Heparin Sod 5000u/0.5ml Inj, 0.5ml

Manufacturer HOSPIRA Active Ingredient Heparin(HEP a rin) Pronunciation HEP-uh-rin SO-dee-um
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 agent; Indirect thrombin inhibitor
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Pregnancy Category
C
FDA Approved
Jan 1939
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Heparin is a medicine that helps prevent blood clots from forming or growing larger in your body. It's often given by injection, either into a vein or under the skin. It's used for conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), or during certain medical procedures.
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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 dosage 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, be sure to 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 may cause injury or bleeding (e.g., contact sports, sharp objects).
  • Use a soft toothbrush and electric razor to minimize bleeding risk.
  • Report any signs of unusual bleeding or bruising to your doctor immediately.
  • Inform all healthcare providers (including dentists) that you are taking heparin.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication (prophylaxis vs. treatment) and route (IV vs. SC).

Condition-Specific Dosing:

DVT/PE Prophylaxis (SC): 5000 units subcutaneously every 8 to 12 hours.
DVT/PE Treatment (IV): Initial bolus of 80 units/kg IV, followed by a continuous infusion of 18 units/kg/hour IV. Adjust dose to maintain aPTT 1.5-2.5 times control or anti-Xa 0.3-0.7 units/mL.
Acute Coronary Syndromes (IV): Initial bolus of 60 units/kg (max 4000 units) IV, followed by a continuous infusion of 12 units/kg/hour (max 1000 units/hour) IV. Adjust dose to maintain aPTT 1.5-2.5 times control.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific adjustment required, monitor aPTT/anti-Xa closely.
Moderate: No specific adjustment required, monitor aPTT/anti-Xa closely.
Severe: Use with caution; increased risk of accumulation and bleeding. Monitor aPTT/anti-Xa closely and consider lower doses.
Dialysis: Heparin is often used during hemodialysis. For therapeutic anticoagulation, monitor closely; may require lower doses due to altered clearance and increased bleeding risk.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution; increased risk of bleeding due to impaired coagulation factor synthesis. Monitor aPTT/anti-Xa closely.
Severe: Use with extreme caution; significantly increased risk of bleeding. Monitor aPTT/anti-Xa closely and consider lower doses.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin (ATIII), a plasma protein, causing a conformational change that greatly accelerates the rate at which ATIII inactivates coagulation enzymes, particularly Factor Xa and thrombin (Factor IIa). This prevents the formation of fibrin clots.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable (10-70%) after subcutaneous administration due to non-specific binding to cells and proteins. 100% after IV administration.
Tmax: Not applicable for IV. For SC, 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: 0.06 L/kg (distributes in plasma volume)
ProteinBinding: High (variable, non-specific binding to plasma proteins, endothelial cells, and macrophages)
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent; typically 1-2 hours for therapeutic doses (e.g., 100 units/kg IV). Increases with dose.
Clearance: Saturable, dose-dependent clearance.
ExcretionRoute: Renal excretion of inactive metabolites and small amounts of unchanged drug.
Unchanged: <5%
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Pharmacodynamics

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

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 or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble 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 all medications, you may experience side effects. While many people do not have any side effects or only minor 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 guidance.

Please note that this list is not exhaustive, and you should consult your doctor if you have any questions or concerns about side effects. 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 (e.g., nosebleeds, bleeding gums, blood in urine or stool, heavy menstrual bleeding)
  • Excessive bruising or large bruises that appear without injury
  • Severe headache or sudden weakness/numbness (could indicate internal bleeding)
  • Red or dark brown urine
  • Black, tarry, or bloody stools
  • Unusual pain or swelling in a joint
  • Sudden shortness of breath or chest pain (could indicate new clot formation despite therapy)
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are allergic to pork products, as this may be relevant to your treatment.
* 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without first consulting your doctor to ensure your safety.
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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, so it is crucial to be cautious and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor for shaving.

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, also 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 stopping the medication. If you have any questions or concerns, discuss them with your doctor. It is also important to undergo blood tests as directed by your doctor and to consult with your doctor regarding any concerns.

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

If you experience a fall, injury, or head trauma, 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, inform your doctor, as some products may contain sulfites.

Individuals over 60 years old should use this medication with caution, 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 the product you are using contains benzyl alcohol and to discuss potential risks.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive bleeding (e.g., hematuria, melena, epistaxis, ecchymoses, petechiae)
  • Significant drop in blood pressure or heart rate due to blood loss
  • Signs of internal hemorrhage (e.g., severe abdominal pain, headache, altered mental status)

What to Do:

Immediately discontinue heparin. The antidote for heparin overdose is protamine sulfate. Call 911 or your local emergency number. For non-emergency advice, call a poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

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Contraindicated Interactions

  • Patients with active major bleeding
  • History of Heparin-Induced Thrombocytopenia (HIT)
  • Severe thrombocytopenia
  • Uncontrolled active hemorrhage
  • Recent brain, spinal, or eye surgery
  • Lumbar puncture or regional anesthetic procedures (epidural/spinal anesthesia) in patients receiving therapeutic anticoagulation
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Major Interactions

  • Other anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban): Increased risk of bleeding.
  • Antiplatelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor, NSAIDs): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, tenecteplase): Increased risk of bleeding.
  • Dextran: Increased risk of bleeding.
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Moderate Interactions

  • Corticosteroids (long-term use): May increase bleeding risk.
  • Nitroglycerin (IV): May decrease heparin effect (monitor aPTT).
  • Probenecid: May increase heparin effect.
  • Cephalosporins (certain, e.g., cefoperazone, cefotetan): May increase bleeding risk due to vitamin K antagonism.
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Minor Interactions

  • Not available

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 for monitoring therapeutic heparin dosing.

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 assessing for other coagulopathies.

Timing: Prior to initiation of therapy.

Renal and Hepatic Function Tests (e.g., BUN, creatinine, AST, ALT)

Rationale: To assess organ function, as severe impairment may affect heparin clearance or increase bleeding risk.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 4-6 hours after initiation or dose change for continuous IV infusion, until two consecutive values are in therapeutic range. Then daily.

Target: Typically 1.5-2.5 times the control value (specific range depends on laboratory and indication).

Action Threshold: Adjust infusion rate based on aPTT results to maintain target range. If too high, hold infusion and/or administer protamine sulfate; if too low, increase infusion rate and/or administer bolus.

Anti-Xa Heparin Assay

Frequency: Alternative to aPTT, especially in conditions affecting aPTT (e.g., lupus anticoagulant). Frequency similar to aPTT.

Target: 0.3-0.7 units/mL for therapeutic anticoagulation.

Action Threshold: Adjust infusion rate based on anti-Xa results.

Platelet Count

Frequency: Every 2-3 days from day 4 to day 14 of therapy, or until heparin is discontinued, to monitor for Heparin-Induced Thrombocytopenia (HIT).

Target: Maintain above 100,000/mm³ or no significant drop from baseline.

Action Threshold: If platelet count drops by >50% from baseline or falls below 100,000/mm³, immediately discontinue heparin and evaluate for HIT.

Signs and Symptoms of Bleeding

Frequency: Continuously

Target: Absence of bleeding

Action Threshold: Any signs of bleeding (e.g., hematuria, melena, epistaxis, petechiae, ecchymoses, significant drop in hemoglobin/hematocrit) require immediate assessment and potential intervention.

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Symptom Monitoring

  • Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, excessive bruising)
  • Petechiae (small red spots on skin)
  • Ecchymoses (large bruises)
  • Signs of internal bleeding (e.g., severe headache, abdominal pain, weakness, dizziness, pallor)
  • Signs of Heparin-Induced Thrombocytopenia (HIT): new or worsening thrombosis, skin lesions at injection site, acute systemic reactions after heparin administration.

Special Patient Groups

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Pregnancy

Heparin is often the anticoagulant of choice during pregnancy because it does not cross the placenta and therefore does not cause fetal anticoagulation or teratogenicity. However, it carries risks of maternal bleeding and osteoporosis.

Trimester-Specific Risks:

First Trimester: Generally considered safe; no known teratogenic effects.
Second Trimester: Generally considered safe; primary risks are maternal bleeding and potential for heparin-induced osteoporosis with prolonged use.
Third Trimester: Generally considered safe; increased risk of bleeding during labor and delivery, especially with regional anesthesia. Discontinuation or dose reduction may be necessary prior to delivery.
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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.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring of aPTT or anti-Xa levels due to differences in pharmacokinetics and pharmacodynamics compared to adults. Higher doses per kg may be required in neonates and infants.

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Geriatric Use

Increased risk of bleeding due to age-related physiological changes (e.g., decreased renal function, increased capillary fragility, concomitant medications). Lower doses or more frequent monitoring may be necessary.

Clinical Information

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Clinical Pearls

  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts closely (every 2-3 days from day 4 to 14 or until discontinued). If HIT is suspected, immediately discontinue heparin and initiate an alternative non-heparin anticoagulant.
  • Protamine sulfate is the specific antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin.
  • Heparin is highly acidic and incompatible with many other drugs; always check compatibility before mixing.
  • Subcutaneous injections should be given in the abdominal fat, at least 2 inches from the navel, and sites should be rotated to prevent hematoma formation.
  • For therapeutic IV infusions, a dedicated IV line is preferred to ensure accurate dosing and minimize interactions.
  • Heparin's half-life is dose-dependent, meaning higher doses are cleared more slowly.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWH) (e.g., enoxaparin, dalteparin): For DVT/PE prophylaxis and treatment, ACS. Offer more predictable pharmacokinetics and once- or twice-daily dosing.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): For DVT/PE treatment and prevention of stroke in non-valvular AF. Not suitable for all indications where heparin is used (e.g., acute MI, ECMO).
  • Warfarin: Oral anticoagulant for long-term anticoagulation, requires INR monitoring.
  • Fondaparinux: Synthetic pentasaccharide, selectively inhibits Factor Xa via ATIII, used for DVT/PE prophylaxis and treatment.
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Cost & Coverage

Average Cost: Varies widely based on concentration, volume, and supplier. Generally inexpensive. per vial/mL
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for 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 correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.