heparin sodium 1,000 units in sodium chloride 0.9% in plastic container
Pharmaranks rates Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container (Heparin Sodium) is an anti-coagulant used to treat Unstable Angina, Cerebral Infarction, Coronary Thrombosis, Myocardial Infarction.
Heparin Sodium · by Fresenius Kabi USA
Generic of Panheprin
⚠ FDA reports a current shortage of the injection form (available) — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Heparin Sodium
- Drug class
- Anti-Coagulant
- Form
- Injectable
- Strength
- Heparin Sodium 200 UNITS/100ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Fresenius Kabi USA
- What the pharmacy pays
- ~$2.12 per ml — not your price
- FDA application
- ANDA212441
What is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container?
From the FDA label:Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, anhydrous, 37 mg and dibasic sodium phosphate, heptahydrate, 430 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.1 mEq; phosphate (as HPO 4 =) 32.1 mEq; citrate 5.8 mEq; and chloride 153.9 mEq. Osmolar concentration, 358 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6- sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of…
How to use
Infuse through intravenous catheter at a rate of 6 units per hour. ( 2.2 ) 2.1 Preparation for Administration Do not administer unless solution is clear and seal is intact. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warning: Do not use plastic containers in series connection. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Do not use Heparin Sodium in Sodium Chloride Injection as a “catheter lock flush” product. Do not admix with other drugs. Discard unused portion. INSTRUCTIONS FOR USE for the free flex ® Bag Leave bag in the overwrap until time of use. The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling. To Open: Always inspect the bag before and after removal from the overwrap. Place the bag on a clean, flat surface. Starting in the bottom corner, peel the overwrap open and remove the bag. Check the bag for leaks by squeezing firmly. If leaks are found, discard the bag. Do not use if the solution is cloudy or a precipitate is present. To Prepare for Administration: Immediately before connecting the infusion set, firmly grasp the BLUE…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] Heparin-Induced Thrombocytopenia and Heparin-Induced thrombocytopenia with Thrombosis [see Warnings and Precautions ( 5.2 )] Thrombocytopenia [see Warnings and Precautions ( 5.3 )] Heparin Resistance [see Warnings and Precautions ( 5.4 )] Hypersensitivity [see Warnings and Precautions ( 5.5 )] Increased Risk of Bleeding in Older Patients, Especially Women [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity, and elevations of aminotransferase levels. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Heparin Sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hemorrhage - Hemorrhage is the chief complication that may result from heparin therapy [see Warnings and Precautions ( 5.1 )] . An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the…
Warnings
Important safety information
Hemorrhage: Fatal hemorrhages have occurred. Monitor for signs of bleeding and manage promptly. ( 5.1 ) HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. ( 5.2 ) Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. ( 5.3 ) Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. ( 5.4 ) Hypersensitivity Reactions: Use in patients with prior reactions only in life threatening situations. ( 5.5 ) Increased Risk of Bleeding in Older Patients, Especially Women: A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age. ( 5.6 ) Laboratory Tests: Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration. ( 5.7 ) 5.1 Hemorrhage Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred. An unexplained fall in hematocrit or fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a hemorrhagic event. Use heparin sodium with caution in disease states in which there is increased risk of hemorrhage, including: Cardiovascular — Subacute bacterial endocarditis. Severe hypertension. Surgical — During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye. Hematologic — Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras. Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine. Patients with hereditary antithrombin III deficiency receiving concurrent antithrombin III therapy – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, reduce the heparin dose during concomitant treatment with antithrombin III (human). Other — Menstruation, liver disease with impaired hemostasis. 5.2 Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis Heparin-induced thrombocytopenia (HIT) is a serious immune-mediated reaction. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor-4-heparin complex that induce in vivo platelet aggregation HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia with thrombosis (HITT). Thrombotic events may also be the initial presentation for HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, thrombus formation on a prosthetic cardiac valve, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. If the platelet count falls below 100,000/mm 3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant. HIT or HITT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin sodium should be evaluated for HIT or HITT. HIT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT. 5.3 Thrombocytopenia Thrombocytopenia in patients receiving heparin has been reported to occur in patients receiving heparin at frequencies up to 30%. It can occur 2 to 20 days (average 5 to 9) following the onset of heparin therapy. Obtain platelet counts before and periodically during heparin therapy. If the count falls below 100,000/mm 3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant [see Warnings and Precautions ( 5.2 )]. 5.4 Heparin Resistance Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. 5.5 Hypersensitivity Reactions Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations. Because Heparin Sodium in Sodium Chloride Injection is derived from animal tissue, it should be used with caution in patients with a history of allergy. 5.6 Increased Risk of Bleeding in Older Patients, Especially Women A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Use in Specific Populations ( 8.5 )]. 5.7 Laboratory Tests Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.
Who should not take Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container
The use of HEPARIN SODIUM IN SODIUM CHLORIDE 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 ( 5.1 )] History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia with thrombosis (HITT) [see Warnings and Precautions ( 5.2 )] Severe thrombocytopenia [see Warnings and Precautions ( 5.3 )] Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 )] Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions: ( 4 ) Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation ( 5.1 ) History of heparin-induced thrombocytopenia (HIT) and heparin induced thrombocytopenia with thrombosis ( 5.2 ) Severe thrombocytopenia ( 5.3 ) Known hypersensitivity to heparin or pork products ( 5.5 , 6.1 )
Overdose — what happens if you take too much
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. No more than 50 mg should be administered, very slowly , 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Drugs that interfere with platelet aggregation or drugs that counteract coagulation may induce bleeding. ( 7 ) 7.1 Oral Anticoagulants Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn if a valid prothrombin time is to be obtained. 7.2 Platelet Inhibitors Drugs such as NSAIDS (including acetylsalicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIv/IIa antagonists (including abciximab, eptifobatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium. To reduce the risk of bleeding, a reduction in the dose of the antiplatelet agent or heparin is recommended. 7.3 Other Medications that May Interfere with Heparin Digitalis, tetracyclines, nicotine or antihistamines may partially counteract the anticoagulant action of heparin sodium. Intravenous nitroglycerin administered to heparinized patients may result in a decrease of the partial thromboplastin time with subsequent rebound effect upon discontinuation of nitroglycerin. Careful monitoring of partial thromboplastin time and adjustment of heparin dosage are recommended during coadministration of heparin and intravenous nitroglycerin. Antithrombin III (human) – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, a reduced dosage of heparin is recommended during treatment with antithrombin III (human).
Drug class
- Anti-coagulant
- Unfractionated Heparin
May treat (source: NIH RxClass)
- unstable angina
- cerebral infarction
- coronary thrombosis
- myocardial infarction
- postoperative complications
- pulmonary embolism
See how Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container ranks — best-rated anti-coagulant for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- What does Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container treat?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container (Heparin Sodium) may be used to treat unstable angina, cerebral infarction, coronary thrombosis, myocardial infarction, postoperative complications, pulmonary embolism, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container rated?
- pharmaranks gives Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.12 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container. To pay less, Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is marketed by Fresenius Kabi USA. You can see Fresenius Kabi USA's full profile, rating, and other products on pharmaranks.
- Is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container a brand-name or generic drug?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is a generic medication; its active ingredient is Heparin Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container available over the counter?
- No. Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container come in?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is classified as anti-coagulant, unfractionated heparin, per the FDA's Established Pharmacologic Class.
- Is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container FDA-registered?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container is on record with the U.S. FDA under application number ANDA212441. You can verify this on its official FDA label.
- Has Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container been recalled by the FDA?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container safe?
- There's no single safe-or-not verdict. pharmaranks gives Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container?
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] Heparin-Induced Thrombocytopenia and Heparin-Induced thrombocytopenia with Thrombosis [see Warnings and Precautions ( 5.2 )] Thrombocytopenia [see Warning… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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heparin sodium 1,000 units in sodium chloride 0.9% in plastic container
68/100