Heparin Sod/nacl 25000u Inj, 500ml

Manufacturer HOSPIRA Active Ingredient Heparin(HEP a rin) Pronunciation HEP-uh-rin
It is used to thin the blood so that clots will not form.It is used to treat blood clots. It is used to keep blood from clotting in catheters. It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anticoagulant
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Pharmacologic Class
Antithrombotic; Indirect Thrombin Inhibitor; Factor Xa Inhibitor
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Heparin is a medicine that thins your blood. It helps prevent and treat blood clots that can form in your veins or arteries, which can lead to serious conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), or heart attack. It works by making it harder for your blood to clot.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication can be administered in different ways, including:

Through a catheter
As an injection into a vein
As an injection into the fatty part of the skin
As an infusion into a vein over a period of time

If you have any questions or concerns, discuss them with your doctor.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Avoid activities that increase your risk of bleeding or injury (e.g., contact sports, using sharp objects carelessly).
  • Use a soft toothbrush and an electric razor to minimize bleeding.
  • Inform all healthcare providers (including dentists) that you are taking heparin.
  • Avoid over-the-counter medications, herbal supplements, or other drugs that can increase bleeding risk (e.g., aspirin, NSAIDs, ginkgo biloba) without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: For treatment of venous thromboembolism (VTE): Initial bolus 80 units/kg IV, then continuous infusion 18 units/kg/hour IV. Adjust dose to maintain aPTT 1.5-2.5 times control or anti-Xa level 0.3-0.7 units/mL. For prophylaxis: 5,000 units subcutaneously every 8-12 hours.

Condition-Specific Dosing:

VTE Treatment (IV): Initial bolus 80 units/kg, then 18 units/kg/hr continuous infusion. Adjust to target aPTT or anti-Xa.
VTE Prophylaxis (SC): 5,000 units SC every 8-12 hours.
Acute Coronary Syndromes (IV): Initial bolus 60 units/kg (max 4000 units), then 12 units/kg/hr (max 1000 units/hr) continuous infusion. Adjust to target aPTT or anti-Xa.
Cardiopulmonary Bypass: Initial bolus 300-400 units/kg IV, then adjust to maintain ACT > 480 seconds.
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Pediatric Dosing

Neonatal: Initial bolus 75 units/kg IV, then 28 units/kg/hour IV continuous infusion. Adjust to target aPTT or anti-Xa.
Infant: Initial bolus 75 units/kg IV, then 28 units/kg/hour IV continuous infusion. Adjust to target aPTT or anti-Xa.
Child: Initial bolus 75 units/kg IV, then 20 units/kg/hour IV continuous infusion. Adjust to target aPTT or anti-Xa.
Adolescent: Initial bolus 75 units/kg IV, then 20 units/kg/hour IV continuous infusion. Adjust to target aPTT or anti-Xa.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: No specific dose adjustment required, but monitor closely. Increased sensitivity may occur.
Severe: No specific dose adjustment required, but monitor closely. Increased sensitivity may occur due to accumulation of smaller fragments.
Dialysis: No specific dose adjustment for therapeutic use. For dialysis anticoagulation, typically 1,000-5,000 units bolus at start of dialysis, or continuous infusion 500-1,000 units/hour.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Monitor closely. May increase bleeding risk due to impaired synthesis of clotting factors.
Severe: Monitor closely. May increase bleeding risk due to impaired synthesis of clotting factors and reduced clearance of heparin.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin III (ATIII), a plasma protein that inactivates thrombin (Factor IIa) and Factor Xa. This binding causes a conformational change in ATIII, greatly accelerating its inhibitory action (by 1,000-fold or more) on these clotting factors. Heparin also inhibits other coagulation factors, including IXa, XIa, XIIa, and plasmin, but its primary anticoagulant effect is mediated through ATIII inhibition of thrombin and Factor Xa.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV); Variable (SC, IM not recommended)
Tmax: Immediate (IV); 2-4 hours (SC)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.06 L/kg (dose-dependent)
ProteinBinding: High (to plasma proteins, endothelial cells, macrophages)
CnssPenetration: Limited

Elimination:

HalfLife: 1-2 hours (dose-dependent, increases with dose)
Clearance: Non-linear, saturable clearance mechanism
ExcretionRoute: Renal (primarily inactive metabolites, some unchanged drug at higher doses)
Unchanged: Small percentage (dose-dependent)
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Pharmacodynamics

OnsetOfAction: Immediate (IV); 20-60 minutes (SC)
PeakEffect: Minutes (IV); 2-4 hours (SC)
DurationOfAction: 2-6 hours (dose-dependent, IV); 8-12 hours (SC)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred vision
Feeling confused
Severe headache
Dizziness or fainting
Upset stomach or vomiting
Unusual burning sensations, particularly on the soles of the feet
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Chest pain or pressure
Shortness of breath
Back pain
Groin or pelvic pain or swelling
Changes in skin color at the injection site
Skin breakdown at the site of administration
Fever or chills

Other Possible Side Effects

As with any medication, you may experience side effects. While many people do not have any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for advice.

Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Any unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, blood in urine or stool, black/tarry stools, excessive bruising, petechiae, heavy menstrual bleeding)
  • Severe headache, dizziness, or weakness (may indicate internal bleeding)
  • Sudden, severe pain or swelling in a limb (could be a new clot or bleeding)
  • Allergic reactions (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are allergic to pork products, discuss this with your doctor.
* Certain health conditions, including:
+ Bleeding problems or a low platelet count.
+ A history of low platelet count caused by heparin or pentosan polysulfate.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

While taking this drug, you may experience easier bleeding. To minimize the risk of injury, be cautious and take precautions such as using a soft toothbrush and an electric razor.

There is a risk of severe and potentially life-threatening bleeding problems associated with this medication. Additionally, this drug can cause a condition known as heparin-induced thrombocytopenia (HIT), which may lead to the formation of blood clots, referred to as heparin-induced thrombocytopenia and thrombosis (HITTS). Both HIT and HITTS can be fatal or cause other complications, and they may occur up to several weeks after discontinuing the medication. If you have any questions or concerns, discuss them with your doctor. It is crucial to undergo blood tests as directed by your doctor and to consult with them regularly.

This medication may interfere with certain laboratory tests. Therefore, it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.

If you fall, injure yourself, or hit your head, contact your doctor immediately, even if you feel fine.

Ensure that you have the correct product, as this medication is available in various containers and strengths. If you are unsure, consult your doctor or pharmacist.

If you have a sulfite allergy, discuss this with your doctor, as some products contain sulfites.

Individuals over 60 years old should exercise caution when using this medication, as they may be more susceptible to side effects.

Some products contain benzyl alcohol, which can cause serious side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss potential risks.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive bleeding (e.g., nosebleeds, gum bleeding, hematuria, melena, hematemesis, excessive bruising, petechiae)
  • Hypotension (low blood pressure)
  • Tachycardia (rapid heart rate)
  • Shock

What to Do:

Seek immediate medical attention. The antidote for heparin overdose is protamine sulfate, which neutralizes heparin's anticoagulant effect. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • History of Heparin-Induced Thrombocytopenia (HIT)
  • Active major bleeding
  • Severe thrombocytopenia
  • Uncontrolled severe hypertension
  • Recent brain, spinal, or eye surgery
  • Bacterial endocarditis
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Major Interactions

  • Other anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban) - increased bleeding risk
  • Antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor, prasugrel) - increased bleeding risk
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib) - increased bleeding risk
  • Thrombolytic agents (e.g., alteplase, tenecteplase) - increased bleeding risk
  • Dextran - increased bleeding risk
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Moderate Interactions

  • Herbal supplements (e.g., ginkgo biloba, garlic, ginger, dong quai, feverfew) - potential increased bleeding risk
  • SSRIs/SNRIs - potential increased bleeding risk
  • Corticosteroids (long-term use) - potential increased bleeding risk
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Minor Interactions

  • Nitroglycerin (IV) - may decrease heparin effect (monitor aPTT)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with Platelets

Rationale: To establish baseline platelet count and assess for anemia or other hematologic abnormalities before initiating therapy. Essential for monitoring for Heparin-Induced Thrombocytopenia (HIT).

Timing: Prior to initiation of therapy

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline coagulation status. Used to monitor therapeutic effect of unfractionated heparin.

Timing: Prior to initiation of therapy

Prothrombin Time (PT) / International Normalized Ratio (INR)

Rationale: To establish baseline coagulation status, especially if transitioning to warfarin or if liver dysfunction is suspected.

Timing: Prior to initiation of therapy

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, as severe renal impairment can affect heparin clearance and increase sensitivity.

Timing: Prior to initiation of therapy

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess liver function, as severe hepatic impairment can affect synthesis of clotting factors and increase bleeding risk.

Timing: Prior to initiation of therapy

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT) or Anti-Xa Heparin Assay

Frequency: Every 4-6 hours after initiation or dose change, then daily once therapeutic range is stable (for continuous IV infusion). Not typically monitored for prophylactic SC doses.

Target: aPTT: 1.5-2.5 times control (specific range varies by lab); Anti-Xa: 0.3-0.7 units/mL (for therapeutic use)

Action Threshold: Adjust infusion rate based on institutional nomogram or protocol to achieve target range. If above range, hold infusion and recheck; if below, increase infusion rate.

Platelet Count

Frequency: Every 2-3 days during therapy, especially between days 5-14, or if new thrombosis or skin lesions develop.

Target: Normal range (e.g., 150,000-450,000/ยตL)

Action Threshold: If platelet count drops by >50% from baseline or falls below 100,000/ยตL, suspect HIT and discontinue heparin immediately. Initiate alternative anticoagulant.

Signs and Symptoms of Bleeding

Frequency: Continuously

Target: Absence of bleeding

Action Threshold: Any signs of bleeding (e.g., hematuria, melena, epistaxis, ecchymosis, petechiae, gum bleeding, excessive bruising, unexplained drop in hemoglobin/hematocrit) require immediate assessment and potential intervention (e.g., dose reduction, discontinuation, administration of protamine sulfate).

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Symptom Monitoring

  • Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, black/tarry stools, excessive bruising, petechiae)
  • Signs of internal bleeding (e.g., severe headache, dizziness, weakness, abdominal pain, swelling, joint pain)
  • Signs of Heparin-Induced Thrombocytopenia (HIT) such as new or worsening thrombosis, skin lesions at injection sites, or sudden drop in platelet count.

Special Patient Groups

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Pregnancy

Heparin is generally considered the anticoagulant of choice during pregnancy because it does not cross the placenta and therefore does not cause fetal anticoagulation or teratogenic effects. However, close monitoring is required due to physiological changes in pregnancy affecting heparin pharmacokinetics and increased risk of bleeding.

Trimester-Specific Risks:

First Trimester: Low risk to fetus. Maternal risk of bleeding.
Second Trimester: Low risk to fetus. Maternal risk of bleeding.
Third Trimester: Low risk to fetus. Increased maternal risk of bleeding, especially around delivery. Regional anesthesia may be contraindicated if therapeutic anticoagulation is present.
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Lactation

Heparin is considered safe during breastfeeding. It is a large molecule and is not excreted into breast milk in clinically significant amounts. It is also poorly absorbed orally by the infant.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing is weight-based and often requires careful titration and monitoring of aPTT or anti-Xa levels. Neonates and infants may require higher doses per kg due to higher antithrombin levels and faster clearance. Risk of bleeding is present, and careful monitoring is crucial.

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Geriatric Use

Elderly patients may be more sensitive to the effects of heparin and have an increased risk of bleeding. Lower initial doses or more conservative dosing strategies may be considered. Close monitoring of aPTT/anti-Xa and for signs of bleeding is essential.

Clinical Information

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Clinical Pearls

  • Heparin is dosed in units, not milligrams. Ensure correct unit conversion and concentration (e.g., 25,000 units in 500 mL = 50 units/mL).
  • Always verify the concentration of heparin before administration to prevent dosing errors.
  • Monitor aPTT (or anti-Xa) and platelet count closely. A significant drop in platelets (>50% from baseline or <100,000/ยตL) should prompt evaluation for Heparin-Induced Thrombocytopenia (HIT).
  • Protamine sulfate is the antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin.
  • Subcutaneous heparin should be administered in the abdomen, at least 2 inches from the navel, using a 90-degree angle, and without aspiration or rubbing after injection to minimize bruising.
  • Heparin can cause hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing diuretics or ACE inhibitors.
  • Avoid intramuscular (IM) injections due to the risk of hematoma formation.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWH) (e.g., enoxaparin, dalteparin) - for VTE treatment and prophylaxis, often preferred for outpatient use.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban) - for VTE treatment and prophylaxis, and stroke prevention in atrial fibrillation.
  • Warfarin (Vitamin K Antagonist) - for long-term anticoagulation.
  • Fondaparinux (Synthetic Factor Xa Inhibitor) - for VTE treatment and prophylaxis.
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Cost & Coverage

Average Cost: Varies widely by concentration, volume, and supplier. Generally inexpensive. per 500ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.