Heparin Sod 1000u/ml Inj, 2ml

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
Indirect thrombin inhibitor; Antithrombin III potentiator
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Pregnancy Category
Category C
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. 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. 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.
  • Report any signs of unusual bleeding or bruising immediately to your healthcare provider.
  • 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, or naproxen, unless approved by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication (e.g., prophylaxis, treatment of VTE, acute coronary syndromes). Typically administered by continuous IV infusion or subcutaneous injection.

Condition-Specific Dosing:

VTE_Prophylaxis_SC: 5000 units SC every 8-12 hours
VTE_Treatment_IV_Bolus: 80 units/kg IV bolus, then 18 units/kg/hour continuous IV infusion (adjusted to aPTT)
VTE_Treatment_IV_Fixed: 5000 units IV bolus, then 1000 units/hour continuous IV infusion (adjusted to aPTT)
Acute_Coronary_Syndromes: 60 units/kg IV bolus (max 4000 units), then 12 units/kg/hour continuous IV infusion (max 1000 units/hour), adjusted to aPTT
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Pediatric Dosing

Neonatal: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 28 units/kg/hour continuous IV infusion. Adjust to target aPTT.
Infant: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 28 units/kg/hour continuous IV infusion. Adjust to target aPTT.
Child: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 20 units/kg/hour continuous IV infusion. Adjust to target aPTT.
Adolescent: Initial: 75 units/kg IV bolus over 10 minutes. Maintenance: 20 units/kg/hour continuous IV infusion. Adjust to target aPTT.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor closely for bleeding.
Moderate: No specific dose adjustment required, but monitor closely for bleeding. Heparin clearance may be slightly prolonged.
Severe: No specific dose adjustment required, but monitor closely for bleeding. Heparin clearance may be prolonged, increasing risk of accumulation and bleeding.
Dialysis: Use with caution. Heparin is not significantly removed by hemodialysis. Monitor aPTT/anti-Xa levels closely.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor closely for bleeding.
Moderate: No specific dose adjustment required, but monitor closely for bleeding. Heparin clearance may be reduced, increasing risk of accumulation and bleeding.
Severe: Use with caution. Heparin clearance may be significantly reduced. Increased risk of bleeding due to both impaired clearance and potential coagulopathy from liver disease. Monitor aPTT/anti-Xa levels closely.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin (AT), a plasma protein that inactivates thrombin (Factor IIa) and Factor Xa. This binding causes a conformational change in AT, accelerating its inhibitory action by approximately 1000-fold. The heparin-AT complex then inactivates thrombin and Factor Xa, preventing the conversion of fibrinogen to fibrin and the activation of platelets, thereby inhibiting clot formation.
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed orally. IV: 100%. SC: Variable (approx. 20-70%) due to saturable binding to endothelial cells and macrophages.
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: Approximately 0.06 L/kg (similar to plasma volume).
ProteinBinding: Highly protein bound (variable, 30-90%) to various plasma proteins (e.g., platelet factor 4, vitronectin, fibronectin) and endothelial cells, which contributes to its variable anticoagulant response.
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent. Typically 1-2.5 hours for therapeutic doses (e.g., 1.5 hours for 100 units/kg IV bolus). Longer at higher doses due to saturable clearance.
Clearance: Saturable, non-linear clearance.
ExcretionRoute: Renal excretion of inactive metabolites and small amounts of unchanged drug (especially at higher doses).
Unchanged: Less than 5% (at therapeutic doses).
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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 (dose-dependent).

Safety & Warnings

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BLACK BOX WARNING

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 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 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 (e.g., nosebleeds, bleeding gums, blood in urine or stools, black/tarry stools, heavy menstrual bleeding)
  • Excessive bruising or large bruises that appear without injury
  • Severe headache, sudden weakness or numbness, vision changes (possible signs of internal bleeding)
  • Dizziness or feeling faint
  • Unusual pain or swelling in joints or abdomen
  • Sudden shortness of breath or chest pain (may indicate new clot formation or bleeding into lungs)
  • Any new rash or skin lesions, especially painful ones
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 in conjunction with your other treatments 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 using this drug, 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.

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 cause blood clots, also referred to as heparin-induced thrombocytopenia and thrombosis (HITTS). Both HIT and HITTS can be fatal or result in 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 vital to undergo blood tests as directed by your doctor and to consult with your doctor about any concerns.

This drug may interfere with certain laboratory tests, so it's essential to inform all your healthcare providers and laboratory personnel that you are taking this medication.

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 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 concerned about this, consult your doctor to determine if the product contains benzyl alcohol.

If you are pregnant, planning to become pregnant, or 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., hematuria, melena, epistaxis, ecchymoses, petechiae)
  • Hypotension
  • Tachycardia
  • Shock

What to Do:

Immediately discontinue heparin. For severe bleeding, protamine sulfate is the specific antidote, which neutralizes heparin's anticoagulant effect. The dose of protamine sulfate depends on the amount of heparin administered and the time since administration. Blood transfusions or other supportive measures may be necessary. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Other anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, LMWHs): Increased risk of bleeding.
  • Antiplatelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor, NSAIDs): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, reteplase, tenecteplase): Increased risk of bleeding.
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Moderate Interactions

  • Nitroglycerin (IV): May cause a decrease in heparin's anticoagulant effect (monitor aPTT closely).
  • Cephalosporins (certain, e.g., cefoperazone, cefotetan): May increase bleeding risk due to hypoprothrombinemia.
  • 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 hemoglobin/hematocrit before initiating therapy, and to monitor for bleeding and heparin-induced thrombocytopenia (HIT).

Timing: Prior to initiation of therapy.

Activated Partial Thromboplastin Time (aPTT)

Rationale: To establish baseline coagulation status. While not used for dose adjustment at baseline, it's important for comparison.

Timing: Prior to initiation of therapy.

Renal and Hepatic Function Tests

Rationale: To assess baseline organ function, as severe impairment may affect heparin clearance and increase bleeding risk.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 4-6 hours after initiation or dose change, then daily once stable (for IV infusion). Not typically monitored for SC prophylaxis.

Target: Typically 1.5-2.5 times the control value (or specific therapeutic range based on institutional protocol, often corresponding to an anti-Xa level of 0.3-0.7 units/mL).

Action Threshold: Adjust infusion rate to maintain target range. If above range, hold infusion and recheck. If below range, consider bolus and increase infusion rate.

Anti-Factor Xa (Anti-Xa) Assay

Frequency: May be used instead of or in conjunction with aPTT, especially in patients with lupus anticoagulant or other conditions affecting aPTT. Frequency similar to aPTT.

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

Action Threshold: Adjust infusion rate to maintain target range.

Platelet Count

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

Target: Maintain above 100,000/mm³ or no more than 50% drop from baseline.

Action Threshold: If platelet count drops by >50% from baseline or below 100,000/mm³, suspect HIT and discontinue heparin immediately, initiate alternative anticoagulant.

Hemoglobin and Hematocrit

Frequency: Daily or as clinically indicated.

Target: Stable.

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, 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)
  • Severe headache or changes in vision (may indicate intracranial bleeding)
  • Unusual pain or swelling (e.g., joint pain, abdominal pain)
  • Dizziness or weakness (signs of blood loss)
  • Rash or skin lesions (may indicate HIT or other hypersensitivity reactions)

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 teratogenicity. However, it carries risks for the mother, including bleeding and heparin-induced osteoporosis.

Trimester-Specific Risks:

First Trimester: Low risk to fetus. Maternal risk of bleeding.
Second Trimester: Low risk to fetus. Maternal risk of bleeding and osteoporosis.
Third Trimester: Low risk to fetus. Maternal risk of bleeding (especially peripartum) and osteoporosis. Consider discontinuing prior to labor if possible, or managing with regional anesthesia considerations.
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Lactation

Heparin is considered safe for use during breastfeeding. It is a large molecule and is not excreted into breast milk in clinically significant amounts. It is also not orally absorbed by the infant.

Infant Risk: Low risk (L3 - Moderately safe, but generally considered safe due to lack of oral absorption and large molecular weight).
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring of aPTT or anti-Xa levels due to variability in response and higher clearance rates in younger children compared to adults. Neonates and infants may require higher doses per kg. Increased risk of bleeding, especially in neonates.

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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 starting doses or more conservative dosing strategies may be appropriate. Close monitoring for bleeding is essential.

Clinical Information

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Clinical Pearls

  • Heparin has a highly variable dose-response relationship due to its binding to various plasma proteins and cells. Therefore, individualized dosing and close monitoring (aPTT or anti-Xa) are crucial.
  • Heparin-induced thrombocytopenia (HIT) is a serious, immune-mediated complication that can lead to paradoxical thrombosis. Monitor platelet counts regularly (every 2-3 days from day 4 to 14 or until discontinued). If HIT is suspected, discontinue heparin immediately and initiate a non-heparin anticoagulant.
  • Protamine sulfate is the antidote for heparin overdose. The dose is calculated based on the amount of heparin given and the time elapsed.
  • Heparin is the preferred anticoagulant for patients with severe renal impairment or those on dialysis, as it is primarily metabolized and does not accumulate significantly in renal failure (unlike LMWHs or DOACs).
  • Subcutaneous heparin for prophylaxis should not be rubbed after injection, as this can increase bruising and alter absorption.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): For VTE prophylaxis and treatment, and certain ACS indications. Offer more predictable pharmacokinetics and do not require routine monitoring.
  • Fondaparinux: Synthetic pentasaccharide, selective Factor Xa inhibitor. Used for VTE prophylaxis and treatment.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for VTE treatment and prevention in non-valvular AF. Not typically used in acute, critical care settings where rapid onset/offset is needed.
  • Warfarin: Oral vitamin K antagonist, used for long-term anticoagulation.
  • Direct Thrombin Inhibitors (e.g., argatroban, bivalirudin, dabigatran): Used in specific situations, such as HIT (argatroban, bivalirudin) or non-valvular AF (dabigatran).
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Cost & Coverage

Average Cost: Price varies widely by manufacturer, concentration, and quantity. Typically inexpensive. per vial/mL
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. 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. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional 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.