Heparin Sod 5,000u/ml Inj, 10ml

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 coagulation factors. Heparin also inhibits other coagulation factors, including IXa, XIa, XIIa, and plasmin, through its interaction with AT. The primary anticoagulant effect is mediated by the inhibition of thrombin and 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
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, consult 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, contact 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 symptoms you experienced as a result of the allergy.
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 (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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, be cautious 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 stopping the medication. If you have any questions or concerns, discuss them with your doctor. It is crucial to undergo blood tests as directed by your doctor and to consult with them regularly.

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.

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

If you are allergic to sulfites, inform your doctor, as some products contain sulfites.

Individuals over 60 years old should exercise caution when using this medication, 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 a parent or caregiver, consult your doctor to determine if the product contains benzyl alcohol and to discuss alternative options.

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.

• Other anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor, prasugrel, NSAIDs): Increased risk of bleeding.
• Thrombolytic agents (e.g., alteplase, tenecteplase): Increased risk of bleeding.
• Nitroglycerin (IV): May decrease heparin's anticoagulant effect (monitor aPTT/anti-Xa).

• 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/stools, excessive bruising)
• Signs of internal bleeding (e.g., severe headache, dizziness, weakness, abdominal pain, black/tarry stools, red/pink urine)
• Signs of allergic reaction (e.g., rash, hives, itching, swelling, difficulty breathing)
• Signs of Heparin-Induced Thrombocytopenia (HIT) (e.g., new or worsening thrombosis, skin lesions at injection site, sudden drop in platelet count)

Heparin does not cross the placenta and is generally considered the anticoagulant of choice for pregnant women requiring anticoagulation. However, it is classified as Pregnancy Category C due to potential for maternal complications (e.g., osteoporosis, thrombocytopenia) and rare reports of fetal adverse events (e.g., stillbirth, prematurity) that are not directly attributable to a teratogenic effect.

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.

Heparin can be used safely in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based and requires careful titration and monitoring of aPTT or anti-Xa levels due to differences in pharmacokinetics and antithrombin levels compared to adults. Neonates and infants may have lower antithrombin levels, potentially requiring higher doses or antithrombin supplementation.

Geriatric patients may be more sensitive to the effects of heparin and have an increased risk of bleeding. Lower doses may be required, and close monitoring of aPTT/anti-Xa and for signs of bleeding is essential. Renal function should be assessed, as impaired renal function can affect heparin clearance.

• Heparin is a high-alert medication; always double-check concentration and dose to prevent fatal medication errors.
• The antidote for heparin is protamine sulfate. 1 mg of protamine sulfate neutralizes approximately 100 units of heparin.
• Heparin-induced thrombocytopenia (HIT) is a serious, immune-mediated complication. Monitor platelet counts regularly (every 2-3 days from day 4 to 14 of therapy). If HIT is suspected, discontinue heparin immediately and initiate an alternative non-heparin anticoagulant.
• Heparin's anticoagulant effect is highly variable among individuals due to binding to plasma proteins and endothelial cells; therefore, dosing requires careful titration based on laboratory monitoring (aPTT or anti-Xa).
• Subcutaneous heparin for prophylaxis should be administered in the abdominal fat, rotating injection sites to prevent hematoma formation.
• Do not administer heparin intramuscularly due to the high risk of hematoma formation.

• Low Molecular Weight Heparins (LMWHs) (e.g., enoxaparin, dalteparin): Preferred for many indications due to more predictable pharmacokinetics, less need for monitoring, and lower risk of HIT.
• Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for VTE treatment/prevention, stroke prevention in AFib.
• Warfarin (Vitamin K antagonist): Oral anticoagulant for long-term anticoagulation.
• Direct Thrombin Inhibitors (DTIs) (e.g., argatroban, bivalirudin, dabigatran): Used in patients with HIT or for specific indications like PCI.
• Factor Xa Inhibitors (e.g., fondaparinux, rivaroxaban, apixaban, edoxaban): Used for VTE treatment/prevention.

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, do not share your prescription medications with others, and never take someone else's medications. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.