Heparin Sod 10,000u/ml Inj, 1ml

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 1000-fold or more) on these coagulation factors. Heparin also inhibits other activated clotting factors, including IXa, XIa, XIIa, and plasmin, but its primary anticoagulant effect is mediated through ATIII's inhibition of thrombin and Factor Xa.

Serious 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 immediately or seek 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 increase in size
+ 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 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 advice.

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 symptoms you experienced.
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 if it is safe to take this medication with your existing health conditions and other drugs. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Bleeding Risks
You may experience easier bleeding, so it is crucial to be cautious and avoid injuries. To minimize bleeding risks, use a soft toothbrush and an electric razor. Severe and potentially life-threatening bleeding problems have been associated with this medication.

Heparin-Induced Thrombocytopenia (HIT) and Thrombosis (HITTS)
This medication can cause a condition called heparin-induced thrombocytopenia (HIT), which may lead to blood clots, known as heparin-induced thrombocytopenia and thrombosis (HITTS). These conditions can be life-threatening or cause 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. Regular blood tests, as directed by your doctor, are necessary to monitor your condition.

Lab Test Interactions
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Injury and Head Trauma
If you fall, injure yourself, or hit your head, contact your doctor immediately, even if you feel fine.

Product Verification
Ensure you have the correct product, as this medication comes in various containers and strengths. If you have any questions, consult your doctor or pharmacist.

Sulfite Allergy
If you are allergic to sulfites, discuss this with your doctor, as some products may contain sulfites.

Age-Related Precautions
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.

Benzyl Alcohol Precautions
Some products contain benzyl alcohol, which can cause serious side effects in newborns and infants, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss potential risks.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to you and your baby.

• History of Heparin-Induced Thrombocytopenia (HIT)
• Active major bleeding
• Severe thrombocytopenia
• Uncontrolled hypertension
• Recent brain, spinal, or eye surgery
• Bacterial endocarditis

• 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) - greatly increased risk of bleeding
• Dextran - increased risk of bleeding

• Certain antibiotics (e.g., penicillins, cephalosporins) - may affect platelet function or gut flora, potentially increasing bleeding risk
• Nitroglycerin (IV) - may decrease heparin effect (monitor aPTT)
• Herbal supplements (e.g., ginkgo biloba, garlic, ginger, dong quai) - may increase bleeding risk
• SSRIs/SNRIs - may increase bleeding risk

• Not available

• Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, excessive bruising)
• Petechiae (small red or purple spots on the skin)
• Signs of internal bleeding (e.g., severe headache, abdominal pain, weakness, dizziness, black tarry stools, red or dark urine)
• Signs of Heparin-Induced Thrombocytopenia (HIT): new or worsening thrombosis, skin lesions at injection sites, acute systemic reactions after heparin administration, sudden drop in platelet count (>50% from baseline or <100,000/mm³)

Heparin is generally considered the anticoagulant of choice during pregnancy because it does not cross the placenta and therefore does not cause fetal anticoagulation or teratogenic effects. It is used for the treatment and prevention of venous thromboembolism (VTE) in pregnant women. However, maternal risks include bleeding, osteoporosis (with long-term use), and heparin-induced thrombocytopenia (HIT).

Heparin is considered safe during breastfeeding. It is a large molecule and is not excreted into breast milk in clinically significant amounts. It is not absorbed orally by the infant.

Heparin can be used safely in pediatric patients, including neonates, infants, children, and adolescents, for various thrombotic conditions. Dosing is weight-based and requires careful titration and monitoring of aPTT or anti-Xa levels due to differences in pharmacokinetics and pharmacodynamics compared to adults. Neonates and infants may require higher doses per kg due to higher antithrombin levels and faster clearance.

Elderly patients (≥65 years) may have an increased risk of bleeding with heparin therapy, particularly those with impaired renal function or multiple comorbidities. Lower initial doses or more conservative dosing strategies may be considered, and close monitoring for bleeding complications is essential.

• Heparin's anticoagulant effect is highly variable among individuals, necessitating careful laboratory monitoring (aPTT or anti-Xa levels) and dose titration.
• 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 increase in thrombotic risk. It usually occurs 5-10 days after initiation of heparin. Discontinue heparin immediately if HIT is suspected and initiate alternative non-heparin anticoagulation.
• Protamine sulfate is the specific antidote for heparin overdose. 1 mg of protamine sulfate neutralizes approximately 100 units of heparin.
• Heparin is not absorbed orally and must be administered parenterally (IV or SC).
• Subcutaneous heparin for prophylaxis should not be rubbed after injection, as this can increase bruising.
• Heparin can cause hyperkalemia by inhibiting aldosterone secretion, especially in patients with renal impairment or those on potassium-sparing diuretics.
• Avoid intramuscular injection of heparin due to the high risk of hematoma formation.

• Low Molecular Weight Heparins (LMWH) (e.g., enoxaparin, dalteparin): Often preferred for prophylaxis and outpatient treatment due to more predictable pharmacokinetics, once-daily dosing, and lower incidence of HIT.
• Direct Oral Anticoagulants (DOACs) (e.g., dabigatran, rivaroxaban, apixaban, edoxaban): Used for DVT/PE treatment and prevention, and stroke prevention in atrial fibrillation. Offer oral administration and do not require routine monitoring.
• Warfarin: Oral vitamin K antagonist, used for long-term anticoagulation. Requires regular INR monitoring.
• Fondaparinux: Synthetic pentasaccharide, selectively inhibits Factor Xa via ATIII. Used for DVT/PE prophylaxis and treatment, and in patients with a history of HIT.

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, and do not take medication prescribed for 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; 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; check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.