Heparin Sod 1000u/ml Inj, 30ml

Manufacturer PFIZER U.S. 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; 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 helps prevent blood clots from forming or growing larger in your body. It works by thinning your blood. It is given as an 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.
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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 an electric razor to minimize bleeding.
  • Inform all healthcare providers, including dentists, that you are taking heparin.
  • Avoid over-the-counter medications that can increase bleeding risk, such as aspirin, ibuprofen, naproxen, or other NSAIDs, unless approved by your doctor.
  • Report any signs of bleeding or unusual bruising immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For VTE treatment: Initial bolus 80 units/kg IV, then 18 units/kg/hr IV infusion. For VTE prophylaxis: 5000 units SC every 8-12 hours.
Dose Range: 5000 - 45000 mg

Condition-Specific Dosing:

VTE Treatment (initial): 80 units/kg IV bolus
VTE Treatment (maintenance): 18 units/kg/hr IV infusion (adjusted to aPTT)
VTE Prophylaxis: 5000 units SC q8-12h
Acute Coronary Syndromes: 60 units/kg IV bolus (max 4000 units), then 12 units/kg/hr IV infusion (max 1000 units/hr)
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Pediatric Dosing

Neonatal: Initial bolus 75 units/kg IV, then 28 units/kg/hr IV infusion (adjust to target anti-Xa or aPTT)
Infant: Initial bolus 75 units/kg IV, then 20 units/kg/hr IV infusion (adjust to target anti-Xa or aPTT)
Child: Initial bolus 75 units/kg IV, then 15 units/kg/hr IV infusion (adjust to target anti-Xa or aPTT)
Adolescent: Dosing similar to adult, adjusted by weight and monitoring
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required; monitor aPTT/anti-Xa closely.
Moderate: No specific dose adjustment required; monitor aPTT/anti-Xa closely.
Severe: No specific dose adjustment required; monitor aPTT/anti-Xa closely due to potential for altered clearance.
Dialysis: No specific dose adjustment required; monitor aPTT/anti-Xa closely. Heparin is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required; monitor aPTT/anti-Xa closely.
Moderate: No specific dose adjustment required; monitor aPTT/anti-Xa closely.
Severe: No specific dose adjustment required; monitor aPTT/anti-Xa closely due to potential for altered clearance and increased bleeding risk.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin III (ATIII), a plasma protein that inactivates thrombin (Factor IIa) and Factor Xa. This binding causes a conformational change in ATIII, greatly accelerating its inhibitory action on these coagulation factors. Heparin also inhibits the activation of Factor IX, Factor XI, and Factor XII, and inhibits the activity of Factor VIIa-tissue factor complex. The overall effect is the prevention of clot formation and growth.
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Pharmacokinetics

Absorption:

Bioavailability: 30% (subcutaneous, highly variable)
Tmax: Not applicable (IV); 2-4 hours (subcutaneous)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.07 L/kg
ProteinBinding: Highly protein bound (to various plasma proteins, including ATIII, fibronectin, lipoproteins, and platelet factor 4)
CnssPenetration: No

Elimination:

HalfLife: 1-2 hours (dose-dependent, increases with higher doses)
Clearance: Complex, saturable, and non-linear (primarily via reticuloendothelial system and renal excretion of depolymerized fragments)
ExcretionRoute: Renal (small amounts of unchanged drug and metabolites)
Unchanged: Less than 5%
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Pharmacodynamics

OnsetOfAction: Immediate (IV); 20-60 minutes (subcutaneous)
PeakEffect: Minutes (IV); 2-4 hours (subcutaneous)
DurationOfAction: 2-6 hours (dose-dependent)

Safety & Warnings

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BLACK BOX WARNING

Spinal/Epidural Hematomas: Epidural or spinal hematomas may occur in patients anticoagulated with heparin or low molecular weight heparins who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
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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 experience no side effects or only mild ones. If you have any side effects that bother you or persist, contact your doctor for guidance.

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 (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 (may indicate internal bleeding)
  • Dizziness or fainting
  • Unusual pain or swelling
  • Red or dark brown urine
  • Black, tarry stools or bright red blood in stools
  • Any new or worsening pain, swelling, or discoloration in your limbs (could indicate a new clot, even while on heparin)
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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 taking this drug, you may experience easier bleeding. To minimize the risk of injury, exercise caution and take preventive measures such as using a soft toothbrush and an electric razor.

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 may occur up to several weeks after discontinuing the medication. If you have any questions or concerns, consult your doctor. It is crucial to undergo blood tests as directed by your doctor and to discuss any findings with them.

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

In the event of 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 contain sulfites.

Individuals over 60 years old should exercise caution when using this medication, 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary 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, ecchymosis, petechiae)
  • Hypotension
  • Tachycardia
  • Shock

What to Do:

Seek immediate medical attention. The antidote for heparin overdose is protamine sulfate. Call 1-800-222-1222 (Poison Control) for advice.

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, ticagrelor, prasugrel): Increased risk of bleeding.
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib): 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

  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT).
  • Digoxin: May decrease digoxin levels.
  • Tetracyclines: May decrease heparin's anticoagulant effect.
  • Antihistamines: May decrease heparin's anticoagulant effect.

Monitoring

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Baseline Monitoring

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline coagulation status before initiating therapy.

Timing: Prior to first dose

Complete Blood Count (CBC) with Platelets

Rationale: To establish baseline hemoglobin, hematocrit, and platelet count; essential for monitoring bleeding and Heparin-Induced Thrombocytopenia (HIT).

Timing: Prior to first dose

Renal and Hepatic Function Tests

Rationale: To assess organ function, although heparin clearance is not primarily renal/hepatic, severe dysfunction may influence overall patient status and bleeding risk.

Timing: Prior to first dose

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 6 hours (for IV infusion) until therapeutic range is achieved, then daily or as clinically indicated.

Target: 1.5-2.5 times control (specific range varies by lab and indication, often 60-85 seconds)

Action Threshold: Adjust infusion rate based on aPTT results according to institutional nomogram.

Anti-Xa Assay

Frequency: Daily or as clinically indicated (especially in patients with unreliable aPTT, e.g., lupus anticoagulant, or in pediatric/renal impairment).

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 during therapy, or more frequently if HIT is suspected.

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

Action Threshold: Discontinue heparin if platelet count drops by >50% from baseline or falls below 100,000/ยตL, and evaluate for HIT.

Hemoglobin and Hematocrit

Frequency: Daily or as clinically indicated.

Target: Normal range

Action Threshold: Significant drop may indicate bleeding; investigate source.

Signs and Symptoms of Bleeding

Frequency: Continuously

Target: Absence of bleeding

Action Threshold: Promptly assess and manage any signs of bleeding (e.g., hematuria, melena, epistaxis, bruising, petechiae, hypotension, tachycardia).

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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)
  • Signs of internal bleeding (e.g., severe headache, dizziness, weakness, abdominal pain, swelling, joint pain)
  • Signs of Heparin-Induced Thrombocytopenia (HIT) such as new or worsening thrombosis, skin lesions at injection sites, or sudden drop in platelet count.

Special Patient Groups

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Pregnancy

Heparin does not cross the placenta and is generally considered the anticoagulant of choice for pregnant women requiring anticoagulation, especially in the first trimester. However, it is classified as Pregnancy Category C due to some animal studies showing adverse effects at high doses, and potential for maternal bleeding or osteoporosis with long-term use.

Trimester-Specific Risks:

First Trimester: Generally preferred over warfarin due to lack of teratogenicity.
Second Trimester: Risk of maternal bleeding and osteoporosis increases with prolonged use.
Third Trimester: Risk of maternal bleeding, especially around delivery. Does not cause fetal anticoagulation.
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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: Minimal to none (L1 - Safest)
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring (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). Close monitoring of aPTT/anti-Xa and signs of bleeding is crucial. Lower starting doses may be considered.

Clinical Information

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Clinical Pearls

  • Heparin is highly variable in its anticoagulant effect; therefore, continuous IV infusions require frequent laboratory monitoring (aPTT or anti-Xa) and dose adjustments based on institutional nomograms.
  • Subcutaneous heparin is typically used for prophylaxis and does not require routine aPTT monitoring, but platelet counts should be monitored for HIT.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication that can lead to paradoxical thrombosis. Monitor platelet counts closely (e.g., every 2-3 days) from day 4 to 14 of therapy, or earlier if prior heparin exposure.
  • Protamine sulfate is the specific antidote for heparin overdose. 1 mg of protamine sulfate neutralizes approximately 100 units of heparin.
  • Avoid intramuscular injections in patients receiving heparin due to the risk of hematoma formation.
  • Heparin is often used as a bridge to warfarin therapy, with heparin continued for at least 5 days and until INR is therapeutic for at least 24 hours.
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Alternative Therapies

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

Average Cost: Varies widely per 30ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 and effective use of your medication, never share your prescription with others, and do not take medication that has been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on the best approach. Additionally, you may want to inquire about potential drug take-back programs in your area, which can offer a safe and environmentally responsible way to dispose of unwanted medications.

It is possible that your medication may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.

In the event of a suspected overdose, it is critical to seek immediate medical attention. Contact your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide as much information as possible about the overdose, including the name of the medication, the amount taken, and the time it was taken. This information will help healthcare professionals provide the most effective treatment and care.