Heparin Sod 1000u/ml Inj,30ml

Manufacturer FRESENIUS KABI USA 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 (via Antithrombin III)
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Pregnancy Category
C
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. It's often called a 'blood thinner,' but it doesn't actually thin your blood; it makes it harder for your blood to clot. It's given by injection, either into a vein or under the skin.
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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. They will advise you on what to do 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.
  • Avoid over-the-counter medications, especially NSAIDs (like ibuprofen, naproxen) and aspirin, without consulting your doctor, as they can increase bleeding risk.
  • Limit alcohol intake, as it can increase bleeding risk.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and route. For DVT/PE prophylaxis: 5,000 units subcutaneously every 8 to 12 hours. For DVT/PE treatment (initial bolus + continuous infusion): 80 units/kg IV bolus, then 18 units/kg/hour IV infusion, adjusted to maintain aPTT 1.5-2.5 times control.

Condition-Specific Dosing:

DVT/PE Prophylaxis: 5,000 units SC q8-12h
DVT/PE Treatment (initial): 80 units/kg IV bolus
DVT/PE Treatment (maintenance): 18 units/kg/hour IV infusion (adjust to aPTT)
Acute Coronary Syndromes (ACS): 60 units/kg IV bolus (max 4000 units), then 12 units/kg/hour IV infusion (max 1000 units/hr)
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Pediatric Dosing

Neonatal: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 28 units/kg/hour IV infusion. Adjust to maintain aPTT 60-85 seconds.
Infant: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 20 units/kg/hour IV infusion. Adjust to maintain aPTT 60-85 seconds.
Child: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 20 units/kg/hour IV infusion. Adjust to maintain aPTT 60-85 seconds.
Adolescent: Dosing similar to adult, but often weight-based. Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 20 units/kg/hour IV infusion. Adjust to maintain aPTT 60-85 seconds.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but close monitoring of aPTT is recommended due to potential for slightly prolonged half-life of smaller fragments.
Moderate: No specific dose adjustment, but close monitoring of aPTT is recommended due to potential for slightly prolonged half-life of smaller fragments.
Severe: No specific dose adjustment, but close monitoring of aPTT is recommended due to potential for slightly prolonged half-life of smaller fragments. Increased risk of bleeding.
Dialysis: No specific dose adjustment for systemic anticoagulation, but close monitoring of aPTT is essential. Heparin is often used for anticoagulation during dialysis procedures.

Hepatic Impairment:

Mild: No specific dose adjustment.
Moderate: No specific dose adjustment, but close monitoring of aPTT is recommended. Hepatic impairment may affect antithrombin III levels, potentially altering response to heparin.
Severe: No specific dose adjustment, but close monitoring of aPTT is recommended. Hepatic impairment may affect antithrombin III levels, potentially altering response to heparin. Increased risk of bleeding due to impaired clotting factor synthesis.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin (ATIII), a plasma protein, causing a conformational change that greatly accelerates ATIII's 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: Variable (20-70% for subcutaneous administration due to protein binding and enzymatic degradation at injection site). 100% for IV.
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: Low (0.07 L/kg), primarily confined to the vascular space. Highly protein bound to various plasma proteins (e.g., platelet factor 4, fibronectin, von Willebrand factor) and endothelial cells.
ProteinBinding: High (variable, non-specific binding to plasma proteins and endothelial cells).
CnssPenetration: Limited

Elimination:

HalfLife: Dose-dependent and non-linear. Approximately 1-2 hours for therapeutic doses (e.g., 100 units/kg IV bolus). Longer with higher doses.
Clearance: Non-linear, saturable clearance mechanism involving cellular uptake and degradation.
ExcretionRoute: Mainly via reticuloendothelial system; small amounts of unchanged drug and metabolites excreted renally.
Unchanged: <50% (dose-dependent)
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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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BLACK BOX WARNING

Fatal medication errors have occurred due to confusion of Heparin Sodium Injection, 10,000 units/mL (1000 units/mL) with Heparin Lock Flush Solution (10 units/mL or 100 units/mL). Ensure correct concentration is chosen and administered.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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 application
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 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 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:

  • Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, blood in urine or stools, black/tarry stools, excessive bruising)
  • Severe headache or dizziness
  • Unusual weakness or fatigue
  • Red or dark brown urine
  • Vomiting blood or material that looks like coffee grounds
  • Any new or worsening pain, swelling, or discoloration in a limb (could indicate a new clot, even while on heparin, or HIT)
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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.
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. 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 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 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 have your blood work checked as directed by your doctor.

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 comes 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 prone to side effects.

Some products may contain benzyl alcohol, which can cause serious side effects in newborns and infants, especially 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, 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., severe nosebleeds, heavy menstrual bleeding, blood in urine or stools, large bruises, internal bleeding symptoms like severe headache or abdominal pain)

What to Do:

Seek immediate medical attention. The antidote for heparin overdose is protamine sulfate. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Patients with a history of Heparin-Induced Thrombocytopenia (HIT) or Heparin-Induced Thrombocytopenia with Thrombosis (HITT).
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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, NSAIDs): 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

  • Cephalosporins (e.g., cefamandole, cefoperazone, cefotetan): May cause hypoprothrombinemia, increasing bleeding risk.
  • Nitroglycerin (IV): May cause heparin resistance, requiring higher heparin doses.
  • Probenecid: May increase heparin levels.
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Minor Interactions

  • Herbal supplements with anticoagulant/antiplatelet effects (e.g., ginkgo biloba, garlic, ginger, dong quai, feverfew): Potential additive bleeding risk.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with Platelets

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

Timing: Prior to initiation of therapy.

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline clotting time and to guide initial dosing and subsequent adjustments for therapeutic anticoagulation.

Timing: Prior to initiation of therapy.

Renal and Hepatic Function Tests

Rationale: To assess overall patient health and identify conditions that may increase bleeding risk or alter drug metabolism/excretion (though heparin is not primarily renally/hepatically cleared, severe dysfunction can impact overall coagulation).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 6 hours initially until therapeutic range is achieved and stable for 2 consecutive readings; then daily or as clinically indicated.

Target: Typically 1.5 to 2.5 times the control value (or specific therapeutic range based on institutional protocol and reagent sensitivity, e.g., 60-85 seconds).

Action Threshold: Below therapeutic range: Increase heparin dose. Above therapeutic range: Decrease heparin dose or hold temporarily.

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 above 50% of baseline.

Action Threshold: Drop in platelet count by >50% from baseline or absolute count <100,000/mm³ (even if within normal range) should prompt evaluation for HIT and discontinuation of heparin.

Hemoglobin and Hematocrit

Frequency: Daily or as clinically indicated.

Target: Maintain within patient's baseline range.

Action Threshold: Significant drop may indicate bleeding and require intervention.

Signs and Symptoms of Bleeding

Frequency: Continuously

Target: Absence of bleeding.

Action Threshold: Any signs of bleeding (e.g., bruising, petechiae, hematuria, melena, epistaxis, gum bleeding, severe headache, abdominal pain) 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 stools, excessive bruising)
  • Petechiae (small red spots on skin)
  • Signs of internal bleeding (e.g., severe headache, abdominal pain, weakness, dizziness, pallor)
  • Signs of Heparin-Induced Thrombocytopenia (HIT) such as new or worsening thrombosis, skin lesions at injection sites, or a 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 increased risk of bleeding in the mother.

Trimester-Specific Risks:

First Trimester: Low risk to fetus. Maternal bleeding risk.
Second Trimester: Low risk to fetus. Maternal bleeding risk.
Third Trimester: Low risk to fetus. Maternal bleeding risk, especially around delivery. Increased risk of maternal osteoporosis with prolonged use.
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Lactation

Heparin is considered safe for use during breastfeeding. It is a large molecule and does not pass into breast milk in clinically significant amounts.

Infant Risk: Low risk (L1 - safest).
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Pediatric Use

Requires careful weight-based dosing and frequent monitoring of aPTT and platelet counts due to higher clearance rates and potential for increased variability in response compared to adults. Risk of bleeding is present.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Heparin's anticoagulant effect is highly variable among individuals, necessitating close laboratory monitoring (aPTT) and dose titration.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication that can lead to paradoxical thrombosis. Monitor platelet counts closely, especially between days 5-14 of therapy, or earlier if prior heparin exposure.
  • The antidote for heparin overdose is protamine sulfate, which rapidly neutralizes heparin's anticoagulant effect.
  • Heparin has a non-linear dose-response relationship and clearance, meaning small changes in dose can lead to disproportionately large changes in effect.
  • Subcutaneous heparin is used for prophylaxis, while intravenous heparin is used for therapeutic anticoagulation.
  • Ensure correct concentration is used, especially distinguishing between therapeutic concentrations (e.g., 1000 units/mL, 5000 units/mL) and flush concentrations (e.g., 10 units/mL, 100 units/mL) to prevent fatal medication errors.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin)
  • Warfarin (Vitamin K antagonist)
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban)
  • Direct Thrombin Inhibitors (e.g., argatroban, bivalirudin, dabigatran)
  • Factor Xa Inhibitors (e.g., fondaparinux, rivaroxaban, apixaban, edoxaban)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and volume (e.g., $10-$50 for a 30mL vial of 1000 units/mL) per 30mL 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.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct 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, do not hesitate to 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 detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.