Fosfomycin

What it is and how it works

Mechanism of Action CONTEPO is an antibacterial drug [ see Microbiology ] .

Indications

is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae . Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis CONTEPO is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae .

Dosage and administration (summary)

Administer CONTEPO, 6 grams every 8 hours by intravenous (IV) infusion over 1 hour for up to 14 days, in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min. The recommended dosage in patients 18 years of age and older with an estimated CLcr of 50 mL/min or less is presented in the table below. a CLcr estimated using Cockcroft-Gault Equation. b All doses of CONTEPO are administered by intravenous infusion over 1 hour.

Contraindications

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

Warnings and precautions

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, renal impairment, cirrhosis, hypertension, hyperaldosteronism, hypernatremia or pulmonary edema.

Pregnancy

Pregnancy Risk Summary Available data from observational studies and pharmacovigilance reports with fosfomycin use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Fosfomycin crosses the placental barrier.

Storage and supply

How Supplied CONTEPO for injection is supplied as a white to almost white sterile powder containing 6 grams of fosfomycin in a single-dose vial. Each gram of fosfomycin disodium contains 330 mg of sodium (i.e., each vial contains 1,980 mg of sodium).

Source: Fosfomycin Disodium (Contepo) — US FDA prescribing information, 2025-11-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.