Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
TRACTINFECT is contraindicated in:
Prescribers must adhere to the principles of antibiotic stewardship.
Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during treatment with TRACTINFECT (see sections 4.3 and 4.8). If such reactions occur, treatment with TRACTINFECT must be discontinued immediately and adequate emergency measures must be initiated.
Fosfomycin trometamol, as contained in TRACTINFECT, is principally excreted by the kidney. Caution should be exercised in administering this antibiotic to patients with impaired renal function (see sections 4.3 and 5.2).
Antibiotic associated colitis (including pseudomembranous colitis) has been reported in association with the use of broad-spectrum antibiotics including TRACTINFECT. It is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of TRACTINFECT. In this situation adequate therapeutic measures should be initiated immediately. Medicines inhibiting peristalsis are contraindicated in this situation.
In case of persistent infections, a thorough examination and a re-evaluation of the diagnosis is recommended as this is often due to complicated urinary tract infections or the prevalence of resistant pathogens (e.g. Staphylococcus saprophyticus, see section 5.1). In general, urinary tract infections in male patients have to be considered as complicated UTIs for which this medicinal product is not indicated (see section 4.1).
Safety and efficacy in children under the age of 12 years has not yet been established.
TRACTINFECT contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take TRACTINFECT.
Concomitant administration of metoclopramide has been shown to lower serum and urinary concentrations and should be avoided.
Other medicinal products that increase gastrointestinal motility may produce similar effects.
Food may delay the absorption of TRACTINFECT, with consequent slight decrease in peak plasma levels and urinary concentrations. It is therefore preferable to take the medicinal product on an empty stomach or about 2 to 3 hours after meals.
Studies indicate increased oral anticoagulant activity have been in patients receiving antibiotic therapy. 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.
The safety and efficacy of single dose therapy has not been established for TRACTINFECT in pregnancy. TRACTINFECT should not be given to lactating women.
No evidence in animals or humans has been found to indicate adverse effects of TRACTINFECT in pregnancy.
Fosfomycin, as contained in TRACTINFECT, has been shown to cross into breast milk.
No clinical data are available; hence the potential risk for humans is unknown.
TRACTINFECT has moderate influence on the ability to drive and operate machinery.
No studies on the effect on the ability to drive and use machines have been performed.
However, there are some side effects such as dizziness and fatigue associated with this product that may affect some patients' ability to drive or use machinery (see section 4.8).
Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that TRACTINFECT do not adversely affect their ability to do so safely (see section 4.8).
| System organ class | Frequent | Less frequent | Frequency unknown (cannot be established from the available data) |
|---|---|---|---|
| Immune system disorders | Anaphylactic shock, allergic reaction | ||
| Nervous system disorders | Headache, dizziness | Paraesthesia | |
| Cardiac disorders | Tachycardia | ||
| Vascular disorders | Hypotension | ||
| Respiratory, thoracic and mediastinal disorders | Pharyngitis, rhinitis | Asthma | |
| Gastrointestinal disorders | Diarrhoea, nausea, abdominal pain, dyspepsia | Vomiting | Pseudomembranous colitis |
| Skin and subcutaneous tissue disorders | Skin rash | Urticaria, pruritus, itching | Angioedema |
| Musculoskeletal and connective tissue disorders | Back pain | ||
| Reproductive system and breast disorders | Vaginitis, dysmenorrhea, vulvovaginitis | ||
| General disorders and administrative site conditions | Pain (non-localised), asthenia | Fatigue |
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/
Aspen Pharmacare: E-mail: Drugsafety@aspenpharma.com Tel: 0800 118 088
Not applicable.
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