Heparin Sod 20000u/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; Indirect Thrombin Inhibitor (via Antithrombin III)
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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 that thins your blood to prevent or treat blood clots. It works by helping a natural substance in your body (antithrombin) stop blood from clotting too much. 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 Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. This medication can be administered in different ways, including:
- Injection into a catheter
- Injection into a vein (intravenous)
- Injection into the fatty part of the skin (subcutaneous)
- Infusion into a vein over a period of time

If you have any questions or concerns about your medication, 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 an 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 and patient weight. For therapeutic anticoagulation: Initial bolus 80 units/kg IV, followed by continuous IV infusion of 18 units/kg/hour. Adjust infusion rate to maintain target aPTT (typically 1.5-2.5 times control). For prophylaxis of VTE: 5,000 units subcutaneously every 8 to 12 hours.
Dose Range: 5000 - 40000 mg

Condition-Specific Dosing:

DVT/PE Treatment: Initial bolus 80 units/kg IV, then 18 units/kg/hr IV infusion. Adjust to target aPTT.
VTE Prophylaxis: 5,000 units SC q8-12h.
Acute Coronary Syndromes: Initial bolus 60 units/kg (max 4000 units) IV, then 12 units/kg/hr (max 1000 units/hr) IV infusion. Adjust to target aPTT.
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Pediatric Dosing

Neonatal: Initial bolus 75 units/kg IV, then 28 units/kg/hour IV infusion. Adjust to target aPTT.
Infant: Initial bolus 75 units/kg IV, then 28 units/kg/hour IV infusion. Adjust to target aPTT.
Child: Initial bolus 75 units/kg IV, then 20 units/kg/hour IV infusion. Adjust to target aPTT.
Adolescent: Similar to adult dosing, weight-based.
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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.
Severe: No specific dose adjustment required, but monitor closely. Accumulation of smaller heparin fragments may occur, increasing bleeding risk. Consider lower initial doses or anti-Xa monitoring.
Dialysis: Heparin is often used during hemodialysis. For systemic anticoagulation, monitor closely. Not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: No specific dose adjustment required, but monitor closely. Increased risk of bleeding due to impaired clotting factor synthesis; use with caution.
Severe: Use with extreme caution due to increased bleeding risk from impaired clotting factor synthesis and potential for reduced heparin clearance. Monitor closely.

Pharmacology

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Mechanism of Action

Heparin binds 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 1,000-fold or more) on these clotting factors. Heparin also inhibits other coagulation factors, including IXa, XIa, XIIa, and plasmin, but its primary anticoagulant effect is mediated through ATIII inhibition of thrombin and Factor Xa.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV), 20-30% (SC, variable)
Tmax: Immediate (IV), 2-4 hours (SC)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.06 L/kg (low, confined to plasma volume)
ProteinBinding: High (non-specific binding to plasma proteins, endothelial cells, macrophages)
CnssPenetration: No

Elimination:

HalfLife: Dose-dependent; typically 1-2 hours for therapeutic doses (increases with dose)
Clearance: Saturable (dose-dependent) and non-saturable mechanisms
ExcretionRoute: Renal (small amounts of unchanged drug and metabolites)
Unchanged: <50%
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Pharmacodynamics

OnsetOfAction: Immediate (IV), 20-60 minutes (SC)
PeakEffect: Immediate (IV), 2-4 hours (SC)
DurationOfAction: 2-6 hours (IV, dose-dependent), 8-12 hours (SC)

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 (LMWH) 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, platelet inhibitors, 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

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 have 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:

  • Unusual bleeding (e.g., nosebleeds, bleeding gums, blood in urine or stool, heavy menstrual bleeding)
  • Excessive bruising or large bruises without injury
  • Severe headache or sudden weakness/numbness (could indicate internal bleeding)
  • Dizziness or feeling faint
  • Unexplained pain or swelling
  • Any new or worsening pain, swelling, or discoloration in a limb (could indicate a new clot, even while on heparin, or HIT)
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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, 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 problems 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 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 serious complications, and they can 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. If possible, avoid products with benzyl alcohol in these age groups, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if the product you are using 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, hematomas)
  • Hypotension
  • Tachycardia
  • Shock

What to Do:

Seek immediate medical attention. The antidote for heparin overdose is protamine sulfate. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Patients with a history of Heparin-Induced Thrombocytopenia (HIT)
  • Active major bleeding
  • Severe thrombocytopenia
  • Uncontrolled severe hypertension
  • Recent brain, spinal, or eye surgery
  • Lumbar puncture or regional anesthetic procedures (epidural/spinal anesthesia) in patients receiving therapeutic anticoagulation
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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): Increased risk of bleeding.
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib): Increased risk of bleeding.
  • Thrombolytic agents (e.g., alteplase, tenecteplase): Profound increase in bleeding risk.
  • Dextran: Increased risk of bleeding.
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Moderate Interactions

  • Drugs that affect platelet function (e.g., dipyridamole, sulfinpyrazone): Increased risk of bleeding.
  • Nitroglycerin (IV): May decrease heparin's anticoagulant effect; monitor aPTT.
  • Digitalis, tetracyclines, nicotine, antihistamines: May partially counteract heparin's anticoagulant effect.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with platelet count

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

Timing: Prior to initiation of therapy

Activated Partial Thromboplastin Time (aPTT) or Anti-Factor Xa (anti-Xa) level

Rationale: To establish baseline coagulation status.

Timing: Prior to initiation of therapy

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

Rationale: To establish baseline coagulation status and rule out pre-existing coagulopathy.

Timing: Prior to initiation of therapy

Renal and Hepatic Function Tests

Rationale: To assess organ function that may influence heparin clearance or 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 until therapeutic range is achieved, then daily.

Target: Typically 1.5-2.5 times the control value (specific target range should be established by the institution's laboratory and clinical protocol).

Action Threshold: Below target: Increase dose. Above target: Decrease dose or hold.

Anti-Factor Xa (anti-Xa) level

Frequency: Alternative to 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: Below target: Increase dose. Above target: Decrease dose or hold.

Platelet count

Frequency: Every 2-3 days during therapy, especially between days 4 and 14, or if there is a sudden drop in platelet count.

Target: Maintain above 100,000/mm³ or no significant drop from baseline.

Action Threshold: Drop of >50% from baseline or absolute count <100,000/mm³: Consider Heparin-Induced Thrombocytopenia (HIT) and discontinue heparin.

Signs and symptoms of bleeding

Frequency: Continuously

Target: Absence of bleeding

Action Threshold: Any signs of bleeding (e.g., hematuria, melena, epistaxis, petechiae, ecchymoses, unexplained drop in hemoglobin): Investigate and manage immediately.

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Symptom Monitoring

  • Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, prolonged bleeding from cuts)
  • Petechiae (small red spots on skin)
  • Ecchymoses (bruising)
  • Signs of internal bleeding (e.g., severe headache, abdominal pain, weakness, dizziness, black/tarry stools, red/pink urine)
  • Signs of Heparin-Induced Thrombocytopenia (HIT): new or worsening thrombosis, skin lesions at injection sites, 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 requiring anticoagulation. However, it is classified as Category C due to potential for maternal bleeding and osteoporosis with long-term use. Close monitoring of aPTT or anti-Xa levels is essential.

Trimester-Specific Risks:

First Trimester: Generally safe, but monitor for bleeding.
Second Trimester: Generally safe, but monitor for bleeding.
Third Trimester: Generally safe, but monitor for bleeding. Discontinue before labor if possible to reduce risk of epidural/spinal hematoma if neuraxial anesthesia is planned.
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Lactation

Heparin is considered safe during breastfeeding. It is a large molecule and does not pass 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 due to variability in response and higher clearance rates in younger children. Neonates and infants may require higher doses per kg. Risk of bleeding 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, concomitant medications). Use with caution and monitor closely. Lower doses may be appropriate for some elderly patients.

Clinical Information

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Clinical Pearls

  • Heparin's half-life is dose-dependent; higher doses lead to disproportionately longer half-lives due to saturation of clearance mechanisms.
  • Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication that can lead to paradoxical thrombosis. Monitor platelet counts closely, especially between days 4-14 of therapy.
  • Protamine sulfate is the specific antidote for heparin overdose, neutralizing its anticoagulant effect.
  • Heparin is highly acidic and incompatible with many other drugs; always check compatibility before mixing.
  • The 20,000 units/mL concentration is highly potent and requires careful dilution for most therapeutic uses (e.g., IV infusions) to prevent dosing errors. It is typically used for specific high-dose boluses or in situations where fluid restriction is critical.
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Alternative Therapies

  • Low Molecular Weight Heparins (LMWH) (e.g., enoxaparin, dalteparin): For VTE prophylaxis and treatment, ACS.
  • Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): For VTE treatment/prophylaxis, stroke prevention in AF.
  • Warfarin: For long-term anticoagulation.
  • Fondaparinux: Synthetic pentasaccharide, selective Factor Xa inhibitor.
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Cost & Coverage

Average Cost: Low to moderate per 1mL vial
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 have 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 quantity, and the time of ingestion to facilitate prompt and effective treatment.