Heparin Sod 5000u/ml Inj, 1ml

Manufacturer MEITHEAL PHARMACEUTICALS 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
Antithrombotic agent; Indirect thrombin inhibitor; Glycosaminoglycan
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Pregnancy Category
Not available
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 thins your blood. It helps prevent and treat blood clots that can form in your veins or arteries. It works by making certain proteins in your blood less active, which stops clots from forming or growing larger. 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 to you. It is essential to follow the instructions carefully. This medication can be administered in various 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 to determine the best way to store it.

Missing a Dose

If you miss a dose, contact your doctor to find out 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.
  • Inform all healthcare providers, including dentists, that you are taking heparin.
  • Report any signs of unusual bleeding or bruising immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication (e.g., prophylaxis vs. treatment) and route (IV vs. SC). For VTE treatment: Initial bolus 80 units/kg IV, then 18 units/kg/hour IV infusion. For VTE prophylaxis: 5000 units SC every 8-12 hours.
Dose Range: 5000 - 40000 mg

Condition-Specific Dosing:

Acute Coronary Syndromes (ACS): Initial bolus 60 units/kg (max 4000 units) IV, then 12 units/kg/hour (max 1000 units/hour) IV infusion.
Pulmonary Embolism (PE): Initial bolus 80 units/kg IV, then 18 units/kg/hour IV infusion.
Deep Vein Thrombosis (DVT): Initial bolus 80 units/kg IV, then 18 units/kg/hour IV infusion.
Prophylaxis of VTE: 5000 units SC every 8-12 hours.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific adjustment needed, but monitor closely.
Moderate: No specific adjustment needed, but monitor closely.
Severe: No specific adjustment needed, but monitor closely. Heparin is primarily cleared by the reticuloendothelial system, not renal excretion. However, accumulation of active metabolites or altered sensitivity may occur in severe renal dysfunction.
Dialysis: No specific adjustment needed, but monitor closely. Heparin is commonly used during hemodialysis.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor closely.
Moderate: No specific adjustment needed, but monitor closely. Heparin metabolism may be altered in severe hepatic dysfunction, potentially leading to increased anticoagulant effect.
Severe: No specific adjustment needed, but monitor closely. Increased risk of bleeding due to underlying coagulopathy.

Pharmacology

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Mechanism of Action

Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides. It exerts its anticoagulant effect by binding to antithrombin III (ATIII), a plasma protein that inactivates thrombin (Factor IIa) and Factor Xa. This binding causes a conformational change in ATIII, greatly accelerating its inhibitory action (by 1000-fold or more) on these coagulation factors. Heparin also inhibits the activation of Factor IX to IXa, and Factor XI to XIa, and Factor XII to XIIa, and the stabilization of fibrin by Factor XIIIa.
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed orally. Bioavailability after subcutaneous (SC) injection is variable (10-70%) and dose-dependent.
Tmax: IV: Immediate. SC: 2-4 hours.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: 0.06 L/kg (distributes in 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: No

Elimination:

HalfLife: Dose-dependent. Typically 1-2 hours for therapeutic doses (e.g., 100 units/kg IV bolus). Longer with higher doses.
Clearance: Saturable, non-linear clearance (reticuloendothelial system) and non-saturable renal clearance.
ExcretionRoute: Renal (small amount of unchanged drug and depolymerized fragments).
Unchanged: Less than 50% (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 affecting hemostasis (e.g., NSAIDs, platelet inhibitors, other anticoagulants), a history of traumatic or repeated epidural or spinal punctures, 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 advice.

Not all possible side effects are listed 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 without injury
  • Severe headache, dizziness, or weakness
  • Sudden, severe pain or swelling in a joint or muscle
  • Red or dark brown urine
  • Black, tarry stools or bright red blood in stools
  • Any new numbness, tingling, or weakness, especially in the legs (report immediately 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 on this medication, 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.

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, 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 also important to have your blood work checked as directed by your doctor.

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

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 comes in various containers and strengths. If you are unsure, consult your doctor or pharmacist.

If you have a sulfite allergy, inform your doctor, as some products may 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, discuss it with your doctor to determine if the product you are using contains benzyl alcohol.

If you are pregnant, plan to become pregnant, or are 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)
  • Hypotension
  • Tachycardia
  • Shock

What to Do:

Discontinue heparin. For severe bleeding, administer protamine sulfate (a specific antidote for heparin) slowly intravenously. The dose of protamine sulfate depends on the amount of heparin administered and the time since administration. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.

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, NSAIDs): 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 (certain types, e.g., cefoperazone, cefotetan): May increase risk of bleeding due to vitamin K antagonism.
  • Probenecid: May increase heparin levels.
  • Digoxin: May decrease digoxin levels (clinical significance uncertain).

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 heparin therapy.

Activated Partial Thromboplastin Time (aPTT)

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

Timing: Prior to initiation of heparin therapy.

Renal and Hepatic Function Tests (e.g., SCr, BUN, LFTs)

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

Timing: Prior to initiation of heparin therapy.

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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 range depends on laboratory and indication, often correlated with anti-Xa levels of 0.3-0.7 units/mL).

Action Threshold: Adjust infusion rate based on institutional nomogram to maintain target range. If below range, consider bolus and increase rate. If above range, hold infusion and decrease rate.

Anti-Factor Xa (Anti-Xa) Assay

Frequency: May be used instead of or in conjunction with aPTT, especially in patients with lupus anticoagulant, liver disease, or those receiving concomitant thrombolytics. Frequency similar to aPTT.

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, whichever comes first.

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, suspect Heparin-Induced Thrombocytopenia (HIT) and discontinue heparin immediately. Initiate alternative anticoagulant if needed.

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 (e.g., dose reduction, discontinuation, protamine administration).

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Symptom Monitoring

  • Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, excessive bruising)
  • Severe headache or vision changes (may indicate intracranial bleed)
  • Unusual pain or swelling (e.g., joint pain, abdominal pain)
  • Dizziness or weakness (signs of blood loss)
  • Cold, pale, or painful limb (may indicate arterial thrombosis, paradoxical effect of HIT)
  • Skin lesions at injection sites (may indicate HIT-related skin necrosis)

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 requiring anticoagulation. However, it is associated with risks such as maternal bleeding, osteoporosis (with long-term use), and heparin-induced thrombocytopenia (HIT). Close monitoring is essential.

Trimester-Specific Risks:

First Trimester: Low risk of teratogenicity. Primary risk is maternal bleeding.
Second Trimester: Primary risk is maternal bleeding and potential for heparin-induced osteoporosis with prolonged use.
Third Trimester: Primary risk is maternal bleeding, especially around delivery. Consider discontinuing prior to labor/delivery if possible.
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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: Low risk (L1)
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring of aPTT or anti-Xa levels. Neonates and infants may require higher doses per kg due to higher antithrombin III levels and faster clearance. Increased risk of bleeding, especially in neonates.

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Geriatric Use

Elderly patients may be more sensitive to the effects of heparin and have an increased risk of bleeding. Lower initial doses or more conservative dosing strategies may be considered. Close monitoring of aPTT/anti-Xa and signs of bleeding is crucial.

Clinical Information

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Clinical Pearls

  • Heparin is highly variable in its anticoagulant response due to binding to plasma proteins and cells; therefore, careful monitoring (aPTT or anti-Xa) is crucial for therapeutic dosing.
  • Always confirm the concentration of heparin before administration to avoid dosing errors (e.g., 10 units/mL vs. 10,000 units/mL).
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts regularly. If HIT is suspected, discontinue all heparin products immediately and initiate an alternative 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.
  • Subcutaneous heparin should be injected into the abdominal fat, at least 2 inches from the navel, using a short needle and not rubbing the site after injection to minimize bruising.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): Often preferred for VTE prophylaxis and outpatient treatment due to more predictable pharmacokinetics and less frequent monitoring.
  • Fondaparinux: Synthetic pentasaccharide, selective Factor Xa inhibitor, used for VTE prophylaxis and treatment, and in patients with HIT.
  • Direct Thrombin Inhibitors (DTIs) (e.g., argatroban, bivalirudin, dabigatran): Used for HIT or as alternatives to heparin.
  • Direct Oral Anticoagulants (DOACs) / Novel Oral Anticoagulants (NOACs) (e.g., rivaroxaban, apixaban, edoxaban, dabigatran): Oral alternatives for long-term VTE treatment and stroke prevention in atrial fibrillation.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 1mL vial (5000 units/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 or take someone else's medication. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult 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, 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 about the medication taken, the amount, and the time of ingestion to ensure timely and effective treatment.