Focin Ultra Sachet (Fosfomycin Trometamol)

Focin Ultra Sachet contains the active substance fosfomycin in the form of trometamol salt. Fosfomycin is an antibiotic (a derivative of phosphonic acid) with bactericidal action. It inhibits bacterial cell wall synthesis by impeding one of the first steps of peptidoglycan synthesis. Fosfomycin shares structural analogies with pe-enol pyruvate: in fact, it inactivates the phosphoenolpyruvate transferase enzyme and doing so it irresponsibly blocks the condensation of uridine diphosphate N-acetylglucosamine with p-enol pyruvate.

What is Focin Ultra Sachet Fosfomycin Sachet Used for?

Focin Ultra Sachet (Fosfomycin Trometamol) is a broad-spectrum antibiotic used for the treatment and prevention of urinary tract infections (UTIs). It works by inhibiting bacterial cell wall synthesis, effectively targeting gram-positive and gram-negative bacteria. Taken as a single-dose sachet, it ensures long-lasting urinary concentrations for up to 48 hours. Ideal for acute UTIs and surgical prophylaxis, it should be used with caution in renal impairment and lactation.

Microbiology

Focin Ultra Sachet has a broad spectrum of antibacterial activity against gram-positive and gram-negative organisms, including B-Lactamase-producing strains and the pathogens most frequently isolated in urinary tract infection (Ecoli, Proteus, Klebsiella, Enterobacter, Staphylococcus). 

Pharmacokinetic Properties Absorption after Oral Administration

Focin Ultra is well absorbed from the gut and has an absolute bioavailability of about 50%. Food delays absorption, not influencing urinary concentrations. After administration of 50mg/kg of body weight t-max is 2-2.5 hours and C-max is 20-30 pg/ml.

Distribution

The plasma protein binding of Focin Ultra is much low (less than 5%).

Distribution volume is 1.5-2.4 l/kg of body weight.

Metabolism

Focin Ultra is not metabolized.

Elimination

The plasma half-life is about 4 hours, 2-4 hours after a single administration of 3 g of fosfomycin trometamol urinary concentration of fosfomycin amounts to 1800-3000 ug/ml.

Therapeutically effective concentrations

The concentration of (200-300 pg/ml) remains up to 48 hours after administration. 40-50% of a single dose is excreted unchanged with urine in the first 48 hours.

Kinetic Relevant Patient Populations

Renal insufficiency reduces the excretion of the drug by the level of limited functionality and extends plasma half-life (t1/2 to 50 hours with creatinine clearance of 10ml/min).

DOSAGE AND METHOD OF ADMINISTRATION

Dosage:

The recommended dose for the treatment of acute uncomplicated lower urinary tract infections is a single Focin Ultra 3 g sachet in women above 12 years of age.

Prophylaxis of Transurethral Surgical Procedures

The recommended regimen for the prophylaxis of urinary tract infections in surgery and diagnostic procedure involving lower urinary tract in adult males and females is one Focin Ultra 3 g sachet 3 hours before surgery and one 3 g sachet 24 hours after surgery.

Children and young people weighing less than 50 kg and/or below 12 years old

At the moment there is not enough experience in children and since the dosage of 3 g is not suitable for people weighing less than 50 kg and/ or below 12 years old’s Focin Ultra 3 g should be used for these patients.

Method of Administration

Focin Ultra is for oral administration. It should be taken on an empty stomach, preferably before bedtime, after emptying the bladder. The dose should be dissolved into a glass of water and taken immediately after its preparation. 

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Patients with severe renal failure (creatinine clearance < 10mL/min). Patients undergoing hemodialysis.

Undesirable Effect

Antibiotic-associated colitis (incl. pseudomembranous colitis) has been reported in association with the use of broad-spectrum antibiotics including fosfomycin Focin Ultra Sachet ( fosfomycin trometamol; therefore it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of fosfomycin trometamol. In this situation, adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation.

Glucose Intolerance

Focin Ultra contains sucrose. Patients with a rare heredity problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

INTERACTION WITH OTHER MEDICI- NAL PRODUCTS AND OTHER FORMS OF INTERACTION

Fosfomycin/Metoclopramide: Co-administered with fosfomycin & amp; metoclopramide lowers the serum and urine concentrations of fosfomycin. For this reason, a delayed administration (about 2-3 hours) is recommended. Other drugs that increase gastrointestinal motility may produce similar effects.

Fosfomycin/antacids or calcium salts: Concomitant administration of antacids or calcium salts induces a significant reduction of fosfomycin therapeutic-cally effective plasmatic and urinary concentrations. For this reason, a delayed administration (about 2-3 hours) is recommended. Similar effects can also occur with other medicines which increase gastrointestinal motility.

Fosfomycin/food: Similarly, if fosfómycin trometamol is administered during meals, fosfomycin plasmatic and urinary rates decrease

Pregnancy and lactation Pregnancy

Data concerning a restricted number of pregnant women indicate neither on pregnancy nor on the health of the fetus / newborn undesirable effects. Studies involving animal experiments indicate neither direct nor indirect toxical effects on pregnancy, embryonic development, development of the fetus, and/or postnatal development. Pregnant women should use extreme caution if administering Focin Ultra.

Lactation

Facin Ultra passes into the breast milk, extreme moderation is recommended while breastfeeding.

Overdosage

The following events have been observed in patients who have taken Focin Ultra in overdose: vestibular loss, impaired hearing, metallic taste, and a general decline in taste perception. In the event of overdosage, treatment should be symptomatic and supportive. The patient should drink large quantities of water to promote urinary elimination of the drug.

Precaution

Store at a dry place below 30°C in the manufacturer’s packaging. The granules should be dissolved in water immediately before use.

Presentation

Focin ultra sachet is supplied as 1xl’s.