HEPARIN SODIUM- 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:

Fresenius Kabi USA, LLC

INN (International Name):

HEPARIN SODIUM

Composition:

HEPARIN 5000 [USP'U] in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heparin sodium is indicated for: - Prophylaxis and treatment of venous thromboembolism and pulmonary embolism; - 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 in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection is contraindicated in patients with the following conditions: - History of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) [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 thro

Product summary:

Heparin Sodium in 0.45% Sodium Chloride Injection is supplied as follows: Heparin Sodium in 5% Dextrose Injection is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Avoid excessive heat.  Do not freeze. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM - HEPARIN SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM IN
0.45% SODIUM CHLORIDE INJECTION OR HEPARIN SODIUM IN 5% DEXTROSE
INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HEPARIN SODIUM
IN 0.45% SODIUM
CHLORIDE INJECTION OR HEPARIN SODIUM IN 5% DEXTROSE INJECTION.
HEPARIN SODIUM, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
RX ONLY
INDICATIONS AND USAGE
Heparin sodium is an anticoagulant indicated for: (1)
Prophylaxis and treatment of venous thromboembolism and pulmonary
embolism
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.
DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
Intermittent Intravenous Injection
Initial Dose
10,000 units
Every 4 to 6 hours
5,000 to 10,000 units
Continuous Intravenous Infusion
Initial Dose
5,000 units by intravenous injection
Continuous
20,000 to
40,000 units/24 hours
*Based on 150 lb. (68 kg) patient.
Surgery of the Heart and Blood Vessels (2.5)
Intravascular via Total Body Perfusion
Initial Dose
≥ 150 units/kg; adjust for longer
procedures
Extracorporeal Dialysis (2.8)
Intravascular via Extracorporeal Dialysis
Follow equipment manufacturer’s operating
directions carefully.
See full prescribing information for recommended pediatric dosage.
(2.4)
DOSAGE FORMS AND STRENGTHS
Heparin sodium is available as: (3)
_HEPARIN SODIUM IN 0.45% SODIUM CHLORIDE INJECTION:_
Injection: 50 USP units per mL in 0.45% Sodium Chloride clear solution
(25,000 USP units per 500 mL)
in single-dose FREE_flex_
bag
Injection: 100 USP units per mL in 0.45% Sodium Chloride clear