"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
Fluoroquinolones, including FLOXIN® (ofloxacin) , 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 transplants (See WARNINGS).
Fluoroquinolones, including FLOXIN® (ofloxacin) , may exacerbate muscle weakness in persons with myasthenia gravis. Avoid FLOXIN® (ofloxacin) in patients with a known history of myasthenia gravis (See WARNINGS).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of FLOXIN® (ofloxacin tablets) Tablets and other antibacterial drugs, FLOXIN® (ofloxacin tablets) Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
FLOXIN® (ofloxacin tablets) Tablets is a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, a fluorinated carboxyquinolone, is the racemate, (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The chemical structure is:
Its empirical formula is C18H20FN3O4, and its molecular weight is 361.4 Ofloxacin is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin at room temperature, as defined by USP nomenclature, indicate that ofloxacin is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni+2 > Pb+2 > Zn+2 > Mg+2 > Ca+2 > Ba+2.
FLOXIN® (ofloxacin) Tablets contain the following inactive ingredients: anhydrous lactose, modified corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and may also contain synthetic yellow iron oxide.
What are the possible side effects of ofloxacin (Floxin)?
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 ofloxacin and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- seizure (convulsions);
- confusion, hallucinations, anxiety, feeling resltess, tremors, insomnia, nightmares, unusual thoughts or behavior, feeling light-headed;
- severe dizziness, fainting, fast or pounding heartbeat;
- sudden pain, snapping or popping sound,...
What are the precautions when taking ofloxacin (Floxin)?
Before taking ofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (e.g., ciprofloxacin, levofloxacin); 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: seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors), nervous system disorders (e.g., peripheral neuropathy), kidney disease, liver disease, myasthenia gravis, joint/tendon problems (e.g., tendonitis, bursitis).
Ofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT...
Last reviewed on RxList: 4/15/2011
This monograph has been modified to include the generic and brand name in many instances.
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