M-MOXIFLOXACIN

Adverse Drug Reaction Overview Over 8600 courses of moxifloxacin hydrochloride tablets and moxifloxacin hydrochloride injection treatment have been evaluated for drug safety during clinical development. Of these, 8050 patients received the 400 mg dose.

Most adverse events reported in trials were described as transient in nature, mild to moderate intensity, and required no additional treatment. 0% of patients (131 out of 1872) treated with intravenous moxifloxacin hydrochloride. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. V. The major difference between the oral and intravenous treatment groups relates to local injection site reactions known to be associated with intravenous administration.

The common adverse drug reactions seen in clinical trials (those judged by the investigators to be possibly or probably related to moxifloxacin) are summarized in Table 2. Table 2 – Common Clinical Trial Adverse Drug Reactions (≥1% to <10%) moxifloxacin hydrochloride n=8606 Body as a Whole abdominal pain 2% headache 2% injection site reaction 1% Cardiovascular in patients with concomitant hypokalemia: QT interval prolongation 1% Digestive nausea 7% diarrhea 5% dyspepsia 1% vomiting 2% Metabolic liver function test abnormal 1% Nervous dizziness 3% M-Moxifloxacin Product Monograph Page 16 of 72 Uncommon Clinical Trial Adverse Drug Reactions Uncommon adverse drug reactions seen in clinical trials (those judged by the investigators to be possibly or probably related to moxifloxacin) are listed in Table 3 and Table 4.

1%) moxifloxacin hydrochloride n=8606 Body as a Whole abdomen enlarged, accidental overdose, aggravation reaction, allergic reaction, back pain, cachexia, cellulitis, chest pain substernal, chills, drug level increased, edema, face edema, hand pain, hernia, infection fungal, inflammation, injection site edema, injection site hypersensitivity, injection site inflammation, injection site pain, lab test abnormal, lack of drug effect, leg pain, multisystem organ failure, neoplasm, overdose, pelvic pain, peritonitis, photosensitivity reaction, reaction unevaluable, sepsis Cardiovascular AV block first degree, angina pectoris, atrial fibrillation, cardiovascular disorder, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, electrocardiogram abnormal, heart failure, hemorrhage, hypotension, migraine, myocardial infarct, peripheral edema, peripheral vascular disorder, postural hypotension, shock, supraventricular tachycardia, syncope, thrombophlebitis, vascular headache, ventricular tachycardia, ventricular extrasystoles M-Moxifloxacin Product Monograph Page 17 of 72 moxifloxacin hydrochloride n=8606 Digestive aphthous stomatitis, cheilitis, cholestatic jaundice, colitis, cholangitis, diarrhea (Clostridium difficile), dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, hepatic failure, hyperchlorhydria, increased appetite, jaundice (predominantly cholestatic), liver damage, melena, mouth ulceration, pancreatitis, pseudomembraneous colitis, salivary gland enlargement, thirst, tongue discoloration, tongue disorder, tongue edema Endocrine diabetes mellitus, female lactation Hemic and Lymphatic abnormal platelets, coagulation disorder, hypochromic anemia, lymphocytosis, lymphangitis, monocytosis, pancytopenia, prothrombin/INR increased, sedimentation rate increased, thrombocytopenia, thromboplastin decreased Hypersensitivity allergic reaction, face edema, urticaria Metabolic and Nutritional bilirubinemia, dehydration, enzymatic abnormality, gamma globulins increased, gout, hypercholesteremia, hyperglycemia, hyperlipemia, hyperuricemia, hypoproteinemia, hypophosphatemia, lipase increased, NPN increased, weight gain Musculo-Skeletal arthritis, arthrosis, leg cramps, myasthenia, tendon disorder Nervous abnormal dreams, agitation, amnesia, aphasia, cerebral infarct, circumoral paresthesia, coma, confusion, convulsion, depersonalization, depression (in very rare cases potentially culminating in self-injurious behavior, […]