Heparin Na 50u/1ml/sod Cl 0.45% Inj

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 agent; Indirect thrombin inhibitor; Glycosaminoglycan
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Pregnancy Category
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. It works by thinning your blood. It's often given by injection, either into a vein or under the skin. The specific concentration (50 units/mL) is very low and is commonly used to keep IV lines or catheters from clotting, rather than for treating large blood clots in the body.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, it's essential to use it exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. Your doctor may administer this medication through a catheter, as an intravenous (IV) injection, or as a subcutaneous injection into the fatty part of your skin. It can also be given as an IV infusion 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 to determine the best way to store it safely.

What to Do If You Miss a Dose

If you miss a dose, contact your doctor immediately to find out what steps you should take next.
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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.
  • Inform all healthcare providers, including dentists, that you are taking heparin.
  • Report any signs of unusual bleeding or bruising immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Note: The concentration 50 units/mL is typically used for catheter flushing or very low-dose prophylaxis, not for full therapeutic anticoagulation. Standard therapeutic dosing for Heparin Sodium (Unfractionated Heparin) is highly individualized based on indication and patient weight/aPTT/anti-Xa levels. Examples for therapeutic use:

Condition-Specific Dosing:

Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) (Therapeutic): Initial IV bolus: 80 units/kg (or 5,000 units). Continuous IV infusion: 18 units/kg/hour (or 1,000-1,300 units/hour). Adjust infusion rate to maintain aPTT 1.5-2.5 times control or anti-Xa 0.3-0.7 units/mL.
DVT Prophylaxis (Low-dose SC): 5,000 units subcutaneously every 8-12 hours.
Catheter Lock/Flush (e.g., Central Venous Catheters): 10 units/mL or 100 units/mL solution, typically 1-5 mL per lumen, to maintain patency. The 50 units/mL concentration may be used for this purpose or for very low-dose arterial line flushes.
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Pediatric Dosing

Neonatal: Initial IV bolus: 75 units/kg. Continuous IV infusion: 28 units/kg/hour. Adjust to maintain aPTT 60-85 seconds or anti-Xa 0.3-0.7 units/mL.
Infant: Initial IV bolus: 75 units/kg. Continuous IV infusion: 20 units/kg/hour. Adjust to maintain aPTT 60-85 seconds or anti-Xa 0.3-0.7 units/mL.
Child: Initial IV bolus: 75 units/kg. Continuous IV infusion: 20 units/kg/hour. Adjust to maintain aPTT 60-85 seconds or anti-Xa 0.3-0.7 units/mL.
Adolescent: Similar to adult dosing, individualized based on weight and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required for therapeutic use, but monitor closely.
Moderate: No specific dose adjustment required for therapeutic use, but monitor closely. Anti-Xa monitoring may be preferred over aPTT.
Severe: No specific dose adjustment required for therapeutic use, but monitor closely. Anti-Xa monitoring may be preferred over aPTT due to potential aPTT prolongation from uremia.
Dialysis: Heparin is not significantly removed by hemodialysis. Use with caution and monitor closely. Anti-Xa monitoring is recommended.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: Use with caution; monitor aPTT/anti-Xa closely due to potential for altered metabolism and increased bleeding risk.
Severe: Use with extreme caution; significant increased risk of bleeding. Monitor aPTT/anti-Xa closely. Dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Heparin is an indirect anticoagulant that binds to antithrombin (AT), a plasma protein. This binding causes a conformational change in AT, greatly accelerating its inhibitory action on several activated coagulation factors, particularly thrombin (Factor IIa) and Factor Xa. Heparin's effect on thrombin is dependent on a pentasaccharide sequence that binds to AT, and a longer polysaccharide chain that allows it to bridge AT and thrombin. Its effect on Factor Xa is primarily mediated by the pentasaccharide sequence.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV. Subcutaneous: 20-30% (variable)
Tmax: Subcutaneous: 2-4 hours
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.06 L/kg (similar to plasma volume)
ProteinBinding: Highly protein bound (to various plasma proteins, including AT, platelet factor 4, fibronectin, von Willebrand factor, lipoproteins). This binding is saturable and contributes to dose-dependent pharmacokinetics.
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent: 0.5-2.5 hours (increases with dose due to saturable binding and clearance mechanisms)
Clearance: Complex, involves both saturable (cellular uptake and degradation) and non-saturable (renal) mechanisms.
ExcretionRoute: Renal excretion of inactive metabolites and small amounts of unchanged drug.
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Intravenous: Immediate; Subcutaneous: 20-60 minutes
PeakEffect: Intravenous: Minutes; Subcutaneous: 2-4 hours
DurationOfAction: Intravenous: 2-6 hours (dose-dependent); Subcutaneous: 8-12 hours (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
Confusion
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, this drug may cause side effects in some individuals. While many people may not experience any side effects or only minor ones, it is essential to consult your doctor if you notice any symptoms that bother you or persist. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Unusual bleeding (e.g., nosebleeds, bleeding gums, blood in urine or stool, black/tarry stools, heavy menstrual bleeding)
  • Excessive bruising or large bruises without injury
  • Severe headache or sudden weakness/numbness (could indicate internal bleeding)
  • Sudden, severe pain or swelling in a limb (could indicate a new clot, despite being on heparin)
  • Rash, hives, itching, or difficulty breathing (signs of allergic reaction)
  • Any new or worsening pain, swelling, or discoloration in a limb, especially if accompanied by a sudden drop in platelet count (could indicate Heparin-Induced Thrombocytopenia with thrombosis)
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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
+ 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.

Remember, do not start, stop, or change the dose 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 using 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-bristled 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 serious 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, discuss this with 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.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive bleeding (e.g., hematuria, melena, epistaxis, ecchymoses, petechiae, gastrointestinal bleeding, intracranial hemorrhage)

What to Do:

Immediately discontinue heparin. For severe bleeding, protamine sulfate is the antidote. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222.

Drug Interactions

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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, dipyridamole): Increased risk of bleeding.
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, reteplase, tenecteplase): Increased risk of bleeding.
  • Dextran: Increased risk of bleeding.
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Moderate Interactions

  • Nitroglycerin (IV): May cause heparin resistance (decreased aPTT response).
  • Digitalis, tetracyclines, nicotine, antihistamines: May partially counteract anticoagulant effect.
  • Cephalosporins (especially those with a methylthiotetrazole side chain, e.g., cefoperazone, cefamandole): May increase bleeding risk due to hypoprothrombinemia.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with platelet count

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) or Anti-Factor Xa (anti-Xa) level

Rationale: To establish baseline coagulation status. While aPTT is the traditional method, anti-Xa is often preferred for more accurate monitoring, especially in certain populations (e.g., renal impairment, obesity, liver disease).

Timing: Prior to initiation of therapy

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

Rationale: To assess baseline extrinsic and common pathway coagulation. Important if transitioning to warfarin.

Timing: Prior to initiation of therapy

Renal function (BUN, Creatinine)

Rationale: To assess kidney function, as heparin metabolites are renally cleared and renal impairment can affect clearance and bleeding risk.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, Bilirubin)

Rationale: To assess liver function, as heparin is metabolized in the liver and hepatic impairment can increase bleeding risk.

Timing: Prior to initiation of therapy

Stool guaiac or occult blood test

Rationale: To assess for baseline gastrointestinal bleeding.

Timing: Prior to initiation of therapy (if clinically indicated)

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Routine Monitoring

aPTT or Anti-Factor Xa (anti-Xa) level

Frequency: Every 4-6 hours after initiation or dose change until therapeutic range is achieved, then at least daily.

Target: aPTT: 1.5-2.5 times control (typically 60-80 seconds, lab-specific); Anti-Xa: 0.3-0.7 units/mL (for therapeutic anticoagulation)

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

Platelet count

Frequency: Every 2-3 days for the first 14 days of therapy, or until heparin is discontinued, then less frequently if therapy is prolonged.

Target: Maintain above 100,000/mm³ or >50% decrease from baseline.

Action Threshold: If platelet count drops by >50% from baseline or below 100,000/mm³, suspect Heparin-Induced Thrombocytopenia (HIT) and discontinue heparin immediately. Consider alternative anticoagulation.

Hemoglobin and Hematocrit

Frequency: Daily or as clinically indicated.

Target: Maintain stable levels.

Action Threshold: Significant drop may indicate bleeding; investigate source and consider dose adjustment or discontinuation.

Signs and symptoms of bleeding

Frequency: Continuously

Target: Absence of bleeding

Action Threshold: Any new or worsening bleeding (e.g., hematuria, melena, epistaxis, bruising, gum bleeding) requires immediate assessment and potential intervention.

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Symptom Monitoring

  • Signs of bleeding (e.g., unusual bruising, petechiae, nosebleeds, gum bleeding, blood in urine or stool, black/tarry stools, severe headache, dizziness, weakness, prolonged bleeding from cuts)
  • Signs of Heparin-Induced Thrombocytopenia (HIT) (e.g., new or worsening thrombosis, skin lesions at injection sites, acute systemic reactions after IV heparin bolus, sudden drop in platelet count)
  • Signs of allergic reaction (e.g., rash, itching, hives, swelling, difficulty breathing)

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 teratogenicity. However, it is classified as Category C due to potential maternal risks (e.g., osteoporosis with long-term use, bleeding). Close monitoring is essential.

Trimester-Specific Risks:

First Trimester: Low risk to fetus. Maternal bleeding risk.
Second Trimester: Low risk to fetus. Maternal bleeding risk, potential for heparin-induced osteoporosis with prolonged use.
Third Trimester: Low risk to fetus. Increased maternal bleeding risk, 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: L1 (Safest)
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Pediatric Use

Heparin can be used in pediatric patients, including neonates. Dosing is weight-based and requires careful titration and monitoring (aPTT or anti-Xa). Neonates and infants may require higher initial doses and infusion rates due to differences in antithrombin levels and clearance. Increased risk of bleeding in neonates.

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Geriatric Use

Elderly patients may be more sensitive to the effects of heparin and have an increased risk of bleeding. Careful dose titration and close monitoring are essential. Renal function should be assessed, as impaired renal function can affect heparin clearance and increase bleeding risk.

Clinical Information

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Clinical Pearls

  • Heparin's half-life is dose-dependent; higher doses lead to disproportionately longer half-lives.
  • The 50 units/mL concentration is typically for catheter flushing or very low-dose applications, not for systemic therapeutic anticoagulation for DVT/PE.
  • Always confirm the concentration of heparin before administration to avoid dosing errors.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts regularly (every 2-3 days for the first 14 days). If HIT is suspected, discontinue heparin immediately and consider alternative anticoagulants.
  • Protamine sulfate is the antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin, but the dose needs to be adjusted based on the time since heparin administration.
  • Avoid intramuscular injections in patients receiving heparin due to the risk of hematoma formation.
  • For therapeutic anticoagulation, aPTT or anti-Xa levels are crucial for monitoring and dose adjustment. Anti-Xa is often preferred for more precise monitoring, especially in patients with abnormal baseline aPTT or conditions affecting aPTT (e.g., liver disease, lupus anticoagulant).
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): Often preferred for DVT/PE treatment and prophylaxis due to more predictable pharmacokinetics, subcutaneous administration, and less need for monitoring.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for DVT/PE treatment and prevention, and stroke prevention in atrial fibrillation. Do not require routine coagulation monitoring.
  • Warfarin: Oral vitamin K antagonist, requires regular INR monitoring.
  • Fondaparinux: Synthetic pentasaccharide, selective Factor Xa inhibitor.
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Cost & Coverage

Average Cost: Varies widely by concentration, volume, and manufacturer. Low-dose flush solutions are generally inexpensive. per vial/syringe
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 evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. 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, do not hesitate to 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 occurred, as this will aid in providing appropriate treatment.