Renewal, Lego, Art 107 & PID referral update June 2010:
Section 4.1 changed to:
“Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older (see section 4.4, 4.8 and 5.1):
- Acute bacterial sinusitis (ABS)
- Acute exacerbations of chronic bronchitis (AECB)
Moxifloxacin should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
- Community acquired pneumonia, except severe cases
Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
- Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
Avelox 400 mg film-coated tablets are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.”
Subsection “children and adolescents”: “Moxifloxacin is contraindicated in children and growing adolescents.” changed to “Moxifloxacin is contraindicated in children and adolescents (< 18 years).”
Subsection “Duration of administration”, addition of the following:
“-Acute bacterial sinusitis 7 days
-Mild to moderate pelvic inflammatory disease 14 days”
“Children and growing adolescents.” changed to “Patients below 18 years of age.”
Addition of the following to section 4.4:
Where small sections of text are added to a long sentence, the additional text is highlighted in green, a stikethrough the text indicates deletion.
“As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval.”
“Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest (see also section 4.3)”
Cases of fulminant hepatitis potentially leading to
life-threatening liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
“Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see section 4.8).”
Information on diarrhoea changed from:
Antibiotic associated colitis (incl. pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including moxifloxacin; therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. In this situation adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation.”
“Antibiotic associated diarrhoea (AAD) and antibiotic associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.”
“Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.”
“For patients with complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with Avelox 400 mg film-coated tablets is not recommended.”
“Pelvic inflammatory disease may be caused by fluoroquinolone resistant Neisseria gonorrhoeae. Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.”
“Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of moxifloxacin in children and adolescents < 18 years is contraindicated (see section 4.3).”
“Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1).”
Addition of the following text highlighted in green:
“However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness; acute, transient loss of vision, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).”
Classification of very rare events changed from: “≤10,000” to “<10,000”
Addition of “Agranulocytosis” as a very rare adverse event observed.
In psychiatric disorders addition of “suicidal ideations/ thoughts, or suicide attempts” as example of self endangering behaviour under the category rare and very rare adverse event observed.
Under eye disorders addition of “Transient loss of vision (especially in the course of CNS reactions, see sections 4.4 and 4.7)” as a very rarely observed adverse event.
Under ear and labyrinth disorders insertion of “Hearing impairment incl. deafness (usually reversible)” as a rarely observed adverse event.
Addition of “haemolytic anaemia” and “peripheral neuropathy” as side effects reported with other fluoroquinolones. Deletion of “transient loss of vision” from this sentence.
Addition of explanation for the event “syncope”: “(i.e., acute and short lasting loss of consciousness)”
Under “Hepatobiliary disorders” addition of the text highlighted in green:
“Fulminant hepatitis potentially leading to life-threatening liver failure (incl. fatal cases, see section 4.4)”
Addition of “Exacerbation of symptoms of myasthenia gravis (see section 4.4)” as a very rare side effect.
“There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin:
trasnient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, haemolytic anaemia, rhabdomyolysis, photosensitivity reactions, peripheral neuropathy (see section 4.4).”
Addition of the following to the commonly susceptible species table:
Addition of the following to the spceies for which acquired resistance might be a problem table:
Addition of the following text highlighted in green:
“Activity has been satisfactorily demonstrated in susceptible strains in clinical studies in the approved clinical indications.”
“Store in the original pack” changed to “Store in the original package in order to protect from moisture.” for Polypropylene/aluminium blisters and Aluminium/aluminium blisters.
“Bayer Healthcare AG” changed to “Bayer Schering Pharma AG”
Change of the date of last renewal to: “30th November 2008”
Changed to “May 2010”