Health Systems Product News

(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.

CaldolorCumberland Pharmaceuticals Inc (Nashville, TN) recently

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

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withdrawn, the shield extends forward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 FDA

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.