Friday, November 23, 2007

FDA Area Changes: Levitra, Minocin, Zyvox

News Maker: Yael Waknine CME Maker: Yael Waknine Disclosures Death Date: August 8, 2007 ;  Valid for reference through August 8, 2008 Credits Available Physicians - uttermost of 0.25 AMA PRA Construct 1 Credit(s) ™ for physicians; Relative Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians

This act is part of an ongoing CME/CE enterprisingness to provide subject matter on labeling changes reported by the FDA.
Activities of this causal agent will be posted on Medscape on a weekly assumption.
August 8, 2007 — The US Food and Drug Disposal (FDA) has approved rubber labeling revisions to advise of drug interactions with vardenafil and the additive validness on QT quantity duration associated with concomitant use of certain medications, and the electric potential for exercise of Clostridium difficile- associated diarrhea more than 2 months after culmination of therapy with minocycline HCl or linezolid.
Vardenafil ( Levitra ) Linked to Drug Interactions and Risk for Additive QT Effects
On April 6, the FDA approved birth control device labeling revisions for vardenafil ( Levitra tablets, made by Bayer Pharmaceuticals Corp) to advise of drug interactions and the additive core on QT amount duration associated with concomitant use of certain medications.
Because vardenafil is metabolized predominantly by the hepatic enzyme cytochrome P450 isoenzyme 3A4 (CYP3A4), serum levels can be significantly increased by concomitant use of indinavir, saquinavir, atazanavir, or other potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole 400 mg daily, or itraconazole 400 mg daily.
This can lead to an increased risk for adverse events such as hypotension, visual changes, and priapism.
Therefore, patients receiving tending with these drugs or regimens should not exceed a dose of 2.5 mg vardenafil within a 24-hour expelling.
For patients taking ketoconazole or itraconazole 200 mg daily, the vardenafil dose should not exceed 5 mg within a 24-hour section.
The FDA notes that though the medicinal drug interactions have not been studied, other CYP3A4 inhibitors (eg, citrous fruit juice) are also likely to gain vardenafil scene.
The implementation also warned of the risk for an additive validity on QT measure continuance with concomitant use of other drugs known to exert this issue, as determined by data from a postmarketing room.
A previous musing of healthy men (n = 59) had revealed that the result of 10 mg of vardenafil is similar to that of 400 mg of moxifloxacin.
This is a part of article FDA Area Changes: Levitra, Minocin, Zyvox Taken from "Levitra Versus Viagra" Information Blog

1 comment:

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