Journal of Drugs in Dermatology - FDA grants approval for new oral solution of Levaquin

Levaquin[R] (levofloxacin) is FDA approved for 9 indications including the treatment of complicated skin and skin structure infections at a dose of 750 mg once daily. The U.S. Food and Drug Administration (FDA) has approved a new, once daily formulation of Levaquin in a 25 mg/mL oral solution. The new liquid formulation provides a convenient option for adult patients who have trouble swallowing tablets, particularly those in nursing home or hospitalized settings. Levaquin is made by Ortho-McNeil c/o Johnson and Johnson Pharmaceuticals.

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Levaquin Oral Solution is indicated to treat infections already approved for the tablet and intravenous formulations and is effective against Staphylococcus aureus, Streptococcus pneumoniae (including all multiple drug-resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. The new oral solution has the same efficacy as the tablet formulation. It should be taken 1 hour before or 2 hours after eating. Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or Videx[R] (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after levofloxacin administration. The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established.
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