Moxifloxacin

AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 6 WARNINGS AND PRECAUTIONS .........................................................................................

6 ADVERSE REACTIONS ......................................................................................................... 15 DRUG INTERACTIONS .........................................................................................................

19 DOSAGE AND ADMINISTRATION ..................................................................................... 21 OVERDOSAGE .......................................................................................................................

22 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 23 STORAGE AND STABILITY ................................................................................................. 31 SPECIAL HANDLING INSTRUCTIONS ...............................................................................

31 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 31 PART II: SCIENTIFIC INFORMATION .............................................................................. 32 PHARMACEUTICAL INFORMATION .................................................................................

32 CLINICAL TRIALS ................................................................................................................. 33 DETAILED PHARMACOLOGY ............................................................................................

46 MICROBIOLOGY ................................................................................................................... 51 TOXICOLOGY ........................................................................................................................

56 REFERENCES ......................................................................................................................... 61 PATIENT MEDICATION INFORMATION ..........................................................................

63 pms-MOXIFLOXACIN Product Monograph Page 3 of 69 Pr pms-MOXIFLOXACIN Moxifloxacin Tablets 400 mg (as moxifloxacin hydrochloride) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Oral Tablet, 400 mg (as moxifloxacin hydrochloride) Colloidal Silicon Dioxide, Croscarmellose Sodium, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Stearyl Fumarate, Talc, and Titanium Dioxide.

INDICATIONS AND CLINICAL USE pms-MOXIFLOXACIN (moxifloxacin hydrochloride) is indicated for the treatment of adults (≥ 18 years of age) with the following bacterial infections caused by susceptible strains of the designated microorganisms for which treatment is appropriate.

1 _________________________________________ 1 Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Desrosiers et al. Allergy, Asthma & Clinical Immunology 2011, 7:2. 2 pms-MOXIFLOXACIN is not indicated for acute bronchitis.

, cefuroxime axetil), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Sequential IV/Oral Administration Note: pms-MOXIFLOXACIN is not available for the IV route of administration. , severe infection or the patient cannot tolerate the oral dosage form, at the discretion of the physician).

, cefuroxime axetil), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. ___________________________________ 2 Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care.

O'Donnell et al. Can Respir J 2008; lS(Suppl A):1A-8A. pms-MOXIFLOXACIN Product Monograph Page 5 of 69 Complicated intra-abdominal infections due to polymicrobial and monomicrobial infections caused by: Bacteroides fragilis* Bacteroides thetaiotaomicron Clostridium perfringens Enterococcus faecalis (Vancomycin sensitive strains […]

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.

pms-MOXIFLOXACIN should be used with caution in patients with known or suspected CNS disorders which may predispose to seizures or lower the seizure threshold (see WARNINGS AND PRECAUTIONS: Central Nervous System Effects). pms-MOXIFLOXACIN Product Monograph Page 7 of 69  Cases of fulminant hepatitis potentially leading to liver failure (including fatal case) have been reported with moxifloxacin hydrochloride (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary).

Carcinogenesis and Mutagenesis From the results of animal studies, there is no evidence to suggest that moxifloxacin hydrochloride is carcinogenic or mutagenic (see TOXICOLOGY). Cardiovascular QT Interval Prolongation Moxifloxacin hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients.

, amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations and the potential risk. Sotalol, a Class III antiarrhythmic, has been shown to increase the QTc interval when combined with high doses of IV moxifloxacin hydrochloride in dogs (see DETAILED PHARMACOLOGY).

Pharmacokinetic studies between moxifloxacin hydrochloride and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics and tricyclic antidepressants have not been performed. An additive effect of moxifloxacin hydrochloride and these drugs cannot be excluded; therefore, pms-MOXIFLOXACIN should be used with caution when given concurrently with these drugs.

The effect of moxifloxacin hydrochloride on patients with congenital prolongation of the QT interval has not been studied, but it is expected that these individuals may be more susceptible to drug-induced QT prolongation. pms-MOXIFLOXACIN should be used with caution in patients with ongoing proarrhythmic conditions such as clinically significant bradycardia, acute myocardial ischemia, clinically relevant heart failure with reduced left-ventricular ejection fraction or previous history of symptomatic arrhythmias.

The magnitude of QT prolongation may increase with increasing plasma concentrations of the drug. Therefore, the recommended dose should not be exceeded (see DOSAGE AND ADMINISTRATION). QT prolongation may lead to an increased risk for ventricular arrhythmias including Torsades de Pointes.

It has been observed with drugs that prolong the QT interval (including moxifloxacin) that females may be at greater risk compared to males for developing Torsades de Pointes because women tend to have a longer baseline QT interval compared to men.

Elderly patients may also be more susceptible to drug-associated effects on the QT interval. pms-MOXIFLOXACIN Product Monograph Page 8 of 69 In 787 patients with paired valid ECGs in Phase III clinical trials, the mean ± SD prolongation of the QTc interval after oral dosing with moxifloxacin hydrochloride 400 mg was 6±26 msec (see ACTION AND CLINICAL PHARMACOLOGY, DETAILED PHARMACOLOGY).

No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin hydrochloride treatment in clinical trials involving over 4,000 patients. However, certain predisposing conditions may increase the risk for ventricular arrhythmias.

If signs of cardiac arrhythmia occur during treatment with pms-MOXIFLOXACIN, treatment should be stopped and an ECG should be performed. pms-MOXIFLOXACIN should be used with caution in patients with liver cirrhosis as pre- existing QT prolongation in these patients cannot be excluded.

, amiodarone, sotalol) […]

8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where: • there is resistance to other first-line antibiotics recommended for the infection; • other first-line antibiotics are contraindicated in an individual patient; • other first-line antibiotics have caused side effects requiring treatment to be stopped; • treatment with other first-line antibiotics has failed.

e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. g. 1). Moxifloxacin 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications: - Community-acquired pneumonia - Complicated skin and skin structure infections Moxifloxacin tablets should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology The recommended dose is one 400 mg film-coated tablet once daily. e. 2 for more details). 3). Other special populations No adjustment of dosage is required in the elderly and in patients with low bodyweight. Paediatric population Moxifloxacin is contraindicated in children and adolescents (< 18 years).

3). Method of administration The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals. Duration of administration Moxifloxacin should be used for the following treatment durations: Acute exacerbation of chronic obstructive pulmonary disease including bronchitis 5 - 10 days Community acquired pneumonia 10 days Acute bacterial sinusitis 7 days Mild to moderate pelvic inflammatory disease 14 days Moxifloxacin 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.

Sequential (intravenous followed by oral) therapy In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections).

The recommended total duration of intravenous and oral treatment is 7 - 14 days for community-acquired pneumonia and 7 -21 days for complicated skin and skin structure infections. The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.

Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed below: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

g. 4) Anaphylaxis incl. 4) Allergic oedema / System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not Known angioedema (incl. 4) Nervous system disorders * Headache Dizziness Par- and Dysaesthesia Taste disorders (incl. ageusia in very rare cases) Confusion and disorientation Sleep disorders (predominantl y insomnia) Tremor Vertigo Somnolence Hypoaesthesia Smell disorders (incl.

anosmia) Abnormal dreams Disturbed co- ordination (incl. gait disturbances, esp. due to dizziness or vertigo) Seizures incl. 4) Disturbed Hyperaesthesia System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not Known attention Speech disorders Amnesia Peripheral neuropathy and polyneuropathy Eye disorders * Visual disturbanc es incl.

4) Ear and labyrinth disorders * Tinnitus Hearing impairment incl. 4) Vascular disorders ** Vasodilat ation Hypertensio n Hypotension Vasculitis System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not Known Respirat ory, thoracic and mediasti nal disorders Dyspnoea (including asthmatic condition) Gastrointestin al disorders Nausea Vomiting Gastrointestinal and abdominal pains Diarrhoea Decreased appetite and food intake Constipation Dyspepsia Flatulence Gastritis Increased amylase Dysphagia Stomatitis Antibiotic associated colitis (incl.

4) Hepatobiliary disorders Increase in transaminases Hepatic impairment (incl. LDH increase) Increased bilirubin Increased gammaglutam yltransferase Increase in blood alkaline phosphatase Jaundice Hepatitis (predominantly cholestatic) Fulminant hepatitis potentially leading to life- threatening liver failure (incl.

4) Rhabdomyolysis Renal and urinary disorders Dehydrati on Renal impairment (incl. 4) General disorders and administration site conditions* Feeling unwell (predominantl y asthenia or fatigue) Painful conditions (incl. pain in back, chest, pelvis and extremities) Sweating Oedema *Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia and neuralgia, fatigue, psychiatric symptoms (including sleep disorders, anxiety, panic attacks, depression and suicidal ideation), memory and concentration impairment and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of […]

6). • Patients below 18 years of age. • Patients with a history of tendon disease/disorder related to quinolone treatment. Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation.

5). Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.

7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

3 )] . MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

4 )]. 5 )]. 6 )] . 5 Plague Moxifloxacin tablets are indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients.

Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. 7 )]. 1 )]. 14 )] and for some patients ABS is self-limiting, reserve moxifloxacin tablets for treatment of ABS in patients who have no alternative treatment options.

2 )]. 14 )] and for some patients ABECB is self-limiting, reserve moxifloxacin tablets, for treatment of ABECB in patients who have no alternative treatment options. 8 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs, moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

7 ) 400 mg 5 • No dosage adjustment in patients with renal or hepatic impairment. 1 Dosage in Adult Patients The dose of moxifloxacin tablets is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

7 ) 400 mg 5 a) Due to the designated pathogens [see Indications and Usage ( 1 )]. b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Conversion of Intravenous to Oral Dosing in Adults Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary.

Patients whose therapy is started with moxifloxacin Injection may be switched to moxifloxacin tablets when clinically indicated at the discretion of the physician. 3 )]. With Food Moxifloxacin tablets can be taken with or without food, drink fluids liberally.

Missed Doses If a dose is missed, it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose.

Double doses should not be taken to compensate for a missed dose.

14 )] Most common reactions (3% or greater) were nausea, diarrhea, headache, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. gov/medwatch. 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 tablets due to adverse reactions occurred in 5% of patients overall, 4% of patients treated with 400 mg PO, and 8% with sequential therapy 400 mg oral/intravenous.

3%) leading to discontinuation with the 400 mg oral doses were nausea, diarrhea, dizziness, and vomiting. The most common adverse reactions leading to discontinuation with the 400 mg intravenous/oral sequential dose were diarrhea, pyrexia.

1 to 1% of moxifloxacin -treated patients, are shown in Tables 2 and Table 3, respectively. The most common adverse drug reactions (3%) are nausea, diarrhea, headache, and dizziness. 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. 2 Postmarketing Experience Table 4 below lists adverse reactions that have been identified during post-approval use of moxifloxacin.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 7 )]

8 )] . 8 )