Levaquin (Levofloxacin)

Levaquin Review

Levofloxacin is used to treat infections of the sinuses, skin, lungs, ears, airways, bones, and joints, caused by susceptible bacteria. Levofloxacin also is frequently used to treat urinary infections, including those resistant to other antibiotics, as well as prostatitis. Levofloxacin is effective in treating infectious diarrheas, caused by E. coli, campylobacter jejuni, and shigella bacteria. Levofloxacin also can be used to treat various obstetric infections, including mastitis.

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Levaquin Drug Class and Mechanism

Many common infections in humans are caused by single cell organisms, called bacteria. Bacteria can grow and multiply, infecting different parts of the body. Medicines that control and eradicate these bacteria are called antibiotics. Levofloxacin is an antibiotic that stops multiplication of bacteria by preventing the reproduction and repair of their genetic material (DNA). It is in a class of antibiotics, called fluoroquinolones, a class that includes ciprofloxacin (Cipro), norfloxacin (Noroxin), ofloxacin (Floxin), trovafloxacin (Trovan), and lomefloxacin (Maxaquin). Levofloxacin was approved by the FDA in 1996. Levofloxacin usually is given once daily. It is important to take it at least 2 hours before or 2 hours after any antacid, or mineral supplement with iron, calcium, zinc, or magnesium since these minerals bind levofloxacin and prevent its absorption.

Levaquin Uses

Levofloxacin is effective against a number of gram-positive and gram-negative bacteria. Because of its broad spectrum of action, levofloxacin is frequently prescribed empirically for a wide range of infections (e.g. pneumonia, urinary tract infection) before the specific causal organism is known. If the causal organism is identified, levofloxacin may be discontinued and the patient may be switched to an antibiotic with a narrower spectrum of activity. Levofloxacin is currently the only respiratory fluoroquinolone approved by the U.S. FDA for the treatment of nosocomial pneumonia.

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Levaquin Side Effects

As with all fluoroquinolones there are numerous documented cases of spontaneous tendon rupture (Maurin, 2008; Mehlhorn & Brown, 2007; Ng & Naughton, 2007; Salvi, 2007). Such ruptures may occur both during as well as long after therapy had been discontinued. There are documented cases where such ruptures have occurred over a year later. It is impossible to calculate the risk of such ruptures as the medical community for the most part fails to associate tendon ruptures with the use of the drugs found within this class. Currently there are two petitions pending with the FDA seeking "Black Box Warnings" as well as "Dear Doctor Letters" regarding this particular adverse reaction. The medical journals have clearly associated such a risk with the fluoroquinolone class since their introduction back in 1982. The FDA has failed to respond to these petitions as required by law and Public Citizen has filed a lawsuit in Federal Court (January 2008) seeking a court order requiring compliance by the FDA. There are other cases of severe pain, and swelling in as little as two days. This is known as "quinolone-induced tendonopathy" and such injury appears to be a life long disability. Within the recent label changes (2007)it is noted that: "Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly...Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Tendon rupture can occur during or after therapy with quinolones. " There are other serious adverse reactions associated with this class including Irreversible Peripheral Neuropathy, (permanent nerve damage), increased QT prolongation, Torsades de Pointes, central nervous system (CNS) events including severe nervousness, agitation, chronic insomnia, anxiety attacks, nightmares, and paranoia. Toxic Pyschosis has also been reported. Life threatening disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, are also associated with the use of Levaquin. In 2004 new warning labels were added to all of the Fluoroquinolones regarding Peripheral Neuropathy (irreversible nerve damage), Tendon Damage, Heart Problems (prolonged QT Interval / Torsades de pointes), Pseudomembranous colitis, Rhabdomyolysis (muscle wasting), Steven Johnson Syndrome, as well as concurrent usage of NSAIDs contributing to the severity of these reactions. Fluoroquinolones caused fetal harm in animal studies, including decreased body weights and malformed bones as well as an increased risk of death. Because of the potential for serious adverse effects to the fetus, these drugs should not be used by pregnant women. Fluoroquinolones are excreted in human milk. Because of the potential for serious adverse effects in nursing infants, you should not take these drugs while nursing. Other adverse events found within the package inserts for Levaquin include the following: Cardiovascular: Palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thromobosis. Cardiovascular collapse, cardiopulmonary arrest, myocardial infarction, arrhythmia, tachycardia, palpitation, cerebral thrombosis, syncope, cardiac murmur, hypertension, hypotension, angina pectoris. Postural hypotension, vasculitis. Central Nervous System: Dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression, paresthesia. Convulsive seizures, paranoia, toxic psychosis, depression, dysphasia, phobia, depersonalization, manic reaction, unresponsiveness, ataxia, confusion, hallucinations, dizziness, lightheadedness, paresthesia, anxiety, tremor, insomnia, nightmares, weakness, drowsiness, irritability, malaise, lethargy Agitation, confusion, delirium, dysphasia, myoclonus, nystagmus, toxic psychosis.

Levaquin Pregnancy

Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface area, or at intravenous doses as high as 160 mg/kg/day corresponding to 1.9 times the highest recommended human dose based upon relative body surface area. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon relative body surface area, or when dosed intravenously as high as 25 mg/kg/day, corresponding to 0.5 times the highest recommended human dose based upon relative body surface area.

Levaquin Overdose

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. LEVAQUIN® exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of LEVAQUIN®: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.

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