HEPARIN SODIUM injection HEPARIN SODIUM injection

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Hikma Pharmaceuticals USA Inc.

INN（国际名称）:

HEPARIN SODIUM

组成:

HEPARIN 1000 [USP'U] in 1 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Heparin Sodium Injection is indicated for: - Prophylaxis and treatment of venous thrombosis and pulmonary embolism; - Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; - Atrial fibrillation with embolization; - Treatment of acute and chronic consumptive 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, and dialysis procedures. The use of Heparin Sodium Injection is contraindicated in patients with the following conditions: - History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)] ; - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1)] ; - 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); - An uncontrolled active bleeding state [see Warnings and Precautions (5.2) ], except when this is due to disseminated intravascular coagulation. Risk Summary There are no available data on Heparin Sodium Injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.  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, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 45,000 units/day [see Data ]. Consider the benefits and risks of Heparin Sodium Injection for the mother and possible risks to the fetus when prescribing Heparin Sodium Injection to a pregnant woman. If available, preservative-free Heparin Sodium Injection is recommended when heparin therapy is needed during pregnancy. There are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see Warnings and Precautions (5.4) ] The 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 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 If available, preservative-free Heparin Sodium Injection is recommended when heparin therapy is needed during lactation. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. There is no information regarding the presence of Heparin Sodium 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 Injection and any potential adverse effects on the breastfed infant from Heparin Sodium 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 (2.5) ]. Carefully examine all Heparin Sodium Injection vials and syringes to confirm choice of the correct strength prior to administration of the drug. Pediatric patients, including neonates, have died as a result of medication errors in which Heparin Sodium Injection vials have been confused with “catheter lock flush” vials [see Warnings and Precautions (5.1) ]. Benzyl Alcohol Toxicity Use preservative-free Heparin Sodium Injection in neonates and infants. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. 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, particularly women, over 60 years of age [see Warnings and Precautions (5.2) ]. Patients over 60 years of age may require lower doses of heparin. Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology (12.3) ].

產品總結:

Heparin Sodium Injection preserved with benzyl alcohol is available in the following strengths and package sizes in single-dose vials: DESCRIPTION NDC 1,000 USP units/mL    25 vials: 1,000 USP units/mL, single-dose* 0641-0391-12 5,000 USP units/mL    25 vials: 5,000 USP units/mL, single-dose* 0641-0400-12 10,000 USP units/mL    25 vials: 10,000 USP units/mL, single-dose* 0641-0410-12 *Discard unused portion Heparin Sodium Injection preserved with benzyl alcohol is available in the following strengths and package sizes in multiple-dose vials: DESCRIPTION NDC 1,000 USP units/mL   1 vial: 30,000 USP units/30 mL, multiple-dose    25 vials: 30,000 USP units/30 mL, multiple-dose 0641-2450-55 5,000 USP units/mL   1 vial: 50,000 USP units/10 mL, multiple-dose    25 vials: 50,000 USP units/10 mL, multiple-dose 0641-2460-55 Heparin Sodium Injection preservative-free is available in the following strengths and package sizes in single-dose prefilled syringes: DESCRIPTION NDC 5,000 USP units/mL 1 Syringe: 5,000 USP units/mL, single-dose* 0641-6199-01 10 Syringes: 5,000 USP units/mL, single-dose* 0641-6199-10 *Discard unused portion Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

授权状态:

New Drug Application

产品特点

HEPARIN SODIUM- HEPARIN SODIUM INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HEPARIN SODIUM
INJECTION.
HEPARIN SODIUM INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
HEPARIN SODIUM INJECTION is an anticoagulant indicated for (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prevention of postoperative deep venous thrombosis and pulmonary
embolism in patients undergoing
major abdominothoracic surgery or who, for other reasons, are at risk
of developing thromboembolic
disease
Atrial fibrillation with embolization
Treatment of acute and chronic consumptive coagulopathies
(disseminated intravascular coagulation)
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Use as an anticoagulant in blood transfusions, extracorporeal
circulation, and dialysis procedures
DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
Therapeutic Anticoagulant Effect with Full-Dose Heparin (2.4)
Deep Subcutaneous
(Intrafat) Injection
_Use a different site for_
_each injection_
Initial Dose
5,000 units by intravenous injection, followed by 10,000 to 20,000
units
of a concentrated solution, subcutaneously
Every 8
hours
or
Every 12
hours
8,000 to 10,000 units of a concentrated solution
15,000 to 20,000 units of a concentrated solution
Intermittent
Intravenous Injection
Initial dose
10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium
Chloride Injection, USP
Every 4 to
6 hours
5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9%
Sodium Chloride Injection, USP
Intravenous Infusion
Initial dose 5,000 units by intravenous injection
Continuous
20,000 to 40,000 units/24 hours in 1000 mL of 0.9% Sodium Chloride
Injection, USP (or in any compatible solution) for infusion
Based on 150 lb (68 kg) patien