Archive for the ‘Diseases’ Category

Pharmaceutical Approval Update

Posted by James

Pharmaceutical Approval

Paliperidone (Invega)

Manufacturer: Janssen (J&J), Titusville, NJ

Indication: Paliperidone, an extended-release tablet, is an atypical antipsychotic agent indicated for the treatment of schizophrenia.

Drug Class: This psychotropic agent belongs to the chemical class of benzisoxazole derivatives. It contains a racemic mixture of (+)- and (-)- paliperidone.

The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 with a molecular weight of 426.49.

Uniqueness of Product: The tablets are available in 3-mg (white), 6-mg (beige), and 9-mg (pink) strengths. OROS technology (Alza Corp.) employs osmotic pressure to deliver paliperidone at a controlled rate.

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Oxymorphone HCl (Opana) for the Relief: Hale et al.

Posted by James

Oxymorphone Relief

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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Oxymorphone HCl (Opana) for the Relief: CLINICAL STUDIES Adams et al.

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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Oxymorphone HCl (Opana) for the Relief: PAIN MANAGEMENT

Posted by James

PAIN MANAGEMENT

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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Oxymorphone HCl (Opana) for the Relief: PATHOPHYSIOLOGY OF PAIN

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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Oxymorphone HCl (Opana) for the Relief

Posted by James

Oxymorphone

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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PREDICTORS OF OUTCOME IN HOSPITALIZED PATIENTS: DISCUSSION

Posted by James

hyponatremia

The major aim of this study was to assess the outcome of severe hyponatremia and characterize factors influencing outcome in hospitalized patients with this disorder. This study suggests that severe hyponatremia is associated with high mortality. It is unclear if this association derives from hyponatremia per se, or the associated comorbidity in these subjects.

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