- Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. Approved Standard – 9 th ed. CLSI Document M7-A9, CLSI, 950 West Valley Rd., Suite 2500, Wayne, PA, 2012.
- CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 22 nd Informational Supplement. CLSI Document M100 – S22, 2012.
- CLSI Performance Standards for Antimicrobial Disk Susceptibility Tests. Approved Standard – 11 th ed. CLSI M2-A11, 2012.
- CLSI. Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline – 2 nd ed. CLSI Document M45-A2, 2010.
16.1 Levofloxacin Tablets, USP
Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, debossed ‘ML 64´ on one side and plain on other side. They are supplied as follows;
NDC 12634-674-00 Bottles of 10
NDC 12634-674-01 Bottles of 100
NDC 12634-674-09 Bottles of 35
NDC 12634-674-12 Bottles of 120
NDC 12634-674-18 Bottles of 180
NDC 12634-674-40 Bottles of 40
NDC 12634-674-42 Bottles of 42
NDC 12634-674-45 Bottles of 45
NDC 12634-674-50 Bottles of 50
NDC 12634-674-52 Blister Pack of 12
NDC 12634-674-54 Blister Pack of 14
NDC 12634-674-57 Blister Pack of 20
NDC 12634-674-59 Blister Pack of 30
NDC 12634-674-60 Bottles of 60
NDC 12634-674-61 Blister Pack of 10
NDC 12634-674-63 Blister Pack of 3
NDC 12634-674-66 Blister Pack of 6
NDC 12634-674-67 Blister Pack of 7
NDC 12634-674-69 Blister Pack of 9
NDC 12634-674-71 Bottles of 30
NDC 12634-674-74 Bottles of 24
NDC 12634-674-78 Bottles of 28
NDC 12634-674-79 Bottles of 25
NDC 12634-674-80 Bottles of 20
NDC 12634-674-81 Bottles of 21
NDC 12634-674-82 Bottles of 12
NDC 12634-674-84 Bottles of 14
NDC 12634-674-85 Bottles of 15
NDC 12634-674-90 Bottles of 90
NDC 12634-674-91 Blister Pack of 1
NDC 12634-674-92 Bottles of 2
NDC 12634-674-93 Bottles of 3
NDC 12634-674-94 Bottles of 4
NDC 12634-674-95 Bottles of 5
NDC 12634-674-96 Bottles of 6
NDC 12634-674-97 Bottles of 7
NDC 12634-674-98 Bottles of 8
NDC 12634-674-99 Bottles of 9
Levofloxacin tablets, USP should be stored at 20° to 25°C (68°to 77°F); excursions permitted to 15°to 30°C (59°to 86°F) in well-closed containers.
Advise the patients to read the FDA-Approved Medication Guide ( 17.6)
Advise patients to stop taking levofloxacin tablets if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.
Inform patients of the following serious adverse reactions that have been associated with levofloxacin tablets or other fluoroquinolone use:
- Disabling and Potentially Irreversible Serious Adverse Reactions That May Occur Together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of levofloxacin tablets and may occur together in the same patient. Inform patients to stop taking levofloxacin tablets immediately if they experience an adverse reaction and to call their healthcare provider.
- Tendinitis and Tendon Rupture: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue levofloxacin tablets treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
- Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with levofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue levofloxacin tablets and tell them to contact their physician.
- Central Nervous System Effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure) : Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including levofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to levofloxacin tablets before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
- Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
- Hypersensitivity Reactions: Inform patients that levofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
- Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking levofloxacin tablets. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
- Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
- Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
- Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child’s physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child’s physician of any joint-related problems that occur during or following levofloxacin therapy [see Warnings and Precautions ( 5.11) and Use in Specific Populations ( 8.4)].
- Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking fluoroquinolones. If patients need to be outdoors while using fluoroquinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.
Antibacterial drugs including levofloxacin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When levofloxacin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by levofloxacin or other antibacterial drugs in the future.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.