Moxivar Special Precautions





Full Prescribing Info
Special Precautions
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 with moxifloxacin and rest the effected limb(s).
Moxifloxacin, as with some other quinolones and macrolides, has been shown to prolong the QT interval. Since there is only limited information available on patients who may be predisposed to develop cardiac arrhythmias associated with QT prolongation, moxifloxacin should be used with caution in patients using concomitant medication that can reduce potassium and magnesium level. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes.
If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
In women and elderly patients who, both may be more susceptible to QT-prolonging drugs. As women tend to have a longer baseline QT interval compared with men, they may be more sensitive to QT prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval. -
Quinolones are known to trigger seizures. Moxifloxacin should be used with caution in patients with central nervous system disorders which may predispose to seizures or lower the seizure threshold.
In some instances, the hypersensitivity and allergic reactions already occur after the first time administration and the doctor should be informed immediately. Anaphylactic reactions in very rare case instances can progress to a life-threatening shock, in some instances after the first administration. In these cases the treatment with moxifloxacin has to be discontinued and medical treatment (e.g., treatment for shock) is required.
Cases of bullous skin reactions like Steven-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosa I reactions occur.
Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin. Patients should be to contact their doctor immediately prior continuing treatment if symptoms related to liver failure occur.
Due to limited clinical data, the use of moxifloxacin is also not recommended in patients with severe hepatic impairment (Child Pugh C).
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Pseudomembranous colitis has been reported with the use of board-spectrum antibiotics; therefore, it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of moxifloxacin. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea.
Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Patients with a family history of or actual defects in glucose-6-phospate dehydrogenase (G6PD) deficiency are prone to hemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.
In patients for whom sodium intake is of medical concerns (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) the additional sodium load of the solution for infusion should be taken into account.
Quinolones have been shown to cause photosensitivity reactions. However, studies have been shown that moxifloxacin has no substantive potential to induce photosensitivity. Nevertheless, patients should be advised to avoid exposure to either UV irradiation or extensive sunlight during treatment with moxifloxacin.
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
For patients with complicated pelvic inflammatory disease (E.G., associated with a tuba-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with moxifloxacin 400 mg film-coated tablet is not recommended.
Use in Pregnancy and Lactation: The safety of use of moxifloxacin in human pregnancy has not been evaluated. Preclinical data indicates that moxifloxacin passes into milk. Therefore, the use of moxifloxacin in pragnancy and lactation is contraindicated.
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