fosfomycin

Contraindicated in:

Hypersensitivity;
Pyelonephritis (PO);
QT interval prolongation or ventricular arrhythmias (IV);
Lactation: Lactation.

Use Cautiously in:

Hypokalemia, hypomagnesemia, or hypocalcemia (correct before administering) (IV);
CCr ≤50 mL/min (↓ IV dose);
Severe hepatic impairment (IV);
OB: Single dose PO fosfomycin may be used for the treatment of asymptomatic bacteriuria and acute cystitis in pregnancy. Use IV therapy during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children <18 yr (IV) or <12 yr (PO).

Adv. Reactions/Side Effects ⬆ ⬇

CV: QT interval prolongation (IV), TORSADES DE POINTES (IV),

F and E: hypernatremia(IV), hypocalcemia (IV), hypokalemia (IV), hypophosphatemia (IV)

GI: ↑liver enzymes (IV), dyspepsia, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, nausea, vomiting(IV)

GU: vaginitis

Hemat: agranulocytosis(IV), neutropenia(IV)

Neuro: dizziness, headache, weakness

Misc: HYPERSENSITIVITY REACTIONS (IV)(INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Metoclopramide may ↓ levels and effectiveness.
QT interval prolonging medications, including class Ia antiarrhythmics, class III antiarrhythmics, tricyclic antidepressants, macrolides, and antipsychotics, may ↑ risk of QT interval prolongation; avoid concurrent use (IV only).

Availability ⬆ ⬇

(Generic available)

Granules for oral solution: 3 g/sachet
Lyophilized powder for injection: 6 g/vial (each vial contains 1,980 mg of sodium)

Route/Dosage ⬆ ⬇

Uncomplicated Urinary Tract Infections

PO (Adults and Children ≥12 yr): 3 g as a single dose.

Complicated Urinary Tract Infections (Including Pyelonephritis)

IV (Adults ): 6 g every 8 hr for up to 14 days.

Renal Impairment

IV (Adults ): CCr 41–50 mL/min: 6 g as a loading dose initially, then 4 g every 8 hr. CCr 31–40 mL/min: 6 g as a loading dose initially, then 3 g every 8 hr. CCr 21–30 mL/min: 6 g as a loading dose initially, then 5 g every 24 hr. CCr 11–20 mL/min: 6 g as a loading dose initially, then 3 g every 24 hr. Hemodialysis: Administer after hemodialysis on hemodialysis days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inactivates an enzyme crucial for bacterial cell wall synthesis.
Decreases adherence of bacteria to uroepithelial cells.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Active against: Enterococcus faecalis, Escherichia coli, and Klebsiella pneumoniae .

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacokinetics ⬆ ⬇

Absorption: 37% absorbed following oral administration. IV administration results in complete bioavailability.

Distribution: Distributes to kidneys and bladder wall.

Metabolism/Excretion: Does not undergo metabolism. Excreted unchanged in urine (38%) and feces (18%).

Half-Life: 5.7 hr.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(bactericidal urine levels‡)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	2–4 hr	unknown
IV	rapid	end of infusion	unknown

‡Symptoms may take 24–48 hr to subside.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication and correct preparation of sachet. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient to notify health care provider immediately if diarrhea, abdominal cramping, fever, or bloody stool occurs and not to self-treat with antidiarrheals.
Advise patient to notify health care provider immediately if allergic reaction occurs.
Advise patient to follow a low sodium diet during IV therapy and to notify health care provider if swelling in legs or feet occurs. Blood tests to monitor electrolytes are required.
Advise patient to notify health care provider if cystitis symptoms have not improved or persist >2–3 days after therapy.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 24 hr following final IV dose.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

12836- Ercros SA
- 12836-0317-
  - 12836-0317-1- 15 kg in 1 DRUM (12836-0317-1)

12836- Ercros SA
- 12836-0318-
  - 12836-0318-1- 20 kg in 1 DOSE PACK (12836-0318-1)

50090- A-S Medication Solutions
- 50090-6130- Fosfomycin Tromethamine
  - 50090-6130-0- 1 PACKET in 1 CARTON (50090-6130-0) / 1 GRANULE, FOR SOLUTION in 1 PACKET

50379- MSN Organics Private Limited
- 50379-0029-
  - 50379-0029-1- 60 kg in 1 DRUM (50379-0029-1)

50379- MSN Organics Private Limited
- 50379-0030-
  50379-0030-1- 60 kg in 1 DRUM (50379-0030-1)

53069- Quimica Sintetica S.A.
- 53069-1080-
  53069-1080-5- 10 kg in 1 DRUM (53069-1080-5)

60219- Amneal Pharmaceuticals NY LLC
- 60219-3955- Fosfomycin Tromethamine
  60219-3955-1- 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3)

67877- Ascend Laboratories, LLC
- 67877-749- Fosfomycin Tromethamine
  - 67877-749-57- 1 PACKET in 1 CARTON (67877-749-57) / 1 GRANULE, FOR SOLUTION in 1 PACKET

69037- Honour Lab Limited
- 69037-0066-
  - 69037-0066-1- 20 kg in 1 DRUM (69037-0066-1)

69097- Cipla USA Inc.
- 69097-579- FOSFOMYCIN TROMETHAMINE
  69097-579-67- 1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK

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Indications ⬇

Contraind./Precautions ⬆ ⬇