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Basic Drug Info
Drug Name:Avelox
Manufacturer:Bayer HealthCare Pharmaceuticals Inc
Other Info:

AVELOX Tablets:Active ingredient: moxifloxacin hydrochlorideInactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and ferric oxideAVELOX I.V.:Active ingredient: moxifloxacin hydrochlorideInactive ingredients: sodium chloride, USP, water for injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustmentRevised October 2008This Medication Guide has been approved by the U.S.

Food and Drug Administration.Manufactured by:Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470Avelox Tablets made in GermanyAvelox I.V.

made in Germany or Avelox I.V.

made in Norway byFresenius Kabi Norge ASNO-1753 Halden, NorwayDistributed by:Schering-PloughSchering CorporationKenilworth, NJ 07033AVELOX is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation.Rx Only81532312, R.010/0814208©2008 Bayer HealthCare Pharmaceuticals Inc.Printed in U.S.A.



Clinical Trials:


Indications and Usage

AVELOX Tablets and I.V.

are indicated for the treatment of adults (? 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

(See DOSAGE AND ADMINISTRATION for specific recommendations.

In addition, for I.V.

use see PRECAUTIONS, Geriatric Use.)Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae.* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S.

pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ? 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae (See Clinical Studies).Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin.

Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

CHRONIC BRONCHITIS -- condition characterized by persistent coughing, increased secretion from the bronchial mucosa, obstruction of the respiratory passages, scanty or profuse expectoration, and necrosis and fibrosis of the respiratory tract.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Mycoplasma pneumonia -- Interstitial pneumonia caused by extensive infection of the lungs (LUNG) and BRONCHI, particularly the lower lobes of the lungs, by MYCOPLASMA PNEUMONIAE in humans. In SHEEP, it is caused by MYCOPLASMA OVIPNEUMONIAE. In CATTLE, it may be caused by MYCOPLASMA DISPAR.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Abdominal Infection --

Abscess -- Accumulation of purulent material in tissues, organs, or circumscribed spaces, usually associated with signs of infection.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Contraindications
Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.THE SAFETY AND EFFECTIVENESS OF MOXIFLOXACIN IN PEDIATRIC PATIENTS, ADOLESCENTS (LESS THAN 18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

(SEE PRECAUTIONS-PEDIATRIC USE, PREGNANCY AND NURSING MOTHERS SUBSECTIONS.)QT prolongation: Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients.

The drug should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations.Pharmacokinetic studies between moxifloxacin 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 and these drugs cannot be excluded, therefore caution should be exercised when moxifloxacin is given concurrently with these drugs.

In premarketing clinical trials, the rate of cardiovascular adverse events was similar in 798 moxifloxacin and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval.Moxifloxacin 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 cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 9,200 patients in controlled clinical studies, including 223 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 moxifloxacin tablet treated patients in a post-marketing observational study in which ECGs were not performed.

(See CLINICAL PHARMACOLOGY, Electrocardiogram.

For I.V.

use see DOSAGE AND ADMINISTRATION and PRECAUTIONS, Geriatric Use.)The oral administration of moxifloxacin 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.

(See ANIMAL PHARMACOLOGY.)Convulsions have been reported in patients receiving quinolones.

Quinolones 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 moxifloxacin, the drug should be discontinued and appropriate measures instituted.

As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders (e.g.

severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.

(See PRECAUTIONS: General, Information for Patients, and ADVERSE REACTIONS.)Hypersensitivity reactions: Serious anaphylactic reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including moxifloxacin.

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.

Moxifloxacin 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 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:fever, rash, or severe dermatologic reactions (e.g., 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.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 (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS).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: Rare 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 quinolones.

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