VPI-PIPERACILLIN AND TAZOBACTAM FOR

Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Clinical Trials (except Nosocomial Pneumonia) During the clinical investigations, 2621 patients worldwide were treated with piperacillin sodium/tazobactam sodium in phase 3 trials.

In the key North American clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature. 5%). 1%). 1%). 5 g every 6 hours in combination with an aminoglycoside and 215 patients were treated with a comparator in combination with an aminoglycoside.

1%) in the comparator group. 05) discontinued treatment due to an adverse event. 4%). 0% or less of the patients are listed below within each body system: Blood and lymphatic system disorders: mesenteric embolism, purpura, epistaxis, pulmonary embolism (see WARNINGS AND PRECAUTIONS, Hematologic).

Cardiac disorders: tachycardia, including supraventricular and ventricular; bradycardia; arrhythmia, including atrial fibrillation, ventricular fibrillation, cardiac arrest, cardiac failure, circulatory failure, myocardial infarction.

Ear and labyrinth disorders: vertigo, tinnitus. Eye disorders: photophobia. Gastrointestinal disorders: ileus, melena, flatulence, hemorrhage, gastritis, hiccough, ulcerative stomatitis. Pseudomembranous colitis was reported in one patient during the clinical trials.

The onset of pseudomembranous colitis symptoms may occur during or over 2 months after the administration of antibacterial treatment (see WARNINGS AND PRECAUTIONS, Gastrointestinal). General disorders and administration site conditions: rigors, malaise, thirst.

Hepatobiliary disorders: jaundice. Immune system disorders: anaphylaxis (including shock). Incidence of rash and fever is higher in patients with cystic fibrosis. Infections and Infestations: candidiasis, vaginitis, pharyngitis. Metabolism and nutrition disorders: symptomatic hypoglycemia.

Musculoskeletal and connective tissue and bone disorders: myalgia, arthralgia, back pain. Nervous system disorders: syncope, tremor, convulsions, taste perversion. Psychiatric disorders: confusion, hallucination, depression. Renal and urinary disorders: retention, dysuria, oliguria, hematuria, incontinence.

1 These were coded under the COSTART term skin necrosis in CSR-44881, Supportive Table 10-3. VPI-Piperacillin and Tazobactam for Injection Page 11 of 45 Reproductive system and breast disorders: leucorrhea, genital pruritus. Respiratory thoracic and mediastinal disorders: pulmonary edema, bronchospasm, coughing.

Skin and subcutaneous tissue disorders: diaphoresis, toxic epidermal necrolysis. Vascular disorders: flushing, hypotension. Nosocomial Pneumonia Trials Drug-related adverse events reported in 1% or less of patients in the nosocomial pneumonia study of piperacillin sodium/tazobactam sodium with an aminoglycoside were: acidosis, acute kidney failure, agitation, alkaline phosphatase increased, anemia, asthenia, atrial fibrillation, chest pain, CNS depression, colitis, confusion, convulsion, cough increased, thrombocytopenia, dehydration, depression, diplopia, drug level decreased, dry mouth, […]