Pronunciation:

dal-TE-pa-rin

Brand Names:

• Fragmin

Dosage Forms:

• Injectable
• Solution

Warnings:

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 .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Low Molecular Weight Heparin

Uses of This Medicine:

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 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 This Medicine:

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.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of dalteparin in children with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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.

Other medicines—

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
• Alclofenac
• Alteplase, Recombinant
• Ancrod
• Anisindione
• Anistreplase
• 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

Other interactions—

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 problems or
• Eye problems caused by diabetes or high blood pressure or
• Heart infection or
• High blood pressure (hypertension) or
• Kidney disease or
• Liver disease or
• Stomach or intestinal ulcer (active) or
• Stroke—The risk of bleeding may be increased

• Also, tell your doctor if you have received dalteparin or heparin before and had a reaction to either of them called thrombocytopenia (a low platelet count in the blood), or if new blood clots formed while you were receiving the medicine.

• In addition, tell your doctor if you have recently had medical surgery. This may increase the risk of serious bleeding when you are taking dalteparin.

Proper Use of This Medicine:

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 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 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 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.

Precautions While Using This Medicine:

Tell all your medical doctors and dentists that you are using this medicine.

Check with your doctor immediately if you notice any of the following side effects:

• Bruising or bleeding, especially bleeding that is hard to stop. (Bleeding inside the body sometimes appears as bloody or black, tarry stools or causes faintness.)
• Back pain; burning, pricking, tickling, or tingling sensation; leg weakness; numbness; paralysis; or problems with bowel or bladder function.

Side Effects of This Medicine:

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.

Stop taking this medicine and get emergency help immediately if any of the following 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.