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AVELOX (Moxifloxacin Hydrochloride

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HIGHLIGHTS OF PRESCRIBING INFORMATION Complicated Intra-Abdominal Infections (1.4) 400 mg 5–14 These highlights do not include all the information needed to use Plague (1.5) 400 mg 10–14 ® AVELOX safely and effectively. See full prescribing information for Acute Bacterial Sinusitis (1.6) 400 mg 10 AVELOX. Acute Bacterial Exacerbation of Chronic AVELOX (moxifloxacin hydrochloride) tablets, for oral use Bronchitis (1.7) 400 mg 5 AVELOX (moxifloxacin hydrochloride) injection, for intravenous use • No dosage adjustment in patients with renal or hepatic impairment. (8.6, Initial U.S. Approval: 1999 8.7) • AVELOX Injection: Slow intravenous infusion over 60 minutes. Avoid rapid or bolus intravenous injection. (2.2) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING • Do not mix with other medications in intravenous bag or in an intravenous TENDINITIS, TENDON RUPTURE, PERIPHERAL line. (2.3) NEUROPATHY, CENTRIAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS ---------------------DOSAGE FORMS AND STRENGTHS---------------------­ See full prescribing information for complete boxed warning • Tablets: Moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin) (3.1) • Fluoroquinolones, including AVELOX, have been associated • Injection: Moxifloxacin hydrochloride (equivalent to 400 mg with disabling and potentially irreversible serious adverse moxifloxacin) in 0.8% sodium chloride solution in a 250 mL flexibag (3.2) reactions that have occurred together (5.1) including: Tendinitis and tendon rupture (5.2) -------------------------------CONTRAINDICATIONS-----------------------------­ o Known hypersensitivity to AVELOX or other quinolones (4, 5.8) o Peripheral Neuropathy (5.3) o Central nervous system effects (5.4) -----------------------WARNINGS AND PRECAUTIONS-----------------------­ Discontinue AVELOX immediately and avoid the use of • Prolongation of the QT interval and isolated cases of torsade de pointes has fluoroquinolones, including AVELOX, in patients who been reported. Avoid use in patients with known prolongation, experience any of these serious adverse reactions (5.1) proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that • Fluoroquinolones, including AVELOX, may exacerbate muscle prolong the QT interval. (5.6, 7.5, 8.5) weakness in patients with myasthenia gravis. Avoid AVELOX in • Hypersensitivity and other serious reactions: Serious and sometimes fatal patients with known history of myasthenia gravis (5.5). reactions, including anaphylactic reactions, may occur after first or • Because fluoroquinolones, including AVELOX, have been subsequent doses of AVELOX. Discontinue AVELOX at first sign of skin associated with serious adverse reactions (5.1–5.13), reserve rash, jaundice or any other sign of hypersensitivity. (5.7, 5.8) AVELOX for use in patients who have no alternative treatment • Clostridium difficile-Associated Diarrhea: Evaluate if diarrhea occurs. options for the following indications: (5.9) o Acute bacterial sinusitis (1.6) ------------------------------ADVERSE REACTIONS------------------------------­ o Acute bacterial exacerbation of chronic bronchitis (1.7) Most common reactions (3% or greater) were nausea, diarrhea, headache, and dizziness. (6) ----------------------------RECENT MAJOR CHANGES-------------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Bayer Boxed Warning M/2016 HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800­ Indications and Usage (1.6, 1.7) M/2016 FDA-1088 or www.fda.gov/medwatch. Dosage and Administration (2.1) M/2016 Warnings and Precautions (5.1) M/2016 ------------------------------DRUG INTERACTIONS------------------------------­ ----------------------------INDICATIONS AND USAGE--------------------------­ Interacting Drug Interaction AVELOX is a fluoroquinolone antibacterial indicated for treating infections in Multivalent cation- Decreased AVELOX absorption. Take AVELOX adults 18 years of age and older caused by designated susceptible bacteria, in containing products Tablet at least 4 hours before or 8 hours after the conditions listed below: including: antacids, these products. (2.2, 7.1, 12.3) Community Acquired Pneumonia (1.1) sucralfate, multivitamins Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) Warfarin Anticoagulant effect enhanced. Monitor Complicated Intra-Abdominal Infections (1.4) prothrombin time/INR, and bleeding. (6, 7.2, Plague (1.5) 12.3) Acute Bacterial Sinusitis (1.6) Class IA and Class III Proarrhythmic effect may be enhanced. Avoid Acute Bacterial Exacerbation of Chronic Bronchitis (1.7) antiarrhythmics: concomitant use. (5.6, 7.5) To reduce the development of drug-resistant bacteria and maintain the Antidiabetic agents Carefully monitor blood glucose. (5.11, 7.3) effectiveness of AVELOX and other antibacterial drugs. AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to -----------------------USE IN SPECIFIC POPULATIONS-----------------------­ be caused by susceptible bacteria. (1.8) • Pregnancy: Based on animal data may cause fetal harm. (8.1) • Geriatrics: Increased risk for severe tendon disorders further ----------------------DOSAGE AND ADMINISTRATION----------------------­ increased by concomitant corticosteroid therapy and increased risk of prolongation of the QT interval. (5.1, 5.6, 8.5) Dose Every Duration Type of Infection 24 hours (days) See 17 for PATIENT COUNSELING INFORMATION and Medication Community Acquired Pneumonia (1.1) 400 mg 7–14 Guide Revised: 7/2016 Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2) 400 mg 7 Complicated SSSI (1.3) 400 mg 7–21 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS ADVERSE REACTIONS INCLUDING 1.5 Plague TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, 1.6 Acute Bacterial Sinusitis CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION 1.7 Acute Bacterial Exacerbation of Chronic Bronchitis OF MYASTHENIA GRAVIS 1.8 Usage 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 1.1 Community Acquired Pneumonia 2.1 Dosage in Adult Patients 1.2 Uncomplicated Skin and Skin Structure Infections 2.2 Important Administration Instructions 1.3 Complicated Skin and Skin Structure Infections 2.3 Drug and Diluent Compatabilities 1.4 Complicated Intra-Abdominal Infections 2.4 Preparation for Administration of AVELOX Injection 1 Reference ID: 3963471 3 DOSAGE FORMS AND STRENGTHS 8.3 Nursing Mothers 3.1 AVELOX Tablets 8.4 Pediatric Use 3.2 AVELOX Injection 8.5 Geriatric Use 4 CONTRAINDICATIONS 8.6 Renal Impairment 5 WARNINGS AND PRECAUTIONS 8.7 Hepatic Impairment 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions 10 OVERDOSAGE Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and 11 DESCRIPTION Central Nervous System Effects 11.1 AVELOX Tablets 5.2 Tendinitis and Tendon Rupture 11.2 AVELOX Injection 5.3 Peripheral Neuropathy 12 CLINICAL PHARMACOLOGY 5.4 Central Nervous System Effects 12.1 Mechanism of Action 5.5 Exacerbation of Myasthenia Gravis 12.2 Pharmacodynamics 5.6 QT Prolongation 12.3 Pharmacokinetics 5.7 Hypersensitivity Reactions 12.4 Microbiology 5.8 Other Serious and Sometimes Fatal Reactions 13 NONCLINICAL TOXICOLOGY 5.9 Clostridium difficile-Associated Diarrhea 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.10 Arthropathic Effects in Animals 13.2 Animal Toxicology and/or Pharmacology 5.11 Blood Glucose Disturbances 14 CLINICAL STUDIES 5.12 Photosensitivity/Phototoxicity 14.1 Acute Bacterial Sinusitis 5.13 Development of Drug Resistant Bacteria 14.2 Acute Bacterial Exacerbation of Chronic Bronchitis 6 ADVERSE REACTIONS 14.3 Community Acquired Pneumonia 6.1 Clinical Trials Experience 14.4 Uncomplicated Skin and Skin Structure Infections 6.2 Postmarketing Experience 14.5 Complicated Skin and Skin Structure Infections 7 DRUG INTERACTIONS 14.6 Complicated Intra-Abdominal Infections 7.1 Antacids, Sucralfate, Multivitamins and Other Products Containing 14.7 Plague Multivalent Cations 15 REFERENCES 7.2 Warfarin 16 HOW SUPPLIED/STORAGE AND HANDLING 7.3 Antidiabetic Agents 16.1 AVELOX Tablets 7.4 Nonsteroidal Anti-Inflammatory Drugs 16.2 AVELOX Injection– Premix Bags 7.5 Drugs that Prolong QT 17 PATIENT COUNSELING INFORMATION 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAI NERVOUS SYTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including AVELOX, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)], including: o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)] o Peripheral neuropathy [see Warnings and Precautions (5.3)] o Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue AVELOX immediately and avoid the use of fluoroquinolones, including AVELOX, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]. • Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)]. • Because fluoroquinolones, including AVELOX, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.13)],
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  • TROVAN® Tablets(Trovafloxacin Mesylate)

    TROVAN® Tablets(Trovafloxacin Mesylate)

    TROVAN- trovafloxacin mesylate tablet, film coated TROVAN- trovafloxacin mesylate injection, solution, concentrate Roerig ---------- TROVAN® Tablets (trovafloxacin mesylate) TROVAN® I.V. (alatrofloxacin mesylate injection) For Intravenous Infusion TROVAN® HAS BEEN ASSOCIATED WITH SERIOUS LIVER INJURY LEADING TO LIVER TRANSPLANTATION AND/OR DEATH. TROVAN-ASSOCIATED LIVER INJURY HAS BEEN REPORTED WITH BOTH SHORT-TERM AND LONG-TERM DRUG EXPOSURE. TROVAN USE EXCEEDING 2 WEEKS IN DURATION IS ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF SERIOUS LIVER INJURY. LIVER INJURY HAS ALSO BEEN REPORTED FOLLOWING TROVAN RE- EXPOSURE. TROVAN SHOULD BE RESERVED FOR USE IN PATIENTS WITH SERIOUS, LIFE- OR LIMB-THREATENING INFECTIONS WHO RECEIVE THEIR INITIAL THERAPY IN AN IN-PATIENT HEALTH CARE FACILITY (I.E., HOSPITAL OR LONG-TERM NURSING CARE FACILITY). TROVAN SHOULD NOT BE USED WHEN SAFER, ALTERNATIVE ANTIMICROBIAL THERAPY WILL BE EFFECTIVE. (SEE WARNINGS.) TROVAN is available as TROVAN Tablets (trovafloxacin mesylate) for oral administration and as TROVAN I.V. (alatrofloxacin mesylate injection), a prodrug of trovafloxacin, for intravenous administration. DESCRIPTION TROVAN Tablets TROVAN Tablets contain trovafloxacin mesylate, a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, trovafloxacin mesylate, a fluoronaphthyridone related to the fluoroquinolone antibacterials, is (1α, 5α, 6α)-7-(6-amino-3-azabicyclo[3.1.0]hex-3-yl)-1-(2,4- difluorophenyl)-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid, monomethanesulfonate. Trovafloxacin mesylate differs from other quinolone derivatives by having a 1,8-naphthyridine nucleus. The chemical structure is: Its empirical formula is C20H15F3N4O3•CH3SO3H and its molecular weight is 512.46. Trovafloxacin mesylate is a white to off-white powder.