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REOPRO
Overview
What is REOPRO?
Abciximab, ReoPro, is the Fab fragment of the chimeric human-murine monoclonal antibody 7E3. Abciximab binds to the glycoprotein (GP) IIb/IIIa receptor of human platelets and inhibits platelet aggregation. Abciximab also binds to the vitronectin (αβ) receptor found on platelets and vessel wall endothelial and smooth muscle cells.
The chimeric 7E3 antibody is produced by continuous perfusion in mammalian cell culture. The 47,615 dalton Fab fragment is purified from cell culture supernatant by a series of steps involving specific viral inactivation and removal procedures, digestion with papain and column chromatography.
ReoPro is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use. Each single use vial contains 2 mg/mL of Abciximab in a buffered solution (pH 7.2) of 0.01 M sodium phosphate, 0.15 M sodium chloride and 0.001% polysorbate 80 in Water for Injection. No preservatives are added.
What does REOPRO look like?
What are the available doses of REOPRO?
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What should I talk to my health care provider before I take REOPRO?
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How should I use REOPRO?
Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications
Safety and efficacy of Abciximab use in patients not undergoing percutaneous coronary intervention have not been established.
Abciximab is intended for use with aspirin and heparin and has been studied only in that setting, as described in .
The safety and efficacy of Abciximab have only been investigated with concomitant administration of heparin and aspirin as described in .
In patients with failed PCIs, the continuous infusion of Abciximab should be stopped because there is no evidence for Abciximab efficacy in that setting.
In the event of serious bleeding that cannot be controlled by compression, Abciximab and heparin should be discontinued immediately.
The recommended dosage of Abciximab in adults is a 0.25 mg/kg intravenous bolus administered 10-60 minutes before the start of PCI, followed by a continuous intravenous infusion of 0.125 μg/kg/min (to a maximum of 10 μg/min) for 12 hours.
Patients with unstable angina not responding to conventional medical therapy and who are planned to undergo PCI within 24 hours may be treated with an Abciximab 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour intravenous infusion of 10 μg/min, concluding one hour after the PCI.
What interacts with REOPRO?
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What are the warnings of REOPRO?
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What are the precautions of REOPRO?
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What are the side effects of REOPRO?
Bleeding-
In the EPIC trial, in which a non-weight-adjusted, longer-duration heparin dose regimen was used, the most common complication during Abciximab therapy was bleeding during the first 36 hours. The incidences of major bleeding, minor bleeding and transfusion of blood products were significantly increased. Major bleeding occurred in 10.6% of patients in the Abciximab bolus plus infusion arm compared with 3.3% of patients in the placebo arm. Minor bleeding was seen in 16.8% of Abciximab bolus plus infusion patients and 9.2% of placebo patients (7). Approximately 70% of Abciximab-treated patients with major bleeding had bleeding at the arterial access site in the groin. Abciximab-treated patients also had a higher incidence of major bleeding events from gastrointestinal, genitourinary, retroperitoneal, and other sites.
Bleeding rates were reduced in the CAPTURE trial, and further reduced in the EPILOG and EPISTENT trials by use of modified dosing regimens and specific patient management techniques. In EPILOG and EPISTENT, using the heparin and Abciximab dosing, sheath removal and arterial access site guidelines described under PRECAUTIONS, the incidence of major bleeding in patients treated with Abciximab and low-dose, weight-adjusted heparin was not significantly different from that in patients receiving placebo.
Subgroup analyses in the EPIC and CAPTURE trials showed that non-CABG major bleeding was more common in Abciximab patients weighing ≤ 75 kg. In the EPILOG and EPISTENT trials, which used weight-adjusted heparin dosing, the non-CABG major bleeding rates for Abciximab-treated patients did not differ substantially by weight subgroup.
Although data are limited, Abciximab treatment was not associated with excess major bleeding in patients who underwent CABG surgery. (The range among all treatment arms was 3-5% in EPIC, and 1-2% in the CAPTURE, EPILOG, and EPISTENT trials.) Some patients with prolonged bleeding times received platelet transfusions to correct the bleeding time prior to surgery. (.)
The rates of major bleeding, minor bleeding and bleeding events requiring transfusions in the CAPTURE, EPILOG, and EPISTENT trials are shown in . The rates of insignificant bleeding events are not included in .
Cases of fatal bleeding have been reported rarely during post-marketing use of Abciximab ().
Pulmonary alveolar hemorrhage has been rarely reported during use of Abciximab. This can present with any or all of the following in close association with ReoPro administration: hypoxemia, alveolar infiltrates on chest x-ray, hemoptysis, or an unexplained drop in hemoglobin.
| a | ||||
| b | ||||
| c | ||||
| d | ||||
| e | ||||
| f | EPILOG and EPISTENT: | |||
| c | (n=1748) | Abciximab +Low-dose Heparin | Abciximab +Standard-dose Heparin | |
| Major | 18 (1.0) | 21 (0.8) | 17 (1.9) | |
| Minor | 46 (2.6) | 82 (3.2) | 70 (7.6) | |
| Requiring transfusion | 15 (0.9) | 13 (0.5) | 7 (0.8) | |
| CAPTURE: | ||||
| Placebo | Abciximab | |||
| Major | 12 (1.9) | 24 (3.8) | ||
| Minor | 13 (2.0) | 30 (4.8) | ||
| Requiring transfusion | 9 (1.4) | 15 (2.4) |
Intracranial Hemorrhage and Stroke-
Thrombocytopenia-
Among patients in the EPILOG and EPISTENT trials who were treated with Abciximab plus low-dose heparin, the proportion of patients with any thrombocytopenia (platelets less than 100,000 cells/μL) ranged from 2.5 to 3.0%. The incidence of severe thrombocytopenia (platelets less than 50,000 cells/μL) ranged from 0.4 to 1.0% and platelet transfusions were required in 0.9 to 1.1%, respectively. Modestly lower rates were observed among patients treated with placebo plus standard-dose heparin. Overall higher rates were observed among patients in the EPIC and CAPTURE trials treated with Abciximab plus longer duration heparin: 2.6 to 5.2% were found to have any thrombocytopenia, 0.9 to 1.7% had severe thrombocytopenia, and 2.1 to 5.5% required platelet transfusion, respectively.
In a readministration registry study of patients receiving a second or subsequent exposure to Abciximab () the incidence of any degree of thrombocytopenia was 5%, with an incidence of profound thrombocytopenia of 2% (<20,000 cell/μL). Factors associated with an increased risk of thrombocytopenia were a history of thrombocytopenia on previous Abciximab exposure, readministration within 30 days, and a positive HACA assay prior to the readministration.
Among 14 patients who had thrombocytopenia associated with a prior exposure to Abciximab, 7 (50%) had recurrent thrombocytopenia. In 130 patients with a readministration interval of 30 days or less, 25 (19%) developed thrombocytopenia. Severe thrombocytopenia occurred in 19 of these patients. Among the 71 patients who had a positive HACA assay at baseline, 11 (15%) developed thrombocytopenia, 7 of which were severe.
Allergic Reactions
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Other Adverse Reactions-
The following additional adverse events from the EPIC, EPILOG and CAPTURE trials were reported by investigators for patients treated with a bolus plus infusion of Abciximab at incidences which were less than 0.5% higher than for patients in the placebo arm.
Cardiovascular System: ventricular tachycardia (1.4%), pseudoaneurysm (0.8%), palpitation (0.5%), arteriovenous fistula (0.4%), incomplete AV block (0.3%), nodal arrhythmia (0.2%), complete AV block (0.1%), embolism (limb) (0.1%); thrombophlebitis (0.1%);
Gastrointestinal System: dyspepsia (2.1%), diarrhea (1.1%), ileus (0.1%), gastroesophogeal reflux (0.1%);
Hemic and Lymphatic System: anemia (1.3%), leukocytosis (0.5%), petechiae (0.2%);
Nervous System: dizziness (2.9%), anxiety (1.7%), abnormal thinking (1.3%), agitation (0.7%), hypesthesia (0.6%), confusion (0.5%), muscle contractions (0.4%), coma (0.2%), hypertonia (0.2%), diplopia (0.1%);
Respiratory System: pneumonia (0.4%), rales (0.4%), pleural effusion (0.3%), bronchitis (0.3%), bronchospasm (0.3%), pleurisy (0.2%), pulmonary embolism (0.2%), rhonchi (0.1%);
Musculoskeletal System: myalgia (0.2%);
Urogenital System: urinary retention (0.7%), dysuria (0.4%), abnormal renal function (0.4%), frequent micturition (0.1%), cystalgia (0.1%), urinary incontinence (0.1%), prostatitis (0.1%);
Miscellaneous: pain (5.4%), sweating increased (1.0%), asthenia (0.7%), incisional pain (0.6%), pruritus (0.5%), abnormal vision (0.3%), edema (0.3%), wound (0.2%), abscess (0.2%), cellulitis (0.2%), peripheral coldness (0.2%), injection site pain (0.1%), dry mouth (0.1%), pallor (0.1%), diabetes mellitus (0.1%), hyperkalemia (0.1%), enlarged abdomen (0.1%), bullous eruption (0.1%), inflammation (0.1%), drug toxicity (0.1%).
| Event | Placebo | Bolus + Infusion |
| Number of Patients (%) | ||
| Cardiovascular system | ||
| Hypotension | 230 (10.3) | 447 (14.4) |
| Bradycardia | 79 (3.5) | 140 (4.5) |
| Gastrointestinal system | ||
| Nausea | 255 (11.5) | 423 (13.6) |
| Vomiting | 152 ( 6.8) | 226 (7.3) |
| Abdominal pain | 49 ( 2.2) | 97 (3.1) |
| Miscellaneous | ||
| Back pain | 304 (13.7) | 546 (17.6) |
| Chest pain | 208 (9.3) | 356 (11.4) |
| Headache | 122 (5.5) | 200 (6.4) |
| Puncture site pain | 58 (2.6) | 113 (3.6) |
| Peripheral edema | 25 (1.1) | 49 (1.6) |
Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. In the EPIC, EPILOG, and CAPTURE trials, positive HACA responses occurred in approximately 5.8% of these patients receiving a first exposure to Abciximab. No increase in hypersensitivity or allergic reactions was observed with Abciximab treatment ().
In a study of readministration of Abciximab to patients () the overall rate of HACA positivity prior to the readministration was 6% and increased post-readministration to 27%. Among the 36 subjects receiving a fourth or greater Abciximab exposure, HACA positive assays were observed post-readministration in 16 subjects (44%). There were no reports of serious allergic reactions or anaphylaxis (). HACA positive status was associated with an increased risk of thrombocytopenia ().
The data reflect the percentage of patients whose test results were considered positive for antibodies to Abciximab using an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Abciximab with the incidence of antibodies to other products may be misleading.
What should I look out for while using REOPRO?
Because Abciximab may increase the risk of bleeding, Abciximab is contraindicated in the following clinical situations:
Abciximab is also contraindicated in patients with known hypersensitivity to any component of this product or to murine proteins.
What might happen if I take too much REOPRO?
There has been no experience of overdosage in human clinical trials.
How should I store and handle REOPRO?
XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.Abciximab (ReoPro) 2 mg/mL is supplied in 5 mL vials containing 10 mg (NDC 0002-7140-01).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
General
Abciximab binds with similar affinity to the vitronectin receptor, also known as the αβ integrin. The vitronectin receptor mediates the procoagulant properties of platelets and the proliferative properties of vascular endothelial and smooth muscle cells. In studies using a model cell line derived from melanoma cells, Abciximab blocked αβ-mediated effects including cell adhesion (IC = 0.34 μg/mL). At concentrations which, , provide > 80% GPIIb/IIIa receptor blockade, but above the therapeutic range, Abciximab more effectively blocked the burst of thrombin generation that followed platelet activation than select comparator antibodies which inhibit GPIIb/IIIa alone (1). The relationship of these data to clinical efficacy is unknown.
Abciximab also binds to the activated Mac-1 receptor on monocytes and neutrophils (2). In studies, Abciximab and 7E3 IgG blocked Mac-1 receptor function as evidenced by inhibition of monocyte adhesion (3). In addition, the degree of activated Mac-1 expression on circulating leukocytes and the numbers of circulating leukocyte-platelet complexes has been shown to be reduced in patients treated with Abciximab compared to control patients (4). The relationship of these data to clinical efficacy is uncertain.
Non-Clinical Toxicology
Because Abciximab may increase the risk of bleeding, Abciximab is contraindicated in the following clinical situations:Abciximab is also contraindicated in patients with known hypersensitivity to any component of this product or to murine proteins.
Drug Interactions-
Bleeding Precautions-
Therapy with Abciximab requires careful attention to all potential bleeding sites including catheter insertion sites, arterial and venous puncture sites, cutdown sites, needle puncture sites, and gastrointestinal, genitourinary, pulmonary (alveolar), and retroperitoneal sites.
Arterial and venous punctures, intramuscular injections, and use of urinary catheters, nasotracheal intubation, nasogastric tubes and automatic blood pressure cuffs should be minimized. When obtaining intravenous access, non-compressible sites (e.g., subclavian or jugular veins) should be avoided. Saline or heparin locks should be considered for blood drawing. Vascular puncture sites should be documented and monitored. Gentle care should be provided when removing dressings.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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