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Fluoroquinolones, including Levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung trans plants [see WARNINGS AND PRECAUTIONS].
Fluoroquinolones, including Levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis [see WARNINGS AND PRECAUTIONS].
Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1- piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-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
Levofloxacin Oral Solution
Levofloxacin 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 Levofloxacin Oral Solution may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency.
Levofloxacin 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.
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: 8/31/2016
This monograph has been modified to include the generic and brand name in many instances.
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