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.

Table 2: Common (1% or more) Adverse Reactions Reported in Active-Controlled Clinical Trials with Moxifloxacin
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
Table 3: Less Common (0.1 to less than 1%) Adverse Reactions Reported in Active-Controlled Clinical Trials with Moxifloxacin (N=14,981)
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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