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Basic Drug Info
Drug Name:Heparin Sodium
Manufacturer:Hospira, Inc.
Other Info:

To OpenTear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed.

This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually.Preparation for Administration(Use aseptic technique)Close flow control clamp of administration set.Remove cover from outlet port at bottom of container.Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.

NOTE: See full directions on administration set carton.Suspend container from hanger.Squeeze and release drip chamber to establish proper fluid level in chamber.Open flow control clamp and clear air from set.

Close clamp.Attach set to venipuncture device.

If device is not indwelling, prime and make venipuncture.Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.



Clinical Trials:


Indications and Usage
Heparin sodium is indicated for:Atrial fibrillation with embolization;Diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);Prevention of clotting in arterial and heart surgery;Prophylaxis and treatment of peripheral arterial embolism; As an anticoagulant in extracorporeal arterial circulation and dialysis procedures.
Atrial Fibrillation -- Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation.

Blood Coagulation Disorders -- Hemorrhagic and thrombotic disorders that occur as a consequence of abnormalities in blood coagulation due to a variety of factors such as COAGULATION PROTEIN DISORDERS; BLOOD PLATELET DISORDERS; BLOOD PROTEIN DISORDERS or nutritional conditions.

Contraindications

Heparin sodium should not be used in patients:With severe thrombocytopenia;In whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc.

— cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);With an uncontrollable active bleeding state (see WARNINGS),except when this is due to disseminated intravascular coagulation.Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
Thrombocytopenia -- A subnormal level of BLOOD PLATELETS.

Disseminated Intravascular Coagulation -- A disorder characterized by procoagulant substances entering the general circulation causing a systemic thrombotic process. The activation of the clotting mechanism may arise from any of a number of disorders. A majority of the patients manifest skin lesions, sometimes leading to PURPURA FULMINANS.

Warnings

Heparin is not intended for intramuscular use.Hypersensitivity: Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations.Hemorrhage: Hemorrhage can occur at virtually any site in patients receiving heparin.

An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage.

Some of the conditions in which increased danger of hemorrhage exists are:Cardiovascular — Subacute bacterial endocarditis.

Severe hypertension.Surgical — During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye.Hematologic— Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia, and some vascular purpuras.Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.Other — Menstruation, liver disease with impaired hemostasis.Coagulation Testing: When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests.

If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly (see OVERDOSAGE).Thrombocytopenia : Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%.

Mild thrombocytopenia (count greater than 100,000/mm3) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops (see White Clot Syndrome, PRECAUTIONS), the heparin product should be discontinued.

If continued heparin therapy is essential, administration of heparin from a different organ source can be reinstituted with caution.The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.Excessive administration of potassium-free solutions may result in significant hypokalemia.Heparin Sodium contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.As the dosage of solutions of heparin sodium must be titrated to individual patient response, additive medications should not be delivered via this solution.
Branded Drugs
The following US Branded drugs contain Heparin Sodium


EMBOLEX -- NOVARTIS PHARMACEUTICALS CORP

HEPARIN LOCK FLUSH -- HOSPIRA INC

HEPARIN LOCK FLUSH -- INTERNATIONAL MEDICATION SYSTEMS LTD

HEPARIN LOCK FLUSH -- LUITPOLD PHARMACEUTICALS INC

HEPARIN LOCK FLUSH -- PARKE DAVIS DIV WARNER LAMBERT CO

HEPARIN LOCK FLUSH -- SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW

HEPARIN LOCK FLUSH -- SOLOPAK MEDICAL PRODUCTS INC

HEPARIN LOCK FLUSH IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- MCGAW INC

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% -- HOSPIRA INC

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% -- HOSPIRA INC

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% -- HOSPIRA INC

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% -- HOSPIRA INC

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% -- HOSPIRA INC

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- MCGAW INC

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% -- HOSPIRA INC

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% -- HOSPIRA INC

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- HOSPIRA INC

HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER -- MCGAW INC

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% -- HOSPIRA INC

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% -- HOSPIRA INC

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

HEPARIN SODIUM IN PLASTIC CONTAINER -- APP PHARMACEUTICALS LLC

HEPARIN SODIUM PRESERVATIVE FREE -- APP PHARMACEUTICALS LLC

HEPARIN SODIUM PRESERVATIVE FREE -- HOSPIRA INC

HEPARIN SODIUM PRESERVATIVE FREE -- MARSAM PHARMACEUTICALS LLC

HEPARIN SODIUM PRESERVATIVE FREE -- PHARMA SERVE INC SUB TORIGIAN LABORATORIES

LIPO-HEPIN -- 3M PHARMACEUTICALS INC

LIQUAEMIN LOCK FLUSH -- ORGANON USA INC

LIQUAEMIN SODIUM -- ORGANON USA INC

LIQUAEMIN SODIUM PRESERVATIVE FREE -- ORGANON USA INC

PANHEPRIN -- HOSPIRA INC

SODIUM HEPARIN -- ABRAXIS PHARMACEUTICAL PRODUCTS

SODIUM HEPARIN -- BAXTER HEALTHCARE CORP


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