HEPARIN SODIUM AND DEXTROSE- heparin sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)

Available from:

Hospira, Inc.

INN (International Name):

HEPARIN SODIUM

Composition:

HEPARIN 10000 [USP'U] in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heparin Sodium in 5% Dextrose Injection is indicated for: The use of Heparin Sodium in 5% Dextrose Injection is contraindicated in patients with the following conditions: Risk Summary In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses up to 10,000 USP units/kg/day, approximately 10 times the maximum recommended human dose (MRHD) of 40,000 USP units/24 hours infusion [see Data] . In pregnant animals, doses up to 10 times higher than the maximum human daily dose based on body weight resulted in increased resorptions. Consider the benefits and risks of Heparin Sodium in 5% Dextrose Injection to a pregnant woman and possible risks to the fetus when prescribing Heparin Sodium in 5% Dextrose Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. Animal Data In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 USP units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects. Risk Summary There is no information regarding the presence of Heparin Sodium in 5% Dextrose Injection in human milk, the effects on the breastfed infant, or the effects on milk production. Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Heparin Sodium in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Heparin Sodium in 5% Dextrose Injection or from the underlying maternal condition [see Use in Specific Populations (8.4)] . There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration (2.4)] . There are limited adequate and well-controlled studies in patients 65 years and older. However, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see Warnings and Precautions (5.2)] . Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology (12.3)] .

Product summary:

Intravenous solutions with heparin sodium are available in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table as follows: NDC 0409-7793-62 Case of 24 Single-dose flexible plastic containers 25,000 USP Units/250 mL (100 USP Units/mL) 5 g 39 42 Isotonic NDC 0409-4520-30 Case of 30 Single-dose flexible plastic containers 25,000 USP Units/250 mL (100 USP Units/mL) 5 g 39 42 Isotonic NDC 0409-7793-23 Case of 24 Single-dose flexible plastic containers 10,000 USP Units/100 mL (100 USP Units/mL) 5 g 39 42 Isotonic NDC 0409-7794-62 Case of 24 Single-dose flexible plastic containers 12,500 USP Units/250 mL (50 USP Units/mL) 5 g 38 42 Isotonic For the above Heparin Sodium products the pH range is 5.7 (5.0 to 6.0) and the osmolarity mOsmol/liter (calc.) is 304. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM AND DEXTROSE- HEPARIN SODIUM INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM IN 5%
DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR HEPARIN
SODIUM IN 5% DEXTROSE INJECTION.
HEPARIN SODIUM IN 5% DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Contraindications (4)
12/2023
Warnings and Precautions, Hemorrhage (5.2)
12/2023
Warnings and Precautions, Heparin-Induced
Thrombocytopenia (HIT) and Heparin-Induced
Thrombocytopenia and Thrombosis (HITT) (5.3)
12/2023
Warnings and Precautions, Hypersensitivity
Reactions (5.7)
12/2023
Warnings and Precautions, Hyperkalemia (5.8)
12/2023
Warnings and Precautions, Elevations of Serum
Aminotransferases (5.9)
12/2023
INDICATIONS AND USAGE
Heparin Sodium in 5% Dextrose Injection is indicated for: (1)
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DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
•
Intermittent Intravenous
Injection
Initial Dose
10,000 Units, either undiluted or in 50 to 100 mL of
5% Dextrose Injection
Subsequent Doses
5,000 to 10,000 Units every 4 to 6 hours, either
undiluted or in 50 to 100 mL of 5% Dextrose
Injection
Continuous Intravenous
Infusion
Initial Dose
5,000 Units by intravenous injection
Continuous
20,000 to 40,000 Units every 24 hours in 1000 mL of
5% Dextrose Injection
*Based on 150 lb. (68 kg) patient.
•
Intravascular via Total
Body Perfusion
Initial Dose
Greater than or equal to 150 units/kg; adjust for
longer procedures
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Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Prophylaxis and treatment of thromboembolic complications associated
with atrial fibrillation.
Treatment of acute and chronic consumption coagulopathies
(disseminated intravascular
coagulation).
Prevention of clotting in arterial and cardiac surgery.
Prophylaxis and treatment of peripheral arterial embolism.
Anticoagulant use in blood transfusions, extracorporeal circulation