Heparin Sod/d5w 100u/ml Inj, 250ml

Heparin binds to antithrombin (AT), a plasma protein that inactivates thrombin (Factor IIa) and Factor Xa. This binding causes a conformational change in AT, greatly accelerating its inhibitory action (by 1000-fold or more) on these and other coagulation proteases (e.g., IXa, XIa, XIIa, plasmin). The inhibition of thrombin prevents the conversion of fibrinogen to fibrin, and the inhibition of Factor Xa prevents the formation of thrombin.

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 application
Fever or chills

Other Possible Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience 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.

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.

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 is crucial to be cautious and avoid injuries. To minimize the risk of bleeding, use a soft-bristled 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, also referred to as heparin-induced thrombocytopenia and thrombosis (HITTS). Both HIT and HITTS can be fatal or cause 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 important to undergo blood tests as directed by your doctor and to consult with them regarding any concerns.

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

If you experience 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 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 should be avoided in newborns and infants whenever possible, as it can cause serious side effects in these age groups, particularly 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, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.

• History of Heparin-Induced Thrombocytopenia (HIT) with or without thrombosis
• Active major bleeding
• Severe thrombocytopenia
• Uncontrolled hypertension
• Recent intracranial hemorrhage or surgery (brain, spinal cord, eye)
• Bacterial endocarditis

• Other anticoagulants (e.g., warfarin, direct oral anticoagulants like dabigatran, rivaroxaban, apixaban, edoxaban)
• Antiplatelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole)
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
• Thrombolytic agents (e.g., alteplase, tenecteplase)
• Dextran

• SSRIs (Selective Serotonin Reuptake Inhibitors)
• SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors)
• Herbal supplements with antiplatelet/anticoagulant effects (e.g., ginkgo biloba, garlic, ginger, dong quai, feverfew)
• Drugs that cause hyperkalemia (e.g., ACE inhibitors, ARBs, potassium-sparing diuretics) due to heparin's potential to cause hyperkalemia.

• Nitroglycerin (may decrease heparin effect, requiring higher doses)

• Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stools, excessive bruising, petechiae)
• Signs of internal bleeding (e.g., severe headache, dizziness, weakness, abdominal pain, black or tarry stools, red or dark urine)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of Heparin-Induced Thrombocytopenia (HIT) such as new or worsening thrombosis (e.g., limb pain, swelling, shortness of breath, chest pain) or a sudden drop in platelet count.

Heparin is classified as Pregnancy Category C. It does not cross the placenta and is often considered the anticoagulant of choice for pregnant women requiring anticoagulation (e.g., for VTE prophylaxis or treatment) due to its safety profile for the fetus compared to warfarin. However, maternal risks include bleeding, osteoporosis (with long-term use), and HIT.

Heparin is considered compatible with breastfeeding (L3 - Moderately Safe). It is a large molecule and is not excreted into breast milk in significant amounts. It is also poorly absorbed orally by the infant, so systemic effects on the infant are unlikely.

Heparin can be used safely in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based and requires careful titration and frequent monitoring of aPTT to achieve therapeutic levels, as pharmacokinetic parameters can vary significantly with age. Higher doses per kg may be required in younger children due to higher heparin clearance.

Elderly patients (≥65 years) may have an increased risk of bleeding with heparin therapy, particularly those with comorbidities or impaired renal function. Close monitoring of aPTT and clinical signs of bleeding is essential. Lower initial doses or slower titration may be considered.

• Protamine sulfate is the specific antidote for heparin overdose or severe bleeding, typically administered at 1 mg per 100 units of heparin given in the last 2-3 hours.
• Heparin has non-linear pharmacokinetics, meaning its half-life increases with higher doses due to saturation of its clearance mechanisms.
• The most serious adverse effect is bleeding, which can be life-threatening. Close monitoring for signs of hemorrhage is crucial.
• Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication characterized by a significant drop in platelet count (typically >50% from baseline) and a paradoxical increased risk of thrombosis. If HIT is suspected, heparin must be immediately discontinued, and an alternative anticoagulant (e.g., argatroban, bivalirudin, fondaparinux) should be initiated.
• Heparin can cause hyperkalemia by inhibiting aldosterone synthesis, especially in patients with renal impairment or those on potassium-sparing medications.
• Heparin resistance can occur due to various factors, including antithrombin deficiency, elevated Factor VIII levels, or high levels of heparin-binding proteins. Higher doses may be required to achieve therapeutic aPTT.

• Low Molecular Weight Heparins (LMWHs) such as enoxaparin (Lovenox), dalteparin (Fragmin), tinzaparin (Innohep) - often preferred for outpatient use and prophylaxis due to more predictable pharmacokinetics and less need for monitoring.
• Direct Thrombin Inhibitors (DTIs) such as argatroban, bivalirudin (Angiomax), dabigatran (Pradaxa) - used for HIT or specific indications.
• Factor Xa Inhibitors such as fondaparinux (Arixtra), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa) - used for VTE treatment/prophylaxis and stroke prevention in AF.
• Warfarin (Coumadin, Jantoven) - oral anticoagulant for long-term therapy.

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further 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 the recommended 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 offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist if you have any questions. If you have concerns or questions about your medication, consult 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.