Urokinase
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Urokinase is a thrombolytic agent that is FDA approved for the treatment of pulmonary embolism. Common adverse reactions include bleeding and anaphylaxis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Pulmonary Embolism
- Dosing Information
- Loading dose: 4,400 IU/kg at a rate of 90 mL/h over a period of 10 minutes.
- Maintenance dose: Continuous infusion of 4,400 IU/kg/h at a rate of 15 mL for 12 hours.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Urokinase in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Urokinase in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Urokinase FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Urokinase in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Urokinase in pediatric patients.
Contraindications
The use of urokinase is contraindicated in patients with a history of hypersensitivity to the product.
Because thrombolytic therapy increases the risk of bleeding, urokinase is contraindicated in the situations listed below.
- Active internal bleeding
- Recent (e.g., within two months) cerebrovascular accident
- Recent (e.g., within two months) intracranial or intraspinal surgery
- Recent trauma including cardiopulmonary resuscitation
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Known bleeding diatheses
- Severe uncontrolled arterial hypertension
Warnings
Bleeding
- The risk of serious bleeding is increased with use of urokinase.
- Fatalities due to hemorrhage, including intracranial and retroperitoneal, have been reported in association with urokinase therapy.
- Concurrent administration of urokinase with other thrombolytic agents, anticoagulants, or agents inhibiting platelet function may further increase the risk of serious bleeding.
- urokinase therapy requires careful attention to all potential bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites, and other needle puncture sites).
- Intramuscular injections and nonessential handling of the patient must be avoided during treatment with urokinase.
- Venipunctures should be performed as infrequently as possible and with care to minimize bleeding.
- Should an arterial puncture be necessary, upper extremity vessels are preferable.
- Direct pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding.
- In the following conditions, the risk of bleeding may be increased and should be weighed against the anticipated benefits:
- Recent (within 10 days) major surgery, obstetrical delivery, organ biopsy, previous puncture of non-compressible vessels
- Recent (within 10 days) serious gastrointestinal bleeding
- High likelihood of a left heart thrombus, for example, mitral stenosis with atrial fibrillation
- Subacute bacterial endocarditis
- Hemostatic defects including those secondary to severe hepatic or renal disease
- Pregnancy
- Cerebrovascular disease
- Diabetic hemorrhagic retinopathy
- Any other condition in which bleeding might constitute a significant hazard or be particularly difficult to manage because of its location
- When internal bleeding occurs, it may be more difficult to manage than that which occurs with conventional anticoagulant therapy.
- Should potentially serious spontaneous bleeding (not controllable by direct pressure) occur, the infusion of urokinase should be terminated immediately, and measures to manage the bleeding implemented.
- Serious blood loss may be managed with volume replacement, including packed red blood cells.
- Dextran should not be used. When appropriate, fresh frozen plasma and/or cryoprecipitate may be considered to reverse the bleeding tendency.
=Anaphylaxis and Other Infusion Reactions
- Post-marketing reports of hypersensitivity reactions have included anaphylaxis (with rare reports of fatal anaphylaxis), bronchospasm, orolingual edema and urticaria
- There have also been reports of other infusion reactions which have included one or more of the following: fever and/or chills/rigors, hypoxia, cyanosis, dyspnea, tachycardia, hypotension, hypertension, acidosis, back pain, vomiting, and nausea.
- Reactions generally occurred within one hour of beginning urokinase infusion.
- Patients who exhibit reactions should be closely monitored and appropriate therapy instituted.
- Infusion reactions generally respond to discontinuation of the infusion and/or administration of intravenous antihistamines, corticosteroids, or adrenergic agents.
- Antipyretics which inhibit platelet function (aspirin and other non-steroidal anti-inflammatory agents) may increase the risk of bleeding and should not be used for treatment of fever.
Cholesterol Embolization
- Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown.
- This serious condition, which can be lethal, is also associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy.
- Clinical features of cholesterol embolism may include livedo reticularis, “purple toe” syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction and rhabdomyolysis.
Product Source and Formulation with Albumin
- urokinase is made from human neonatal kidney cells grown in tissue culture.
- Products made from human source material may contain infectious agents, such as viruses, that can cause disease.
- The risk that urokinase will transmit an infectious agent has been reduced by screening donors for prior exposure to certain viruses, by testing donors for the presence of certain current virus infections, by testing for certain viruses during manufacturing, and by inactivating and/or removing certain viruses during manufacturing.
- Despite these measures, urokinase may carry a risk of transmitting infectious agents, including those that cause Creutzfeldt-Jakob disease (CJD) or other diseases not yet known or identified; thus, the risk of transmission of infectious agents cannot be totally eliminated.
- A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is considered extremely remote.
- This product is formulated in 5% albumin, a derivative of human blood.
- Based on effective donor screening and product manufacturing processes, albumin carries an extremely remote risk for transmission of viral diseases.
- A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote.
- No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Urokinase Clinical Trials Experience in the drug label.
Postmarketing Experience
(Description)
Drug Interactions
- Drug 1
- Drug 2
- Drug 3
- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
(Description)
Labor and Delivery
(Description)
Nursing Mothers
(Description)
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Y-Site
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Admixture
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Syringe
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Urokinase
| |
| Systematic (IUPAC) name | |
| ? | |
| Identifiers | |
| CAS number | ? |
| ATC code | ? |
| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status | |
| Routes | ? |
Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
Clinical Studies
Condition 1
(Description)
Condition 2
(Description)
Condition 3
(Description)
How Supplied
(Description)
Storage
There is limited information regarding Urokinase Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Urokinase |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Urokinase |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Urokinase interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Urokinase Brand Names in the drug label.
Look-Alike Drug Names
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.