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Heparin sodium

Heparin is an injectable anticoagulant, nowadays usually made synthetically. The injectable form of heparin is commonly derived from porcine intestine. It is used both as an anticoagulant in people, and in various medical devices such as test tubes and extracorporeal circulation devices such as renal dialysis machines. more...

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Native heparin is a glycosaminoglycan with a molecular weight ranging from 6 kDa to 40 kDa. The average molecular weight of most commercial heparin preparations is in the range of 12 kDa to 15 kDa. Heparin consists of alternating units of sulfated D-glucosamine and D-glucuronic acid. Because of its ester and amide groups of sulfuric acid, it exists as the anion at physiologic pH and is usually administered as the sodium salt.

History

Heparin was originally isolated from liver cells, hence its name (hepar or "ηπαρ" is Greek for "liver"). Scientists were looking for an anticoagulant that could work safely in humans, and Jay McLean, a second-year medical student from Johns Hopkins University working under the guidance of William Henry Howell, found a compound extracted from liver that acted as an anticoagulant.

Mechanism of action

Heparin works by potentiating the action of antithrombin III, as it is similar to the heparan sulfate proteoglycans that are naturally present on the cell membrane of the endothelium. Because antithrombin III inactivates many coagulation proteins, the process of coagulation will slow down.

The effects of heparin are measured in the lab by the partial thromboplastin time (aPTT), (the time it takes the blood plasma to clot).

Administration

Heparin has to be adminstered parenterally: It is digested when taken by mouth. It can be injected intravenously, into a muscle, or subcutaneously (under the skin). Because of its short biologic half-life of approximately one hour, heparin must be given frequently or as a continuous infusion.

If long-term anticoagulation is required, heparin is often only used to commence anticoagulation therapy until the oral anticoagulant warfarin is working effectively.

Medical use

When given parenterally, heparin acts as an anticoagulant, preventing the formation of clots and extension of existing clots within the blood. While heparin does not break down clots that have already formed, it allows the body's natural clot lysis mechanisms to work normally to break down clots that have already formed. Heparin is used for anticoagulation for the following conditions:

Acute coronary syndrome, e.g., myocardial infarction
Atrial fibrillation
Deep-vein thrombosis/pulmonary embolism.

Other uses

Test tubes, Vacutainers, and capillary tubes that use lithium heparin as an anticoagulant are usually marked with green stickers and green tops. Heparin has the advantage over EDTA as an anticoagulant, as it does not affect levels of ions (such as calcium). Heparin can interfere with some immunoassays, however. As lithium heparin is usually used, a person's lithium levels cannot be obtained from these tubes; for this purpose, royal-blue topped Vacutainers containing sodium heparin are used.

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Vancomycin Hydrochloride and Heparin Sodium Injection
From International Journal of Pharmaceutical Compounding, 1/1/04

METHOD OF PREPARATION

Note: This preparation should be prepared in a laminar airflow hood in a cleanroom (or via isolation barrier technology) by a validated aseptic compounding pharmacist using strict aseptic technique.

1. Calculate the required quantity of each ingredient for the total amount to be prepared.

2. Reconstitute the vancomycin hydrochloride for injection according to the manufacturer's instructions.

3. Aseptically, add the vancomycin hydrochloride and heparin sodium solution to the sodium chloride for injection and mix well.

4. Package and label.

PACKAGING

The final package is usually the sodium chloride for injection container.

LABELING

For professional use only. Use only as directed. Discard after ________ (see below).

STABILITY

Due to the variability in vancomycin hydrochloride formulations, the manufacturer's literature should be referenced for establishing a beyond-use date. One study reported a beyonduse date of 5 days for this type of preparation.1

USE

Vancomycin hydrochloride and heparin solution is used to prevent infections in central venous catheters and heparin locks/ports.2

QUALITY CONTROL

Quality-control assessment can include weight/volume, physical observation, pH, specific gravity, osmolality, assay, color, clarity, particulate matter, sterility and pyrogenicity.3,4

DISCUSSION

Long-term drug administration through central venous catheters requires heparin to maintain patency of the injection port and catheter. Infections can be a problem in some patients; therefore, various antibiotics have been used to decrease their frequency, including cefazolin, ceftazidime, ciprofloxacin, gentamicin, vancomycin and others. A number of studies have reported the stability and compatibility of vancomycin with heparin solutions.5-9

Vancomycin hydrochloride (C^sub 66^H^sub 75^Cl^sub 2^N^sub 9^O^sub 24^.HCl, MW 1485.71) occurs as a tan to brown, free-flowing powder that is odorless but has a bitter taste. It is freely soluble in water.10

Vancomycin hydrochloride injection contains not more than 0.33 USP Endotoxin units per milligram of vancomycin. The pH of a 50-mg/mL solution is between 2.5 and 4.5.10

Heparin sodium is the sodium salt of sulfated glycosaminoglycans present as a mixture of heterogeneous molecules varying in molecular weights. It is usually obtained from the intestinal mucosa or other suitable tissues of domestic mammals used for food by man. It occurs as a white or pale-colored, amorphous, odorless (or almost odorless) hygroscopic powder that is soluble in water. The pH of the injection is between 5.0 and 7.5. It contains not more than 0.03 USP Endotoxin units per USP heparin unit.10

Sodium chloride injection contains not less than 95.0% and not more than 105.0% of the labeled amount of sodium chloride in water for injection. It has a pH between 4.5 and 7.0 and contains no added antimicrobial agents.10,11

REFERENCES

1. Vaughan LM, Poon CY. Stability of ceftazidime and vancomycin alone and in combination in heparinized and nonheparinized peritoneal dialysis solution. Ann Pharmacothei 1994;28:572-576.

2. Barriga FJ, Varas M, Potin M et al. Efficacy of a vancomycin solution to prevent bacteremia associated with an indwelling central venous catheter in neutropenic and non-neutropenic cancer patients. Med Pediatr Oncol 1997)28:196-200.

3. Alien LV Jr. Standard operating procedure for particulate testing for sterile products. IJPC 1998:2:78.

4. Alien LV Jr. Standard operating procedure: Quality assessment for injectable solutions. IJPC 1999;3:406-407.

5. Yao JD, Arkin CF, Karchmer AW. Vancomycin stability in heparin and total parenteral nutrition solutions: Novel approach to therapy of central venous catheter-related infections. J Parenter Enterai Nutr 1992;16:268-274.

6. Vercaigne LM, Sitar DS, Penner SB et al. Antibiotic-heparin lock: In vitro antibiotic stability combined with heparin in a central venous catheter. Pharmacotherapy 2000;20:394-399.

7. Anthony TU, Rubin LG. Stability of antibiotics used for antibiotic-lock treatment of infections of implantable venous devices (ports). Antimicrob Agents Chemother 1999;43:2074-2076.

8. Haimi-Cohen Y, Husain N, Meenan J et al. Vancomycin and ceftazidime bioactivities persist for at least 2 weeks in the lumen in ports: Simplifying treatment of port-associated bloodstream infections by using the antibiotic lock technique. Antimicrob Agents Chemother 2001:45:1565-1567.

9. Droste JC, Jeraj HA, MacDonald A et al. Stability and in vitro efficacy of antibiotic-heparin lock solutions potentially useful for treatment of central venous catheter-related sepsis. J Antimicrob Chemother 2003:51:849-855.

10. US Pharmacopeial Convention, Inc. United States Pharmacopeia 26-NationalFormulary 21. Rockville, MD:US Pharmacopeial Convention, Inc.; 2003:897-898, 1691, 1920-1922, 2197-2201, 2563, 2586.

11. Cable CG. Sodium chloride. In: Kibbe AH, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:478-481.

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