Manufacturer: Ortho-McNeil Johnson & Johnson) Indication: To treat multidrug-resistant strains of Streptococcus pneumoniae (MDRSP) in community acquired pneumonia (CAP).
Drug Class: Levofloxacin generic is a fluoroquinolone (a chiral flu-orinated carboxyquinolone).
Uniqueness of Drug: Data from the Tracking Resistance in the U.S. Today (TRUST) trial have demonstrated that 98% of MDRSP isolates are susceptible to levofloxacin. TRUST, the largest and most comprehensive respiratory pathogen surveillance study in the U.S., has been conducted annually since 1997. However, in vitro activity does not necessarily correlate with clinical results. Levofloxacin is indicated to treat mild-to-severe CAP caused by S. pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumo-niae, Legionella pneumophila, or Mycoplasma pneumoniae.
Warnings: The safety and efficacy of levofloxacin in children, adolescents younger than 18 years of age, pregnant women, and nursing women have not been established.
In immature rats and dogs, the oral and intravenous (IV) administration of levofloxacin canadian increased the incidence and severity of osteochondrosis. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and are associated with signs of arthropathy in immature animals of various species.
Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central nervous system (CNS) stimulation, which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions do occur in patients receiving levofloxacin, the drug should be discontinued and appropriate measures should be instituted.
As with other quinolones, levofloxacin should be used with caution in patients with a known or suspected CNS disorder that might predispose them to seizures or that lower the seizure threshold (e.g., severe cerebral arteriosclerosis or epilepsy) or patients with other risk factors for seizures (e.g., patients who are receiving certain drug therapies or who have renal dysfunction.)
Precautions: Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to benefit patients and increases the risk that drug-resistant bacteria will develop. canadian discount pharmacy
Because a rapid or bolus IV injection can result in hypotension, levofloxacin injection should only be administered by slow IV infusion over 60 or 90 minutes, depending on the dosage.
Dosage and Administration: The usual doses of levofloxacin tablets or injection are as follows:
- 250 or 500 mg administered orally or by slow infusion over 60 minutes every 24 hours
- 750 mg administered orally or by slow infusion over 90 minutes every 24 hours, as indicated by the infection
For patients with normal or impaired renal function, oral doses should be administered at least two hours before or two hours after magnesium or aluminum antacids, sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine drug (Videx generic, Bristol-Myers Squibb).
For patients with CAP, the dose is either 500 mg every 24 hours for seven to 14 days or 750 mg once daily for five days.
- If creatinine clearance is from 50 to 80 ml/minute, no dosage adjustment is required.
- If creatinine clearance is from 20 to 49 ml/minute, 500 or 250 mg should be given every 24 hours.
- If creatinine clearance is from 10 to 19 ml/minute, 500 or 250 mg should be given every 48 hours.
- If the patient is receiving hemodialysis, 500 or 250 mg should be given every 48 hours.
- If the patient is receiving chronic ambulatory peritoneal dialysis, 500 or 250 mg should be given every 48 hours.
Although levofloxacin is more soluble than other quinolones, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine. Levofloxacin should be given with caution in patients with renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed before and during therapy because the elimination of levofloxacin may be reduced.
In patients with impaired renal function (i.e., a creatinine clearance below 50 ml/minute), the dosage regimen should be adjusted as necessary to avoid the accumulation of levofloxacin because of the decreased clearance.
P&T Committee Considerations: CAP affects almost four million people in the U.S. each year. S. pneumoniae is one of the primary bacteria that cause CAP. MDRSP are forms of bacteria that are resistant to two or more therapeutic classes of antibiotics (e.g., penicillin, second-generation cephalo-sporins, macrolides, tetracyclines, and sulfonamides. The presence of MDRSP has increased significantly over time and today represents almost 23% of all strains.
Levofloxacin may be used to treat CAP in a five-day, 750-mg once-daily regimen (Leva-pak), or 500 mg daily can be taken for seven to 14 days.
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The Food and Drug Administration’s approval of this product is important because it increases the flexibility of physicians in terms of their ability to treat patients with drug-resistant bacterial infections using a safe medication. P&T committees should consider levofloxacin for patients with MDRSP in CAP.