FDA label f25b1ff7-36c3-4a6f-828b-5e1eb84f201f

WARNINGS For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Patients should be continuously monitored, and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available. For sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit (ICU), DIPRIVAN Injectable Emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. In the elderly, debilitated, or ASA III/IV patients, rapid (single or repeated) bolus administration should not be used during general anesthesia or MAC sedation in order to minimize undesirable cardiorespiratory depression, including hypotension, apnea, airway obstruction, and/or oxygen desaturation. MAC sedation patients should be continuously monitored by persons not involved in the conduct of the surgical or diagnostic procedure; oxygen supplementation should be immediately available and provided where clinically indicated; and oxygen saturation should be monitored in all patients. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid initiation (loading) boluses or during supplemental maintenance boluses, especially in the elderly, debilitated, or ASA III/IV patients. DIPRIVAN Injectable Emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals. The clinical significance is not known. STRICT ASEPTIC TECHNIQUE MUST ALWAYS BE MAINTAINED DURING HANDLING. DIPRIVAN INJECTABLE EMULSION IS A SINGLE-USE PARENTERAL PRODUCT WHICH CONTAINS 0.005% DISODIUM EDETATE TO RETARD THE RATE OF GROWTH OF MICROORGANISMS IN THE EVENT OF ACCIDENTAL EXTRINSIC CONTAMINATION. HOWEVER, DIPRIVAN INJECTABLE EMULSION CAN STILL SUPPORT THE GROWTH OF MICROORGANISMS AS IT IS NOT AN ANTIMICROBIALLY PRESERVED PRODUCT UNDER USP STANDARDS. ACCORDINGLY, STRICT ASEPTIC TECHNIQUE MUST STILL BE ADHERED TO. DO NOT USE IF CONTAMINATION IS SUSPECTED. DISCARD UNUSED PORTIONS AS DIRECTED WITHIN THE REQUIRED TIME LIMITS (SEE DOSAGE AND ADMINISTRATION , HANDLING PROCEDURES). THERE HAVE BEEN REPORTS IN WHICH FAILURE TO USE ASEPTIC TECHNIQUE WHEN HANDLING DIPRIVAN INJECTABLE EMULSION WAS ASSOCIATED WITH MICROBIAL CONTAMINATION OF THE PRODUCT AND WITH FEVER, INFECTION/SEPSIS, OTHER LIFE-THREATENING ILLNESS, AND/OR DEATH.

ADVERSE REACTIONS General Adverse event information is derived from controlled clinical trials and worldwide marketing experience. In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. Anesthesia and MAC Sedation in Adults The following estimates of adverse events for DIPRIVAN Injectable Emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with DIPRIVAN Injectable Emulsion was greater than the comparator incidence rate in these trials. Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship. The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with DIPRIVAN Injectable Emulsion during anesthesia (see below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea. Anesthesia in Pediatric Patients Generally the adverse experience profile from reports of 506 DIPRIVAN Injectable Emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with DIPRIVAN Injectable Emulsion during anesthesia in adults ( see Pediatric percentages [Peds %] below). Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients. ICU Sedation in Adults The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients). Probably related incidence rates for ICU sedation were determined by individual case report form review. Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown. Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship. Incidence greater than 1% - Probably Causally Related Anesthesia/MAC Sedation ICU Sedation Cardiovascular: Bradycardia Bradycardia Arrhythmia [Peds: 1.2%] Tachycardia Nodal [Peds: 1.6%] Hypotension* [Peds 17%] (see also CLINICAL PHARMACOLOGY Decreased Cardiac Output [Hypertension Peds:8%] Hypotension 26% Central Nervous System: Movement* [Peds: 17%] Injection Site: Burning/Stinging or Pain, 17.6% [Peds: 10%] Metabolic/Nutritional: Hyperlipemia* Respiratory Apnea (see also CLINICAL PHARMACOLOGY ) Respiratory Acidosis During Weaning* Skin and Appendages: Rash [Peds: 5%] Pruritus [Peds:2%] Events without an * or % had an incidence of 1%-3% *Incidence of events 3% to 10% Incidence less than 1% - Probably Causally Related Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Anaphylaxis/Anaphylactoid Reaction Perinatal Disorder [Tachycardia] [Bigeminy] [Bradycardia] [Premature Ventricular Contractions] [Hemorrhage] [ECG Abnormal] [Arrhythmia Atrial] [Fever] [Extremities Pain] [Anticholinergic Syndrome] Cardiovascular: Premature Atrial Contractions Syncope Central Nervous System: Hypertonia/Dystonia, Paresthesia Agitation Digestive: [Hypersalivation] [Nausea] Hemic/Lymphatic: [Leukocytosis] Injection Site: [Phlebitis] [Pruritus] Metabolic: [Hypomagnesemia] Musculoskeletal: Myalgia Nervous: [Dizziness] [Agitation] [Chills] [Somnolence] [Delirium] Respiratory: Wheezing [Cough] [Laryngospasm] [Hypoxia] Decreased Lung Function Skin and Appendages: Flushing, Pruritus Special Senses: Amblyopia [Vision Abnormal] Urogenital: Cloudy Urine Green Urine Incidence less than 1% - Causal Relationship Unknown Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug Effect, Neck Rigidity/Stiffness, Trunk pain Fever, Sepsis, Trunk Pain, Whole Body Weakness Cardiovascular: Arrhythmia, Atrial Fibrillation, Atrioventricular Heart Block, Bigeminy, Bleeding, Bundle Branch Block, Cardiac Arrest, ECG Abnormal, Edema, Extrasystole, Heart Block, Hypertension, Myocardial Infarction, Myocardial Ischemia, Premature Ventricular Contractions, ST Segment Depression, Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac Arrest, Extrasystole, Right Heart Failure, Ventricular Tachycardia Central Nervous System: Abnormal Dreams, Agitation, Amorous Behavior, Anxiety, Bucking/Jerking/Thrashing, Chills/Shivering/Clonic/Myoclonic Movement, Combativeness, Confusion, Delirium, Depression, Dizziness, Emotional Lability, Euphoria, Fatigue, Hallucinations, Headache, Hypotonia, Hysteria, Insomnia, Moaning, Neuropathy, Opisthotonos, Rigidity, Seizures, Somnolence, Tremor, Twitching Chills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal Digestive: Cramping, Diarrhea, Dry Mouth, Enlarged Parotid, Nausea, Swallowing, Vomiting Ileus, Liver Function Abnormal Hematologic/Lymphatic: Coagulation Disorder, Leukocytosis Injection Site: Hives/Itching, Phlebitis, Redness/Discoloration Metabolic/Nutritional: Hyperkalemia, Hyperlipemia BUN Increased, Creatinine Increased, Dehydration, Hyperglycemia, Metabolic Acidosis, Osmolality Increased Respiratory: Bronchospasm, Burning in Throat, Cough, Dyspnea, Hiccough, Hyperventilation, Hypoventilation, Hypoxia, Laryngospasm, Pharyngitis, Sneezing, Tachypnea, Upper Airway Obstruction Hypoxia Skin and Appendages: Conjunctival Hyperemia, Diaphoresis, Urticaria Rash Special Senses: Diplopia, Ear Pain, Eye Pain, Nystagmus, Taste Perversion, Tinnitus Urogenital: Oliguria, Urine Retention Kidney Failure

<table width="100%"> <col width="33%"/> <col width="33%"/> <col width="33%"/> <thead> <tr> <th align="left" styleCode="Botrule " valign="top"/> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">Anesthesia/MAC Sedation</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">ICU Sedation</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Cardiovascular:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Bradycardia</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Bradycardia</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>Arrhythmia [Peds: 1.2%]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <list listType="ordered"> <item> <caption> </caption>Tachycardia Nodal [Peds: 1.6%]</item> </list> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>Hypotension* [Peds 17%]</paragraph> <paragraph>(see also <linkHtml href="#springac1130871351763">CLINICAL PHARMACOLOGY</linkHtml> </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Decreased Cardiac Output</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Hypertension Peds:8%]</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Hypotension 26%</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Central Nervous System:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Movement* [Peds: 17%]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Injection Site:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Burning/Stinging or Pain, 17.6% [Peds: 10%]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Metabolic/Nutritional:</paragraph> </td> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>Hyperlipemia*</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Respiratory</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Apnea (see also <linkHtml href="#springac1130871351763">CLINICAL PHARMACOLOGY</linkHtml>)</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Respiratory Acidosis During Weaning*</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Skin and Appendages:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Rash [Peds: 5%]</paragraph> <paragraph>Pruritus [Peds:2%]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td colspan="3" styleCode="Botrule " valign="top"> <paragraph>Events without an * or % had an incidence of 1%-3%</paragraph> <paragraph>*Incidence of events 3% to 10%</paragraph> </td> </tr> </tbody> </table>

<table width="100%"> <col width="33%"/> <col width="33%"/> <col width="33%"/> <thead> <tr> <th align="left" styleCode="Botrule " valign="top"/> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">Anesthesia/MAC Sedation</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">ICU Sedation</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Body as a Whole:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Anaphylaxis/Anaphylactoid Reaction</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>Perinatal Disorder</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Tachycardia]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Bigeminy]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Bradycardia]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Premature Ventricular Contractions]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Hemorrhage]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[ECG Abnormal]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Arrhythmia Atrial]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Fever]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Extremities Pain]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Anticholinergic Syndrome]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Cardiovascular:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Premature Atrial Contractions</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>Syncope</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Central Nervous System:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Hypertonia/Dystonia, Paresthesia</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Agitation</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Digestive:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>[Hypersalivation]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Nausea]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Hemic/Lymphatic: </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>[Leukocytosis]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Injection Site:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>[Phlebitis]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>[Pruritus]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Metabolic:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>[Hypomagnesemia]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Musculoskeletal:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Myalgia</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Nervous:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>[Dizziness]</paragraph> <paragraph>[Agitation]</paragraph> <paragraph>[Chills]</paragraph> <paragraph>[Somnolence]</paragraph> <paragraph>[Delirium]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Respiratory:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Wheezing</paragraph> <paragraph>[Cough]</paragraph> <paragraph>[Laryngospasm]</paragraph> <paragraph>[Hypoxia]</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Decreased Lung Function</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Skin and Appendages: </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Flushing, Pruritus</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Special Senses:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Amblyopia</paragraph> <paragraph>[Vision Abnormal]</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Urogenital:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Cloudy Urine</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Green Urine</paragraph> </td> </tr> </tbody> </table>

<table width="100%"> <col width="33%"/> <col width="35%"/> <col width="32%"/> <thead> <tr> <th align="left" styleCode="Botrule " valign="top"/> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">Anesthesia/MAC Sedation</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">ICU Sedation</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Body as a Whole:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Asthenia, Awareness, Chest Pain,</paragraph> <paragraph>Extremities Pain, Fever, Increased</paragraph> <paragraph>Drug Effect, Neck Rigidity/Stiffness,</paragraph> <paragraph>Trunk pain</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Fever, Sepsis, Trunk Pain, Whole Body Weakness</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Cardiovascular:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Arrhythmia, Atrial Fibrillation,</paragraph> <paragraph>Atrioventricular Heart Block,</paragraph> <paragraph>Bigeminy, Bleeding, Bundle Branch</paragraph> <paragraph>Block, Cardiac Arrest, ECG Abnormal, Edema, Extrasystole, Heart Block, Hypertension, Myocardial</paragraph> <paragraph>Infarction, Myocardial Ischemia,</paragraph> <paragraph>Premature Ventricular Contractions,</paragraph> <paragraph>ST Segment Depression,</paragraph> <paragraph>Supraventricular Tachycardia, </paragraph> <paragraph>Tachycardia, Ventricular Fibrillation</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac</paragraph> <paragraph>Arrest, Extrasystole, Right Heart Failure, Ventricular</paragraph> <paragraph>Tachycardia</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Central Nervous System:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Abnormal Dreams, Agitation,</paragraph> <paragraph>Amorous Behavior, Anxiety,</paragraph> <paragraph>Bucking/Jerking/Thrashing, </paragraph> <paragraph>Chills/Shivering/Clonic/Myoclonic</paragraph> <paragraph>Movement, Combativeness,</paragraph> <paragraph>Confusion, Delirium, Depression,</paragraph> <paragraph>Dizziness, Emotional Lability,</paragraph> <paragraph>Euphoria, Fatigue, Hallucinations,</paragraph> <paragraph>Headache, Hypotonia, Hysteria,</paragraph> <paragraph>Insomnia, Moaning, Neuropathy,</paragraph> <paragraph>Opisthotonos, Rigidity, Seizures,</paragraph> <paragraph>Somnolence, Tremor, Twitching</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Chills/Shivering, Intracranial Hypertension,</paragraph> <paragraph>Seizures, Somnolence, Thinking Abnormal</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Digestive:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Cramping, Diarrhea, Dry Mouth,</paragraph> <paragraph>Enlarged Parotid, Nausea, Swallowing,</paragraph> <paragraph>Vomiting</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Ileus, Liver Function Abnormal</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Hematologic/Lymphatic:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Coagulation Disorder, Leukocytosis</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Injection Site:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Hives/Itching, Phlebitis,</paragraph> <paragraph>Redness/Discoloration</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Metabolic/Nutritional:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Hyperkalemia, Hyperlipemia</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>BUN Increased, Creatinine Increased, Dehydration,</paragraph> <paragraph>Hyperglycemia, Metabolic Acidosis, Osmolality</paragraph> <paragraph>Increased</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Respiratory:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Bronchospasm, Burning in Throat,</paragraph> <paragraph>Cough, Dyspnea, Hiccough,</paragraph> <paragraph>Hyperventilation, Hypoventilation,</paragraph> <paragraph>Hypoxia, Laryngospasm, Pharyngitis,</paragraph> <paragraph>Sneezing, Tachypnea, Upper Airway</paragraph> <paragraph>Obstruction</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Hypoxia</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Skin and Appendages:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Conjunctival Hyperemia, Diaphoresis,</paragraph> <paragraph>Urticaria</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Rash</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Special Senses:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Diplopia, Ear Pain, Eye Pain,</paragraph> <paragraph>Nystagmus, Taste Perversion,</paragraph> <paragraph>Tinnitus</paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph>Urogenital:</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Oliguria, Urine Retention</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>Kidney Failure</paragraph> </td> </tr> </tbody> </table>