{{DrugProjectFormSinglePage
|authorTag=Kiran Singh, M.D.[1]
|genericName=moxifloxacin hydrochloride
|aOrAn=an
|drugClass=antibiotic
|indicationType=treatment
|indication=acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, skin and skin structure infections: uncomplicated and complicated, complicated intra-abdominal infections
|hasBlackBoxWarning=Yes
|adverseReactions=nausea, diarrhea, headache, and dizziness
|blackBoxWarningTitle=WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
|blackBoxWarningBody=* Fluoroquinolones, including AVELOX®, 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.
Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis.
|fdaLIADAdult===Indications==
For treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria.
Acute Bacterial Sinusitis
Acute Bacterial Exacerbation of Chronic Bronchitis
Community Acquired Pneumonia
Skin and Skin Structure Infections: Uncomplicated and Complicated
The dose of AVELOX is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
This image is provided by the National Library of Medicine.
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 AVELOX IV may be switched to AVELOX Tablets when clinically indicated at the discretion of the physician.
AVELOX IV Solution for Infusion
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
AVELOX IV should be administered by INTRAVENOUS infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
AVELOX IV should be administered by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Caution: rapid or bolus intravenous infusion must be avoided.
Because only limited data are available on the compatibility of AVELOX intravenous injection with other intravenous substances, additives or other medications should not be added to AVELOX IV or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of AVELOX IV with an infusion solution compatible with AVELOX IV as well as with other drug(s) administered via this common line.
This image is provided by the National Library of Medicine.
Preparation for Administration of AVELOX IV
To prepare AVELOX IV injection premix in flexible containers:
Close flow control clamp of administration set.
Remove cover from port at bottom of container.
Insert piercing pin from an appropriate transfer set (for example, one that does :*Not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.
NOTE: Refer to complete directions that have been provided with the administration set.
DOSAGE FORMS AND STRENGTHS
Containing 400 mg moxifloxacin in 0.8% saline (moxifloxacin hydrochloride in sodium chloride injection) with pH ranging from 4.1 to 4.6.
Ready-to-use 250 mL latex-free flexibags. No further dilution is necessary
|offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Moxifloxacin (injection) in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Moxifloxacin (injection) in adult patients.
|fdaLIADPed=There is limited information regarding FDA-Labeled Use of Moxifloxacin (injection) in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Moxifloxacin (injection) in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Moxifloxacin (injection) in pediatric patients.
|contraindications=* AVELOX is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
|warnings=Tendinopathy and Tendon Rupture
Fluoroquinolones, including AVELOX, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture 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. Factors, in addition to age and corticosteroid use, 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. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. AVELOX should be discontinued 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.
Exacerbation of Myasthenia Gravis
Fluoroquinolones, including AVELOX, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis.
QT Prolongation
AVELOX has been shown to prolong the QT interval of the electrocardiogram in some patients. Following oral dosing with 400 mg of AVELOX 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).
The drug should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and patients receiving Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations.
Pharmacokinetic studies between AVELOX and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. An additive effect of AVELOX and these drugs cannot be excluded; therefore caution should be exercised when AVELOX is given concurrently with these drugs. In premarketing clinical trials, the rate of cardiovascular adverse events was similar in 798 AVELOX and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval.
AVELOX should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. 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. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsade de pointes. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with AVELOX 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 AVELOX tablet treated patients in a postmarketing observational study in which ECGs were not performed. Elderly patients using IV AVELOX may be more susceptible to drug-associated [[QT prolongation\\ . In addition, AVELOX should be used with caution in patients with mild, moderate, or severe liver cirrhosis.
Hypersensitivity Reactions
Serious anaphylactic reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including AVELOX. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. AVELOX should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Oxygen, intravenous steroids, and airway management, including intubation, may be administered as indicated.
Other Serious and Sometimes Fatal Reactions
Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including AVELOX. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.
Convulsions and increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones.
Fluoroquinolones may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving AVELOX, the drug should be discontinued and appropriate measures instituted. As with all fluoroquinolones, AVELOX should be used with caution 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.
Clostridium Difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AVELOX, 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 antibiotic 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.
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 AVELOX. Symptoms may occur soon after initiation of AVELOX and may be irreversible. AVELOX should be discontinued 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.
Arthropathic Effects in Animals
The oral administration of AVELOX caused lameness in immature dogs. 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.
Blood Glucose Disturbances
As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with AVELOX. In AVELOX-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, AVELOX should be discontinued and appropriate therapy should be initiated immediately.
Photosensitivity/Phototoxicity
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, 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 quinolone antibiotics after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs.
Development of Drug Resistant Bacteria
Prescribing AVELOX 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.
|clinicalTrials=There is limited information regarding Clinical Trial Experience of Moxifloxacin (injection) in the drug label.
|postmarketing=There is limited information regarding Postmarketing Experience of Moxifloxacin (injection) in the drug label.
|useInPregnancyFDA=* Pregnancy Category
|useInPregnancyAUS=* Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Moxifloxacin (injection) in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of Moxifloxacin (injection) during labor and delivery.
|useInNursing=There is no FDA guidance on the use of Moxifloxacin (injection) with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of Moxifloxacin (injection) with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of Moxifloxacin (injection) with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of Moxifloxacin (injection) with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of Moxifloxacin (injection) with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of Moxifloxacin (injection) in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of Moxifloxacin (injection) in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of Moxifloxacin (injection) in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of Moxifloxacin (injection) in patients who are immunocompromised.
|administration=* Oral
Intravenous
|monitoring=There is limited information regarding Monitoring of Moxifloxacin (injection) in the drug label.
Description
|IVCompat=There is limited information regarding IV Compatibility of Moxifloxacin (injection) in the drug label.
|overdose====Acute Overdose===
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Moxifloxacin (injection) in the drug label.
|PD=There is limited information regarding Pharmacodynamics of Moxifloxacin (injection) in the drug label.
|PK=There is limited information regarding Pharmacokinetics of Moxifloxacin (injection) in the drug label.
|nonClinToxic=There is limited information regarding Nonclinical Toxicology of Moxifloxacin (injection) in the drug label.
|clinicalStudies=There is limited information regarding Clinical Studies of Moxifloxacin (injection) in the drug label.
|howSupplied=*
|packLabel=
|fdaPatientInfo=There is limited information regarding Patient Counseling Information of Moxifloxacin (injection) in the drug label.
|alcohol=* Alcohol-Moxifloxacin (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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