DailyMed Label: Heparin Sodium in Sodium Chloride

DailyMed Label: Heparin Sodium in Sodium Chloride

2023

DailyMed Prescription

Heparin Sodium in Sodium Chloride

Heparin Sodium in Sodium Chloride

B. Braun Medical Inc.

NDC: 0264-9872

NDC: 0264-9872

Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations of  alpha-L-iduronic acid 2-sulfate (1),  2-deoxy-2-sulfamino-alpha-D-glucose 6-sulfate (2),  beta-D-glucuronic acid (3),  2-acetamido-2-deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5). Structure of Heparin Sodium (representative subunits): Heparin Sodium in 0.9% Sodium Chloride Injection is a sterile, single-dose, clear, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) in 0.9% Sodium Chloride Injection. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Each 100 mL contains 200 USP Units Heparin Sodium, 0.43 g Dibasic Sodium Phosphate•7H 2 O USP and 0.037 g Citric Acid Anhydrous USP as a buffer system, 0.9 g Sodium Chloride USP, and Water for Injection USP qs. pH: 7.0 (6.8-7.2); Calculated Osmolarity:  360 mOsmol/liter Concentration of Electrolytes (mEq/liter):  Sodium 186; Chloride 154; Phosphate (HPO ) 32; Citrate 6 The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The plastic container is not made with natural rubber latex, PVC or DEHP. The closure system has two ports; the one for the administration set has a tamper evident plastic protector.

Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency.

HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION is a sterile, single-dose, clear, nonpyrogenic solution available as: Heparin Sodium 1,000 USP units per 500 mL (2 USP units per mL) in 0.9% Sodium Chloride Injection. Heparin Sodium 2,000 USP units per 1,000 mL (2 USP units per mL) in 0.9% Sodium Chloride Injection.

The use of HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION is contraindicated in patients with the following conditions: Uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation [see Warnings and Precautions (5.2) ] History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT) [see Warnings and Precautions (5.3) ] Severe thrombocytopenia [see Warnings and Precautions ( 5.3 , 5.4 )] Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions (5.5)  and Adverse Reactions (6.1) ]

The following serious adverse reactions are described elsewhere in the labeling:

Heparin Sodium in 0.9% Sodium Chloride Injection is a clear solution and is supplied sterile and nonpyrogenic in single-dose EXCEL ® Containers. The 1,000 mL containers are packaged 12 per case and 500 mL containers are packaged 24 per case. NDC   REF   Concentration Size    0264-9872-10  P8721 Heparin Sodium 1,000 USP units per 500 mL (2 USP units per mL) in 0.9% Sodium Chloride Injection   500 mL  0264-9872-00 P8720  Heparin Sodium 2,000 USP units per 1,000 mL (2 USP units per mL) in 0.9% Sodium Chloride Injection  1,000 mL  Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the closing sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.

Long term studies in animals to evaluate the carcinogenic potential, reproduction studies in animals to determine effects on fertility of males and females, and studies to determine mutagenic potential have not been conducted.

NDC 0264-9872-00 HEPARIN SODIUM in 0.9% Sodium Chloride Injection 2,000 USP units per 1000 mL (2 USP units per mL) LD-756-1   Y94-003-481 For Intravenous Use Only Each 100 mL contains: Heparin Sodium USP (porcine intestinal mucosa) 200 USP Heparin units; Sodium Chloride USP 0.9 g; Dibasic Sodium Phosphate•7H 2 O USP 0.43 g; Citric Acid Anhydrous USP 0.037 g; Water for Injection USP qs Electrolytes (mEq/liter):     Sodium  186;     Chloride  154;                                               Phosphate (HPO ) 32;      Citrate  6 WARNING: Do not admix with other drugs. Sterile. Single dose container. Discard unused portion. Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. Recommended Dosage: see Prescribing Information. Do not remove overwrap until ready for use. Not made with natural rubber latex, PVC or DEHP. EXCEL is a registered trademark of B. Braun Medical Inc. 1000 mL   EXCEL ®  CONTAINER Rx only REF P8720 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Prepared in USA. API from Spain. Y94-003-480   LD-755-1 EXP LOT