Fosfomycin 3 G Oral Solution

FOSFOMYCIN 3 g AUSTELL is indicated:

• as a single dose in the treatment of acute uncomplicated lower urinary tract infections caused by sensitive E. coli, in women and female adolescents.
• for prophylaxis in diagnostic and surgical transurethral procedures in adult men.

Posology

The recommended dose for uncomplicated urinary tract infections in women, including the elderly up to seventy-five years, is a single 3 g dose. The recommended dose for prophylaxis prior to transurethral surgical and diagnostic procedures in adult men, including the elderly, is two doses of 3 g. The first dose should be taken three hours before surgery. The second dose should be taken twenty-four hours after surgery.

Method of administration

FOSFOMYCIN 3 g AUSTELL is administered orally after reconstitution in water. To be taken at least two hours prior to the next meal.

• Hypersensitivity to fosfomycin trometamol or to any of the excipients listed in section 6.1.
• severe renal insufficiency (creatinine clearance < 10 mL/min)
• patients undergoing haemodialysis.

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during fosfomycin treatment and may be life-threatening (see section 4.8). If such reaction occurs, fosfomycin should never be re-administered and adequate medical treatment is required.

Antibiotic-associated diarrhoea

Antibiotic-associated diarrhoea (AAD) has been reported with use of nearly all antibacterial medicines, including fosfomycin, such as in FOSFOMYCIN 3 g AUSTELL. AAD may range in severity from mild diarrhoea to fatal colitis. Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with FOSFOMYCIN 3 g AUSTELL (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with FOSFOMYCIN 3 g AUSTELL. If CDAD is suspected or confirmed, appropriate treatment should be initiated without delay (see section 4.8). Anti-peristaltic medicines are contraindicated in this clinical situation.

Renal insufficiency

Urinary concentrations of fosfomycin remain effective for 48 hours after a usual dose if creatinine clearance is above 10 mL/min.

Paediatric population

Experience in children with fosfomycin 3 g is limited. FOSFOMYCIN 3 g AUSTELL is not recommended for children below the age of 12.

Excipients: sucrose intolerance

FOSFOMYCIN 3 g AUSTELL contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take FOSFOMYCIN 3 g AUSTELL.

Metoclopramide

Concomitant administration of metoclopramide has been shown to lower serum and urinary concentrations of fosfomycin and use of FOSFOMYCIN 3 g AUSTELL with metoclopramide should be avoided. Other medicines that increase gastrointestinal motility may produce similar effects.

Food

Food may delay the absorption of the active ingredient of fosfomycin, with consequent slight decrease in peak plasma levels and urinary concentrations. It is therefore preferable to take FOSFOMYCIN 3 g AUSTELL on an empty stomach or about 2 u2013 3 hours after meals.

Alteration in INR

Numerous cases of increased antivitamin K antagonists activity have been reported in patients receiving antibiotics. Risk factors include severe infection or inflammation, age and poor general health. Under these circumstances, it is difficult to determinate whether the alteration in INR is due to the infectious disease or its treatment. However, certain classes of antibiotics are more often involved and in particular: fluoroquinolones, macrolides, cyclins, cotrimoxazole and certain cephalosporins.

Pregnancy

No evidence in animals or humans has been found to indicate adverse effects of FOSFOMYCIN 3 g AUSTELL in pregnancy. However, the safety and efficacy of single dose therapy has not been established for FOSFOMYCIN 3 g AUSTELL in pregnancy.

Breastfeeding

FOSFOMYCIN 3 g AUSTELL should not be given to breastfeeding women. Fosfomycin has been shown to cross into breast milk.

Fertility

No effect on fertility has been reported in animal studies. No data are available in humans.

No specific studies have been performed but patients should be informed that dizziness has been reported. This may influence some patients' ability to drive and use machines.

The most frequent adverse reactions following the single-dose administration of fosfomycin trometamol involve the gastrointestinal tract, mainly diarrhoea. These events are usually self-limited in duration and resolve spontaneously.

System Organ Class (MedDRA)

Frequent

Less frequent

Frequency not known

Infections and infestations

Vulvovaginitis

Immune system disorders

Anaphylactic reactions including anaphylactic shock, hypersensitivity

Nervous system disorders

Headache, dizziness

Respiratory, thoracic and mediastinal disorders

Pharyngitis (sore throat), rhinitis (runny or stuffy nose).

Gastrointestinal disorders

Diarrhoea, nausea, abdominal pain, dyspepsia (heartburn, indigestion)

Vomiting

Antibiotic-associated colitis (see section 4.4)

Skin and subcutaneous tissue disorders

Skin rash

Urticaria, pruritus

Angioedema

Musculoskeletal and connective tissue disorders

Back pain

Reproductive system and breast disorders

Dysmenorrhoea

General disorders and administration site conditions

Pain (non-localised), asthenia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

In the event of overdose, urinary elimination of fosfomycin can be accelerated through adequate administration of oral fluids.