HEPARIN

Heparin Pregnancy Warnings

Early studies evaluating the safety and efficacy of heparin in pregnancy suggested heparin offered no advantage over other anticoagulants. However, these studies failed to recognize maternal comorbid conditions as possible risk factors for adverse pregnancy outcomes. Exclusion of these cases resulted in more favorable outcomes in the heparin treated patients. In a retrospective cohort study of 100 pregnancies in 77 women treated with heparin, the rates of prematurity, spontaneous abortions, stillbirths, neonatal deaths, as well as congenital abnormalities were not significantly different than those in the normal population. In addition, there was no evidence of increased risk of maternal complications such as bleeding with heparin when compared to the normal population. A medical literature review found similar results. When pregnancies associated with comorbid conditions as independent risk factors and pregnancies complicated by prematurity were excluded, outcomes in heparin treated pregnancies were not significantly different from the normal population. Several studies have evaluated the risk of osteoporosis in women treated with long-term heparin therapy. Symptomatic osteoporosis is uncommon, but reductions in bone density are well documented. The clinical significance of this remains to be determined. Neonatal osteopenia has not been noted. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages greater than 99 mg/kg/day in neonates and low-birthweight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

Heparin has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted and there are no controlled data in human pregnancy. It does not cross the placenta due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered the anticoagulant of choice during pregnancy, although anticoagulation and maternal disease state may pose a risk to both the mother and fetus. Heparin should be given during pregnancy only when need has been clearly established. Do not administer heparin, preserved with benzyl alcohol to pregnant women. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. Heparin, preservative free, when indicated, should be used in these populations.

Heparin Breastfeeding Warnings

Heparin is not excreted into human milk due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered compatible with breast-feeding. Do not administer heparin, preserved with benzyl alcohol to nursing mothers. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. Heparin, preservative free, when indicated, should be used in these populations.

Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages greater than 99 mg/kg/day in neonates and low-birthweight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

• Minor side effects (if these symptoms persist or worsen, inform your doctor).
  • Mild pain/redness/irritation at the injection site may occur.
• Serious side effects (inform your doctor immediately).
  • Swelling at injection site, bone pain, easily broken bones, pain/loss of feeling in the arms/legs, change in color of the arms/legs, chest pain, trouble breathing, confusion, weakness on one side of the body, slurred speech, vision changes.
  • May cause bleeding if its effect on your clotting proteins is too much:
    • unusual pain/swelling/discomfort, prolonged bleeding from cuts or gums, persistent nosebleeds, unusually heavy/prolonged menstrual periods, unusual/easy bruising, dark urine, black stools, severe headache, unusual dizziness.

• Severe allergic reactions are rare. Get immediate medical help if you notice the following:
  • Rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Precautions

• Inform your doctor
  • Allergy to the medication or to pork products or any allergies
  • Medical History of very low platelet count (thrombocytopenia), uncontrollable bleeding, high blood pressure (hypertension), heart problems (such as infection of the heart, heart attack), recent surgery/procedure, cancer, bleeding/clotting disorders (such as hemophilia, antithrombin III deficiency), stomach/intestinal ulcers or tube drainage, liver disease, current/recent bleeding (such as from wounds, menstrual period).

• To avoid getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and do not engage in activities such as contact sports.
• May cause stomach bleeding. Limit alcoholic beverages as this will increase your risk for bleeding.
• This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could worsen if you have more salt (such as congestive heart failure).
• Should only be used when there is a clear need during pregnancy as it may harm an unborn baby. If you are planning to be pregnant or think you may be pregnant, discuss the risks and benefits of use with your doctor.
• Does not pass into the breastmilk. Before breast-feeding, consult your physician.

Interactions

Taking multiple drugs may affect how medications work and/or cause unwanted side effects. List down all the medications you are taking and inform your physician and pharmacist. Do not take, discontinue, or alter any dose of medications without prior approval of your physician.

• Products that may interact with this medication include:
  • mifepristone, oritavancin, telavancin

• Sometimes used in conjuction with other drugs that have “blood thinning” or anti-platelet effects(ex. aspirin, clopidogrel, or warfarin). Keep all medical and laboratory appointments.

• Double check all the labels of the medications you are currently taking as many drugs contain pain relievers/fever reducers such as aspirin, NSAIDs such as aspirin, celecoxib, ibuprofen, ketorolac that may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise.

• Cigarette smoking decreases blood levels of this medication. Inform your physician if you smoke or if you have recently stopped smoking.

• Laboratory tests that may be affected:
  • liver function tests, prothrombin time

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Laboratory and/or medical tests (such as hematocrit, complete blood count, platelet counts, activated partial thromboplastin time, test for blood in stool) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

• Consult product instructions and your pharmacist for storage details
• Keep all medications away from pets and children

Brands

Available Brands

• Britton Heparin Na [ CCPC ]
• DéGa Heparin Sodium (Bovine) [ DéGa ]
• Hemastat [ Karnataka ]
• Heparin LEO [ LEO Pharma ]
• Hepastal [ Stallion Labs ]
• Heprin [ Gland Pharma ]

Also marketed as

• Bruhep 5000 [ Brawn Labs ]
• Heptin [ Mustafa ]
• Lioton Gel [ Transfarma ]
• Nuparin [ Troikaa Pharma ]