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Floxsafe IV: Tendinitis and tendon ruptures of the shoulder, the hand, the Achilles tendon or other tendons that may require surgical repair or may cause prolonged disability have been reported in patients administered quinolones including this drug. In the post-marketing surveillance, this risk has been increased in older patients, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Moxifloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should be advised to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after completion of therapy.
Quinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing serious adverse events, including deaths and requirement for ventilator support, have been associated with quinolone use in persons with myasthenia gravis. [See as follows.]
Cases of fulminant hepatitis potentially leading to hepatic failure (including fatal cases) have been reported with moxifloxacin. Patients should discontinue moxifloxacin treatment and contact their doctor if signs and syndromes of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
This drug should be used with caution in the following patients: Patients with known or suspected CNS disorders or in the presence of other risk factors that may predispose to seizure or lower the seizure threshold. (Quinolones may cause seizures).
This drug should be used with caution in following patients because the magnitude of QT interval prolongation may increase.
Patients with ongoing proarrhythmic conditions, such as acute myocardial ischemia.
Patients with liver cirrhosis who cannot be excluded the existing QT prolongation.
Women and the elderly people who may be more susceptible to drug-associated QTc-prolongation.
Patients with myasthenia gravis (the symptoms can be exacerbated).
Patients with glucose-6-phosphate dehydrogenase deficiency (patients are prone to haemolytic reactions when treated with quinolones.)
