Pharmacy & Therapeutics - June 2008 - (Page 332)

NEW DRUGS DRUG NEWS HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PATANASE® Nasal Spray safely and effectively. See full prescribing information for PATANASE Nasal Spray. PATANASE (olopatadine hydrochloride) Nasal Spray Initial U.S. Approval: 1996 INDICATIONS AND USAGE PATANASE Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. (1) DOSAGE AND ADMINISTRATION For intranasal use only. The recommended dose of PATANASE Nasal Spray in patients 12 years and older is two sprays per nostril twice daily. (2) Priming Information: Prime PATANASE Nasal Spray before initial use and when PATANASE Nasal Spray has not been used for more than 7 days. (2.2) DOSAGE FORMS AND STRENGTHS Nasal spray 0.6%: 665 mcg of olopatadine hydrochloride in each 100-microliter spray. (3) Supplied as a 30.5 g bottle containing 240 sprays. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS • Epistaxis, nasal ulceration, and nasal septal perforation. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with nasal disease other than allergic rhinitis. (5.1) • Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking PATANASE Nasal Spray. (5.2) • Avoid concurrent use of alcohol or other central nervous system depressants with PATANASE Nasal Spray. (5.2) ADVERSE REACTIONS The most common adverse reactions (>1%) included bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. suggest the real-world rate might be closer to 3%. In their study, which included a long follow-up period (median, 34 months), most cases of delayed thrombosis occurred very late. During follow-up, thrombosis developed in 17 of 604 patients. Nearly all 14 events took place more than one year after the stent was placed (median, 19 months). All patients who developed late definite thrombosis experienced STelevation myocardial infarction (MI), and four patients died. Thrombosis was independently related to a higher risk of allcause death, cardiac death, nonfatal MI, and further revascularization. (Source: Am Heart J 2008;155:648–653.) Venlafaxine ER (Effexor) In Late-Life Depression Health care providers might consider Wyeth’s venlafaxine extended-release (Effexor) as a first-choice drug for late-life depression, say researchers from Madrid, Spain. Their study of 59 patients found response rates of 82% and remission rates of 60% by week 24. Only 7% of patients reported adverse drug events throughout the study; all events were mild to moderate. Although no significant effects were observed on blood pressure or heart rate, the researchers caution that the sample size was small. Nevertheless, they add, their data are reinforced by other data from double-blind or single-blind studies. (Source: Arch Gerontol Geriatr 2008;46:317–326.) For Best Results, Reduce Blood Pressure And LDL-Cholesterol Even More Aggressively lowering targets for low-density lipoproteincholesterol (LDL-C) and blood pressure (BP) produced impressive results for 499 American Indian adults with diabetes, say researchers in the Stop Atherosclerosis in Native Diabetics Study (SANDS) randomized trial. Researchers assigned patients to receive aggressive therapy (with a goal of 70 mg/dL or less for LDL-C and 115 mm Hg or less for systolic BP) or to standard therapy (with a goal of 100 mg/dL or less and 130 mm Hg or below). After 36 months, mean carotid intimal media thickness progressed slightly with standard treatment and regressed with aggressive therapy. At 36 months, there was a significant difference between the two groups, and plaque scores increased slightly in both groups. Left ventricular mass and left ventricular mass index decreased slightly in both groups of patients but to a greater degree with intensive therapy. Rates of adverse events were low in both groups; eight participants died. ©2008 Alcon, Inc. 4/08 PTN08501JA 332 P&T® • June 2008 • Vol. 33 No. 6 http://www.fda.gov/medwatch

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Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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