Moxifloxacin Hydrochloride (moxifloxacin hydrochloride 400 mg) Dailymed

Moxifloxacin hydrochloride tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions uled below:

Community Acquired Pneumonia (1.1) Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) Complicated Intra-Abdominal Infections (1.4) Plague (1.5)Acute Bacterial Sinusitis (1.6) Acute Bacterial Exacerbation of Chronic Bronchitis (1.7)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs. Moxifloxacin hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.8)

1.1 Community Acquired Pneumonia

Moxifloxacin hydrochloride tablets are indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies (14.3)].

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

1.2 Uncomplicated Skin and Skin Structure Infections

Moxifloxacin hydrochloride tablets are indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies (14.4)].

1.3 Complicated Skin and Skin Structure Infections

Moxifloxacin hydrochloride tablets are indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies (14.5)].

1.4 Complicated Intra-Abdominal Infections

Moxifloxacin hydrochloride tablets are indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections (cIAI) including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies (14.6)].

1.5 Plague

Moxifloxacin hydrochloride 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. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.7)].

1.6 Acute Bacterial Sinusitis

Moxifloxacin hydrochloride tablets are indicated in adult patients (18 years of age and older) for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.1)].

Because fluoroquinolones, including moxifloxacin hydrochloride tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.13)] and for some patients ABS is self-limiting, reserve moxifloxacin hydrochloride tablets for treatment of ABS in patients who have no alternative treatment options.

1.7 Acute Bacterial Exacerbation of Chronic Bronchitis

Moxifloxacin hydrochloride tablets are indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies (14.2)].

Because fluoroquinolones, including moxifloxacin hydrochloride tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.13)] and for some patients ABECB is self-limiting, reserve moxifloxacin hydrochloride tablets for treatment of ABECB in patients who have no alternative treatment options.

1.8 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride 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.

2 Dosage And Administration

Type of Infection	Dose Every 24 hours	Duration (days)
Community Acquired Pneumonia (1.1)	400 mg	7 to 14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2)	400 mg	7
Complicated SSSI (1.3)	400 mg	7 to 21
Complicated Intra-Abdominal Infections (1.4)	400 mg	5 to 14
Plague (1.5)	400 mg	10 to 14
Acute Bacterial Sinusitis (1.6)	400 mg	10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.7)	400 mg	5

• •No dosage adjustment in patients with renal or hepatic impairment. (8.6, 8.7)

2.1 Dosage in Adult Patients

The dose of moxifloxacin hydrochloride tablets is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

Table 1: Dosage and Duration of Therapy in Adult Patients

Type of InfectionDue to the designated pathogens [see Indications and Usage (1)].	DoseEvery 24hours	DurationSequential therapy (intravenous to oral) may be instituted at the discretion of the physician (days)
Community Acquired Pneumonia (1.1)	400 mg	7 to 14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.2)	400 mg	7
Complicated SSSI (1.3)	400 mg	7 to 21
Complicated Intra-Abdominal Infections (1.4)	400 mg	5 to 14
Plague (1.5)Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.	400 mg	10 to 14
Acute Bacterial Sinusitis (ABS) (1.6)	400 mg	10
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) (1.7)	400 mg	5

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 hydrochloride injection may be switched to moxifloxacin hydrochloride tablets when clinically indicated at the discretion of the physician.

2.2Important Administration Instructions

With Multivalent Cations

Administer moxifloxacin hydrochloride tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

With Food

Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.

3 Dosage Forms And Strengths

• •Tablets: Moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin) (3.1)

3.1Moxifloxacin Hydrochloride Tablets

Moxifloxacin Hydrochloride Tablets are available containing 436.331 mg of moxifloxacin hydrochloride, USP (equivalent to 400 mg of moxifloxacin).

• •The 400 mg tablets are pink, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and MO1 on the other side.

4 Contraindications

Moxifloxacin hydrochloride tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8) ].


Known hypersensitivity to moxifloxacin hydrochloride tablets or other quinolones (4, 5.8)

5 Warnings And Precautions

• •Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. (5.6, 7.5, 8.5)
• •Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin. Discontinue moxifloxacin at first sign of skin rash, jaundice or any other sign of hypersensitivity. (5.7, 5.8)
• • Clostridium difficile-Associated Diarrhea: Evaluate if diarrhea occurs. (5.9)

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting moxifloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4)].

Discontinue moxifloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including moxifloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

5.2 Tendinitis and Tendon Rupture

Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur within hours or days of starting moxifloxacin or as long as several months after completion of therapy. Tendinitis and tendon rupture can occur bilaterally.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue moxifloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. Avoid fluoroquinolones, including moxifloxacin, in patients who have a history of tendon disorders or who have experienced tendinitis or tendon rupture [see Adverse Reactions (6.2)].

5.3 Peripheral Neuropathy

Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including moxifloxacin. Symptoms may occur soon after initiation of moxifloxacin and may be irreversible in some patients [see Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2)].

Discontinue moxifloxacin immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation. Avoid fluoroquinolones, including moxifloxacin, in patients who have previously experienced peripheral neuropathy.

5.4 Central Nervous System Effects

Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis. Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving moxifloxacin, discontinue moxifloxacin immediately and institute appropriate measures. As with all fluoroquinolones, use moxifloxacin when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (for example, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold [see Drug Interactions (7.4)].

5.5Exacerbation of Myasthenia Gravis

Fluoroquinolones, including moxifloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis.

5.6 QT Prolongation

Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. Following oral dosing with 400 mg of moxifloxacin the mean (± SD) change in QTc from the pre-dose value at the time of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in QTc from the Day 1 pre-dose value was 10 msec (± 22) on Day 1 (n = 667) and 7 msec (± 24) on Day 3 (n = 667).

Avoid moxifloxacin in patients with the following risk factors due to the lack of clinical experience with the drug in these patient populations:

• •Known prolongation of the QT interval
• •Ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions
• •Ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia
• •Uncorrected hypokalemia or hypomagnesemia
• •Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents
• •Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants

In patients with mild, moderate, or severe liver cirrhosis, metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation. Monitor ECG in patients with liver cirrhosis treated with moxifloxacin [see Clinical Pharmacology (12.3)].

The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded.

In premarketing clinical trials, the rate of cardiovascular adverse reactions was similar in 798 moxifloxacin and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 15,500 patients in controlled clinical studies, including 759 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 moxifloxacin hydrochloride tablets treated patients in a postmarketing observational study in which ECGs were not performed.

5.7 Other Serious and Sometimes Fatal Adverse Reactions

Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with fluoroquinolones, including moxifloxacin. These reactions may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• •Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome)
• •Vasculitis; arthralgia; myalgia; serum sickness
• •Allergic pneumonitis
• •Interstitial nephritis; acute renal insufficiency or failure
• •Hepatitis; jaundice; acute hepatic necrosis or failure
• •Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities

Discontinue moxifloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures.

5.8 Hypersensitivity Reactions

Serious anaphylactic reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including moxifloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Discontinue moxifloxacin at the first appearance of a skin rash or any other sign of hypersensitivity [see Warnings and Precautions (5.7)].

5.9 Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including moxifloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.10Arthropathic Effects in Animals

In immature dogs, oral administration of moxifloxacin caused lameness. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species [see Nonclinical Toxicology (13.2)].

5.11 Blood Glucose Disturbances

As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin. In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, sulfonylurea) or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs, moxifloxacin should be discontinued and appropriate therapy should be initiated immediately [see Drug Interactions (7.3)].

5.12 Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, bulering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones, including moxifloxacin, after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Moxifloxacin should be discontinued if phototoxicity occurs [see Clinical Pharmacology (12.2)].

5.13Development of Drug Resistant Bacteria

Prescribing moxifloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

6 Adverse Reactions

The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label:

• •Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1)]
• •Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)]
• •Peripheral Neuropathy [see Warnings and Precautions (5.3)]
• •Central Nervous System Effects [see Warnings and Precautions (5.4)]
• •Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5)]
• •QT Prolongation [see Warnings and Precautions (5.6)]
• •Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.7)]
• •Hypersensitivity Reactions [see Warnings and Precautions (5.8)]
• • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.9)]
• •Blood Glucose Disturbances [see Warnings and Precautions (5.11)]
• •Photosensitivity/Phototoxicity [see Warnings and Precautions (5.12)]
• •Development of Drug Resistant Bacteria [see Warnings and Precautions (5.13)]

Most common reactions (3% or greater) were nausea, diarrhea, headache, and dizziness. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 14,981 patients in 71 active controlled Phase II to 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 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 Diarrhea Vomiting Constipation Abdominal pain Dyspepsia	7 6 2 2 2 1
General Disorders and Administration Site Conditions	Pyrexia	1
Investigations	Alanine aminotransferase increased	1
Metabolism and Nutritional Disorder	Hypokalemia	1
Nervous System Disorders	Headache Dizziness	4 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 PalpitationsTachycardia 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	DysgeusiaSomnolence 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

Changes in laboratory parameters, which are not uled 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 (pO₂), 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.

6.2Postmarketing Experience

Table 4 below uls 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.

Table 4: Postmarketing Reports of Adverse Drug Reactions

System Organ Class	Adverse Reactions
Blood and Lymphatic System Disorders	Agranulocytosis Pancytopenia [see Warnings and Precautions (5.7) ]
Cardiac Disorders	Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions)
Ear and Labyrinth Disorders	Hearing impairment, including deafness (reversible in majority of cases)
Eye Disorders	Vision loss (especially in the course of CNS reactions, transient in majority of cases)
Hepatobiliary Disorders	Hepatitis (predominantly cholestatic) Hepatic failure (including fatal cases) Jaundice Acute hepatic necrosis [see Warnings and Precautions (5.7) ]
Immune System Disorders	Anaphylactic reaction Anaphylactic shock Angioedema (including laryngeal edema) [see Warnings and Precautions (5.7 , 5.8) ]
Musculoskeletal and Connective Tissue Disorders	Tendon rupture [see Warnings and Precautions (5.2) ]
Nervous System Disorders	Altered coordination Abnormal gait [see Warnings and Precautions (5.3) ] Myasthenia gravis (exacerbation of) [see Warnings and Precautions (5.5) ] Muscle weaknessPeripheral neuropathy (that may be irreversible), polyneuropathy [see Warnings and Precautions (5.3) ]
Psychiatric Disorders	Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts) [see Warnings and Precautions (5.4) ]
Renal and Urinary Disorders	Interstitial nephritis [see Warnings and Precautions (5.7) ]
Respiratory, Thoracic and Mediastinal Disorders	Allergic pneumonitis [see Warnings and Precautions (5.7) ]
Skin and Subcutaneous Tissue Disorders	Photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.12) ] Stevens-Johnson syndrome Toxic epidermal necrolysis [see Warnings and Precautions (5.7) ]