Levofloxacin how supplied

Template:Levofloxacin Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

How supplied

LEVAQUIN Tablets

• 250 mg tablets
• 500 mg tablets
• 750 mg tablets
• Storage of tablets

LEVAQUIN Oral solution

• LEVAQUIN Oral Solution
• Storage of Oral solution

LEVAQUIN Injection

• Single-Use Vials
• Single injectable dose storage
• Premix in Flexible Containers
• Storage of Premix

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250 mg tablets

250 mg tablets are terra cotta pink and are imprinted: "LEVAQUIN" on one side and "250" on the other side.

• bottles of 50 (NDC 0045-1520-50)
• unit-dose/100 tablets (NDC 0045-1520-10)

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500 mg tablets

500 mg tablets are peach and are imprinted: "LEVAQUIN" on one side and "500" on the other side

• bottles of 50 (NDC 0045-1525-50)
• unit-dose/100 tablets (NDC 0045-1525-10)

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750 mg tablets

750 mg tablets are white and are imprinted “LEVAQUIN” on one side and "750" on the other side

• bottles of 20 (NDC 0045-1530-20)
• unit-dose/100 tablets (NDC 0045-1530-10)
• LĒVA-pak 5 tablets (NDC 0045-1530-05)

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Storage of tablets

Stored at 15° to 30°C (59° to 86°F) in well-closed containers. Return to top

LEVAQUIN Oral Solution

LEVAQUIN Oral Solution is supplied in a 16 oz. multi-use bottle (NDC 0045-1515-01). Each bottle contains 480 mL of the 25-mg/mL-levofloxacin oral solution. Return to top

Storage of Oral solution

LEVAQUIN Oral Solution should be stored at 25°C (77°F); excursions permitted to 15° - 30°C (59° to 86°F). Return to top
LEVAQUIN Injection

Single-Use Vials

LEVAQUIN (levofloxacin) Injection is supplied in single-use vials. Each vial contains a concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials and 750 mg of levofloxacin in 30 mL vials.

• 25 mg/mL, 20 mL vials (NDC 0045-0069-51)
• 25 mg/mL, 30 mL vials (NDC 0045-0065-55)

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Single injectable dose storage

LEVAQUIN Injection in Single-Use Vials should be stored at controlled room temperature and protected from light. Return to top

Premix in Flexible Containers

LEVAQUIN (levofloxacin in 5% dextrose) Injection is supplied as a single-use, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W).

• 5 mg/mL (250 mg), 100 mL flexible container, 50 mL fill (NDC 0045-0067-01)
• 5 mg/mL (500 mg), 100 mL flexible container, 100 mL fill (NDC 0045-0068-01)
• 5 mg/mL (750 mg), 150 mL flexible container, 150 mL fill (NDC 0045-0066-01)

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Storage of Premix

LEVAQUIN Injection Premix in Flexible Containers should be stored at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat and protect from freezing and light. Return to top

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Adapted from the FDA Package Insert.

References

http://www.fda.gov/downloads/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/UCM133684.pdf