Moxifloxacin Hydrochloride (Page 5 of 14)
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to moxifloxacin in 14981 patients in 71 active controlled Phase II–IV clinical trials in different indications [see Indications and Usage (1)] . The population studied had a mean age of 50 years (approximately 73% of the population was less than 65 years of age), 50% were male, 63% were Caucasian, 12% were Asian and 9% were Black. Patients received moxifloxacin tablets 400 mg once daily oral, intravenous, or sequentially (intravenous followed by oral). Treatment duration was usually 6 to 10 days, and the mean number of days on therapy was 9 days.
Discontinuation of moxifloxacin due to adverse reactions occurred in 5% of patients overall, 4% of patients treated with 400 mg PO, 4% with 400 mg intravenous and 8% with sequential therapy 400 mg oral/intravenous. The most common adverse reactions (>0.3%) leading to discontinuation with the 400 mg oral doses were nausea, diarrhea, dizziness, and vomiting. The most common adverse reaction leading to discontinuation with the 400 mg intravenous dose was rash. The most common adverse reactions leading to discontinuation with the 400 mg intravenous/oral sequential dose were diarrhea, pyrexia.
Adverse reactions occurring in 1% of moxifloxacin-treated patients and less common adverse reactions, occurring in 0.1 to 1% of moxifloxacin-treated patients, are shown in Table 2 and Table 3, respectively. The most common adverse drug reactions (3%) are nausea, diarrhea, headache, and dizziness.
| System Organ Class | Adverse Reactions | % (N=14,981) |
|---|---|---|
| Blood and Lymphatic System Disorders | Anemia | 1 |
| Gastrointestinal Disorders | Nausea | 7 |
| Diarrhea | 6 | |
| Vomiting | 2 | |
| Constipation | 2 | |
| Abdominal pain | 2 | |
| Dyspepsia | 1 | |
| General Disorders and Administration Site Conditions | Pyrexia | 1 |
| Investigations | Alanine aminotransferase increased | 1 |
| Metabolism and Nutritional Disorder | Hypokalemia | 1 |
| Nervous System Disorders | Headache | 4 |
| Dizziness | 3 | |
| Psychiatric Disorders | Insomnia | 2 |
| System Organ Class | Adverse Reactions |
|---|---|
| Blood and Lymphatic System Disorders | Thrombocythemia |
| Eosinophilia | |
| Neutropenia | |
| Thrombocytopenia | |
| Leukopenia | |
| Leukocytosis | |
| Cardiac Disorders | Atrial fibrillation |
| Palpitations | |
| Tachycardia | |
| Angina pectoris | |
| Cardiac failure | |
| Cardiac arrest | |
| Bradycardia | |
| Ear and Labyrinth Disorders | Vertigo |
| Tinnitus | |
| Eye Disorders | Vision blurred |
| Gastrointestinal Disorders | Dry mouth |
| Abdominal discomfort | |
| Flatulence | |
| Abdominal distention | |
| Gastritis | |
| Gastroesophageal reflux disease | |
| General Disorders and Administration Site Conditions | Fatigue |
| Chest pain | |
| Asthenia | |
| Pain | |
| Malaise | |
| Infusion site extravasation | |
| Edema | |
| Chills | |
| Chest discomfort | |
| Facial pain | |
| Hepatobiliary disorders | Hepatic function abnormal |
| Infections and Infestations | Candidiasis |
| Vaginal infection | |
| Fungal infection | |
| Gastroenteritis | |
| Investigations | Aspartate aminotransferase increased |
| Gamma-glutamyltransferase increased | |
| Blood alkaline phosphatase increased | |
| Electrocardiogram QT prolonged | |
| Blood lactate dehydrogenase increased | |
| Blood amylase increased | |
| Lipase increased | |
| Blood creatinine increased | |
| Blood urea increased | |
| Hematocrit decreased | |
| Prothrombin time prolonged | |
| Eosinophil count increased | |
| Activated partial thromboplastin time prolonged | |
| Blood triglycerides increased | |
| Blood uric acid increased | |
| Metabolism and Nutrition Disorders | Hyperglycemia |
| Anorexia | |
| Hyperlipidemia | |
| Decreased appetite | |
| Dehydration | |
| Musculoskeletal and Connective Tissue Disorders | Back pain |
| Pain in extremity | |
| Arthralgia | |
| Muscle spasms | |
| Musculoskeletal pain | |
| Nervous System Disorders | Dysgeusia |
| Somnolence | |
| Tremor | |
| Lethargy | |
| Paresthesia | |
| Hypoesthesia | |
| Syncope | |
| Psychiatric Disorders | Anxiety |
| Confusional state | |
| Agitation | |
| Depression | |
| Nervousness | |
| Restlessness | |
| Hallucination | |
| Disorientation | |
| Renal and Urinary Disorders | Renal failure |
| Dysuria | |
| Reproductive System and Breast Disorders | Vulvovaginal pruritus |
| Respiratory, Thoracic, and Mediastinal Disorders | Dyspnea |
| Asthma | |
| Wheezing | |
| Bronchospasm | |
| Skin and Subcutaneous Tissue Disorders | Rash |
| Pruritus | |
| Hyperhidrosis | |
| Erythema | |
| Urticaria | |
| Dermatitis allergic | |
| Night sweats | |
| Vascular Disorders | Hypertension |
| Hypotension | |
| Phlebitis |
Laboratory Changes
Changes in laboratory parameters, which are not listed above and which occurred in 2% or more of patients and at an incidence greater than in controls included: increases in mean corpuscular hemoglobin (MCH), neutrophils, white blood cells (WBCs), prothrombin time (PT) ratio, ionized calcium, chloride, albumin, globulin, bilirubin; decreases in hemoglobin, red blood cells (RBCs), neutrophils, eosinophils, basophils, glucose, oxygen partial pressure (pO 2 ), bilirubin, and amylase. It cannot be determined if any of the above laboratory abnormalities were caused by the drug or the underlying condition being treated.
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