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New Oral Contraceptive Means Fewer Menstrual
Periods
The FDA has approved Seasonale (levonorgestrel
0.15 mg and ethinyl estradiol 0.03 mg), an oral contraceptive for
women. Because of the 91-day regimen, women will usually have an
expected menstrual period once every three months instead of monthly.
Patients take tablets containing the active hormones for 12 weeks
(84 days), followed by one week (seven days) of placebo tablets,
(compared with 21 days of active tablets followed by seven days
of placebo tablets). Seasonale's active ingredients, progestin and
an estrogen, are active ingredients in other already approved oral
contraceptives. As with the conventional 28-day regimen, women will
have their period while taking the placebo tablets.
Like other oral contraceptives, the risks of using Seasonale include
an increased risk of blood clots, heart attack, and stroke. However,
clinical trial results indicate that women taking Seasonale may
have more unplanned bleeding and spotting between the expected menstrual
periods than women taking a conventional 28-day cycle oral contraceptive.
This may be especially so during the first few cycles of use.
U.S. Food and Drug Administration. "FDA approves
Seasonale oral contraceptive." 2003. www.fda.gov/bbs/topics/ANSWERS/2003/ANS01251.html
(10 Oct. 2003).
Shorter Antibiotic Course May Have Added
Benefit
A five-day regimen of Levaquin 750 mg once a day has been approved
by the FDA as a short-course treatment of community-acquired pneumonia.
Because this shorter treatment with Levaquin (levofloxacin) tablets/injection
or Levaquin (levofloxacin in 5% dextrose) injection reduces exposure
to the drug by 25%, it may help stem resistance caused by antibiotic
overexposure.
Results from a clinical trial demonstrated that Levaquin 750 mg
for five days produced similar clinical cure rates to the longer
10-day course of Levaquin 500 mg.
The trial also found no increase in adverse effects with the 750
mg dose. The most common side effects, which are usually mild, include
nausea, diarrhea, itching, abdominal pain, and dizziness. Patients
who have had a severe allergic reaction to any quinolone antibiotic,
such as ciprofloxacin, shouldn't take Levaquin.
Johnson & Johnson. "Levaquin receives FDA
approval for five-day treatment of community acquired pneumonia."
2003. www.levaquin.com/news/10-24-03.html (11 Nov. 2003).
A Viagra Rival-Levitra-Gets FDA Nod
The FDA has cleared a second oral medication to treat erectile dysfunction.
The drug, vardenafil (Levitra), was studied in randomized, placebo-controlled
clinical trials involving more than 2,000 participants who suffered
from erectile dysfunction. Trial participants had improved ability
to achieve and maintain an erection. The drug works by relaxing
muscles in the penis and blood vessels, allowing more blood to flow
into the penis for an erection.
Vardenafil shouldn't be used more than once a day. The recommended
dose of vardenafil is 10 mg taken one hour before sexual activity.
If patients' response to this dose is inadequate, a 20 mg dose is
available. Lower doses (2.5 mg and 5.0 mg) are available for patients
who are taking other medications or who have medical conditions
that may compromise the body's ability to metabolize the drug. Patients
using nitrates, such as nitroglycerin tablets or patches, or alpha-blockers
such as tamsulosin HCl (Flomax), terazosin (Hytrin), doxazosin mesylate
(Cardura), and alfuzosin HCl (Uroxatral), shouldn't use vardenafil.
The combination may result in significantly lower blood pressure.
Commonly reported side effects include flushing, headache, and stuffy
or runny nose.
U.S. Food and Drug Administration. "FDA approves
new drug for treatment of erectile dysfunction in men." 2003.
www.fda.gov/bbs/topics/ANSWERS/2003/ans01249.html (25 Aug. 2003).
Bayer Pharmaceuticals Corporation & GlaxoSmith-Kline. "Levitra
(vardenafil HCl)." 2003. www.levitra.com/landing/htm (20 Aug.
2003).
OTC Talk
Offer A Dose Of Reality About That Diet Pill
Overweight patients may be tempted by the many weight-loss products
available over the counter, and especially on the Internet. Caution
your patients, however, that none of those products are FDA approved,
and thus their claims are not regulated.
Currently, most OTC weight-loss products are ephedrine-based, such
as Stacker 2 and Metabolife 356. Such products contain Ma huang
or other ephedra alkaloids.
Ephedrine is a sympathomimetic agent (with indirect stimulatory
effects on adrenergic receptors) that possesses some anorectic and
thermogenic properties. As a result, ephedrine may induce weight
loss in some people. Studies have shown that when ephedrine is combined
with caffeine, the combination may lead to even more weight loss.
However, ephedrine-related weight loss has been demonstrated only
over a very short period of time.
Ephedrine may, through its sympathomimetic effects, increase heart
rate and blood pressure. Patients with heart disease, hypertension,
glaucoma, and anxiety disorders should avoid ephedrine and ephedrine-based
products.
Manufacturers of certain other products may also make weight-loss
claims. Those products include chromium picolinate, which may increase
basal metabolic rate, and guarana, which may also increase metabolic
rate and increase fat breakdown.
issertation, Texas Woman's University, College of Nursing,
2002). Dissertation Abstracts International, 63, 03B.
THE AUTHORS JOHN P. SANTELL, MS, RPh, is director,
education program initiatives at the U.S. Pharmacopeia Center for
the Advancement of Patient Safety (CAPS). RODNEY W. HICKS, RN, MSN,
is research coordinator at the Center. MARSHA PROTZEL, RN, BS, is
quality control/quality analyst at the Center.
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