Hep Sod/nacl 25000unt Inj, 250ml

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-dependent anticoagulant
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Pregnancy Category
Category C
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 given by injection (into a vein or under the skin) that helps prevent blood clots from forming or growing larger. It works by thinning your blood. It's often used in hospitals to treat or 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 to you. 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 to determine the best way to store it.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next.
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Lifestyle & Tips

  • Avoid activities that could lead to injury or bleeding (e.g., contact sports, sharp objects).
  • Use a soft toothbrush and an electric razor to minimize bleeding risk.
  • Inform all healthcare providers, including dentists, that you are on heparin.
  • Report any signs of bleeding or unusual bruising immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and protocol. For DVT/PE treatment: Initial bolus 80 units/kg IV, then continuous infusion 18 units/kg/hr IV. Adjust infusion rate to maintain aPTT 1.5-2.5 times control or anti-Xa 0.3-0.7 units/mL.

Condition-Specific Dosing:

DVT/PE Treatment: Initial bolus 80 units/kg IV, then continuous infusion 18 units/kg/hr IV. Adjust to target aPTT/anti-Xa.
DVT/PE Prophylaxis (low dose IV): Typically 5,000 units IV every 8-12 hours, or 100 units/hr continuous infusion, though subcutaneous is more common for prophylaxis.
Acute Coronary Syndromes: Initial bolus 60 units/kg (max 4000 units) IV, then continuous infusion 12 units/kg/hr (max 1000 units/hr) IV. Adjust to target aPTT.
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Pediatric Dosing

Neonatal: Initial bolus 75 units/kg IV, then continuous infusion 28 units/kg/hr IV. Adjust to target anti-Xa 0.3-0.7 units/mL.
Infant: Initial bolus 75 units/kg IV, then continuous infusion 28 units/kg/hr IV. Adjust to target anti-Xa 0.3-0.7 units/mL.
Child: Initial bolus 75 units/kg IV, then continuous infusion 20 units/kg/hr IV. Adjust to target anti-Xa 0.3-0.7 units/mL.
Adolescent: Initial bolus 75 units/kg IV, then continuous infusion 20 units/kg/hr IV. Adjust to target anti-Xa 0.3-0.7 units/mL.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required, but monitor closely.
Moderate: No specific adjustment typically required, but monitor closely. Increased risk of accumulation and bleeding.
Severe: Use with caution. Consider lower initial doses and/or slower titration. Monitor aPTT/anti-Xa closely. Increased risk of accumulation and bleeding.
Dialysis: Heparin is not significantly removed by hemodialysis. Use with caution and monitor closely. Often used for anticoagulation during dialysis itself.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution. Hepatic metabolism may be impaired, increasing half-life and bleeding risk. Monitor aPTT/anti-Xa closely.
Severe: Contraindicated in severe hepatic disease with impaired hemostasis. Use with extreme caution if absolutely necessary, with frequent monitoring.

Pharmacology

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Mechanism of Action

Heparin binds to antithrombin (ATIII), causing a conformational change that greatly accelerates the rate at which ATIII inactivates thrombin (Factor IIa) and Factor Xa. It also inactivates Factors IXa, XIa, XIIa, and plasmin. The primary anticoagulant effect is mediated through the inhibition of thrombin and Factor Xa.
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed orally. IV: 100%. SC: Variable (approx. 20-30% for low doses, higher for therapeutic doses, but still incomplete and variable).
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: 0.06 L/kg (low, confined to plasma volume).
ProteinBinding: Highly protein bound (to various plasma proteins, including non-specific binding, which contributes to dose-dependent kinetics).
CnssPenetration: Limited

Elimination:

HalfLife: Dose-dependent. Typically 1-2 hours for therapeutic doses (e.g., 100 units/kg), increasing with higher doses (e.g., 2.5 hours for 400 units/kg).
Clearance: Complex, involves both rapid saturable binding to endothelial cells and macrophages, and slower renal excretion of depolymerized fragments.
ExcretionRoute: Renal (metabolites and some unchanged drug).
Unchanged: Small percentage (less than 50%) of unchanged drug excreted renally.
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Pharmacodynamics

OnsetOfAction: IV: Immediate. SC: 20-60 minutes.
PeakEffect: IV: Immediate. SC: 2-4 hours.
DurationOfAction: Dose-dependent. IV: 2-6 hours (after discontinuation of infusion). SC: 8-12 hours.

Safety & Warnings

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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 encounter any side effects that bother you or persist, contact your doctor for guidance.

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:

  • 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 sudden weakness/numbness (could indicate internal bleeding)
  • Sudden chest pain or shortness of breath (could indicate new clot or bleeding)
  • Severe abdominal pain
  • Any new or worsening pain, swelling, or discoloration in a limb (could indicate a new clot or bleeding)
  • Sudden drop in platelet count (monitored by blood tests, but symptoms like new thrombosis or skin lesions should be reported)
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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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Bleeding Risks
You may experience easier bleeding while taking this drug. To minimize the risk of injury, be cautious and take precautions such as using a soft toothbrush and an electric razor. Severe and potentially life-threatening bleeding problems have been associated with this medication.

Heparin-Induced Thrombocytopenia (HIT) and Thrombosis (HITTS)
This drug can cause a condition known as heparin-induced thrombocytopenia (HIT), which may lead to blood clots, also referred to as heparin-induced thrombocytopenia and thrombosis (HITTS). These conditions can be fatal or cause other complications and may occur up to several weeks after stopping the medication. If you have any questions or concerns, discuss them with your doctor. Regular blood tests, as directed by your doctor, are crucial to monitor your condition.

Lab Test Interactions
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this drug to ensure accurate test interpretations.

Injury and Head Trauma
If you fall, injure yourself, or experience a head injury, contact your doctor immediately, even if you feel fine. Prompt medical attention is necessary to assess and manage any potential complications.

Product Verification and Strength
Ensure 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 for clarification.

Sulfite Allergy
If you are allergic to sulfites, discuss this with your doctor, as some products may contain sulfites.

Age-Related Precautions
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.

Benzyl Alcohol Precautions
Some products contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.

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

Overdose Symptoms:

  • Excessive bleeding (e.g., epistaxis, hematuria, melena, hematemesis, ecchymoses, petechiae)
  • Hypotension
  • Tachycardia
  • Shock

What to Do:

Immediately discontinue heparin. For severe bleeding, protamine sulfate is the antidote. It neutralizes heparin's anticoagulant effect. Dosage of protamine sulfate depends on the amount of heparin administered and the time since administration. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

  • History of Heparin-Induced Thrombocytopenia (HIT) or Heparin-Induced Thrombocytopenia with Thrombosis (HITT)
  • Active major bleeding
  • Severe thrombocytopenia
  • Uncontrolled severe hypertension
  • Recent intracranial hemorrhage or surgery (brain, spinal cord, eye)
  • Bacterial endocarditis
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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, dipyridamole, NSAIDs): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, tenecteplase): Greatly increased risk of bleeding.
  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT/anti-Xa).
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Moderate Interactions

  • Dextran: Increased risk of bleeding.
  • Some cephalosporins (e.g., cefoperazone, cefotetan): May increase bleeding risk due to vitamin K antagonism.
  • Valproic acid: May displace heparin from protein binding sites, potentially increasing free heparin levels.
  • Probenecid: May increase heparin levels.
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Minor Interactions

  • Herbal supplements with anticoagulant/antiplatelet effects (e.g., garlic, ginger, ginkgo biloba, ginseng, feverfew): Potential additive 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) or Anti-Factor Xa (anti-Xa) activity

Rationale: To establish baseline coagulation status and for subsequent therapeutic monitoring.

Timing: Prior to initiation of therapy.

Renal function (BUN, Creatinine)

Rationale: To assess baseline kidney function, as heparin metabolites are renally cleared and severe impairment can increase accumulation risk.

Timing: Prior to initiation of therapy.

Liver function tests (LFTs)

Rationale: To assess baseline liver function, as heparin is metabolized in the liver and severe impairment can increase bleeding risk.

Timing: Prior to initiation of therapy.

Stool guaiac or occult blood test

Rationale: To assess for baseline gastrointestinal bleeding.

Timing: Prior to initiation of therapy, if clinically indicated.

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Routine Monitoring

Activated Partial Thromboplastin Time (aPTT)

Frequency: Every 4-6 hours after initiation or dose change until therapeutic range is achieved, then at least daily.

Target: Typically 1.5-2.5 times the control value (specific therapeutic range should be established by the laboratory).

Action Threshold: Adjust infusion rate based on institutional nomogram to maintain target range. If supratherapeutic, hold infusion and recheck; if subtherapeutic, increase infusion rate.

Anti-Factor Xa (anti-Xa) activity

Frequency: Alternative to aPTT, especially in conditions affecting aPTT (e.g., lupus anticoagulant). Every 4-6 hours after initiation or dose change until therapeutic range is achieved, then at least 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: Baseline, then every 2-3 days for the first 14 days of therapy or until heparin is discontinued, whichever comes first.

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 Heparin-Induced Thrombocytopenia (HIT). Discontinue heparin immediately and initiate alternative anticoagulant therapy.

Signs and symptoms of bleeding

Frequency: Continuously throughout therapy.

Target: Absence of new bleeding.

Action Threshold: If bleeding occurs, assess severity. For minor bleeding, consider dose reduction. For major bleeding, discontinue heparin and consider protamine sulfate administration.

Hemoglobin and Hematocrit

Frequency: Daily or as clinically indicated.

Target: Stable.

Action Threshold: Significant drop may indicate occult bleeding.

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Symptom Monitoring

  • Unusual bleeding (e.g., nosebleeds, gum bleeding, prolonged bleeding from cuts)
  • Easy bruising or purpura
  • Red or dark brown urine (hematuria)
  • Red or black, tarry stools (melena)
  • Severe headache or dizziness (suggestive of intracranial hemorrhage)
  • Unusual pain, swelling, or discomfort (suggestive of internal bleeding)
  • Signs of Heparin-Induced Thrombocytopenia (HIT): new or worsening thrombosis, skin lesions at injection sites, acute systemic reactions after heparin administration, or unexplained platelet count drop.

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 teratogenic effects. However, it is classified as Category C due to potential maternal risks (e.g., osteoporosis, 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. Increased maternal bleeding risk, especially around delivery. Regional anesthesia may be contraindicated if therapeutic anticoagulation is present.
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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 not orally absorbed by the infant.

Infant Risk: L1 (Safest) - No known adverse effects on the breastfed infant.
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Pediatric Use

Dosing is weight-based and often requires higher units/kg than adults due to faster clearance. Close monitoring of aPTT or anti-Xa levels is crucial. Risk of bleeding and HIT is present as in adults.

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Geriatric Use

Increased risk of bleeding due to age-related physiological changes (e.g., decreased renal function, increased capillary fragility, comorbidities, polypharmacy). Lower doses or more conservative dosing strategies may be considered, and close monitoring is essential.

Clinical Information

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Clinical Pearls

  • Heparin's half-life is dose-dependent; higher doses lead to disproportionately longer half-lives.
  • Monitoring with aPTT can be unreliable in certain conditions (e.g., lupus anticoagulant, high Factor VIII levels); anti-Factor Xa levels are preferred in these cases and for pediatric patients.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts closely (every 2-3 days for the first 14 days). If HIT is suspected, discontinue heparin immediately and initiate a non-heparin anticoagulant (e.g., argatroban, bivalirudin).
  • Protamine sulfate is the specific antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin.
  • Heparin is not absorbed orally and must be given parenterally (IV or SC). This specific formulation (25000 units/250mL) is typically for IV infusion.
  • Flush IV lines thoroughly before and after heparin administration to prevent drug interactions or inactivation.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): For DVT/PE treatment and prophylaxis, often preferred for outpatient use due to predictable pharmacokinetics and less need for monitoring.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): For DVT/PE treatment and prophylaxis, and stroke prevention in atrial fibrillation.
  • Warfarin: Oral anticoagulant for long-term anticoagulation.
  • Direct Thrombin Inhibitors (e.g., argatroban, bivalirudin, dabigatran): Used in specific situations, such as HIT or percutaneous coronary intervention.
  • Factor Xa Inhibitors (e.g., fondaparinux, rivaroxaban, apixaban, edoxaban): For DVT/PE treatment and prophylaxis.
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Cost & Coverage

Average Cost: Price varies widely by manufacturer, contract, and pharmacy. Typically ranges from $10-$50 for a 250mL bag of 25,000 units. per 250mL bag (25,000 units)
Generic Available: Yes
Insurance Coverage: Generally covered by most insurance plans as a Tier 1 or Tier 2 medication, especially in inpatient settings.
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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 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 throwing them away. However, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the correct disposal method, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.