Fragmin

Brand Name

Fragmin

Common Name

dalteparin

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Dalteparin is a type of medication called a low-molecular-weight heparin. It belongs to a class of medications called anticoagulants or antithrombotic agents. It helps prevent blood clots from forming or from getting bigger, but it does not dissolve existing blood clots.

Dalteparin works by blocking clotting factors and enzymes that help the blood to clot. Circulating blood clots are dangerous because they can cause medical problems such as heart attack, stroke, and pulmonary embolism.

Dalteparin is used to treat blood clots in deep veins (deep vein thrombosis), treat people with unstable coronary artery disease, and to treat symptoms of blood clots in order to prevent the recurrence of blood clots in people with cancer.

Dalteparin is also used to prevent blood clots during surgery, blood dialysis associated with kidney disease, and for people who are at risk for blood clots because of being bedridden due to illness.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

Dalteparin is given by subcutaneous (under the skin) injection, usually in the lower abdominal area. Sometimes, in a hospital setting, dalteparin is given intravenously (into the vein). The recommended dose and route of administration of dalteparin varies according to the individual and the condition being treated. Your doctor will order blood tests to determine how effective the medication is for you and will adjust the dose based on the effect of dalteparin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

If you are injecting the medication yourself, your doctor or health care professional will show you how to inject the medication properly. If you have any questions about how to use your medication, contact your doctor or health care professional.

Do not use the medication if the syringe is leaky, or if the medication appears cloudy or discoloured.

To use the medication:

• Wash your hands and clean the injection site with an alcohol swab. Do not rub the injection site.
• Remove the needle shield. Avoid pressing on the syringe plunger so as not to lose any of the syringe content. Hold the syringe like a pencil.
• Pinch a fold of skin in the lower (left or right) region of your abdomen. Choose a different injection site for each injection so that you are not always injecting the same area.
• While holding the skin fold, insert the entire needle into the skin fold vertically and press the syringe plunger down completely.
• Remove the needle and let go of the syringe plunger. (The syringe will move into the device until the needle is guarded.)
• Apply pressure to the injection site with the alcohol swab for 5 to 10 seconds. Do not rub the injection site.
• Safely dispose of the used syringe device in approved containers, and keep it out of the reach of children.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, inject it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not inject a double dose for to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. If you are using the multiple dose vial, the medication must be used within 14 days after first use.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Ampules

Each mL of solution for injection contains 10,000 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, sodium chloride, and water for injection.

Multidose vials

Each multidose vial contains dalteparin sodium at 25,000 IU/mL. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, benzyl alcohol, sodium chloride, and water for injection.

Prefilled syringes

2,500 IU/0.2 mL
Each syringe contains 2,500 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, sodium chloride, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

3,500 IU/0.28 mL
Each syringe contains 3,500 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

5,000 IU/0.2 mL
Each syringe contains 5,000 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

7,500 IU/0.3 mL
Each syringe contains 7,500 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

10,000 IU/0.4 mL
Each syringe contains 10,000 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

12,500 IU/0.5 mL
Each syringe contains 12,500 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

15,000 IU/0.6 mL
Each syringe contains 15,000 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

16, 500 IU/0.66 mL
Each syringe contains 16,000 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

18,000 IU/0.72 mL
Each syringe contains 18,000 IU of dalteparin sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to dalteparin or any ingredients of the medication
• are allergic to other low-molecular-weight heparins or heparin
• are allergic to pork products
• are actively bleeding
• are receiving spinal or epidural anesthesia and will be needing multiple high doses of dalteparin
• have a history of severe low platelet count caused by heparin
• have a bacterial infection of the heart
• have a history of cerebral hemorrhage (bleeding in or against the brain)
• have a history of thrombocytopenia (a decreased platelet count)
• have a severe blood clotting disorder
• have an active gastric (stomach) or duodenal (intestinal) ulcer
• have eye or retina problems due to bleeding or diabetes
• have injuries and operations on the brain, spinal cord, eyes, or ears
• have other conditions that put you at an increased risk of bleeding
• have severe uncontrolled high blood pressure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• easy bruising without apparent cause
• pain and redness at the injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bruising at injection site
• nosebleeds
• reddish or purplish discolouration at the injection site

Stop taking the medication and seek immediate medical attention if any of the following occur:

• bleeding from a wound or injection site
• blood in the urine
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• signs of allergic reaction (e.g., swelling of the face, lips, or tongue; difficulty breathing; skin hives or rash)
• signs of bleeding (nosebleeds, bleeding gums, blood in urine, increased menstrual bleeding)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of stroke (sudden weakness or numbness, trouble speaking, vision problems, severe headache, dizziness, especially with any of the above signs)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding: The most serious risk associated with dalteparin is bleeding in any tissue or organ. It is extremely important to have regular blood tests as recommended by your doctor to ensure proper levels of clotting.

If you experience bleeding gums, bleeding from the mouth, bleeding from the anus or vagina, or you notice blood in your urine, contact your doctor as soon as possible. If you have an increased risk of bleeding you should be closely monitored by your doctors while taking this medication.

Blood counts: While you are taking dalteparin, your doctor will also be monitoring your blood cell counts, including a platelet count. If your platelet level drops very suddenly, you may have to stop this medication and switch to another type of medication. Make sure to tell your doctor if you have had any problems with low platelets or platelet defects in the past.

Body weight: The safety and effectiveness of dalteparin for people of high weight (e.g., over 120 kg) and low weight (e.g., under 46 kg) have not been fully established. If you have a high or low body weight, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart problems: Blood clots have occurred for people with prosthetic heart valves using low molecular weight heparins. People with unstable coronary artery disease may be at increased risk of bleeding. If you have a history of heart disease or have prosthetic heart valves your doctor should closely monitor your condition while you are taking dalteparin.

Kidney problems: The kidneys remove much of this medication from your body. People with decreased kidney function or kidney disease may experience increased side effects of dalteparin as a result of the medication building up in the body. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: People with liver problems may be at an increased risk for bleeding. If you have decreased liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Osteoporosis: Other medications in the heparin family have been reported to encourage the development of osteoporosis. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Potassium levels: Increases in blood levels of potassium occur for a small percentage of people taking medications in the heparin family, including dalteparin. This may be more likely to happen if you have diabetes or chronic kidney failure, or if you are taking potassium sparing diuretics. Your doctor may want to monitor your potassium levels. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor.

Stomach or intestinal ulcers: Dalteparin increases the risk of unwanted bleeding. If you have a history of stomach or intestinal ulcers, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with active stomach or intestinal ulcers should not use this medication.

Surgery: The risk of bleeding while using low molecular weight heparin may be greater in knee surgery than other orthopedic surgeries. Your doctor will weigh the potential risks and benefits to decide whether low molecular weight heparins will be used during surgery.

There have been cases of spinal bleeding and blood clots when dalteparin is used along with spinal or epidural anesthesia. These spinal blood clots may lead to long-term or permanent paralysis. The risk is greater with higher treatment doses of dalteparin than with deep vein thrombosis prevention doses. The risk is also greater for people who are taking other medications that affect blood such as naproxen or ibuprofen, or other anticoagulants. If you notice a sudden inability to move your body or sudden back pain or tenderness, get medical help immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

If you do use dalteparin while you are pregnant, your doctor should closely monitor you because of an increased risk of bleeding. Pregnant women who have artificial heart valves also need to be closely monitored by their doctors if they use this medication because of a higher risk of developing clots in their heart valves.

Pregnant women should not use dalteparin from multidose vials containing benzyl alcohol as a preservative.

Breast-feeding: It is not known if dalteparin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors may be at an increased risk of bleeding while using dalteparin. Your doctor may adjust your dose, especially if you weigh less than 45 kg or have decreased kidney function.

What other drugs could interact with this medication?

There may be an interaction between dalteparin and any of the following:

• acetylsalicylic acid (ASA)
• aliskiren
• angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• apixaban
• celecoxib
• chamomile
• dabigatran
• dasatinib
• deferasirox
• dipyridamole
• edoxaban
• eplerenone
• epoprostenol
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• evening primrose
• feverfew
• garlic
• ginger
• ginseng
• green tea
• ibrutinib
• mesalamine
• mifepristone
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, ketorolac, naproxen)
• obinutuzumab
• omega-3 fatty acids
• pentoxifylline
• platelet inhibitors (e.g., ticlopidine, clopidogrel, ticagrelor)
• potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene)
• potassium supplements
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• sulfasalazine
• thrombolytic agents (e.g., alteplase, streptokinase, urokinase)
• tipranavir
• vitamin E
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Fragmin