Dalteparin

(dal te pa' rin)

PCaution when used during lactation : Caution when used during pregnancy

LCaution when used during lactation : Caution when used during lactation

Molecule Info

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WARNING

SPINAL/EPIDURAL HEMATOMAS

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.

Description

Dalteparin Sodium Injection is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2500, 5000, 7500, 10,000, 12,500, 15,000 or 18,000 anti-Factor Xa international units (IU), equivalent to 16, 32, 48, 64, 80, 96 or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains either 10,000 or 25,000 anti-Factor Xa IU per 1 mL (equivalent to 64 or 160 mg dalteparin sodium, respectively), for a total of 95,000 anti-Factor Xa IU per vial.

Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5.

Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulphated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5000 and about 90% of the material within the range 2000–9000.

Indication(s)

Prevention of clotting in the extracorporeal circulation during haemodialysis or haemofiltration, in patients with chronic renal insufficiency or acute renal failure.

Treatment of venous thromboembolism (VTE) presenting clinically as deep vein thrombosis (DVT), pulmonary embolism (PE) or both.

Unstable angina and non-Q wave myocardial infarction (unstable coronary artery disease-UCAD), administered concurrently with aspirin.

Extended Use

Dalteparin Sodium may be used beyond 8 days in patients awaiting angiography/ revascularisation procedures.

Dosage & Administration

 

Recommended dosage for adults are as follows:

 

(i) Prevention of clotting during haemodialysis and haemofiltration

 

In chronic renal insufficiency for patients with no known additional bleeding risk, the dosage is:

 

(a) Long-term haemodialysis or haemofiltration - duration of haemodialysis/haemofiltration more than 4 hours;

 

An I.V. bolus injection of Dalteparin Sodium 30-40 IU (anti-Factor Xa)/kg bodyweight, followed by an infusion of 10-15 IU (anti-Factor Xa)/kg bodyweight/hour.

 

(b) Short-term haemodialysis or haemofiltration - duration of haemodialysis/haemofiltration less than 4 hours:

 

Either as above, or, a single IV. bolus injection of Dalteparin Sodium 5000 IU (anti-Factor Xa).

 

Both for long and short-term haemodialysis and haemofiltration, the plasma anti-Factor Xa levels should be within the range 0.5-1.0 IU (anti-Factor Xa)/ml.

 

In acute renal failure, or chronic renal failure in patients with a high risk of bleeding, the dosage is:

 

An I.V. bolus injection of Dalteparin Sodium 5-10 IU (anti-Factor Xa)/kg bodyweight, followed by an infusion of 4-5 IU (anti-Factor Xa)/kg bodyweight/hour.

 

The plasma anti-Factor Xa levels should be within the range 0.2-0.4 IU (anti-Factor Xa)/ml.

 

When considered necessary, it is recommended that the antithrombotic effect of Dalteparin Sodium be monitored by analysing anti-Factor Xa activity using a suitable chromogenic substrate assay. This is because Dalteparin Sodium has only a moderate prolonging effect on clotting time assays such as APTT or thrombin time.

 

(ii) Treatment of venous thromboembolism (VTE).

 

Dalteparin Sodium can be administered subcutaneously either as a single daily injection or as twice daily injections.

 

(a) Once daily administration

 

200 IU/kg body weight is administered sc. once daily. Monitoring of the anticoagulant effect is not necessary. The single daily dose should not exceed 18,000 IU.

 

(b) Twice daily administration

 

A dose of 100 IU/kg body weight administered sc. twice daily can be used for patients with increased risk of bleeding. Monitoring of the treatment is generally not necessary but can be performed with a functional anti-Factor Xa assay. Maximum plasma levels are obtained 3-4 hours after sc. injection, when samples should be taken. Recommended plasma levels are between 0.5-1.0 IU (anti-Factor Xa)/ml.

 

Simultaneous anticoagulation with oral vitamin K antagonists can be started immediately. Treatment with Dalteparin Sodium is continued until the prothrombin complex levels (factor II, VII, IX and X) have decreased to a therapeutic level. At least five days of combined treatment is normally required.

 

(iii) Unstable coronary artery disease

 

120 IU/kg body weight are administered subcutaneously twelve hourly for up to 8 days if considered of benefit by the physician. The maximum dose is 10,000 IU/12 hours

 

Patients needing treatment beyond 8 days, while awaiting angiography/revascularisation, should receive a fixed dose of either 5,000 IU (women < 80 kg and men <70 kg) or 7,500 IU (women ≥80 kg and men ≥70 kg) 12 hourly. Treatment is recommended to be given until the day of the revascularisation procedure (PTCA or CA BG) but not for more than 45 days.

 

Paediatric population

 

The safety and efficacy of dalteparin sodium in children has not been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.

 

Monitoring Anti-Xa levels in children

 

Measurement of peak anti-Xa levels at about 4 hours post-dose should be considered for certain special populations receiving Dalteparin Sodium, such as children. For therapeutic treatment with doses administered once daily, peak anti-Xa levels should generally be maintained between 0.5 and 1.0 IU/mL measured at 4 hours post-dose. In the case of low and changing physiologic renal function such as in neonates, close monitoring of anti-Xa levels is warranted. For prophylaxis treatment the anti- Xa levels should generally be maintained between 0.2-0.4 IU/mL.

 

As with all antithrombotic agents, there is a risk of systemic bleeding with Dalteparin Sodium administration. Care should be taken with Dalteparin Sodium use in high dose treatment of newly operated patients. After treatment is initiated patients should be carefully monitored for bleeding complications. This may be done by regular physical examination of the patients, close observation of the surgical drain and periodic measurements of hemoglobin, and anti-Xa determinations.

 

Elderly

 

Dalteparin Sodium has been used safely in elderly patients withoutut the need for dosage adjustment.

 

May be taken with or withoutut food.  Dose for OA/RA may be given with or without meals, but doses for FAP must be given with meals.

Overdosage

Prolongation of the aPTT.  Prolonged clotting time induced by dalteparin may be neutralised by protamine, but the anti-Factor Xa activity is only neutralised to about 25-50%.  As protamine has an inhibitory effect on primary haemostasis, it should be used only in an emergency.1 mg of protamine inhibits the effect of 100 IU of dalteparin.

Contraindications

Hypersensitivity.  Active major bleeding, severe coagulation disorders; lumbar puncture; sympathetic block; brain, spinal cord, eye or ear surgery; severe hypertension.

Special Precautions

Preexisting thrombocytopenia, recent childbirth, DM, subacute bacterial endocarditis, pericarditis, recent lumbar puncture, vasculitis. Monitor coagulation time.  Hepatic or renal dysfunction; high doses; osteoporosis; familial antithrombin III deficiency; elderly; children; platelet count and stool occult blood test recommended during treatment; GI ulceration.  Pregnancy and lactation.

Adverse Drug Reaction(s)

Hypersensitivity reactions; thrombocytopenia; inj site pain and tenderness; ecchymoses; haematoma.  Prolonged use may lead to alopecia and osteoporosis Potentially Fatal: Severe haemorrhage.

Drug Interactions

Increased risk of hyperkalaemia when used with potassium sparing drugs such as ACE inhibitors. Potentially Fatal: Oral   anticoagulants, platelet inhibitors and NSAIDs may increase risk of haemorrhage.

Lab Interference

Dalteparin-induced transaminases may interfere with interpretation of LFT results and diagnosis of MI, liver disease and pulmonary embolism.

Pregnancy Category (FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1sttrimester.

Storage

Intravenous  : Store below 25°C.  Subcutaneous: Store below 25°C.

Pharmacology

Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In man, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).

Dalteparin sodium is a low molecular weight heparin analogue which inhibits factor Xa more than factor IIa.  Absorption: Almost completely absorbed from the GI tract; peak plasma concentrations after 4 hr.  Excretion: Via kidneys; prolonged in renal impairment. Elimination half-life: 2 hr, 3-5 hr.

ATC Classification

B01AB04 - dalteparin; Belongs to the class of heparin group.  Used in the treatment of thrombosis.

 

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Brand/Product Info


Total Products : 1 
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
FRAGMIN Janata Traders Dalteparin sodium 5000 & 7500 IU Injection 10's each: 3375.00 & 6314.80 MRP

Gen. MedInfo

IMPORTANT WARNING:

If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as dalteparin, you are at risk for internal bleeding that could cause you to become paralyzed.

Inform your doctor if you are taking abciximab; anagrelide; other anticoagulants such as warfarin; aspirin, ibuprofen, indomethacin, ketoprofen, naproxen, or other nonsteroidal anti-inflammatory drugs; cilostazol; clopidogrel; dipyridamole; eptifibatide; sulfinpyrazone; ticlopidine; and tirofiban.

If you experience any of the following symptoms, consult your doctor immediately: numbness, tingling, leg weakness or paralysis, and loss of control over your bladder or bowels.  Talk to your doctor about the risk of taking dalteparin.

About Dalteparin sodium

Your doctor has ordered dalteparin sodium, an anticoagulant, to prevent harmful blood clots from forming.  The drug will be injected under the skin once a day.  This medication is sometimes prescribed for other uses; ask your Doctor for more information.

Your health care provider may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations.  It is important to keep all appointments with your doctor and the laboratory.  The length of treatment depends on how you respond to the medication.

Precautions

Before administering dalteparin,

  • tell your Doctor if you are allergic to dalteparin, heparin, enoxaparin, any other drugs, or pork products.
  • tell your Doctor what prescription and nonprescription medications you are taking, especially those listed in the IMPORTANT WARNING section and vitamins.
  • tell your doctor if you have or have ever had liver or kidney disease or diabetes.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.  If you become pregnant while taking dalteparin, consult your doctor.

Administering Dalteparin sodium

Before you administer dalteparin, look at the solution closely.  It should be clear and free of floating material.  Observe the solution container to make sure there are no leaks.  Do not use the solution if it is discolored, if it contains particles, or if the container leaks.  Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed.  Do not change your dosing schedule withoutut talking to your health care provider.

Side effects

Dalteparin may cause side effects. Inform your health care provider if the following symptom is severe or does not go away:

  • upset stomach
  • unusual bleeding
  • vomiting or spitting up blood or brown material that resembles coffee grounds
  • bloody or black, tarry stools
  • blood in urine
  • red or dark-brown urine
  • easy bruising
  • excessive menstrual bleeding
  • fever
  • dizziness or lightheadedness

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, consult your doctor or health care provider immediately:

If you experience a serious adverse effect, you or your doctor may send a report to the Office of Directorate General, Drugs Administration.

Storing Dalteparin sodium

  • Your health care provider will probably give you several days supply of dalteparin at a time.  You will be told to store it at room temperature.

Store your medication only as directed.  Make sure you understand what you need to store your medication properly.

Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children.  Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.

In case of emergency/overdose

In case of overdose, consult your Doctor.  If the victim has collapsed or is not breathing, consult local medical emergency services.

Do not let anyone else take your medicine.  

It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted into a hospital.  It is also important information to carry with you in case of emergencies.

Ref: MedlinePlus, U.S. Natl. Library of Medicine

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