Levofloxacin (Page 15 of 17)

15 REFERENCES

  1. 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.
  2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 22 nd Informational Supplement. CLSI Document M100 – S22, 2012.
  3. CLSI Performance Standards for Antimicrobial Disk Susceptibility Tests. Approved Standard – 11 th ed. CLSI M2-A11, 2012.
  4. 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 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

Advise the patients to read the FDA-Approved Medication Guide ( 17.6)

17.1 Serious Adverse Reactions

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.

17.2 Antibacterial Resistance


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.

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