Sandbox Abciximab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Sandbox Abciximab is a Platelet aggregation inhibitor that is FDA approved for the {{{indicationType}}} of prevention of cardiac ischemic complications in patients undergoing percutaneous coronary intervention and in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours. Common adverse reactions include Chest pain , Hypotension ,Injection site pain ,Abdominal pain , Nausea, Vomiting Bleeding Backache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Preparation of PCI
- Dosing Information
- initial dosage:0.25 mg/kg IV bolus (10-60 minutes before the start of PCI)
- maitaining dosage: 0.125 mg/kg/min IV for 12 hours (max 10 ug/min)
Treatment of patient with unstable angina planned to undergo PCI within 24 hours
- Dosing Information
- initial dosage:0.25 mg/kg IV (10-60 minutes before the start of PCI)
- maitaining dosage: 10 ug/min IV for 18- 24h(concluding one hour after the PCI)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Myocardial ischemia
- Class of Recommendation: Class IIa
- Level of Evidence: Level A
- Recommendation
- initial dosage: 0.25 mg/kg IV bolus (over 5 minutes)
- maitaing dosage: 10 ug/min IV (continued for 12 hours unless complications developed)
Non–Guideline-Supported Use
Acute myocardial infarction
- Dosing information
- initial dosage: 0.25 mg/kg IV bolus
- maitaing dosage: 10 ug/min IV for 12h [1]
Acute arterial thrombosis
- Dosing information
- initial dosage: 0.25 mg/kg IV bolus
- maitaing dosage: 10 ug/min IV for 12h [2]
Cerebrovascular accident
- Dosing information
- initial dosage: 0.25 mg/kg IV bolus
- maitaing dosage: 10 ug/min IV for 12h [3]
Myocardial infarction
- Dosing information
- initial dosage: 0.25 mg/kg IV bolus
- maitaing dosage: 10 ug/min IV for 12h [4]
Prophylaxis of myocardial ischemia
- Dosing information
- initial dosage: 0.25 mg/kg IV bolus
- maitaing dosage: 10 ug/min IV for 12h
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sandbox Abciximab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Non–Guideline-Supported Use
Aneurysm of coronary vessels
- Dosing information
- loading dose: 0.25 mg/kg IV
- follow-up: 0.125 mg/min IV for 12h [5]
Contraindications
There is limited information regarding Sandbox Abciximab Contraindications in the drug label.
Warnings
There is limited information regarding Sandbox Abciximab Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Sandbox Abciximab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Sandbox Abciximab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Sandbox Abciximab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sandbox Abciximab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox Abciximab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sandbox Abciximab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sandbox Abciximab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Sandbox Abciximab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sandbox Abciximab in geriatric settings.
Gender
There is no FDA guidance on the use of Sandbox Abciximab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sandbox Abciximab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sandbox Abciximab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sandbox Abciximab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sandbox Abciximab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sandbox Abciximab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Sandbox Abciximab Administration in the drug label.
Monitoring
There is limited information regarding Sandbox Abciximab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Sandbox Abciximab and IV administrations.
Overdosage
There is limited information regarding Sandbox Abciximab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Sandbox Abciximab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Sandbox Abciximab Mechanism of Action in the drug label.
Structure
There is limited information regarding Sandbox Abciximab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Sandbox Abciximab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Sandbox Abciximab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sandbox Abciximab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sandbox Abciximab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Sandbox Abciximab How Supplied in the drug label.
Storage
There is limited information regarding Sandbox Abciximab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Sandbox Abciximab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sandbox Abciximab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Sandbox Abciximab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Sandbox Abciximab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Giri S, Mitchel J, Azar RR, Kiernan FJ, Fram DB, McKay RG et al. (2002) Results of primary percutaneous transluminal coronary angioplasty plus abciximab with or without stenting for acute myocardial infarction complicated by cardiogenic shock. Am J Cardiol 89 (2):126-31. PMID: 11792329
- ↑ Duda SH, Tepe G, Luz O, Ouriel K, Dietz K, Hahn U et al. (2001) Peripheral artery occlusion: treatment with abciximab plus urokinase versus with urokinase alone--a randomized pilot trial (the PROMPT Study). Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis. Radiology 221 (3):689-96. DOI:10.1148/radiol.2213010400 PMID: 11719664
- ↑ Abciximab in Ischemic Stroke Investigators (2000) Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose-escalation study. Stroke 31 (3):601-9. PMID: 10700492
- ↑ (2000) Trial of abciximab with and without low-dose reteplase for acute myocardial infarction. Strategies for Patency Enhancement in the Emergency Department (SPEED) Group. Circulation 101 (24):2788-94. PMID: 10859283
- ↑ Williams RV, Wilke VM, Tani LY, Minich LL (2002) Does Abciximab enhance regression of coronary aneurysms resulting from Kawasaki disease? Pediatrics 109 (1):E4. PMID: 11773572