Moxifloxacin Hydrochloride (Page 5 of 17)

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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride-treated patients and less common adverse reactions, occurring in 0.1 to 1% of Moxifloxacin Hydrochloride-treated patients, are shown in Tables 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 Hydrochloride

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 Hydrochloride (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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2019. All Rights Reserved.