FDA Refuge Changes: Levitra, Minocin, Zyvox CME
This activeness is part of an ongoing CME/CE opening move to provide cognition on labeling changes reported by the FDA.
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August 8, 2007 — The US Food and Drug Direction (FDA) has approved preventative labeling revisions to advise of drug interactions with vardenafil and the additive validity on QT quantity lengthiness associated with concomitant use of certain medications, and the potential difference for use 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 preventive labeling revisions for vardenafil (Levitra tablets, made by Bayer Pharmaceuticals Corp) to advise of drug interactions and the additive symptom on QT amount continuance 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 care with these drugs or regimens should not exceed a dose of 2.5 mg vardenafil within a 24-hour flow.
For patients taking ketoconazole or itraconazole 200 mg daily, the vardenafil dose should not exceed 5 mg within a 24-hour point.
The FDA notes that though the medication interactions have not been studied, other CYP3A4 inhibitors (eg, citrus tree juice) are also likely to gain vardenafil light unit.
The activeness also warned of the risk for an additive outcome on QT separation length with concomitant use of other drugs known to exert this core, as determined by data from a postmarketing immersion.
A previous subject of healthy men (n = 59) had revealed that the meaning of 10 mg of vardenafil is similar to that of 400 mg of moxifloxacin.
These observations should be considered in clinical decisions when prescribing vardenafil for patients with a known knowledge of QT perpetuation or those taking medications known to prolong the QT musical notation.
Patients taking educational activity 1A (eg, quinidine, procainamide) or gathering III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT protraction should avoid using vardenafil.
Vardenafil is indicated for the management of erectile dysfunction.
The recommended daily starting dose for most patients is 10 mg taken approximately 1 hour before sexual bodily function and then lowered to 5 mg or increased to a extremum of 20 mg based on efficacy and adverse events.
Minocycline HCl (Minocin) and Linezolid (Zyvox) Linked to Risk for Clostridium difficile-Associated Diarrhea
On April 2 and 26, the FDA approved refuge labeling revisions for minocycline HCl (Minocin pellet-filled capsules, made by Triax Pharmaceuticals, LLC) and linezolid (Zyvox medical care, tablets, and oral debarment, made by Pharmacia & Upjohn [a air unit of Pfizer, Inc]) to warn of the risk for Clostridium difficile-associated diarrhea (CDAD).
Communicating with antibacterial agents such as minocycline and linezolid can alter the colon’s normal aggregation, strip to hypertrophy of C difficile and subsequent ending of toxins A and B that contribute to the utilisation of CDAD.
Nearly all antibiotics have been implicated in CDAD, which may chain of mountains in difficultness from mild diarrhea to fatal colitis.
Because hypertoxin-producing strains of C difficile can be refractory to antimicrobial therapy, they are associated with increased state of mind and fatality rate and may require colectomy.
The FDA advises that CDAD be considered in all patients who present tense with diarrhea after antibiotic use.
Careful questioning of medical account is required because of the potentiality for late-onset disease; cases of CDAD have been reported more than 2 months after play of an antimicrobial line of therapy.
The FDA notes that course antibiotic therapy for the pinion corruptness may need to be discontinued in patients with known or suspected CDAD.
Appropriate substance and electrolyte direction, protein expansion, antibiotic therapy for C difficile, and surgical judgment also may be required.
Patients should be advised that diarrhea is a common trouble caused by antibiotics and usually ceases after windup of therapy; watery and bloody stools (with or without body part cramps and fever) can occur after origination of therapy, sometimes as late as 2 or more months after the last dose has been taken.
Patients should be instructed to lens their healthcare clinician as soon as possible action if symptoms occur.
Minocycline is a tetracycline-derived antibiotic indicated for the discussion of gram-positive and gram-negative infections resulting from susceptible strains of designated microorganisms.
It also may be used as adjunctive therapy for acute intestinal amebiasis and severe acne.
Linezolid is indicated for the tending of infections caused by susceptible strains of designated microorganisms.
Indications include vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated infections of the skin or skin make-up (including diabetic foot infections, without concomitant osteomyelitis), uncomplicated infections of the skin or skin social structure, and community-acquired pneumonia.
http://www.fda.gov/medwatch/SAFETY/2007/Apr_PI/Levitra_PI.pdf
http://www.fda.gov/medwatch/SAFETY/2007/Apr_PI/Minocin_PI.pdf
http://www.fda.gov/medwatch/SAFETY/2007/Apr_PI/Zyvox_PI.pdf
Pearls for Recitation
Because serum levels of vardenafil can be increased by potent CYP3A4 inhibitors and change of magnitude the risk for adverse events, patients receiving indinavir, saquinavir, atazanavir, clarithromycin, ketoconazole 400 mg daily, or itraconazole 400 mg daily should not take more than 2.5 mg of vardenafil within 24 hour.
For patients taking ketoconazole or itraconazole 200 mg daily, the vardenafil dose should not exceed 5 mg.Vardenafil with certain other medications has an additive symptom on QT distance lengthening.
Postmarketing reflection data suggest that vardenafil and moxifloxacin have a similar force.Minocycline HCl and linezolid are associated with a risk for potentially fatal Clostridium difficile-associated diarrhea.
Some cases have been reported more than 2 months after maneuver of therapy.
1. Which of the followers statements is not correct regarding the appropriate use of vardenafil and other drugs? (Required for credit) Patients taking itraconazole 400 mg daily may not use vardenafil The dose of vardenafil should not exceed a 2.5 mg daily dose in those taking indinavir Patients requiring 200 mg daily ketoconazole may use 5 mg vardenafil daily Intake of citrous fruit vim is likely to change of magnitude the risk for vardenafil view
2. Which of the the great unwashed statements is correct regarding the risk for QT set lengthiness in patients taking vardenafil tablets? (Required for credit) The import on QT musical interval of 10 mg of vardenafil is more than that of 400 mg of moxifloxacin A lower dose of vardenafil is recommended for patients taking sotalol The risk for QT lengthiness is additive with other medications known to have this effect Patients with a known past of QT protraction should not take vardenafil
3. Which of the motion statements is not correct regarding the risk for Clostridium difficile-associated diarrhea in patients receiving tending with minocycline HCl or linezolid? (Required for credit) Infection with hypertoxin-producing strains may require colectomy No cases of Clostridium difficile-associated diarrhea have been reported beyond 1 calendar month after therapy Clostridium difficile-associated diarrhea can potpourri in rigor from mild diarrhea to fatal colitis Discontinuation of linezolid may be required in patients with Clostridium difficile-associated diarrhea
Medscape Medical News 2007. ©2007 Medscape
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