Heparin Sod 1000u/ml Inj, 1ml

Manufacturer FRESENIUS KABI 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
Antithrombin III activator
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Pregnancy Category
Category C
FDA Approved
Jun 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 in your blood vessels. It's often given by injection, either into a vein or under the skin. It works by thinning your blood, which helps blood flow more smoothly.
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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.

What to Do If You Miss 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 could 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.
  • Report any signs of unusual bleeding or bruising immediately.
  • Do not take over-the-counter pain relievers like aspirin or NSAIDs (e.g., ibuprofen, naproxen) without consulting your doctor, as they can increase bleeding risk.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For DVT/PE treatment: Initial bolus 80 units/kg IV, then continuous infusion 18 units/kg/hour IV. For prophylaxis: 5000 units SC every 8-12 hours.
Dose Range: 5000 - 40000 mg

Condition-Specific Dosing:

DVT_PE_Treatment: Initial bolus 80 units/kg IV, then continuous infusion 18 units/kg/hour IV, adjusted to target aPTT or anti-Xa.
DVT_PE_Prophylaxis: 5000 units SC every 8-12 hours.
Acute_Coronary_Syndrome: Initial bolus 60 units/kg (max 4000 units) IV, then continuous infusion 12 units/kg/hour (max 1000 units/hour) IV, adjusted to target aPTT or anti-Xa.
Cardiopulmonary_Bypass: Initial bolus 300-400 units/kg IV, adjusted to achieve ACT > 480 seconds.
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Pediatric Dosing

Neonatal: Initial bolus 75 units/kg IV, then continuous infusion 28 units/kg/hour IV. Adjust to target aPTT or anti-Xa.
Infant: Initial bolus 75 units/kg IV, then continuous infusion 28 units/kg/hour IV. Adjust to target aPTT or anti-Xa.
Child: Initial bolus 75 units/kg IV, then continuous infusion 20 units/kg/hour IV. Adjust to target aPTT or anti-Xa.
Adolescent: Initial bolus 75 units/kg IV, then continuous infusion 20 units/kg/hour IV. Adjust to target aPTT or anti-Xa.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor closely.
Moderate: No specific adjustment recommended, but monitor closely.
Severe: No specific adjustment recommended, but monitor closely. Heparin is primarily cleared by the reticuloendothelial system, not renal excretion. However, patients with severe renal impairment may have altered heparin sensitivity or increased bleeding risk.
Dialysis: No specific adjustment recommended for therapeutic dosing. For dialysis circuit anticoagulation, adjust dose based on local protocol and monitoring (e.g., ACT).

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor closely.
Moderate: No specific adjustment recommended, but monitor closely. Patients with severe hepatic impairment may have altered coagulation factors and increased bleeding risk, requiring careful monitoring.
Severe: No specific adjustment recommended, but monitor closely. Patients with severe hepatic impairment may have altered coagulation factors and increased bleeding risk, requiring careful monitoring.

Pharmacology

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Mechanism of Action

Heparin is an indirect anticoagulant that binds to antithrombin III (ATIII), causing a conformational change that greatly accelerates the rate at which ATIII inactivates coagulation enzymes, particularly thrombin (Factor IIa) and Factor Xa. It also inactivates Factors IXa, XIa, XIIa, and plasmin. The inhibition of thrombin prevents the conversion of fibrinogen to fibrin, and the inhibition of Factor Xa prevents the formation of thrombin.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV/SC administration). SC bioavailability is approximately 30% (variable).
Tmax: Not applicable (IV). For SC, 2-4 hours.
FoodEffect: Not applicable

Distribution:

Vd: 0.06 L/kg (low, primarily confined to plasma volume)
ProteinBinding: Highly protein bound (to various plasma proteins, including platelet factor 4, fibronectin, von Willebrand factor, and lipoproteins), which contributes to its variable anticoagulant response.
CnssPenetration: Limited

Elimination:

HalfLife: Dose-dependent; typically 1-2 hours for therapeutic doses (e.g., 100 units/kg IV). Increases with higher doses.
Clearance: Saturable, non-linear clearance (zero-order at higher doses, first-order at lower doses).
ExcretionRoute: Renal excretion of small amounts of unchanged drug and depolymerized fragments.
Unchanged: < 5%
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Pharmacodynamics

OnsetOfAction: Immediate (IV), 20-60 minutes (SC)
PeakEffect: Minutes (IV), 2-4 hours (SC)
DurationOfAction: 2-6 hours (IV, dose-dependent), 8-12 hours (SC, 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 (LMWH) 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. Factors that can increase the risk of developing these hematomas include: use of indwelling epidural catheters, concomitant use of other drugs affecting hemostasis (e.g., NSAIDs, platelet inhibitors, other anticoagulants), traumatic or repeated epidural or spinal puncture, and a history of spinal deformity or spinal surgery. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
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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 immediately or seek emergency 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

Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you encounter 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:

  • Any unusual bleeding (e.g., nosebleeds, bleeding gums, blood in urine or stool, heavy menstrual bleeding)
  • Excessive bruising or purple spots on the skin
  • Severe headache or dizziness
  • Unusual weakness or fatigue
  • Red or dark brown urine
  • Black, tarry, or bloody stools
  • Severe pain or swelling in a joint or muscle
  • Sudden shortness of breath or chest pain
  • Signs of allergic reaction: rash, itching, hives, swelling of face/lips/tongue, difficulty breathing
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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 existing health conditions and other drugs. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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. To minimize the risk of injury, exercise caution and take preventive measures such as using a soft toothbrush and an electric razor.

This medication can cause severe and potentially life-threatening bleeding problems. Additionally, it may lead to a condition known as heparin-induced thrombocytopenia (HIT), which can progress to heparin-induced thrombocytopenia and thrombosis (HITTS). Both HIT and HITTS can be fatal or result in other serious 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 concerns 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 medication.

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. If possible, avoid using products with benzyl alcohol in these age groups. Consult your doctor to determine if the product contains benzyl alcohol.

If you are pregnant, planning to become pregnant, or 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., nosebleeds, gum bleeding, hematuria, melena, ecchymoses, petechiae)
  • Hypotension (low blood pressure)
  • Tachycardia (rapid heart rate)
  • Shock

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. The antidote for heparin overdose is protamine sulfate, which neutralizes heparin's anticoagulant effect. Dosage of protamine sulfate depends on the amount of heparin administered and the time elapsed since administration. Supportive care (e.g., blood transfusions) may also be necessary.

Drug Interactions

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Major Interactions

  • Other anticoagulants (e.g., warfarin, direct oral anticoagulants, LMWH): Increased risk of bleeding.
  • Antiplatelet agents (e.g., aspirin, clopidogrel, NSAIDs): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, reteplase): Increased risk of bleeding.
  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT).
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Moderate Interactions

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

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with Platelets

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

Timing: Prior to initiation

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline coagulation status, though not used for dose adjustment at baseline.

Timing: Prior to initiation

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

Rationale: To assess baseline coagulation status, especially if transitioning from or to warfarin.

Timing: Prior to initiation

Renal and Hepatic Function Tests (BUN, Creatinine, LFTs)

Rationale: To assess organ function, as severe impairment may alter bleeding risk or drug sensitivity.

Timing: Prior to initiation

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 4-6 hours after initiation or dose change until therapeutic, then daily.

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

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

Anti-Factor Xa (Anti-Xa) Assay

Frequency: Alternative to aPTT, especially in conditions affecting aPTT (e.g., lupus anticoagulant). Every 4-6 hours after initiation or dose change until therapeutic, then daily.

Target: 0.3-0.7 units/mL for therapeutic anticoagulation.

Action Threshold: Adjust infusion rate based on anti-Xa results according to institutional nomogram.

Platelet Count

Frequency: Every 2-3 days from day 4 to day 14 of therapy, or until heparin is discontinued.

Target: >100,000/mm³ or no significant drop from baseline.

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

Signs and Symptoms of Bleeding

Frequency: Continuously

Target: Absence of new or worsening bleeding.

Action Threshold: Any signs of bleeding (e.g., hematuria, melena, epistaxis, bruising, significant drop in Hgb/Hct) require immediate assessment and potential dose reduction or discontinuation.

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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)
  • Headache, dizziness, or weakness (may indicate internal bleeding)
  • Severe pain or swelling at injection sites (for SC administration)
  • Signs of allergic reaction (rash, itching, hives, swelling, difficulty breathing)
  • Signs of Heparin-Induced Thrombocytopenia (HIT) such as new or worsening thrombosis, skin lesions at injection sites, or acute systemic reactions after heparin administration.

Special Patient Groups

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Pregnancy

Heparin is generally considered the anticoagulant of choice during pregnancy when anticoagulation is required, as it does not cross the placenta and therefore does not cause fetal anticoagulation or teratogenicity. However, it is classified as Pregnancy Category C due to potential maternal risks (e.g., osteoporosis, thrombocytopenia, bleeding).

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. Maternal bleeding risk, especially around delivery. Consider discontinuation prior to labor/delivery if possible, or use regional anesthesia with caution due to spinal hematoma risk.
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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) - No known risk to the infant.
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring due to higher heparin requirements per kg and increased variability in response compared to adults. Neonates and infants may require higher doses per kg due to higher antithrombin levels and faster clearance. Close monitoring of aPTT or anti-Xa levels is crucial.

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Geriatric Use

No specific dose adjustment is typically required based on age alone. However, elderly patients may be more susceptible to bleeding complications due to age-related physiological changes (e.g., decreased renal function, increased capillary fragility, polypharmacy). Close monitoring of anticoagulant effect and bleeding is essential.

Clinical Information

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Clinical Pearls

  • Heparin is highly variable in its anticoagulant effect due to binding to plasma proteins and cells; therefore, close laboratory monitoring (aPTT or anti-Xa) is essential for therapeutic dosing.
  • The primary serious adverse effect is bleeding. Protamine sulfate is the specific antidote.
  • Heparin-induced thrombocytopenia (HIT) is a serious, immune-mediated complication that can lead to paradoxical thrombosis. Monitor platelet counts regularly.
  • For subcutaneous administration, inject into the abdominal wall, thigh, or upper arm, rotating sites. Do not rub the injection site.
  • Heparin can cause hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing diuretics or ACE inhibitors.
  • Heparin is generally preferred over warfarin for anticoagulation during pregnancy due to its inability to cross the placenta.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWH) (e.g., enoxaparin, dalteparin): Often preferred for prophylaxis and outpatient treatment due to more predictable pharmacokinetics and less frequent monitoring.
  • Fondaparinux: Synthetic pentasaccharide, selective Factor Xa inhibitor.
  • Direct Thrombin Inhibitors (DTIs) (e.g., dabigatran, argatroban, bivalirudin): Used for specific indications, including HIT.
  • Direct Oral Anticoagulants (DOACs) (e.g., rivaroxaban, apixaban, edoxaban, dabigatran): Used for DVT/PE treatment and prevention, stroke prevention in AFib.
  • Warfarin: Oral vitamin K antagonist, used for long-term anticoagulation.
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Cost & Coverage

Average Cost: Varies widely by concentration, volume, and supplier. Typically low cost for generic. per 1ml 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 your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.

Additionally, some medications may come with a separate 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 reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.

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 was taken, to ensure prompt and effective treatment.