Heparin Sod 10,000u/ml Inj, 4ml

Manufacturer SAGENT PHARMACEUTICAL 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
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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 helps prevent blood clots from forming or growing larger in your body. It is often given by injection, either into a vein or under the skin. It works by thinning your blood, which can help prevent serious conditions like deep vein thrombosis (DVT) or pulmonary embolism (PE).
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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

  • Report any signs of bleeding immediately to your doctor or nurse.
  • Avoid activities that may cause injury or bruising.
  • Use a soft toothbrush and an electric razor to minimize bleeding risk.
  • Inform all healthcare providers, including dentists, that you are taking heparin.
  • Do not take any new medications, including over-the-counter drugs, herbal supplements, or vitamins, without consulting your doctor or pharmacist, especially aspirin or NSAIDs.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication and patient factors; typically titrated to aPTT or anti-Xa levels.

Condition-Specific Dosing:

Acute Venous Thromboembolism (VTE) Treatment (IV): Initial bolus: 80 units/kg (or 5000 units) IV, followed by continuous infusion: 18 units/kg/hr (or 1000-1200 units/hr). Adjust infusion rate to maintain aPTT 1.5-2.5 times control.
VTE Prophylaxis (SC): 5000 units subcutaneously every 8 to 12 hours.
Acute Coronary Syndromes (ACS): Initial bolus: 60 units/kg (max 4000 units) IV, followed by continuous infusion: 12 units/kg/hr (max 1000 units/hr). Adjust to maintain aPTT 1.5-2 times control.
Cardiopulmonary Bypass: Initial bolus: 300-400 units/kg IV, then additional doses as needed to maintain ACT >400-480 seconds.
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Pediatric Dosing

Neonatal: Initial bolus: 75 units/kg IV over 10 minutes. Maintenance infusion: 28 units/kg/hr IV. Adjust to maintain aPTT 60-85 seconds (or anti-Xa 0.3-0.7 units/mL).
Infant: Initial bolus: 75 units/kg IV over 10 minutes. Maintenance infusion: 20 units/kg/hr IV. Adjust to maintain aPTT 60-85 seconds (or anti-Xa 0.3-0.7 units/mL).
Child: Initial bolus: 75 units/kg IV over 10 minutes. Maintenance infusion: 15-20 units/kg/hr IV. Adjust to maintain aPTT 60-85 seconds (or anti-Xa 0.3-0.7 units/mL).
Adolescent: Similar to adult dosing, but often starting with pediatric infusion rates and titrating.
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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 and risk of bleeding due to accumulation of smaller heparin fragments and altered platelet function. Consider lower starting doses and closer monitoring.
Dialysis: Heparin is often used during hemodialysis. For systemic anticoagulation, monitor closely; not significantly dialyzable. Consider lower doses or alternative anticoagulants for non-dialysis indications.

Hepatic Impairment:

Mild: No specific dose adjustment.
Moderate: No specific dose adjustment, but monitor closely due to potential for altered coagulation factor synthesis and increased bleeding risk.
Severe: No specific dose adjustment, but monitor closely; increased risk of bleeding due to impaired synthesis of coagulation factors and potential for altered heparin clearance. Consider lower starting doses and closer monitoring.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin (AT), a plasma protein, causing a conformational change that greatly accelerates its inhibitory action on several activated coagulation factors, most notably thrombin (Factor IIa) and Factor Xa. This prevents the formation of fibrin clots and the propagation of existing clots.
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed orally. IV: 100%. SC: Variable, approximately 20-30% (due to binding to endothelial cells and macrophages).
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: Approximately 0.07 L/kg (small, primarily confined to plasma volume).
ProteinBinding: High (to various plasma proteins, endothelial cells, and macrophages), which contributes to its variable anticoagulant response.
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent. Approximately 1-2 hours for therapeutic doses (e.g., 100 units/kg IV), but can range from 30 minutes to 2.5 hours. Increases with higher doses.
Clearance: Complex, involves both saturable (cellular binding/degradation) and non-saturable (renal excretion of smaller fragments) mechanisms.
ExcretionRoute: Renal excretion of metabolites and some unchanged drug (especially at higher doses).
Unchanged: Small percentage, primarily metabolites.
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Pharmacodynamics

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

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 increase in size
+ 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

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or persist, contact your doctor for advice.

Not all possible side effects are listed 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:

  • Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, blood in urine or stool, black/tarry stools, heavy menstrual bleeding)
  • Severe headache or dizziness
  • Unusual weakness or fatigue
  • Red or dark brown urine
  • Vomiting blood or vomit that looks like coffee grounds
  • Severe pain or swelling in a joint
  • Any new or worsening pain, swelling, or discoloration in a limb (could indicate a new clot, even while on heparin)
  • Sudden shortness of breath or chest pain (could indicate a PE)
  • Rash, hives, or itching (signs of allergic reaction)
  • Sudden drop in platelet count (may be monitored by your doctor, but watch for new bruising or bleeding)
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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

Important Warnings and Cautions

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

Bleeding Risks
You may experience easier bleeding, so it is crucial to be cautious and avoid injuries. To minimize bleeding risks, use a soft toothbrush and an electric razor. Severe and potentially life-threatening bleeding problems have been associated with this medication.

Heparin-Induced Thrombocytopenia (HIT) and Thrombosis (HITTS)
This medication can cause a condition called heparin-induced thrombocytopenia (HIT), which may lead to blood clots, known as heparin-induced thrombocytopenia and thrombosis (HITTS). These conditions can be life-threatening or cause other serious problems. They may occur up to several weeks after stopping the medication. If you have any questions or concerns, discuss them with your doctor. Regular blood tests, as directed by your doctor, are necessary to monitor your condition.

Lab Test Interference
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

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

Product Verification
Ensure you have the correct product, as this medication comes in various containers and strengths. If you have any questions, consult your doctor or pharmacist.

Sulfite Allergy
If you are allergic to sulfites, discuss this with your doctor, as some products may contain sulfites.

Age-Related Precautions
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.

Benzyl Alcohol Precautions
Some products contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive bleeding (e.g., hematuria, melena, epistaxis, ecchymoses, hematomas)
  • Hypotension
  • Tachycardia
  • Shock

What to Do:

Immediately discontinue heparin. The effects of heparin can be rapidly reversed by administering protamine sulfate. The dose of protamine sulfate depends on the amount of heparin administered and the time elapsed since administration. Call 911 or your local poison control center (1-800-222-1222 in the US) immediately.

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, NSAIDs): Increased risk of bleeding.
  • Thrombolytic Agents (e.g., alteplase, reteplase, tenecteplase): Greatly increased risk of bleeding.
  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT closely).
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Moderate Interactions

  • Dextran: Increased risk of bleeding.
  • Cephalosporins (certain, e.g., cefoperazone, cefotetan): May increase bleeding risk due to vitamin K antagonism.
  • Probenecid: May increase heparin levels.
  • Hydrocortisone: May decrease heparin's anticoagulant effect.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with Platelets

Rationale: To establish baseline platelet count and hemoglobin/hematocrit before initiating therapy, and to monitor for bleeding and heparin-induced thrombocytopenia (HIT).

Timing: Prior to initiation of therapy.

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline coagulation status and for subsequent therapeutic monitoring.

Timing: Prior to initiation of therapy.

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

Rationale: To establish baseline coagulation status, especially if transitioning to warfarin.

Timing: Prior to initiation of therapy.

Renal and Hepatic Function Tests

Rationale: To assess organ function that may influence drug clearance or 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 until therapeutic range is achieved, then at least daily.

Target: Typically 1.5-2.5 times the control value (specific target range varies by lab and indication, often corresponds to anti-Xa 0.3-0.7 units/mL).

Action Threshold: Adjust infusion rate based on aPTT results to maintain target range. If supratherapeutic, hold infusion and/or consider protamine sulfate. If subtherapeutic, increase infusion rate and/or consider bolus.

Platelet Count

Frequency: Every 2-3 days (or daily for first 5-10 days) during therapy, then less frequently if prolonged therapy.

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

Action Threshold: Monitor for a drop of >50% from baseline or absolute count <100,000/ยตL, which may indicate Heparin-Induced Thrombocytopenia (HIT). If suspected, discontinue heparin immediately and consider alternative anticoagulation.

Hemoglobin and Hematocrit

Frequency: Daily or as clinically indicated.

Target: Normal range.

Action Threshold: Significant drop may indicate bleeding.

Signs and Symptoms of Bleeding

Frequency: Continuously.

Target: Absence of bleeding.

Action Threshold: Any signs of bleeding (e.g., hematuria, melena, epistaxis, bruising, gum bleeding, significant drop in BP/HR) require 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 stools, 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 heparin administration, significant drop in platelet count)
  • Signs of allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling)

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, it carries risks for the mother, including bleeding and osteoporosis.

Trimester-Specific Risks:

First Trimester: Low risk to fetus. Maternal risk of bleeding.
Second Trimester: Low risk to fetus. Maternal risk of bleeding and potential for heparin-induced osteoporosis with prolonged use.
Third Trimester: Low risk to fetus. 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 not orally absorbed by the infant.

Infant Risk: L2 (Safer) - No known adverse effects on the breastfed infant.
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Pediatric Use

Heparin can be used safely in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based and often requires higher units/kg than adults due to higher antithrombin levels and faster clearance in younger children. Close monitoring of aPTT or anti-Xa levels 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 starting doses and more frequent monitoring may be appropriate. Renal function should be considered, as impaired renal function can affect clearance of heparin fragments and increase sensitivity.

Clinical Information

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Clinical Pearls

  • Heparin is highly acidic and incompatible with many drugs; always check compatibility before mixing.
  • Heparin-induced thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts closely, especially between days 5-10 of therapy or within hours if previous heparin exposure. If HIT is suspected, discontinue heparin immediately and initiate alternative anticoagulation.
  • Protamine sulfate is the antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin.
  • Subcutaneous heparin injection sites should be rotated to prevent hematoma formation and improve absorption.
  • For continuous IV infusions, use an infusion pump to ensure accurate delivery.
  • Heparin resistance can occur due to antithrombin deficiency, acute phase reactants, or high heparin binding proteins. Consider antithrombin supplementation if resistance is suspected and AT levels are low.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWH) (e.g., enoxaparin, dalteparin): Often preferred for VTE prophylaxis and outpatient treatment due to more predictable pharmacokinetics and lower risk of HIT.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for VTE treatment/prophylaxis, stroke prevention in AFib. Do not require routine monitoring.
  • Warfarin: Oral anticoagulant, requires regular INR monitoring, used for long-term anticoagulation.
  • Fondaparinux: Synthetic selective Factor Xa inhibitor, used for VTE prophylaxis and treatment, does not cause HIT.
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Cost & Coverage

Average Cost: Highly variable, typically low cost for generic unfractionated heparin. per vial/mL
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, 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. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; if you have questions, consult your pharmacist. If you have any concerns or questions 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 occurred, as this will aid in prompt and effective treatment.