Based on the results of animal studies, the Food and Drug Administration considers Ofloxacin a pregnancy Category C medication. This means that although the drug is generally not recommended for use in pregnant woman, it could be prescribed if the benefits to the woman outweigh the possible risks to the unborn child. This might occur if other, more suitable antibiotics are not available. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Ofloxacin(CAS NO:82419-36-1) can cause retarded ossification and arthropathy in young animals, but there is no published information about its teratogenicity in humans. A 36-year-old woman was treated with ofloxacin 200 mg bid for 6 days during the 19th week of gestation.
Research indicates that Ofloxacin(CAS NO:82419-36-1) can rapidly cross the blood-placenta and blood-milk barrier, and are extensively distributed into the fetal tissues. Peak concentration in human breast milk is similar to levels attained in plasma. Breast-feeding mothers who take ofloxacin may expose their infants to severe adverse reactions.
Other flouroquinolones have also been reported as being present in the mother’s milk and are passed on to the nursing child, which may increases the risk of the child suffering from this syndrome as well, even though the child had never been prescribed or taken any of the drugs found within this class.
The data on the safety of the fluoroquinolones in pregnancy contains conflicting reports and is to be considered incomplete due to the lack of adequate studies. But it should be noted that several studies have reported spontaneous abortions following the exposure to the fluoroquinolones during pregnancy, as well as therapeutic/elective abortions due to the perceived, as well as actual, risk of birth defects.
However, within one study the authors concluded that the use of quinolones during pregnancy may in some cases be necessary; e.g. drug resistant serious infections, but if safer antibiotics such as penicillin, cephalosporins or erythromycin are an option they should be used instead due to their clearer safety profile.
Ultrasound follow-up of the measurements and structure of the fetal long bones revealed no abnormalities. The neonate's physical examination and X-rays of the chest and long bones were normal. Although no teratogenic or toxic effects were observed in this patient, the use of ofloxacin in human pregnancy should only be a clinical consideration until sufficient evidence regarding its safety in the human fetus has been published.
Ofloxacin is a prescription antibiotic used to treat a variety of bacterial infections. It is available as a tablet, an ophthalmic (eye) solution, and an otic (ear) solution. Ofloxacin belongs to a group of medications called fluoroquinolones, or "quinolones" for short. At this time, it is not known if Ofloxacin is safe for use during pregnancy.
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Ofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone. The original brand, Floxin, has been discontinued by the manufacturer in the United States on 18 June 2009, though generic equivalents continue to be available.
Ofloxacin(CAS NO:82419-36-1) is sold under a wide variety of brand names as well as generic drug equivalents, for oral and intravenous administration. It is also available for topical use, as eye drops and ear drops.
Ofloxacin(CAS NO:82419-36-1) is not licensed by the FDA for use in children due to the risk of serious reversible and irreversible injury to the musculoskeletal system. Other fluoroquinolones do have a limited licensed uses in children but are generally not recommended due to safety concerns.Ofloxacin (and its derivatives) has also been associated with a few isolated reports of unexplained pediatric fatalities. Children (those under 18) are also at an increased risk of bone, joint, or tendon toxicities.
Prescribing ofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of severe adverse drug reactions.
In the adult population ofloxacin is limited to the treatment of proven serious and life threatening bacterial infections such as:
1.Community-acquired pneumonia
2.Acute pelvic inflammatory disease
3.Nongonococcal urethritis and cervicitis
4.Mixed Infections of the urethra and cervix
5.Uncomplicated skin and skin structure infections
6.Acute bacterial exacerbations of chronic bronchitis
It has not been shown to be effective in the treatment of syphilis. It is now considered to be contraindicated for the treatment of certain sexually transmitted diseases by some experts due to bacterial resistance
Like other quinolones, ofloxacin has been associated with a significant number of serious adverse drug reactions.These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years, patients who take corticosteroids (eg, prednisone), and in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, hand). Problems may occur while you take this medicine or up to several months after you stop taking it.
Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take ofloxacin or within several months after you stop taking it.
Ofloxacin may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take ofloxacin if you have a history of myasthenia gravis.
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