Heparin Sod 5000u/ml Carpuject, 1ml

Manufacturer HOSPIRA 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-dependent anticoagulant
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Pregnancy Category
Not available
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FDA Approved
Jan 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 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, 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 could 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 that can increase bleeding risk, such as aspirin, ibuprofen, naproxen, or other NSAIDs, unless specifically approved by your doctor.
  • Report any signs of bleeding or unusual bruising immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. For DVT/PE treatment: Initial IV bolus 80 units/kg, then continuous IV infusion 18 units/kg/hr. For prophylaxis: SC 5000 units every 8-12 hours.

Condition-Specific Dosing:

DVT/PE Treatment (IV): Initial bolus 80 units/kg, then 18 units/kg/hr continuous infusion. Adjust to maintain aPTT 1.5-2.5 times control or anti-Xa 0.3-0.7 units/mL.
DVT/PE Prophylaxis (SC): 5000 units subcutaneously every 8 to 12 hours.
Acute Coronary Syndromes (IV): Initial bolus 60 units/kg (max 4000 units), then 12 units/kg/hr (max 1000 units/hr) continuous infusion. Adjust to maintain aPTT 1.5-2 times control.
Cardiopulmonary Bypass: Initial bolus 300-400 units/kg, then adjust to maintain ACT >400-480 seconds.
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Pediatric Dosing

Neonatal: Initial IV bolus 75 units/kg, then continuous IV infusion 28 units/kg/hr. Adjust to maintain anti-Xa 0.3-0.7 units/mL or aPTT 60-85 seconds.
Infant: Initial IV bolus 75 units/kg, then continuous IV infusion 28 units/kg/hr. Adjust to maintain anti-Xa 0.3-0.7 units/mL or aPTT 60-85 seconds.
Child: Initial IV bolus 75 units/kg, then continuous IV infusion 20 units/kg/hr. Adjust to maintain anti-Xa 0.3-0.7 units/mL or aPTT 60-85 seconds.
Adolescent: Similar to adult dosing, often weight-based. Initial IV bolus 75 units/kg, then continuous IV infusion 15-20 units/kg/hr. Adjust to maintain anti-Xa 0.3-0.7 units/mL or aPTT 60-85 seconds.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor closely for accumulation and bleeding risk.
Moderate: No specific dose adjustment, but monitor closely for accumulation and bleeding risk. Consider lower initial doses or slower titration.
Severe: No specific dose adjustment, but monitor closely for accumulation and bleeding risk. Consider lower initial doses or slower titration. Heparin clearance may be reduced.
Dialysis: Heparin is not significantly removed by hemodialysis. Use with caution and monitor closely. Dosing for anticoagulation during dialysis is specific to the procedure.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor closely for bleeding risk due to potential coagulopathy.
Moderate: No specific dose adjustment, but monitor closely for bleeding risk due to potential coagulopathy. Heparin clearance may be reduced.
Severe: No specific dose adjustment, but monitor closely for bleeding risk due to potential coagulopathy. Heparin clearance may be significantly reduced. Consider lower doses and frequent monitoring.

Pharmacology

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Mechanism of Action

Heparin is a heterogeneous mixture of glycosaminoglycans that acts as an anticoagulant by binding to antithrombin III (ATIII), a plasma protein. This binding causes a conformational change in ATIII, greatly accelerating its inhibitory action on several activated coagulation factors, particularly thrombin (Factor IIa) and Factor Xa. 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 absorbed orally. IV: 100%. SC: 20-30% (variable).
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: 0.07 L/kg (low, primarily confined to plasma volume)
ProteinBinding: Highly variable (up to 95%), binds to various plasma proteins, endothelial cells, and macrophages, leading to non-linear kinetics.
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent; typically 1-2 hours for therapeutic doses (e.g., 100 units/kg IV). Longer with higher doses due to saturable binding.
Clearance: Non-linear, dose-dependent. Primarily via renal excretion of depolymerized fragments and uptake by reticuloendothelial system.
ExcretionRoute: Renal (metabolites and small amount of unchanged drug)
Unchanged: <5% (renal)
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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

Spinal/Epidural Hematomas: Epidural or spinal hematomas may occur in patients anticoagulated with heparin or low molecular weight heparins (LMWHs) who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. The risk is increased by use of indwelling epidural catheters, concomitant use of other drugs affecting hemostasis (e.g., NSAIDs, antiplatelet agents, other anticoagulants), and traumatic or repeated epidural or spinal puncture. 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

Serious 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 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 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.

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 (e.g., nosebleeds, bleeding gums, blood in urine or stool, heavy menstrual bleeding)
  • Excessive bruising or large bruises that appear without injury
  • Severe headache, dizziness, or weakness
  • Sudden, severe pain or swelling in a joint or limb
  • Red or dark brown urine
  • Black, tarry, or bloody stools
  • Coughing up blood or blood clots
  • Any new or worsening pain, numbness, or tingling, especially in the legs (could indicate spinal hematoma if you had an epidural/spinal procedure)
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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, 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

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, be cautious 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 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 crucial to undergo blood tests as directed by your doctor and to consult with them regularly.

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.

If you experience 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 this product contains benzyl alcohol and to discuss potential risks.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive bleeding (e.g., epistaxis, hematuria, melena, ecchymoses, petechiae)
  • Hypotension (low blood pressure)
  • Tachycardia (rapid heart rate)
  • Signs of shock

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. The antidote for heparin overdose is protamine sulfate, which can reverse its anticoagulant effects. Supportive care may also be necessary.

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, dipyridamole): Increased risk of bleeding.
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, reteplase, tenecteplase): Increased risk of bleeding.
  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT).
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Moderate Interactions

  • Cephalosporins (e.g., cefoperazone, cefotetan): May increase bleeding risk due to vitamin K antagonism.
  • Penicillins (high dose): May inhibit platelet aggregation, increasing bleeding risk.
  • Probenecid: May increase heparin levels.
  • Herbal supplements (e.g., ginkgo biloba, garlic, ginger, dong quai, feverfew): May increase bleeding risk.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with Platelets

Rationale: To establish baseline platelet count and assess for anemia or other hematologic abnormalities before initiating therapy. Essential for monitoring for Heparin-Induced Thrombocytopenia (HIT).

Timing: Prior to initiation of therapy.

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline coagulation status. Used for therapeutic monitoring of unfractionated heparin.

Timing: Prior to initiation of therapy.

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

Rationale: To establish baseline coagulation status, especially if transitioning to warfarin or if underlying liver disease is suspected.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, as impaired renal function can affect heparin clearance and increase bleeding risk.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

Rationale: To assess liver function, as severe hepatic impairment can affect coagulation factor synthesis and increase bleeding risk.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 6 hours after initiation or dose change until therapeutic range is achieved, then at least daily for continuous IV infusion. Not typically used for prophylactic SC heparin.

Target: Typically 1.5-2.5 times the control value (specific range depends on laboratory and clinical protocol).

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

Anti-Factor Xa (Anti-Xa) Assay

Frequency: May be used instead of or in addition to aPTT, especially in specific populations (e.g., pediatrics, renal impairment, obesity) or when aPTT is unreliable. Frequency similar to aPTT.

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

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

Platelet Count

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

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

Action Threshold: A fall in platelet count by >50% from baseline, or a platelet count <100,000/ยตL, especially if associated with new thrombosis, should prompt evaluation for HIT.

Signs and Symptoms of Bleeding

Frequency: Continuously throughout therapy.

Target: Absence of bleeding.

Action Threshold: Any signs of bleeding (e.g., hematuria, melena, epistaxis, bruising, petechiae, 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 stool, excessive bruising)
  • Petechiae (small red spots on skin)
  • Severe headache or changes in vision (may indicate intracranial bleed)
  • Unusual pain or swelling (e.g., joint pain, abdominal pain)
  • Dizziness or weakness (signs of blood loss)
  • Signs of allergic reaction (rash, itching, hives, swelling, difficulty breathing)
  • Signs of Heparin-Induced Thrombocytopenia (HIT): new or worsening thrombosis, skin lesions at injection site, acute systemic reactions after heparin administration.

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 when anticoagulation is required. However, it carries risks of maternal bleeding and osteoporosis. Close monitoring is essential.

Trimester-Specific Risks:

First Trimester: Low risk of teratogenicity. Risk of maternal bleeding.
Second Trimester: Risk of maternal bleeding and potential for heparin-induced osteoporosis with prolonged use.
Third Trimester: Risk of maternal bleeding, especially around delivery. Increased risk of spinal/epidural hematoma if neuraxial anesthesia is used.
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Lactation

Heparin is a large molecule and is not excreted into breast milk in clinically significant amounts. It is generally considered compatible with breastfeeding.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring (often using anti-Xa levels) due to variability in response and higher clearance rates in younger children. Increased risk of bleeding, especially 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). Lower doses or more conservative dosing strategies may be appropriate, with close monitoring of aPTT/anti-Xa and for signs of bleeding.

Clinical Information

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Clinical Pearls

  • Heparin is highly acidic and incompatible with many drugs; always check compatibility before mixing.
  • Subcutaneous injection sites should be rotated to prevent localized irritation and hematoma formation.
  • Do not rub the injection site after subcutaneous administration, as this can increase bruising.
  • Protamine sulfate is the specific antidote for heparin overdose.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication that can lead to thrombosis. Monitor platelet counts closely.
  • For therapeutic anticoagulation, continuous IV infusion is generally preferred over intermittent IV bolus due to more stable drug levels and reduced bleeding risk.
  • Heparin resistance can occur due to low antithrombin III levels or other factors; consider ATIII replacement if resistance is suspected.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): Often preferred for prophylaxis and outpatient treatment due to more predictable pharmacokinetics and less need for monitoring.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for DVT/PE treatment and prevention, stroke prevention in atrial fibrillation.
  • Warfarin (Vitamin K Antagonist): Oral anticoagulant for long-term anticoagulation.
  • Fondaparinux (Synthetic Factor Xa Inhibitor): Used for DVT/PE prophylaxis and treatment.
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Cost & Coverage

Average Cost: Varies widely, typically low for generic per 1ml vial/syringe
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, 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.