PMS-MOXIFLOXACIN

Adverse Drug Reaction Overview Over 8,600 courses of moxifloxacin hydrochloride tablets and moxifloxacin hydrochloride injection treatment have been evaluated for drug safety during clinical development. Of these, 8,050 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 1,872) treated with IV 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. The overall rate of adverse drug reactions during clinical trials was 26% (1,734/6,734) with moxifloxacin hydrochloride tablet.

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 = 8,606 Body as a Whole Abdominal pain 2% Headache 2% 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% pms-MOXIFLOXACIN Product Monograph Page 16 of 69 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 = 8,606 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, 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 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, pseudomembranous colitis, salivary gland enlargement, thirst, tongue discoloration, tongue disorder, tongue edema Endocrine Diabetes mellitus, female lactation pms-MOXIFLOXACIN Product Monograph Page 17 of 69 Moxifloxacin hydrochloride n = 8,606 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, such as suicidal ideation/thoughts or suicide attempts), emotional lability, euphoria, grand mal convulsion, hallucinations, hyperkinesia, hypertonia, hypesthesia, hypotonia, incoordination, paresthesia, personality disorder, sleep disorder, speech disorder, thinking abnormal, twitching, vestibular disorder Respiratory Apnea, asthma, atrophic […]

 Patients who are hypersensitive to pms-MOXIFLOXACIN (moxifloxacin hydrochloride) or other quinolone antibacterial agents (see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS).  Patients who are hypersensitive to any ingredient in the formulation or component of the container (see DOSAGE FORMS, COMPOSITION AND PACKAGING).

WARNINGS AND PRECAUTIONS Serious Warnings and Precautions  Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendonitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.

 Moxifloxacin hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients (see WARNINGS AND PRECAUTIONS: Cardiovascular: QT Interval Prolongation).  Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving quinolone therapy, including moxifloxacin hydrochloride (see WARNINGS AND PRECAUTIONS: Hypersensitivity).

 Fluoroquinolones, including pms-MOXIFLOXACIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk 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 (see WARNINGS AND PRECAUTIONS: Musculoskeletal).

 Fluoroquinolones, including pms-MOXIFLOXACIN, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid pms-MOXIFLOXACIN in patients with a known history of myasthenia gravis (see WARNINGS AND PRECAUTIONS: Musculoskeletal).

 Seizures and toxic psychoses may occur with quinolone therapy. Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychoses have been reported in patients receiving quinolones, including moxifloxacin hydrochloride.