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dalteparin (Subcutaneous route)

dal-te-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 neurological 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.

Fragmin

Available Dosage Forms:

Injectable
Solution

Therapeutic Class: Anticoagulant

Pharmacologic Class: Low Molecular Weight Heparin

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Uses For dalteparin

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. dalteparin 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.

Dalteparin is available only with your doctor's prescription.

Before Using dalteparin

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 dalteparin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dalteparin 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

Using dalteparin 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 dalteparin 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 dalteparin

A nurse or other trained health professional will give you dalteparin. dalteparin is given as a shot under your skin.

If you are using dalteparin at home, your health care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional 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 health care professional.

Dosing

The dose of dalteparin 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 dalteparin. 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 of body weight injected under the skin (but no 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 daily.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of dalteparin, 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 dalteparin

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 dalteparin. You may need to stop using dalteparin several days before having surgery or medical tests.

dalteparin may increase your chance of bleeding. 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 dalteparin and call your doctor right away if you start having pain in chest, groin, or legs, especially the calves; difficulty 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.

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.

dalteparin 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 place of injection

Less common

Bleeding of 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 dark brown urine
red or black, tarry stools
shortness of breath
unexplained pain, swelling, or discomfort, especially in the chest, abdomen, joints, or muscles
unusual bruising
vomiting of blood or coffee ground–like material
weakness

Rare

Back pain
bleeding from mucous membranes
bluish or black discoloration, flushing, or redness of 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 skin at place of injection
swelling of eyelids, face, or lips
tightness in 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.

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