Health Systems Product News

Published Online: Saturday, August 15, 2009

Azithromycin InjectionAzithromycin Injection
Sagent Pharmaceuticals Inc
(Schaumburg, IL) recently received FDA approval for
Azithromycin Injection. The generic equivalent of Pfizer Inc's Zithromax, the product
is a semisynthetic, macrolide antibiotic. Azithromycin
Injection is indicated for the treatment of patients with
infections caused by susceptible strains of the designated
microorganisms in the following conditions:
community-acquired pneumonia due to Chlamydia
pneumoniae, Haemophilus influenzae, Legionella pneumophila,
Moraxella catarrhalis, Mycoplasma pneumoniae,
Staphylococcus aureus, or Streptococcus pneumoniae in
patients who require initial intravenous (IV) therapy and
pelvic inflammatory disease due to Chlamydia trachomatis,
Neisseria gonorrhoeae, or Mycoplasma hominis in
patients who require initial IV therapy. For more information,
visit www.SagentPharma.com, or call 866-625-1618.

Caldolor
Cumberland Pharmaceuticals Inc
(Nashville, TN) recentlyCumberland Pharmaceuticals logo
received FDA approval for Caldolor-the first injectable
dosage form of ibuprofen-to treat pain and fever. The
product should be used with caution in patients with congestive
heart failure or kidney impairment, those at risk of blood clots, and those who have a prior history of ulcers
and gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest
time period is important to reduce the risk of serious adverse events. For acute pain, the recommended dose is
400 to 800 mg over 30 minutes every 6 hours. To treat fever, the recommended dose is 400 mg administered over 30
minutes, followed by 400 mg every 4 to 6 hours, or 100 to 200 mg every 4 hours as necessary. For more information,
visit www.cumberlandpharma.com, or call 877-484-2700.NovaGuard

NovaGuard
West Pharmaceutical Services Inc
(Lionville, PA) recently introduced the
NovaGuard system, a passive safety
needle compatible with Luer-Lok
syringes. The system, designed to help
mitigate the risk of accidental needlestick
injuries, recently received 510(k)
FDA approval. With the NovaGuard
system, a plastic shield surrounds the
needle before the injection is given,
leaving only the needle tip exposed
for injection site orientation. When the
needle is pressed into the patient's skin
to administer the injection, the protective
shield is activated. As the needle is
withdrawn, the shield extends forward
to cover the needle fully, and the shield
is locked in place. Unlike active needle
safety devices, the NovaGuard system
provides a safety feature without
changing standard injection practices,
and requires no extra steps to activate
the safety feature. For more information,
visit www.westpharma.com.

Reclast (zoledronic acid) Injection
Novartis Pharmaceuticals Corp (East Hanover, NJ) recently received FDAReclast
approval for Reclast Injection as the first and only therapy to prevent postmenopausal
osteoporosis for 2 years with a single dose. The product is
already approved as a once-yearly infusion for the treatment of postmenopausal
osteoporosis. Reclast Injection also is indicated for the treatment and
prevention of glucocorticoid-induced osteoporosis in patients expected to be
on glucocorticoids for at least 12 months, treatment to increase bone mass
in men with osteoporosis, and treatment of Paget's disease of bone in men
and women. For the prevention of osteoporosis in postmenopausal women,
the recommended dose is a 5-mg infusion given once every 2 years given
intravenously over no less than 15 minutes. Reclast injection is available in
5 mg in a 100-mL ready-to-infuse solution. For more information, visit
www.reclast.com, or call 866-732-5278.



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