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(levofloxacin) Tablets, Oral Solution, and IV
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
- Fluoroquinolones, including LEVAQUIN®,
have been associated with disabling and potentially irreversible serious
adverse reactions that have occurred together [see WARNINGS AND PRECAUTIONS],
- Tendinitis and tendon rupture [see WARNINGS AND PRECAUTIONS]
- Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
- Central nervous system
effects [see WARNINGS AND PRECAUTIONS]
Discontinue LEVAQUIN immediately and avoid the use of fluoroquinolones, including LEVAQUIN, in patients who experience any of these serious adverse reactions [see WARNINGS AND PRECAUTIONS]
- Fluoroquinolones, including LEVAQUIN® , may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVAQUIN® in patients with a known history of myasthenia gravis [see WARNINGS AND PRECAUTIONS].
- Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS], reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:
LEVAQUIN® is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine6-carboxylic acid hemihydrate.
Figure 1 : The Chemical Structure of Levofloxacin
The empirical formula is C18H20FN3O4 • ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine.
The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.
Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2 .
Excipients And Description Of Dosage Forms
LEVAQUIN® Tablets are available as film-coated tablets and contain the following inactive ingredients:
- 250 mg (as expressed in the anhydrous form): crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, synthetic red iron oxide and titanium dioxide.
- 500 mg (as expressed in the anhydrous form): crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, synthetic red and yellow iron oxides and titanium dioxide.
- 750 mg (as expressed in the anhydrous form): crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.
LEVAQUIN® Oral Solution
LEVAQUIN® Oral Solution, 25 mg/mL, is a multi-use self-preserving aqueous solution of levofloxacin with pH ranging from 5.0 to 6.0. The appearance of LEVAQUIN® Oral Solution may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency.
LEVAQUIN® Oral Solution contains the following inactive ingredients: artificial and natural flavors, ascorbic acid, benzyl alcohol, caramel color, glycerin, hydrochloric acid, propylene glycol, purified water, sucralose and sucrose. It may also contain a solution of sodium hydroxide for pH adjustment.
The appearance of LEVAQUIN® Injection may range from a clear yellow to a clear greenish-yellow solution. This does not adversely affect product potency.
LEVAQUIN® Injection Premix in Single-Use Flexible Containers is a sterile, preservative-free aqueous solution of levofloxacin with pH ranging from 3.8 to 5.8. This is a dilute, nonpyrogenic, nearly isotonic premixed solution that contains levofloxacin in 5% Dextrose (D5W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH.
The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyester (CR3). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
What are the possible side effects of levofloxacin (Levaquin, Levaquin Leva-Pak)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using levofloxacin and call your doctor at once if you have a serious side effect such as:
- chest pain and severe dizziness, fainting, fast or pounding heartbeats;
- sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
- diarrhea that is watery or bloody;
- confusion, hallucinations, depression,...
What are the precautions when taking levofloxacin (Levaquin)?
Before taking levofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (such as chest pain, recent heart attack), joint/tendon problems (such as tendonitis, bursitis), kidney disease, myasthenia gravis, nerve problems (such as peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (such as brain/head injury, brain tumors, stroke, TIA-transient ischemic...
Last reviewed on RxList: 8/4/2016
This monograph has been modified to include the generic and brand name in many instances.
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