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warnings and cautions
5 WARNINGS AND PRECAUTIONS Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.3 , 7.5 , 8.5 ) Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses. Discontinue drug use at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.4 , 5.5 ) Central nervous system (CNS) events including dizziness, confusion, hallucination, depression, and suicidal thoughts or acts may occur after first dose. Use caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold. ( 5.6 ) Clostridium difficile -associated diarrhea: Evaluate if diarrhea occurs. ( 5.7 ) Peripheral neuropathy: Discontinue if symptoms occur in order to prevent irreversibility. ( 5.8 ) 5.1 Tendinopathy and Tendon Rupture Fluoroquinolones, including moxifloxacin hydrochloride, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Moxifloxacin hydrochloride tablets should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. 5.2 Exacerbation of Myasthenia Gravis Fluoroquinolones, including moxifloxacin hydrochloride, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis . 5.3 QT Prolongation Moxifloxacin hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients. Following oral dosing with 400 mg of moxifloxacin hydrochloride the mean (± SD) change in QTc from the pre-dose value at the time of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in QTc from the Day 1 pre-dose value was 10 msec (±22) on Day 1 (n=667) and 7 msec (± 24) on Day 3 (n = 667). Avoid moxifloxacin hydrochloride tablets in patients with the following risk factors due to the lack of clinical experience with the drug in these patient populations: Known prolongation of the QT interval Ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions Ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia, Uncorrected hypokalemia or hypomagnesemia Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants Elderly patients using intravenous moxifloxacin hydrochloride may be more susceptible to drug-associated QT prolongation. [see Use In Specific Populations (8.5) ] In patients with mild, moderate, or severe liver cirrhosis, metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation. Monitor ECG in patients with liver cirrhosis treated with moxifloxacin hydrochloride. [See Clinical Pharmacology (12.3) ] The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded. In premarketing clinical trials, the rate of cardiovascular adverse reactions was similar in 798 moxifloxacin hydrochloride and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin hydrochloride treatment in over 15,500 patients in controlled clinical studies, including 759 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 moxifloxacin hydrochloride tablet treated patients in a postmarketing observational study in which ECGs were not performed. 5.4 Hypersensitivity Reactions Serious anaphylactic reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including moxifloxacin hydrochloride. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Discontinue moxifloxacin hydrochloride tablets at the first appearance of a skin rash or any other sign of hypersensitivity. [See Warnings and Precautions (5.5) ] 5.5 Other Serious and Sometimes Fatal Reactions Other serious and sometimes fatal reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with fluoroquinolones, including moxifloxacin hydrochloride. These reactions may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens- Johnson syndrome) Vasculitis; arthralgia; myalgia; serum sickness Allergic pneumonitis Interstitial nephritis; acute renal insufficiency or failure Hepatitis; jaundice; acute hepatic necrosis or failure Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities Discontinue moxifloxacin hydrochloride tablets immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures . 5.6 Central Nervous System Effects Fluoroquinolones, including moxifloxacin hydrochloride, may cause central nervous system (CNS) reactions, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia . Convulsions and increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones, including moxifloxacin hydrochloride. Moxifloxacin hydrochloride tablets may also cause central nervous system (CNS) reactions including: dizziness, confusion, tremors, hallucinations, depression, and, suicidal thoughts or acts. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving moxifloxacin hydrochloride tablets, the drug should be discontinued and appropriate measures instituted. As with all fluoroquinolones, use moxifloxacin hydrochloride tablets when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (for example, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. [See Drug Interactions (7.4) ] 5.7 Clostridium Difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including moxifloxacin hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated . 5.8 Peripheral Neuropathy Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including moxifloxacin hydrochloride. Symptoms may occur soon after initiation of moxifloxacin hydrochloride tablets and may be irreversible. Moxifloxacin hydrochloride tablets should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation . 5.9 Arthropathic Effects in Animals In immature dogs, oral administration of moxifloxacin hydrochloride tablets caused lameness. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone- class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. [See Nonclinical Toxicology (13.2) .] 5.10 Blood Glucose Disturbances As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin hydrochloride. In moxifloxacin hydrochloride-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, sulfonylurea) or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs, moxifloxacin hydrochloride tablets should be discontinued and appropriate therapy should be initiated immediately. [See Drug Interactions (7.3) .] 5.11 Photosensitivity/Phototoxicity Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones, including moxifloxacin hydrochloride, after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Moxifloxacin hydrochloride tablets should be discontinued if phototoxicity occurs. [See Clinical Pharmacology (12.2) .] 5.12 Development of Drug Resistant Bacteria Prescribing moxifloxacin hydrochloride tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria .