Xiflox Special Precautions

Film-coated tablet: As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders (e.g. lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke).
Antibiotic associated colitis have been reported with the use of broad-spectrum antibiotics including Moxifloxacin; therefore it is important to consider this diagnosis in patients who develop serious diarrhea is association with the use of Moxifloxacin.
Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients, 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 sensitive to drug associated effects on the QT interval.
Moxifloxacin should be used with caution in patients treated concomitantly with drugs that prolong QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants, in the patients with ongoing proarrythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia, in the patients with liver cirrhosis as preexisting QT prolongation, in women and elderly patients who are susceptible to QTc prolonging drugs.
Tendon inflammation and/or rupture have been reported with quinolone antibiotics. Risk may be increased with concurrent corticosteroids, particularly in the elderly. Discontinue at first signs or symptoms of tendon pain.
For patients with pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), treatment with Moxifloxacin 400 mg film-coated tablets is not recommended.
Use with caution in diabetes as glucose regulation may be altered.
Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due MRSA, treatment with an appropriate antibacterial agent should be started.
Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.
Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. If an allergic reaction occurs discontinue drug immediately.
Quinolones should be used with caution as they may exacerbate myasthenia gravis.
Peripheral neuropathy may rarely occur.
Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Moxifloxacin may result in an impairment of the patients ability to drive or operate machinery due to CNS reactions (e.g. dizziness; acute, transient loss of vision) or acute and short lasting loss of consciousness. Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
Solution for injection: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as bradycardia or acute myocardial ischemia.
Anaphylactic reactions in very rare instances can progress to a life threatening shock, in some instances after the first administration. In these cases the treatment with moxifloxacin must be discontinued, medical treatment (e.g. treatment for shock) is required.
As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders or in the presence of other risk factors that may predispose to seizures or lower the threshold.
Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy. Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Antibiotic associated colitis has been reported with the use of broad-spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhea in association with the use of moxifloxacin. If antibiotic associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation.
Quinolones may cause central nervous system (CNS) events, including nervousness, agitation, insomnia, anxiety, nightmares or paranoia. As the magnitude of QT prolongation may increase with increasing concentrations of the drug, the recommended dose and the infusion rate (400 mg within 60 minutes) should not be exceeded.
Moxifloxacin should be used with caution in patients with liver cirrhosis as pre-existing QT prolongation in these patients cannot be excluded.
Tendon inflammation and rupture may occur with quinolone therapy, particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment and rest the affected limbs.
Quinolones have been shown to cause photosensitivity reactions in patients. Patients should be advised to avoid extensive exposure to either UV irradiation or sunlight.
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis can occur due to use of moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) the additional sodium load of the solution for infusion should be taken into account.