CONTEPO

The mean pharmacokinetic parameters of fosfomycin in healthy adults with normal renal function after single doses of 6 grams administered as 1-hour IV infusion are summarized along with additional pharmacokinetic information in Table 4 .

Table 4Exposure Parameter Estimates (Mean ± SD) a Following Single Dose of 6 grams Fosfomycin Administered as 1-hour IV Infusion in Healthy Adults with Normal Renal Function a Based on non-compartmental analysis of PK data C max (mcg/mL) 228 ± 43 AUC 0-inf (mcg...

14.1 Complicated Urinary Tract Infections, Including Acute Pyelonephritis A total of 464 adults hospitalized with cUTI (including acute pyelonephritis) were randomized and received study medications in a multinational, double-blind study (

Trial 1NCT02753946 ) comparing CONTEPO 6 g intravenously every 8 hours to piperacillin/tazobactam 4.5 g intravenously every 8 hours for 7 days of therapy. Treatment was allowed for up to 14 days in bacteremic patients. The study did not include a switch to oral antibacterial drugs. The microbiological modified intent-to-treat (mMITT) population included all...

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Serum Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Increased Transaminase Levels [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Neutropenia Including Agranulocytosis [see Warnings and Precautions ( 5.5 )] Clostridioides difficile -Associated Diarrhea [see Warnin...

CONTEPO is contraindicated in patients with known serious hypersensitivity to fosfomycin, or any of the excipients [see Warnings and Precautions ( 5.2 ) ] . CONTEPO is contraindicated in patients with known serious hypersensitivity to fosfomycin, or any of the excipients. ( 4 )

Serum Electrolyte Abnormalities : CONTEPO contains 1980 mg sodium in each vial. The high sodium load associated with the use of CONTEPO may result in changes in serum electrolytes, such as increased levels of sodium and decreased levels of potassium, calcium and phosphorus. A low-sodium diet is recommended during CONTEPO treatment. Monitor serum electrolyte levels and fluid status during CONTEPO treatment. Monitor signs and symptoms of edema, particularly in patients with cardiac insufficiency, ...

7 DRUG INTERACTIONS Avoid co-administration of CONTEPO with drugs known to prolong the QT interval. ( 5.2 , 7.1 ) 7.1 Drugs that prolong QT interval Co-administration of CONTEPO with other drugs known to prolong the QT interval may increase the risk for ventricular arrhythmia. Avoid co-administration of CONTEPO with drugs known to prolong the QT interval, such as class IA or class III antiarrhythm...