Posted by James
A multicenter, randomized, double-blind, placebo-controlled, active-controlled trial was conducted to compare the analgesic efficacy and safety of oxymorphone ER with placebo and oxycodone controlled release (CR) in ambulatory patients with moderate-to-severe chronic low back pain who required opioid therapy. Patients received oxymorphone ER 10 to 110 mg or oxycodone CR 20 to 220 mg every 12 hours during a seven-day to 14-day dose-titration phase.
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Posted by James
A randomized, three-period, four-sequence, crossover study assessed the pharmacokinetics of four dose levels of oxymorphone ER in 24 healthy volunteers. Patients were randomly assigned to receive three of four possible doses of oxymorphone ER tablets: 5, 10, 20, and 40 mg. The three eight-day administration periods were separated by seven-day washout periods.
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Posted by James
Available options for the treatment of moderate-to-severe pain include non-opioid and opioid analgesics. Non-opioid analgesics approved for moderate-to-severe pain are ketorolac (Toradol, Roche) and indomethacin (Indometha-cin ER, Sandoz). They work by preventing the formation of prostaglandins produced in response to noxious stimuli, thereby decreasing the number of pain impulses received by the central nervous system (CNS).
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Posted by James
The most common type of pain is nociceptive. Clinically, pain can be classified as “nociceptive” if it can be determined that the pain is related to the degree of receptor stimulation by processes that cause tissue injury. Potential causes of the tissue injury include a cut, bruise, bone fracture, crush injury, a burn, or cancer.
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Posted by James
INTRODUCTION
Pain is an unpleasant sensory and emotional sensation that ranges in intensity, and it has the potential to cause patients unnecessary emotional and physical distress. It is a primary reason for seeking medical attention for 50 million Americans who might be partially or totally disabled by pain. The management of pain costs Americans billions of dollars annually, and the demand for appropriate pain management is expected to escalate even further as many Americans plan to work until older ages and live longer.
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Posted by James
Venous Thromboembolism. In the estrogen-alone sub-study, the risk of VTE (DVT and pulmonary embolism), was increased for women taking conjugated estrogens compared with those receiving placebo (30 vs. 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 vs. 15 per 10,000 women-years). The increased risk of VTE was demonstrated during the first two years.
In the estrogen-plus-progestin substudy, a statistically significant two-fold greater rate of VTE was reported for conjugated estrogens plus MPA compared with placebo (35 vs. 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 vs. 13 per 10,000 women-years) and pulmonary embolism (18 vs. 8 per 10,000 women-years) were also noted. The increased VTE risk occurred during the first year and persisted.
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Posted by James
Manufacturer: Upsher-Smith Laboratories, Inc., Maple Grove, MN
Indication: Estradiol gel 0.1% is indicated for the treatment of moderate-to-severe hot flashes associated with menopause.
Drug Class: The clear, colorless topical gel is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin, quick-drying layer. The active component of the gel is estra-diol, chemically defined as estra-1,3,5(10)-triene-3,17f>-diol.
Uniqueness of Product: Estradiol, the major estrogenic hormone secreted by the human ovary, is delivered to the systemic circulation after topical application. The gel offers the lowest approved dose of estradiol available for women with menopausal vasomotor symptoms.
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