Heparin Sod 10,000u/ml Inj, 5ml

Manufacturer FRESENIUS KABI USA Active Ingredient Heparin(HEP a rin) Pronunciation HEP-a-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
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Pregnancy Category
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 block blood vessels and cause serious problems like heart attacks, strokes, or clots in your legs or lungs. It is given by injection, either into a vein or under the skin.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. This medication can be administered in various 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.

What to Do If You Miss a Dose

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

  • Report any signs of unusual bleeding or bruising immediately to your doctor or nurse.
  • Avoid activities that could cause injury or bleeding (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.
  • Do not take aspirin, NSAIDs (like ibuprofen or naproxen), or other blood thinners unless specifically instructed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For DVT/PE treatment: Initial bolus 80 units/kg IV, followed by continuous infusion of 18 units/kg/hr IV. Adjusted to maintain aPTT 1.5-2.5 times control. For DVT prophylaxis: 5,000 units SC every 8-12 hours.
Dose Range: 5000 - 40000 mg

Condition-Specific Dosing:

DVT/PE Treatment: Initial bolus 80 units/kg IV, then 18 units/kg/hr IV infusion, adjusted to target aPTT.
DVT Prophylaxis: 5,000 units SC every 8-12 hours.
Acute Coronary Syndromes (ACS): Initial bolus 60 units/kg IV (max 4000 units), then 12 units/kg/hr IV infusion (max 1000 units/hr), adjusted to target aPTT.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific dose adjustment required, but monitor aPTT closely.
Moderate: No specific dose adjustment required, but monitor aPTT closely.
Severe: No specific dose adjustment required, but monitor aPTT closely due to potential for accumulation of metabolites or altered sensitivity.
Dialysis: No specific dose adjustment required for unfractionated heparin during dialysis, but careful monitoring of aPTT is essential. Heparin is often used for anticoagulation during hemodialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor aPTT closely.
Moderate: No specific dose adjustment required, but monitor aPTT closely. Hepatic impairment may affect synthesis of clotting factors, potentially increasing sensitivity to heparin.
Severe: No specific dose adjustment required, but monitor aPTT closely. Increased risk of bleeding due to impaired clotting factor synthesis.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin (AT), a plasma protein that inactivates thrombin (Factor IIa) and Factor Xa. The binding of heparin to AT causes a conformational change in AT, greatly accelerating its inhibitory action on these coagulation factors. Heparin also inhibits other coagulation factors (IXa, XIa, XIIa, plasmin) indirectly via AT. The primary anticoagulant effect is mediated through the inhibition of thrombin and Factor Xa.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100%; SC: 30-70% (variable)
Tmax: IV: Immediate; SC: 2-4 hours
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.06 L/kg (similar to plasma volume)
ProteinBinding: Highly protein bound (to plasma proteins, endothelial cells, macrophages)
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent; typically 0.5-2.5 hours (increases with dose)
Clearance: Non-linear, saturable clearance mechanism
ExcretionRoute: Renal (small amount of unchanged drug and metabolites)
Unchanged: <5%
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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 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

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.

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 (e.g., nosebleeds, bleeding gums, blood in urine or stools, heavy menstrual bleeding)
  • Excessive bruising or large bruises that appear without injury
  • Severe headache or dizziness
  • Weakness or numbness on one side of the body
  • Sudden, severe pain or swelling in a limb
  • Chest pain or shortness of breath
  • Any new rash or skin lesions, especially at injection sites
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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 allergic reaction you experienced, including any symptoms that occurred.
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 health problems and medications with your doctor.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
* Your complete medical history, including any health problems.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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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 on this medication, you may experience easier bleeding, so it's 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 them regarding any concerns.

This medication may interfere with certain laboratory tests, so it's 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 have any doubts, consult your doctor or pharmacist.

If you are allergic to sulfites, 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. If you are a parent or caregiver, consult your doctor to determine if the product contains benzyl alcohol and to discuss alternative options.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor 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., nosebleeds, gum bleeding, hematuria, melena, petechiae, ecchymoses)
  • 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 hypertension
  • Recent surgery of the brain, spinal cord, or eye
  • Bacterial endocarditis
  • 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, ticagrelor, prasugrel): Increased risk of bleeding.
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, tenecteplase): Significantly increased risk of bleeding.
  • Dextran: Increased risk of bleeding.
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Moderate Interactions

  • Corticosteroids (long-term use): May increase risk of bleeding.
  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT).
  • Probenecid: May increase heparin levels.
  • Certain herbal supplements (e.g., ginkgo biloba, garlic, ginger, dong quai, feverfew): May increase bleeding risk.
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Minor Interactions

  • Not many specific minor interactions; most interactions relate to bleeding risk.

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, and to monitor for thrombocytopenia (including HIT).

Timing: Prior to initiation of therapy

Activated Partial Thromboplastin Time (aPTT)

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

Timing: Prior to initiation of therapy

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

Rationale: To establish baseline coagulation status and assess for other coagulopathies.

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

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

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 4-6 hours initially for continuous IV infusion until therapeutic range is achieved, then daily or as per protocol. Not typically monitored for SC prophylaxis.

Target: 1.5-2.5 times the control value (or specific institutional therapeutic range, e.g., 60-80 seconds)

Action Threshold: Values outside target range require dose adjustment as per nomogram or protocol.

Platelet count

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

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

Action Threshold: A drop in platelet count by >50% from baseline, or new onset thrombocytopenia (<100,000/ยตL), especially if associated with new thrombosis, should prompt suspicion for HIT and discontinuation of heparin.

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, petechiae, gum bleeding, severe headache, altered mental status) 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)
  • Melena (black, tarry stools)
  • Hematuria (blood in urine)
  • Severe headache or dizziness (may indicate intracranial bleeding)
  • Unusual pain or swelling (may indicate internal bleeding)
  • Signs of Heparin-Induced Thrombocytopenia (HIT): new or worsening thrombosis (e.g., limb pain, swelling, coolness, discoloration), skin lesions at injection sites, sudden drop in platelet count.

Special Patient Groups

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Pregnancy

Heparin does not cross the placenta and is generally considered safe for use during pregnancy when anticoagulation is required. However, it is classified as Pregnancy Category C by the FDA due to animal studies showing some adverse effects at high doses, though human data suggest low risk.

Trimester-Specific Risks:

First Trimester: Generally considered safe; no increased risk of congenital malformations.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe; risk of maternal hemorrhage at delivery, but does not cause fetal bleeding.
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Lactation

Heparin is considered safe for use during breastfeeding (Lactation Risk Category L1). It is a large molecule and is not excreted into breast milk in clinically significant amounts, and it is not orally absorbed by the infant.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring of aPTT. Neonates and infants may require higher doses per kg due to higher antithrombin levels and faster clearance. Increased risk of bleeding, especially in very low birth weight infants. Close monitoring for bleeding and HIT is essential.

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Geriatric Use

Elderly patients (โ‰ฅ65 years) may have an increased risk of bleeding compared to younger adults, even at standard doses. This may be due to age-related changes in renal function, hepatic function, or increased fragility of blood vessels. Close monitoring of aPTT, platelet count, and signs of bleeding is crucial. Lower initial doses or more conservative dosing may be considered.

Clinical Information

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Clinical Pearls

  • Heparin has a narrow therapeutic window, requiring careful monitoring of aPTT for therapeutic efficacy and safety.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication characterized by a significant drop in platelet count (typically >50% from baseline) and a paradoxical increase in thrombotic risk. It usually occurs 5-10 days after heparin initiation. If suspected, discontinue heparin immediately and initiate an alternative non-heparin anticoagulant.
  • Protamine sulfate is the specific antidote for heparin overdose, effectively neutralizing its anticoagulant effects.
  • Heparin clearance is non-linear and dose-dependent; higher doses lead to disproportionately longer half-lives.
  • Subcutaneous heparin is used for prophylaxis, while intravenous heparin is used for therapeutic anticoagulation.
  • Heparin is safe in patients with renal impairment, unlike many LMWHs, as its primary clearance is non-renal.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): For DVT/PE prophylaxis and treatment, ACS.
  • Fondaparinux: For DVT/PE prophylaxis and treatment.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): For DVT/PE treatment and prevention of recurrence, stroke prevention in atrial fibrillation.
  • Warfarin: For long-term anticoagulation.
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Cost & Coverage

Average Cost: Low to moderate per 5ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the best disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.