Moxifloxacin (Page 5 of 12)

6.2 Postmarketing Experience

Table 4 below lists adverse reactions that have been identified during post-approval use of moxifloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 4: Postmarketing Reports of Adverse Drug Reactions

System Organ Class	Adverse Reaction s
Blood and Lymphatic System Disorders	Agranulocytosis Pancytopenia [see Warnings and Precautions ( 5.7) ]
Cardiac Disorders	Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions)
Ear and Labyrinth Disorders	Hearing impairment, including deafness (reversible in majority of cases)
Eye Disorders	Vision loss (especially in the course of CNS reactions, transient in majority of cases)
Hepatobiliary Disorders	Hepatitis (predominantly cholestatic) Hepatic failure (including fatal cases) Jaundice Acute hepatic necrosis [see Warnings and Precautions ( 5.7) ]
Immune System Disorders	Anaphylactic reaction Anaphylactic shock Angioedema (including laryngeal edema) [see Warnings and Precautions ( 5.7, 5.8) ]
Musculoskeletal and Connective Tissue Disorders	Tendon rupture [see Warnings and Precautions ( 5.2) ]
Nervous System Disorders	Altered coordination Abnormal gait [see Warnings and Precautions ( 5.3) ] Myasthenia gravis (exacerbation of) [see Warnings and Precautions ( 5.5) ] Muscle weakness Peripheral neuropathy (that may be irreversible), polyneuropathy [ see Warnings and Precautions ( 5.3)]
Psychiatric Disorders	Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts [see Warnings and Precautions ( 5.4)]
Renal and Urinary Disorders	Interstitial nephritis [see Warnings and Precautions ( 5.7) ]
Respiratory, Thoracic and Mediastinal Disorders	Allergic pneumonitis [see Warnings and Precautions ( 5.7) ]
Skin and Subcutaneous Tissue Disorders	Photosensitivity/phototoxicity reaction [see Warnings and Precautions ( 5.13) ] Stevens-Johnson syndrome Toxic epidermal necrolysis [see Warnings and Precautions ( 5.7)]

7 DRUG INTERACTIONS

7.1 Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations

Fluoroquinolones, including moxifloxacin, form chelates with alkaline earth and transition metal cations. Oral administration of moxifloxacin with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of moxifloxacin, resulting in systemic concentrations considerably lower than desired. Therefore, moxifloxacin should be taken at least 4 hours before or 8 hours after these agents [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]

7.2 Warfarin

Fluoroquinolones, including moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. In addition, infectious disease and its accompanying inflammatory process, age, and general status of the patient are risk factors for increased anticoagulant activity. Therefore the prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if moxifloxacin is administered concomitantly with warfarin or its derivatives [see Adverse Reactions (6.2) and Clinical Pharmacology (12.3)].

7.3 Antidiabetic Agents

Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones, including moxifloxacin, and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered. If a hypoglycemic reaction occurs, moxifloxacin should be discontinued and appropriate therapy should be initiated immediately [see Warnings and Precautions ( 5.12) and Adverse Reactions ( 6.1) ]

7.4 Nonsteroidal Anti-Inflammatory Drugs

The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with a fluoroquinolone, including moxifloxacin, may increase the risks of CNS stimulation and convulsions [see Warnings and Precautions ( 5.4) ].

7.5 Drugs that Prolong QT

There is limited information available on the potential for a pharmacodynamic interaction in humans between moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (IV) moxifloxacin in dogs. Therefore, moxifloxacin should be avoided with Class IA and Class III antiarrhythmics [see Warnings and Precautions ( 5.6), and Nonclinical Toxicology ( 13.2) ].