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Trasylol
Overview
What is Trasylol?
Trasylol (aprotinin injection), CHNOS, is a natural proteinase inhibitor obtained from bovine lung. Aprotinin (molecular weight of 6512 daltons), consists of 58 amino acid residues that are arranged in a single polypeptide chain, cross-linked by three disulfide bridges. It is supplied as a clear, colorless, sterile isotonic solution for intravenous administration. Each milliliter contains 10,000 KIU (Kallikrein Inhibitor Units) (1.4 mg/mL) and 9 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used to adjust the pH to 4.5-6.5.
What does Trasylol look like?
What are the available doses of Trasylol?
Sorry No records found.
What should I talk to my health care provider before I take Trasylol?
Sorry No records found
How should I use Trasylol?
Sorry No records found
What interacts with Trasylol?
Hypersensitivity to aprotinin.
Administration of Trasylol to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated. For patients with known or suspected history of exposure to aprotinin greater than 12 months previously, see . Aprotinin may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.
What are the warnings of Trasylol?
Cases of tinnitus and reversible or irreversible hearing impairment have been reported. Usually, reports indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, doses exceeding several times the usual recommended dose, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used).
Anaphylactic or anaphylactoid reactions have occurred with Trasylol administration, including fatal reactions in association with the initial (test) dose. The initial (test) dose does not fully predict a patient’s risk for a hypersensitivity reaction, including a fatal reaction. Fatal hypersensitivity reactions have occurred among patients who tolerated an initial (test) dose.
Hypersensitivity reactions often manifest as anaphylactic/anaphylactoid reactions with hypotension the most frequently reported sign of the hypersensitivity reaction. The hypersensitivity reaction can progress to anaphylactic shock with circulatory failure. If a hypersensitivity reaction occurs during injection or infusion of Trasylol, administration should be stopped immediately and emergency treatment should be initiated. Even when a second exposure to aprotinin has been tolerated without symptoms, a subsequent administration may result in severe hypersensitivity/anaphylactic reactions.
Trasylol should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. Before initiating treatment with Trasylol, the recommendations below should be followed to manage a potential hypersensitivity or anaphylactic reaction: 1) Have standard emergency treatments for hypersensitivity or anaphylactic reactions readily available in the operating room (e.g., epinephrine, corticosteroids). 2) Administration of the initial (test) dose and loading dose should be done only when the patient is intubated and when conditions for rapid cannulation and initiation of cardiopulmonary bypass are present. 3) Delay the addition of Trasylol into the pump prime solution until after the loading dose has been safely administered.
Re-exposure to aprotinin:
In a retrospective review of 387 European patient records with documented re-exposure to Trasylol, the incidence of hypersensitivity/anaphylactic reactions was 2.7%. Two patients who experienced hypersensitivity/anaphylactic reactions subsequently died, 24 hours and 5 days after surgery, respectively. The relationship of these 2 deaths to Trasylol is unclear. This retrospective review also showed that the incidence of a hypersensitivity or anaphylactic reaction following re-exposure is increased when the re-exposure occurs within 6 months of the initial administration (5.0% for re-exposure within 6 months and 0.9% for re-exposure greater than 6 months). Other smaller studies have shown that in case of re-exposure, the incidence of hypersensitivity/anaphylactic reactions may reach the five percent level.
An analysis of all spontaneous reports from the Bayer Global database covering a period from 1985 to March 2006 revealed that of 291 possibly associated spontaneous cases of hypersensitivity (fatal: n=52 and non-fatal: n=239), 47% (138/291) of hypersensitivity cases had documented previous exposure to Trasylol. Of the 138 cases with documented previous exposure, 110 had information on the time of the previous exposure. Ninety-nine of the 110 cases had previous exposure within the prior 12 months.
Renal Dysfunction:
What are the precautions of Trasylol?
General:
Initial (Test) Dose:
Allergic Reactions:
Loading Dose:
Renal Dysfunction:
Use of Trasylol
in patients undergoing deep hypothermic circulatory arrest:
The first study showed an increase in both renal failure and mortality compared to age-matched historical controls. Similar results were not observed, however, in a second case control study. The strength of this association is uncertain because there are no data from randomized studies to confirm or refute these findings.
Drug Interactions:
Trasylol is known to have antifibrinolytic activity and, therefore, may inhibit the effects of fibrinolytic agents.
In study of nine patients with untreated hypertension, Trasylol infused intravenously in a dose of 2 million KIU over two hours blocked the acute hypotensive effect of 100mg of captopril.
Trasylol, in the presence of heparin, has been found to prolong the activated clotting time (ACT) as measured by a celite surface activation method. The kaolin activated clotting time appears to be much less affected. However, Trasylol should not be viewed as a heparin sparing agent (see ).
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term animal studies to evaluate the carcinogenic potential of Trasylol or studies to determine the effect of Trasylol on fertility have not been performed.
Results of microbial tests using and indicate that Trasylol is not a mutagen.
Reproduction studies have been performed in rats at intravenous doses up to 200,000 KIU/kg/day for 11 days, and in rabbits at intravenous doses up to 100,000 KIU/kg/day for 13 days, 2.4 and 1.2 times the human dose on a mg/kg basis and 0.37 and 0.36 times the human mg/m dose. They have revealed no evidence of impaired fertility or harm to the fetus due to Trasylol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mother:
Not applicable.
Pediatric Use:
Safety and effectiveness in pediatric patient(s) have not been established.
Geriatric Use:
Of the total of 3083 subjects in clinical studies of Trasylol, 1100 (35.7 percent) were 65 and over, while 297 (9.6 percent) were 75 and over. Of patients 65 years and older, 479 (43.5 percent) received Regimen A and 237 (21.5 percent) received Regimen B. No overall differences in safety or effectiveness were observed between these subjects and younger subjects for either dose regimen, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Laboratory Monitoring of Anticoagulation during Cardiopulmonary Bypass:
Trasylol prolongs whole blood clotting times by a different mechanism than heparin. In the presence of aprotinin, prolongation is dependent on the type of whole blood clotting test employed. If an activated clotting time (ACT) is used to determine the effectiveness of heparin anticoagulation, the prolongation of the ACT by aprotinin may lead to an overestimation of the degree of anticoagulation, thereby leading to inadequate anticoagulation. During extended extracorporeal circulation, patients may require additional heparin, even in the presence of ACT levels that appear adequate.
In patients undergoing CPB with Trasylol therapy, one of the following methods may be employed to maintain adequate anticoagulation:
Protamine Administration
What are the side effects of Trasylol?
Studies of patients undergoing CABG surgery, either primary or repeat, indicate that Trasylol is generally well tolerated. The adverse events reported are frequent sequelae of cardiac surgery and are not necessarily attributable to Trasylol therapy. Adverse events reported, up to the time of hospital discharge, from patients in US placebo-controlled trials are listed in the following table. The table lists only those events that were reported in 2% or more of the Trasylol treated patients without regard to causal relationship.
In comparison to the placebo group, no increase in mortality in patients treated with Trasylol was observed. Additional events of particular interest from controlled US trials with an incidence of less than 2%, are listed below:
Listed below are additional events, from controlled US trials with an incidence between 1 and 2%, and also from uncontrolled, compassionate use trials and spontaneous post-marketing reports. Estimates of frequency cannot be made for spontaneous post-marketing reports .
Body as a Whole:
hemoperitoneum
Cardiovascular:
Digestive:
Hematologic and Lymphatic:
pulmonary thrombosis
Metabolic and Nutritional:
Musculoskeletal:
Nervous:
Respiratory:
Skin:
Skin discoloration
Urogenital:
| 76 | 77 | |
| Fever | 15 | 14 |
| Infection | 6 | 7 |
| Chest Pain | 2 | 2 |
| Asthenia | 2 | 2 |
| Atrial Fibrillation | 21 | 23 |
| Hypotension | 8 | 10 |
| Myocardial Infarct | 6 | 6 |
| Atrial Flutter | 6 | 5 |
| Ventricular Extrasystoles | 6 | 4 |
| Tachycardia | 6 | 7 |
| Ventricular Tachycardia | 5 | 4 |
| Heart Failure | 5 | 4 |
| Pericarditis | 5 | 5 |
| Peripheral Edema | 5 | 5 |
| Hypertension | 4 | 5 |
| Arrhythmia | 4 | 3 |
| Supraventricular Tachycardia | 4 | 3 |
| Atrial Arrhythmia | 3 | 3 |
| Nausea | 11 | 9 |
| Constipation | 4 | 5 |
| Vomiting | 3 | 4 |
| Diarrhea | 3 | 2 |
| Liver Function Tests Abnormal | 3 | 2 |
| Anemia | 2 | 8 |
| Creatine Phosphokinase Increased | 2 | 1 |
| Any Event | 2 | 3 |
| Confusion | 4 | 4 |
| Insomnia | 3 | 4 |
| Lung Disorder | 8 | 8 |
| Pleural Effusion | 7 | 9 |
| Atelectasis | 5 | 6 |
| Dyspnea | 4 | 4 |
| Pneumothorax | 4 | 4 |
| Asthma | 2 | 3 |
| Hypoxia | 2 | 1 |
| Rash | 2 | 2 |
| Kidney Function Abnormal | 3 | 2 |
| Urinary Retention | 3 | 3 |
| Urinary Tract Infection | 2 | 2 |
| Thrombosis | 1.0 | 0.6 |
| Shock | 0.7 | 0.4 |
| Cerebrovascular Accident | 0.7 | 2.1 |
| Thrombophlebitis | 0.2 | 0.5 |
| Deep Thrombophlebitis | 0.7 | 1.0 |
| Lung Edema | 1.3 | 1.5 |
| Pulmonary Embolus | 0.3 | 0.6 |
| Kidney Failure | 1.0 | 0.6 |
| Acute Kidney Failure | 0.5 | 0.6 |
| Kidney Tubular Necrosis | 0.8 | 0.4 |
Myocardial Infarction:
| Treatment | Definite MI % | Definite or Probable MI% | Definite, Probable or Possible MI% |
| TrasylolRegimen A n = 646 | 4.6 | 10.7 | 14.1 |
| Placebo n = 661 | 4.7 | 11.3 | 13.4 |
| TrasylolRegimen B n = 241 | 8.7 | 15.9 | 18.7 |
| TrasylolPump Prime Regimenn = 239 | 6.3 | 15.7 | 18.1 |
| Placebo n = 240 | 6.3 | 15.1 | 15.8 |
Graft Patency:
Although there was a statistically significantly increased risk of graft closure for Trasylol treated patients compared to patients who received placebo (p=0.035), further analysis showed a significant treatment by site interaction for one of the non-U.S. sites vs. the U.S. centers. When the analysis of graft closures was repeated for U.S. centers only, there was no statistically significant difference in graft closure rates in patients who received Trasylol vs. placebo. These results are the same whether analyzed as the proportion of patients who experienced at least one graft closure postoperatively or as the proportion of grafts closed. There were no differences between treatment groups in the incidence of myocardial infarction as evaluated by the blinded consultant (2.9% Trasylol vs. 3.8% placebo) or of death (1.4% Trasylol vs. 1.6% placebo) in this study.
| Overall Closure Rates* | Incidence of MI** | Incidence of Death*** | ||
| All Centersn = 703% | U.S. Centersn = 381% | All Centersn = 831% | All Centersn = 870% | |
| Trasylol | 15.4 | 9.4 | 2.9 | 1.4 |
| Placebo | 10.9 | 9.5 | 3.8 | 1.6 |
| CI for theDifference (%) (Drug - Placebo) | (1.3, 9.6)† | (-3.8, 5.9)† | -3.3 to 1.5‡ | -1.9 to 1.4‡ |
Hypersensitivity and Anaphylaxis:
Hypersensitivity and anaphylactic reactions during surgery were rarely reported in U.S. controlled clinical studies in patients with no prior exposure to Trasylol (1/1424 patients or <0.1% on Trasylol vs. 1/861 patients or 0.1% on placebo). In case of re-exposure the incidence of hypersensitivity/anaphylactic reactions has been reported to reach the 5% level. A review of 387 European patient records involving re-exposure to Trasylol showed that the incidence of hypersensitivity or anaphylactic reactions was 5.0% for re-exposure within 6 months and 0.9% for re-exposure greater than 6 months.
Laboratory Findings
Serum Creatinine:
®
WARNINGS: Renal Dysfunction
Serum Transaminases:
®
®
Other Laboratory Findings:
What should I look out for while using Trasylol?
Hypersensitivity to aprotinin.
Administration of Trasylol to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated. For patients with known or suspected history of exposure to aprotinin greater than 12 months previously, see . Aprotinin may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.
Anaphylactic or anaphylactoid reactions have occurred with Trasylol administration, including fatal reactions in association with the initial (test) dose. The initial (test) dose does not fully predict a patient’s risk for a hypersensitivity reaction, including a fatal reaction. Fatal hypersensitivity reactions have occurred among patients who tolerated an initial (test) dose.
Hypersensitivity reactions often manifest as anaphylactic/anaphylactoid reactions with hypotension the most frequently reported sign of the hypersensitivity reaction. The hypersensitivity reaction can progress to anaphylactic shock with circulatory failure. If a hypersensitivity reaction occurs during injection or infusion of Trasylol, administration should be stopped immediately and emergency treatment should be initiated. Even when a second exposure to aprotinin has been tolerated without symptoms, a subsequent administration may result in severe hypersensitivity/anaphylactic reactions.
Trasylol should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. Before initiating treatment with Trasylol, the recommendations below should be followed to manage a potential hypersensitivity or anaphylactic reaction: 1) Have standard emergency treatments for hypersensitivity or anaphylactic reactions readily available in the operating room (e.g., epinephrine, corticosteroids). 2) Administration of the initial (test) dose and loading dose should be done only when the patient is intubated and when conditions for rapid cannulation and initiation of cardiopulmonary bypass are present. 3) Delay the addition of Trasylol into the pump prime solution until after the loading dose has been safely administered.
What might happen if I take too much Trasylol?
The maximum amount of Trasylol that can be safely administered in single or multiple doses has not been determined. Doses up to 17.5 million KIU have been administered within a 24 hour period without any apparent toxicity. There is one poorly documented case, however, of a patient who received a large, but not well determined, amount of Trasylol (in excess of 15 million KIU) in 24 hours. The patient, who had pre-existing liver dysfunction, developed hepatic and renal failure postoperatively and died. Autopsy showed hepatic necrosis and extensive renal tubular and glomerular necrosis. The relationship of these findings to Trasylol therapy is unclear.
How should I store and handle Trasylol?
Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:NDC 0591-3230-01; Bottles of 100NDC 0591-3230-05; Bottles of 500NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:NDC 0591-3231-01; Bottles of 100NDC 0591-3231-05; Bottles of 500NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USAManufactured by: Cipla Ltd.Kurkumbh, INDIARevised: August 2006
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Aprotinin is a broad spectrum protease inhibitor which modulates the systemic inflammatory response (SIR) associated with cardiopulmonary bypass (CPB) surgery. SIR results in the interrelated activation of the hemostatic, fibrinolytic, cellular and humoral inflammatory systems. Aprotinin, through its inhibition of multiple mediators [e.g., kallikrein, plasmin] results in the attenuation of inflammatory responses, fibrinolysis, and thrombin generation.
Aprotinin inhibits pro-inflammatory cytokine release and maintains glycoprotein homeostasis. In platelets, aprotinin reduces glycoprotein loss (e.g., GpIb, GpIIb/IIIa), while in granulocytes it prevents the expression of pro-inflammatory adhesive glycoproteins (e.g., CD11b).
The effects of aprotinin use in CPB involves a reduction in inflammatory response which translates into a decreased need for allogeneic blood transfusions, reduced bleeding, and decreased mediastinal re-exploration for bleeding.
Non-Clinical Toxicology
Hypersensitivity to aprotinin.Administration of Trasylol to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated. For patients with known or suspected history of exposure to aprotinin greater than 12 months previously, see . Aprotinin may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.
Anaphylactic or anaphylactoid reactions have occurred with Trasylol administration, including fatal reactions in association with the initial (test) dose. The initial (test) dose does not fully predict a patient’s risk for a hypersensitivity reaction, including a fatal reaction. Fatal hypersensitivity reactions have occurred among patients who tolerated an initial (test) dose.
Hypersensitivity reactions often manifest as anaphylactic/anaphylactoid reactions with hypotension the most frequently reported sign of the hypersensitivity reaction. The hypersensitivity reaction can progress to anaphylactic shock with circulatory failure. If a hypersensitivity reaction occurs during injection or infusion of Trasylol, administration should be stopped immediately and emergency treatment should be initiated. Even when a second exposure to aprotinin has been tolerated without symptoms, a subsequent administration may result in severe hypersensitivity/anaphylactic reactions.
Trasylol should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. Before initiating treatment with Trasylol, the recommendations below should be followed to manage a potential hypersensitivity or anaphylactic reaction: 1) Have standard emergency treatments for hypersensitivity or anaphylactic reactions readily available in the operating room (e.g., epinephrine, corticosteroids). 2) Administration of the initial (test) dose and loading dose should be done only when the patient is intubated and when conditions for rapid cannulation and initiation of cardiopulmonary bypass are present. 3) Delay the addition of Trasylol into the pump prime solution until after the loading dose has been safely administered.
Trasylol is known to have antifibrinolytic activity and, therefore, may inhibit the effects of fibrinolytic agents.
In study of nine patients with untreated hypertension, Trasylol infused intravenously in a dose of 2 million KIU over two hours blocked the acute hypotensive effect of 100mg of captopril.
Trasylol, in the presence of heparin, has been found to prolong the activated clotting time (ACT) as measured by a celite surface activation method. The kaolin activated clotting time appears to be much less affected. However, Trasylol should not be viewed as a heparin sparing agent (see ).
Initial (Test) Dose:
®
®
®
®
WARNINGS
Studies of patients undergoing CABG surgery, either primary or repeat, indicate that Trasylol is generally well tolerated. The adverse events reported are frequent sequelae of cardiac surgery and are not necessarily attributable to Trasylol therapy. Adverse events reported, up to the time of hospital discharge, from patients in US placebo-controlled trials are listed in the following table. The table lists only those events that were reported in 2% or more of the Trasylol treated patients without regard to causal relationship.
In comparison to the placebo group, no increase in mortality in patients treated with Trasylol was observed. Additional events of particular interest from controlled US trials with an incidence of less than 2%, are listed below:
Listed below are additional events, from controlled US trials with an incidence between 1 and 2%, and also from uncontrolled, compassionate use trials and spontaneous post-marketing reports. Estimates of frequency cannot be made for spontaneous post-marketing reports .
Body as a Whole:
hemoperitoneum
Cardiovascular:
Digestive:
Hematologic and Lymphatic:
pulmonary thrombosis
Metabolic and Nutritional:
Musculoskeletal:
Nervous:
Respiratory:
Skin:
Skin discoloration
Urogenital:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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