is important. Fragmin should not be used by individuals with certain medical conditions, including major bleeding, drug-induced low platelet count, allergies to heparin or pork, and specific heart problems.

Product Overview

Fragmin (Dalteparin) is an anticoagulant medication primarily used to prevent blood clotting formation in your blood vessels. It’s part of a group of drugs called low molecular weight heparins. Fragmin works by slowing down the body’s natural blood clotting process, reducing the chance of forming harmful clots. Doctors often prescribe it for conditions like deep vein thrombosis (DVT), pulmonary embolism, and some heart conditions.

The medication is administered through subcutaneous injections or intravenously, depending on the patient’s condition and the healthcare provider’s recommendation. This medicine comes in 3 forms and has many strengths. The dosage of Fragmin is determined based on the patient’s body weight, the specific condition being treated, and other individual factors. It is available in various strengths, including ampules, multidose vials, and prefilled syringes. You may experience some common and mild side effects of Fragmin, including increased bruising or bleeding, swelling at the injection site, and longer bleeding times from minor injuries. More serious side effects can include spinal hematoma, leading to paralysis, and increased risk of bleeding in individuals with certain medical conditions such as a history of spinal surgery, major bleeding, drug-induced low platelet count, allergies to heparin or pork, and specific heart problems.

It is crucial for patients to follow their doctor’s instructions regarding dosage and administration of Fragmin. Regular monitoring through blood tests may be required to ensure the medication’s effectiveness and to adjust the dosage as necessary. Fragmin can interact with various drugs, increasing the risk of side effects, thus talking to a healthcare professional becomes crucial. This is an effective medication for managing and preventing blood clots, but it needs careful monitoring and adherence to prescribed guidelines to ensure safety and effectiveness. Remember, this information is just a general overview and not a replacement for advice from a healthcare provider. Always consult a healthcare professional for specific details about any medication.

Uses of Fragmin

Fragmin (Dalteparin) is used to: 

  • Prevention and Treatment of Blood Clots
  • Acute Coronary Syndrome
  • Pulmonary Embolism (PE)
  • Deep Vein Thrombosis (DVT)
  • Prevent clotting of blood after certain types of surgery
  • Reduction of Recurrence of Venous Thromboembolism (VTE) in Children One Month of Age and Older
  • Treatment (long-term)of Venous Thromboembolism (VTE) in people with cancer

How to Use Fragmin?

Dosage

Fragmin comes in 3 forms, and these following strengths:

  • Ampules
  • The solution for injection contains 10,000 IU of dalteparin sodium per ml.
  • Multidose vials
  • Each multidose vial contains dalteparin sodium at 25,000 IU/ml.
  • Prefilled syringes
  • 2,500 IU/0.2 ml
  • 3,500 IU/0.28 ml
  • 5,000 IU/0.2 ml
  • 7,500 IU/0.3 ml
  • 10,000 IU/0.4 ml
  • 12,500 IU/0.5 ml
  • 15,000 IU/0.6 ml
  • 16, 500 IU/0.66 ml
  • 18,000 IU/0.72 ml

Recommended Dosage for Different Patients

For Blood Clots Prevention After Unstable Angina or Non–Q-Wave Myocardial Infarction:

  • Dosage: Based on body weight, determined by your doctor.
  • Typical Dose: 120 IU per kg of body weight every 12 hours for 5 to 8 days (maximum 10,000 IU per dose).
  • Aspirin: 75 to 165 milligrams (mg) once a day unless advised otherwise by your doctor.

For Deep Venous Thrombosis Prevention After Abdominal Surgery:

  • Adults: 2,500 or 5,000 IU, once a day for 5 to 10 days. Alternatively, 2,500 IU, followed by another 2,500 IU 12 hours later, then 5,000 IU once a day.
  • Children: Dosage must be determined by your doctor.

For Deep Venous Thrombosis Prevention After Hip Replacement Surgery:

  • If started the evening dose before surgery: 5,000 IU, 10 to 14 hours before the surgery. Then followed by 5,000 IU 4 to 8 hours after surgery, then 5,000 IU once a day.
  • If started on the day of surgery: 2,500 IU within 2 hours before surgery, followed by 2,500 IU 4 to 8 hours after surgery, then 5,000 IU once a day.
  • If started after surgery: 2,500 IU, 4 to 8 hours after surgery, then 5,000 IU once a day for 5 to 10 days.

For Prevention of Deep Venous Thrombosis in Medical Patients With Acute Illness:

  • Dosage: 5,000 IU, once a day for 12 to 14 days.

For Prevention of Symptomatic Pulmonary Embolism and Deep Venous Thrombosis in Children:

  • 8 to 16 years: Dosage based on body weight, determined by your doctor. Initially, 100 IU per kg of body weight, twice a day.
  • 2 to 7 years: Dosage based on body weight, determined by your doctor. Initially, 125 IU per kg of body weight twice a day.
  • Four weeks to 1 year: Dosage based on body weight, determined by your doctor. Initially, 100 IU per kg of body weight, twice a day.
  • Younger than four weeks: Dosage must be determined by your doctor.

For Symptomatic Deep Venous Thrombosis and Pulmonary Embolism in Patients With Cancer:

  • Dosage: Based on body weight, determined by your doctor.
  • First 30 days: 200 IU per kg of body weight, once a day (maximum 18,000 IU).
  • Months 2 to 6: 150 IU per kg of body weight, once a day.

Note that these dosages are guidelines and must be adjusted by a doctor based on the patient’s needs and circumstances.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

  • Dalteparin is given through an injection just under the skin, often in the lower belly area. In some cases, it can be given through an IV (intravenous) in the hospital. 
  • The exact dose and way it’s given depends on the person and their health condition. 
  • Your doctor will take your blood tests to see how well the medicine is working and might adjust your dose as needed.
  • The right dose for you can be influenced by many factors, including your weight, other health issues, and other medicines you might be taking. 
  • If your doctor suggests a different dose than usual, don’t change how you use the medication without talking to your doctor first.
  • If you’re giving yourself the shot, your doctor or healthcare professional will teach you the right way to do it. 
  • If you have any questions about how to use your medication, reach out to your doctor or healthcare professional.
  • Don’t use the medication if the syringe is leaking or if the medication looks cloudy or discolored.

Steps to Use This Medication

  • Wash your hands and clean the area where you’ll inject with an alcohol swab. Don’t rub the injection site.
  • Take off the needle cover. Be careful not to push the syringe plunger and lose any medicine. Hold the syringe like a pen.
  • Take hold of a fold of skin in the lower part of your belly (left or right side). Use a different spot for each shot to avoid always injecting in the same place.
  • While holding the skin fold, put the whole needle straight into the skin fold and push the syringe plunger all the way down.
  • Take out the needle and release the syringe plunger. (The syringe will move into the device until the needle is covered.)
  • Press the injection site with the alcohol swab for 5 to 10 seconds. Don’t rub the injection site.
  • Dispose of the used syringe safely in approved containers, and keep it away from children.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Fragmin Work?

Fragmin, also known as Dalteparin, is a medication that prevents blood clots. It works by blocking a specific enzyme called Factor Xa, which is essential in blood clotting. By doing this, Fragmin also indirectly reduces the formation of another enzyme called thrombin, which helps turn a protein called fibrinogen into fibrin. Fibrin is critical in blood clots, forming a mesh that traps blood cells to create a stable clot. As a result, Fragmin helps prevent the growth of existing blood clots and then the formation of new ones, ensuring smooth blood flow through the vessels and reducing the risk of blockages that can lead to serious health issues. This action is crucial in preventing conditions like deep vein thrombosis (DVT) and pulmonary embolism, as well as preserving blood vessels’ health. Fragmin effectively controls events where blood clots can move through the bloodstream and cause life-threatening problems.

Important Safety Information

Side Effects

Common side effects that may occur with Fragmin include:

  • Increased bleeding or bruising
  • Swelling at the injection site (filled with blood)
  • Longer bleeding from scrapes or cuts

Serious side effects of Fragmin may include:

  • Bleeding symptoms may consist of:
    • Increased bruising
    • Blood filled swelling in the spine, with symptoms of numbness in the legs, tingling, and muscle weakness
    • Coughing up blood
    • Vomiting blood
    • Increased nosebleeds
    • Blood in your urine
    • Blood in your stools (may be dark red, tarry, bright red, and black)
    • Increased gum bleeding after brushing or flossing
    • Dark red spots under your skin
  • Gasping syndrome (premature infants) with signs of trouble breathing
  • Increased liver enzymes symptoms may include:
    • Vomiting
    • Pain in the abdomen (stomach area)
    • Yellowing of your skin or the whites of your eyes
    • Nausea
  • Allergic reactions symptoms may consist of:
    • Fever
    • Reaction at the injection site, including swelling, redness, or itching
    • Itching
    • Rash
    • Trouble breathing
    • Hives (itchy welts)

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

  • History of Spinal Surgery or Defects: If you’ve had injections into your spine’s epidural space or a procedure involving a spinal puncture, this medication increases your risk of bleeding in that area. The risk is higher if you have a spinal defect or recent spinal surgery. This bleeding can lead to serious movement issues, including paralysis, which may be permanent.
  • Major Bleeding: Do not use this medication if you currently have serious bleeding.
  • History of Drug-Induced Low Platelet Count: If you’ve experienced a low platelet count due to using the drug heparin, avoid this medication.
  • Allergic to Heparin or Pork: Do not use this medication if you’ve had a reaction to heparin or pork.
  • Current or Past Heart Problems: If you have a history of certain heart issues, your risk of bleeding increases when taking this medication. These issues include uncontrolled high blood pressure and heart infections.
  • History of Stroke: Your risk of bleeding increases when taking this medication.
  • Severe Kidney or Liver Problems: Your chances of bleeding increases when taking this medication. Consult with your doctor about whether this medication is safe for you.
  • Eye Problems: If you have eye issues whether it is caused by high eye pressure or diabetes, your chances of bleeding increases when taking this medication. Consult with your doctor about whether this medication is safe for you.
  • Bleeding Disorders: If you have these disorders, such as a low platelet count or dysfunctional platelets, your risk of bleeding increases when taking this medication. Consult with your doctor about whether this medication is safe for you.
  • Recent Stomach Bleeding or Stomach Ulcers: Your risk of bleeding increases when taking this medication. Consult with your doctor about whether this medication is safe for you.

Boxed Warning

The label for the medication Fragmin includes a critical warning. It alerts doctors and patients that a severe condition called spinal or epidural hematoma can happen. This condition is when blood builds up and puts pressure on the spinal cord. 

It can occur in patients who are taking certain blood-thinning medications, such as low molecular weight heparins (LMWH) or heparinoids, and are undergoing spinal puncture (a procedure to remove spinal fluid for testing) or receiving neuraxial anesthesia (injections near the spine). These blood clots can lead to long-term or permanent paralysis, which is the inability to move body parts. Doctors should carefully consider these risks when planning spinal procedures for patients, as they may have a higher risk of developing blood clots.

Precautions

  • Pregnant Women: There is no clear evidence that dalteparin negatively affects the fetus, but the possibility of harm cannot be completely ruled out. If you are pregnant or planning to become pregnant, discuss the use of this medication with your doctor. It should only be used during pregnancy if necessary. Be aware that some versions of this medication contain benzyl alcohol, which can be harmful to premature infants. If you are pregnant, ensure your doctor prescribes a version without benzyl alcohol.
  • Breastfeeding Women: Dalteparin may pass into breast milk and may cause some side effects in a breastfed infant. Consult your doctor if you are breastfeeding. You may need to choose between stopping the medication or discontinuing breastfeeding.
  • Seniors: As people age, their kidneys may not function as efficiently, leading to slower drug processing in the body. This can increase the risk of side effects, such as bleeding. If you are over 65 years old, weigh 99 pounds (45 kg) or even less, or have kidney problems, you have a higher risk of bleeding with this medication.
  • Children: Dalteparin has not been tested in children and should not be used in individuals under 18 years of age.
  • Alcohol Use: Dalteparin increases the risk of bleeding, and consuming alcohol while taking this medication can further elevate this risk. If you consume alcohol, discuss it with your doctor. You may need to monitor the signs of bleeding.

Fragmin Contraindications

Fragmin (Dalteparin) should not be used in patients with the following conditions:

  • A known or suspected history of a severe allergic reaction to heparin, known as heparin-induced thrombocytopenia (type II).
  • Active bleeding that is significant, such as bleeding from a stomach ulcer or a brain hemorrhage.
  • Serious blood clotting disorders.
  • Infection of the heart’s inner lining (septic endocarditis).
  • Recent injuries or surgeries involving the eyes, brain, or ears.
  • Allergy to dalteparin, pork products, other low-molecular-weight heparins, or heparins.

Missed Dose

  • Should you forget to take your dose, take it as soon as you recall. But if your next dose is due in a few hours, simply continue with your regular dosing schedule. 
  • Avoid taking two doses simultaneously, as it may lead to adverse reactions.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

Taking too much of this medication can lead to harmful levels in your body, leading to severe bleeding. If you believe you have overdosed, contact the local poison control center or your doctor immediately. In case of severe symptoms, call emergency services (911) or go to the hospital’s emergency room that is nearest to you without delay.

[Note: If you consumed more than recommended dose, get medical help right away, or call the Poison Help line at 1-800-222-1222.]

Storage

  • Store Fragmin (Dalteparin) in a closed container at room temperature.
  • Do not freeze it, and keep it away from direct sunlight.
  • Keep it away from moisture and heat. 
  • Keep Fragmin out of the reach of children.
  • Do not keep medication that is outdated or no longer needed.
  • Consult your healthcare professional for guidance on properly disposing of unused medication.
  • If you have been provided with a bottle of medication for use with syringes, ensure to use the medication within 14 days of the first injection. 
  • Dispose of any unused medication after fourteen days.
  • Dispose of used needles in a sturdy, sealed container that prevents the needles from piercing through. Keep this container out of reach of children and pets.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Fragmin Interactions

Fragmin may interact with the medications mentioned below:

  • Eptifibatide
  • Rivaroxaban
  • Eltrombopag
  • Prasugrel
  • Urokinase
  • Dipyridamole
  • Dabigatran
  • Ticlopidine
  • Romiplostim
  • Clopidogrel
  • NSAIDs (nonsteroidal anti-inflammatory drugs)
  • Heparin
  • Tenecteplase
  • Alteplase
  • Ticagrelor
  • Tinzaparin
  • Ticagrelor
  • Anagrelide
  • Lepirudin
  • Oprelvekin
  • Reteplase
  • Cilostazol
  • Abciximab
  • Fondaparinux
  • Tirofiban
  • Nonsteroidal anti-inflammatory drugs
  • Argatroban
  • Salicylates such as aspirin and others
  • Warfarin
  • Enoxaparin
  • Dextran

Ensure to consult your doctor for personalized advice regarding these interactions.

[Note: This isn’t a complete list, and there could be other drugs that interact with Fragmin. Make sure to tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

Fragmin Alternatives

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Can Fragmin be used during pregnancy?

Yes, Fragmin can be used during pregnancy. Studies suggest it poses minimal risk to the baby. However, it’s not recommended for preventing blood clots on artificial heart valves during pregnancy. If Fragmin is used to treat blood clots, caution is advised when administering it with certain types of anesthesia. Always consult a healthcare provider for personalized advice.

Can Fragminbe taken with other medications?

Yes, Fragmin can be taken with other medications. However, it’s crucial to consult a healthcare provider before starting or stopping any medication, as some drugs may interact with Fragmin, potentially affecting its effectiveness or increasing the risk of side effects. This ensures safe and effective treatment.

Is Dalteparin safe for children?

Dalteparin can be used in pediatric patients, but it’s essential to follow specific dosing guidelines tailored to the child’s age and weight. The starting doses are based on age groups, and adjustments may be necessary for certain conditions like thrombocytopenia or renal insufficiency. As with any medication, it should only be administered under the guidance and supervision of a healthcare provider experienced in pediatric care.

Can Fragmin be used for long-term treatment?

Yes, Fragmin (Dalteparin) can be used for long-term treatment. It is often prescribed for extended periods to manage conditions like deep vein thrombosis (DVT) and as an extended treatment for symptomatic venous thromboembolism (VTE) in adult patients with cancer. However, the specific duration and dosage will be determined by a healthcare provider based on the individual’s medical condition and response to treatment. Regular monitoring is crucial for safety and effectiveness. Always follow your healthcare provider’s instructions.

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