Heparin Sod 5000u/ml Prefilled Syr

Heparin binds to antithrombin III (ATIII), greatly accelerating its inhibitory action on various activated coagulation factors, most notably thrombin (Factor IIa) and Factor Xa. This prevents the conversion of fibrinogen to fibrin and the activation of Factor XIII, thereby inhibiting clot formation. Higher doses are required to inhibit thrombin, while lower doses can inhibit Factor Xa.

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
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 application
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.

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. To minimize the risk of injury, exercise caution and take preventive measures such as using a soft toothbrush and an electric razor.

This medication can cause severe and potentially life-threatening bleeding problems. Additionally, it may lead to a condition known as heparin-induced thrombocytopenia (HIT), which can cause blood clots, also referred to as heparin-induced thrombocytopenia and thrombosis (HITTS). Both HIT and HITTS can be fatal or result in other complications, and may occur up to several weeks after discontinuing the medication. If you have any questions or concerns, consult your doctor. It is crucial to undergo blood tests as directed by your doctor and to discuss any findings with them.

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

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. It is necessary to discuss the benefits and risks of this medication to both you and your baby.

• 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): Greatly increased risk of bleeding.
• Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT/anti-Xa closely).

• Cephalosporins (certain, e.g., cefoperazone, cefotetan): May increase bleeding risk due to hypoprothrombinemia.
• Probenecid: May increase heparin levels.
• Digoxin: May decrease digoxin levels.
• Tetracyclines: May decrease heparin's anticoagulant effect.
• Antihistamines: May decrease heparin's anticoagulant effect.

• Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, excessive bruising)
• Severe headache or dizziness (may indicate intracranial bleeding)
• Weakness or fatigue (may indicate anemia from blood loss)
• New or worsening pain, swelling, or discoloration (may indicate thrombosis or hematoma)
• Rash or skin lesions (may indicate heparin-induced skin necrosis)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling, difficulty breathing)

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 complications (e.g., osteoporosis, thrombocytopenia) and rare fetal adverse events (e.g., stillbirth, prematurity) that may be related to the underlying maternal condition or complications of therapy.

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 poorly absorbed orally by the infant.

Dosing is weight-based and requires careful titration and monitoring of anti-Xa levels due to higher clearance rates and variability in response compared to adults. Neonates and infants may require higher initial doses and infusion rates. Risk of bleeding is present, and careful monitoring is essential.

Increased risk of bleeding due to age-related physiological changes (e.g., decreased renal function, increased capillary fragility, polypharmacy). Lower initial doses and closer monitoring of aPTT/anti-Xa and bleeding signs are recommended.

• Heparin dosing is highly individualized and requires frequent laboratory monitoring (aPTT or anti-Xa) to ensure therapeutic efficacy and minimize bleeding risk.
• Always confirm the concentration of heparin before administration to avoid dosing errors (e.g., 1,000 units/mL vs. 10,000 units/mL).
• Heparin-Induced Thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts every 2-3 days from day 4 to day 14 of therapy. A >50% drop in platelets from baseline or new thrombosis should prompt immediate discontinuation of heparin and evaluation for HIT.
• Protamine sulfate is the antidote for heparin overdose. 1 mg of protamine neutralizes approximately 100 units of heparin, but the dose needs to be adjusted based on the amount of heparin given and the time since administration.
• Subcutaneous heparin should be administered in the abdominal fat, rotating injection sites, and avoiding aspiration or rubbing the site to minimize bruising.
• Heparin can cause hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing diuretics or ACE inhibitors. Monitor potassium levels.
• Long-term use of heparin (especially high doses) can lead to osteoporosis.

• Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): Often preferred for VTE prophylaxis and treatment due to more predictable pharmacokinetics, subcutaneous administration, and less frequent monitoring.
• Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for VTE treatment and prevention in non-valvular atrial fibrillation. Do not require routine coagulation monitoring.
• Warfarin: Oral anticoagulant, requires frequent INR monitoring, but widely used for long-term anticoagulation.
• Fondaparinux: Synthetic selective Factor Xa inhibitor, used for VTE prophylaxis and treatment.

If your symptoms or health problems persist or worsen, 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. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. 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 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 it was taken to ensure prompt and effective treatment.