Heparin Sod 1000u/ml Inj, 10ml

Manufacturer FRESENIUS KABI Active Ingredient Heparin(HEP a rin) Pronunciation HEP-uh-rin
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
Not available
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 given by injection, either into a vein or under the skin. It's used for conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), or during certain medical procedures to keep blood flowing 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, 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

  • Report any signs of unusual bleeding or bruising immediately to your doctor or nurse.
  • Avoid activities that carry a high risk of injury or falls.
  • Inform all healthcare providers (including dentists) that you are taking heparin.
  • Do not take over-the-counter pain relievers like aspirin or ibuprofen without consulting your doctor, as they can increase bleeding risk.
  • Avoid alcohol in excessive amounts, as it can also increase bleeding risk.

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.

Condition-Specific Dosing:

VTE Treatment (initial): 80 units/kg IV bolus, then 18 units/kg/hr IV infusion
VTE Prophylaxis: 5000 units SC every 8-12 hours
Acute Coronary Syndromes: 60 units/kg IV bolus (max 4000 units), then 12 units/kg/hr IV infusion (max 1000 units/hr)
Arterial Line Flush: 10-100 units/mL solution for flushing
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Pediatric Dosing

Neonatal: VTE Treatment: Initial bolus 75 units/kg IV, then 28 units/kg/hr IV infusion (infants <1 year). VTE Prophylaxis: Not routinely recommended.
Infant: VTE Treatment: Initial bolus 75 units/kg IV, then 28 units/kg/hr IV infusion (infants <1 year).
Child: VTE Treatment: Initial bolus 75 units/kg IV, then 20 units/kg/hr IV infusion (children >1 year).
Adolescent: VTE Treatment: Initial bolus 75 units/kg IV, then 20 units/kg/hr IV infusion (children >1 year).
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: No specific dose adjustment required, but monitor closely; increased risk of accumulation and bleeding.
Severe: No specific dose adjustment required, but monitor closely; increased risk of accumulation and bleeding. Consider lower initial doses or use of anti-Xa monitoring.
Dialysis: Heparin is not significantly removed by hemodialysis. Monitor closely for bleeding. Dosing for anticoagulation during dialysis is specific to the procedure.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required, but monitor closely due to potential for impaired synthesis of clotting factors and increased bleeding risk.
Severe: No specific dose adjustment required, but monitor closely due to potential for impaired synthesis of clotting factors and increased bleeding risk.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin III (ATIII), a plasma protein that inactivates several coagulation factors, especially thrombin (Factor IIa) and Factor Xa. This binding causes a conformational change in ATIII, greatly accelerating its inhibitory action (by 1000-fold or more). By inactivating thrombin, heparin prevents the conversion of fibrinogen to fibrin, and by inactivating Factor Xa, it prevents the formation of thrombin.
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed orally. IV: 100%. SC: Variable (approx. 20-30% for therapeutic doses), dose-dependent.
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.06 L/kg (low, primarily confined to plasma volume)
ProteinBinding: Highly variable (up to 95%), binds to various plasma proteins, endothelial cells, and macrophages, which contributes to its unpredictable dose-response.
CnssPenetration: Limited

Elimination:

HalfLife: Dose-dependent. Typically 1-2.5 hours for therapeutic doses (e.g., 25-100 units/kg). Longer with higher doses due to saturable clearance mechanisms.
Clearance: Complex, involves both saturable (cellular uptake and degradation) and non-saturable (renal excretion of smaller fragments) mechanisms.
ExcretionRoute: Renal (small amounts of unchanged drug and metabolites)
Unchanged: Less than 5% (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

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. Factors that can increase the risk of developing these hematomas include: use of indwelling epidural catheters, concomitant use of other drugs that affect 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
+ Balance problems
+ 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 have any side effects that bother you or persist, contact your doctor for advice.

Please note that this list is not exhaustive. 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, heavy menstrual bleeding)
  • Excessive bruising or large bruises that appear without injury
  • Severe headache or dizziness
  • Unusual weakness or fatigue
  • Red or dark brown urine
  • Black or tarry stools
  • Severe pain or swelling in a joint or muscle
  • Any new numbness, tingling, or weakness, especially in the legs (if receiving spinal/epidural anesthesia)
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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, as this may be relevant to your treatment.
* 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with 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 using 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.

Be aware that severe and potentially life-threatening bleeding complications have been 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 result in other serious complications, and may occur up to several weeks after discontinuing the medication. If you have any concerns or questions, consult your doctor. It is crucial to undergo regular blood tests as directed by your doctor.

This medication may interfere with certain laboratory tests. Therefore, it is vital to notify 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 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. Consult your doctor to determine if this product contains benzyl alcohol and to discuss potential risks.

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., epistaxis, hematuria, melena, ecchymoses, petechiae, surgical site bleeding)
  • Hypotension
  • Tachycardia
  • Signs of internal hemorrhage (e.g., abdominal pain, headache, altered mental status)

What to Do:

Discontinue heparin. For severe bleeding, protamine sulfate is the antidote. The dose of protamine sulfate depends on the amount of heparin administered and the time since administration. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Other anticoagulants (e.g., warfarin, direct oral anticoagulants)
  • Antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Thrombolytic agents (e.g., alteplase, tenecteplase)
  • Dextran
  • Nitroglycerin (may decrease heparin effect)
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Moderate Interactions

  • Cephalosporins (some, e.g., cefoperazone, cefotetan, cefazolin - may increase bleeding risk)
  • Penicillins (high dose, may inhibit platelet function)
  • Probenecid (may increase heparin levels)
  • Quinine/Quinidine (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, though not used for initial dosing decisions.

Timing: Prior to initiation of therapy

Renal Function (SCr, BUN)

Rationale: Heparin clearance can be affected by renal function, and renal impairment increases bleeding risk.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, as severe hepatic impairment can affect clotting 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/dose change until therapeutic range achieved, then daily.

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

Action Threshold: Adjust infusion rate based on institutional nomogram to maintain target range.

Anti-Factor Xa (Anti-Xa) Assay

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

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

Action Threshold: Adjust infusion rate based on institutional nomogram to maintain target range.

Platelet Count

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

Target: Maintain above 100,000/mm³ or above 50% of baseline.

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

Hemoglobin/Hematocrit

Frequency: Daily or as clinically indicated.

Target: Stable

Action Threshold: Significant drop may indicate bleeding; investigate and manage.

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Symptom Monitoring

  • Unusual bleeding (e.g., nosebleeds, gum bleeding, bruising, blood in urine/stools)
  • Excessive bruising or petechiae
  • Headache, dizziness, weakness (signs of internal bleeding)
  • Pain, swelling, or discomfort at injection sites
  • Signs of allergic reaction (rash, itching, hives, difficulty breathing)
  • New or worsening pain/swelling in limbs (may indicate thrombosis despite therapy or HIT with thrombosis)

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, close monitoring is essential due to physiological changes in pregnancy that can affect heparin pharmacokinetics and increased risk of bleeding.

Trimester-Specific Risks:

First Trimester: Low risk of teratogenicity. Risk of bleeding.
Second Trimester: Risk of bleeding, particularly at delivery. Osteoporosis risk with prolonged use.
Third Trimester: Increased risk of bleeding during labor and delivery. Consider discontinuing prior to planned delivery or neuraxial anesthesia.
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Lactation

Heparin is considered safe during breastfeeding as 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
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring (aPTT or anti-Xa). Neonates and infants may require higher doses per kg due to higher antithrombin levels and faster clearance. Increased risk of bleeding, especially in neonates. Use preservative-free formulations in neonates to avoid benzyl alcohol toxicity.

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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 initial doses or more conservative dosing strategies may be considered. Close monitoring of aPTT/anti-Xa and bleeding signs is crucial.

Clinical Information

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Clinical Pearls

  • Heparin is highly acidic and can bind to basic proteins, leading to unpredictable effects. Dosing should always be based on a weight-based nomogram and adjusted based on aPTT or anti-Xa levels.
  • Heparin-induced thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts regularly (every 2-3 days from day 4-14 or until discontinued). If HIT is suspected, discontinue heparin immediately and initiate an alternative anticoagulant.
  • Protamine sulfate is the antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin. Administer slowly to avoid hypotension.
  • Heparin flush solutions (e.g., 10 units/mL, 100 units/mL) are used to maintain catheter patency and are distinct from therapeutic anticoagulation doses.
  • Avoid intramuscular (IM) injections in patients receiving heparin due to risk of hematoma formation.
  • Heparin resistance can occur due to antithrombin III deficiency, acute phase reactants, or high levels of Factor VIII. Consider anti-Xa monitoring in these cases.
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Alternative Therapies

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

Average Cost: Highly variable 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 for further evaluation and 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. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs; your pharmacist can provide information on these programs. Some medications may come with an additional patient information leaflet; consult your pharmacist if you have questions. If you have any concerns or questions 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 emergency medical attention. Be prepared to provide information on the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.