Levofloxacin how supplied: Difference between revisions
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LEVAQUIN Tablets | {{CMG}} | ||
==How supplied== | |||
<font size="4">LEVAQUIN Tablets'''</font> | |||
*<font size="3">[[Levofloxacin how supplied#250 mg tablets|250 mg tablets]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#500 mg tablets|500 mg tablets]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#750 mg tablets|750 mg tablets]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#Storage of tablets|Storage of tablets]]</font> | |||
<br> | |||
<font size="4">LEVAQUIN Oral solution'''</font> | |||
*<font size="3">[[Levofloxacin how supplied#LEVAQUIN Oral Solution|LEVAQUIN Oral Solution]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#Storage of Oral solution|Storage of Oral solution]]</font> | |||
<br> | |||
<font size="4">LEVAQUIN Injection'''</font> | |||
*<font size="3">[[Levofloxacin how supplied#Single-Use Vials|Single-Use Vials]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#Single injectable dose storage|Single injectable dose storage]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#Premix in Flexible Containers|Premix in Flexible Containers]]</font> | |||
*<font size="3">[[Levofloxacin how supplied#Storagge of Premix|Storage of Premix]]</font> | |||
<br> | |||
---- | |||
<br> | |||
===250 mg tablets=== | ===250 mg tablets=== | ||
250 mg tablets are terra cotta pink and are imprinted: "LEVAQUIN" on one side and "250" on | 250 mg tablets are terra cotta pink and are imprinted: "LEVAQUIN" on one side and "250" on | ||
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*bottles of 50 (NDC 0045-1520-50) | *bottles of 50 (NDC 0045-1520-50) | ||
*unit-dose/100 tablets (NDC 0045-1520-10) | *unit-dose/100 tablets (NDC 0045-1520-10) | ||
''[[Levofloxacin how supplied#How supplied|Return to top]]'' | |||
<br> | <br> | ||
===500 mg tablets=== | ===500 mg tablets=== | ||
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*bottles of 50 (NDC 0045-1525-50) | *bottles of 50 (NDC 0045-1525-50) | ||
*unit-dose/100 tablets (NDC 0045-1525-10) | *unit-dose/100 tablets (NDC 0045-1525-10) | ||
''[[Levofloxacin how supplied#How supplied|Return to top]]'' | |||
<br> | <br> | ||
===750 mg tablets=== | ===750 mg tablets=== | ||
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*unit-dose/100 tablets (NDC 0045-1530-10) | *unit-dose/100 tablets (NDC 0045-1530-10) | ||
*LĒVA-pak 5 tablets (NDC 0045-1530-05) | *LĒVA-pak 5 tablets (NDC 0045-1530-05) | ||
''[[Levofloxacin how supplied#How supplied|Return to top]]'' | |||
<br> | <br> | ||
===Storage of tablets=== | ===Storage of tablets=== | ||
Stored at 15° to 30°C (59° to 86°F) in well-closed containers | Stored at 15° to 30°C (59° to 86°F) in well-closed containers. ''[[Levofloxacin how supplied#How supplied|Return to top]]'' | ||
<br> | <br> | ||
===LEVAQUIN Oral Solution=== | ===LEVAQUIN Oral Solution=== | ||
LEVAQUIN Oral Solution is supplied in a 16 oz. multi-use bottle (NDC 0045-1515-01). Each | 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 | bottle contains 480 mL of the 25-mg/mL-levofloxacin oral solution. ''[[Levofloxacin how supplied#How supplied|Return to top]]'' | ||
<br> | <br> | ||
===Storage of Oral solution=== | ===Storage of Oral solution=== | ||
LEVAQUIN Oral Solution should be stored at 25°C (77°F); excursions permitted to 15° - 30°C | LEVAQUIN Oral Solution should be stored at 25°C (77°F); excursions permitted to 15° - 30°C | ||
(59° to 86°F) | (59° to 86°F). ''[[Levofloxacin how supplied#How supplied|Return to top]]'' | ||
<br> | <br> | ||
LEVAQUIN Injection | LEVAQUIN Injection | ||
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*25 mg/mL, 20 mL vials (NDC 0045-0069-51) | *25 mg/mL, 20 mL vials (NDC 0045-0069-51) | ||
*25 mg/mL, 30 mL vials (NDC 0045-0065-55) | *25 mg/mL, 30 mL vials (NDC 0045-0065-55) | ||
''[[Levofloxacin how supplied#How supplied|Return to top]]'' | |||
<br> | <br> | ||
===Single injectable dose storage=== | ===Single injectable dose storage=== | ||
LEVAQUIN Injection in Single-Use Vials should be stored at controlled room temperature and | LEVAQUIN Injection in Single-Use Vials should be stored at controlled room temperature and | ||
protected from light | protected from light. ''[[Levofloxacin how supplied#How supplied|Return to top]]'' | ||
<br> | <br> | ||
===Premix in Flexible Containers=== | ===Premix in Flexible Containers=== | ||
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*5 mg/mL (500 mg), 100 mL flexible container, 100 mL fill (NDC 0045-0068-01) | *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) | *5 mg/mL (750 mg), 150 mL flexible container, 150 mL fill (NDC 0045-0066-01) | ||
''[[Levofloxacin how supplied#How supplied|Return to top]]'' | |||
<br> | <br> | ||
=== | ===Storage of Premix=== | ||
LEVAQUIN Injection Premix in Flexible Containers should be stored at or below 25°C (77°F); | 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 | however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid | ||
excessive heat and protect from freezing and light. | excessive heat and protect from freezing and light. ''[[Levofloxacin how supplied#How supplied|Return to top]]'' | ||
<br> | <br> | ||
<br> | <br> | ||
Revision as of 17:49, 20 December 2011
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
How supplied
LEVAQUIN Tablets
LEVAQUIN Oral solution
LEVAQUIN Injection
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)
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)
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)
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)
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)
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
Adapted from the FDA Package Insert.