Heparin Sodium in Dextrose

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Overview

What is Heparin Sodium in Dextrose?

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 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from heparin sodium (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP in Water for Injection USP. 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.

The pH range is 5.6 (4.5 – 7.0) and the osmolarity mOsmol/L (calc.) is 315. The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate.

40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient.

50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient.

100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP, 0.0686 g Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient.

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.

What does Heparin Sodium in Dextrose look like?

What are the available doses of Heparin Sodium in Dextrose?

HEPARIN SODIUM IN 5% DEXTROSE INJECTION is available as:

•     Heparin Sodium 20,000 USP units per 500 mL (40 USP units per mL) in 5% Dextrose Injection.

•     Heparin Sodium 25,000 USP units per 500 mL (50 USP units per mL) in 5% Dextrose Injection.

•     Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection.

What should I talk to my health care provider before I take Heparin Sodium in Dextrose?

How should I use Heparin Sodium in Dextrose?

Heparin sodium is indicated for:

Confirm the selection of the correct formulation and strength prior to administration of the drug. Do not use Heparin Sodium in 5% Dextrose Injection as a “catheter lock flush” product.Do not admix with other drugs.Do not use plastic containers in series connection. This product should not be infused under pressure.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

What interacts with Heparin Sodium in Dextrose?

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What are the warnings of Heparin Sodium in Dextrose?

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What are the precautions of Heparin Sodium in Dextrose?

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What are the side effects of Heparin Sodium in Dextrose?

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What should I look out for while using Heparin Sodium in Dextrose?

The use of HEPARIN SODIUM is contraindicated in patients:

•     With history of heparin-induced thrombocytopenia (HIT) (With or Without Thrombosis) []

•     With a known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) []

•     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) []

What might happen if I take too much Heparin Sodium in Dextrose?

Bleeding is the chief sign of heparin overdosage.

Neutralization of heparin effect:

When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. should be administered, , in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100 USP Heparin Units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 1/2 hour after intravenous injection.

Because fatal reactions often resembling anaphylaxis have been reported, protamine sulfate should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.

For additional information, consult the prescribing information for Protamine Sulfate Injection, USP.

How should I store and handle Heparin Sodium in Dextrose?

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both and . Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. 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.

Non-Clinical Toxicology

The use of HEPARIN SODIUM is contraindicated in patients:

•     With history of heparin-induced thrombocytopenia (HIT) (With or Without Thrombosis) []

•     With a known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) []

•     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) []

Drug Interactions

Effect of Concomitant Use of Benzodiazepines and Opioids:

In a study in which the 2 mg clonazepam orally disintegrating tablet was administered with and without propantheline (an anticholinergic agent with multiple effects on the GI tract) to healthy volunteers, the AUC of clonazepam was 10% lower and the C of clonazepam was 20% lower when the orally disintegrating tablet was given with propantheline compared to when it was given alone.

Fluoxetine does not affect the pharmacokinetics of clonazepam. Cytochrome P-450 inducers, such as phenytoin, carbamazepine and phenobarbital, induce clonazepam metabolism, causing an approximately 30% decrease in plasma clonazepam levels. Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents, should be used cautiously in patients receiving clonazepam.

Do not use this product as a “catheter lock flush” product. Heparin is supplied in various strengths. Fatal hemorrhages have occurred due to medication errors. Carefully examine all heparin products to confirm the correct container choice prior to administration of the drug.

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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