Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • January 1, 2011

    Uses:

    Prevention of skeletal-related events in patients with bone metastases from solid tumors

    Data from three randomized, double-blind trials comparing denosumab 120 mg with zoledronic acid 4 mg (Zometa—Novartis), both given once every 4 weeks, showed that denosumab was superior to zoledronic acid in preventing skeletal-related events in patients with breast or prostate cancer and bone metastasis and was noninferior to zoledronic acid in preventing these events in patients with multiple myeloma or other solid tumors. The FDA-recommended dose is 120 mg administered as a subcutaneous injection every 4 weeks. It is important to distinguish the dosing and indication differences between Prolia and Xgeva, both of which contain denosumab. Prolia is dosed as a 60-mg subcutaneous injection once every 6 months and is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

  • January 1, 2011

    Uses:

    Treatment of type 2 diabetes as an adjunct to diet and exercise as monotherapy or in combination with other oral antidiabetic agents

    The exact mechanism by which bromocriptine improves glycemic control is unknown; it may normalize aberrant hypothalamic neurotransmitter activities that induce, potentiate, and maintain the insulin-resistant, glucose-intolerant state. Data from four double-blind, placebo-controlled trials (one monotherapy and three add-on trials) involving more than 3,700 patients with type 2 diabetes showed that bromocriptine produced clinically significant improvements in glycosylated hemoglobin (A1C) (difference from placebo [range –0.4% to –0.6%]) and postprandial glucose, and more patients given bromocriptine reached an A1C goal of 7% or less compared with placebo. The recommended dose is 1.6–4.8 mg once daily. The tablets are currently available in pharmacies in a 0.8-mg strength.

  • January 1, 2011

    Uses:

    Treatment of hypertension in patients not controlled on any two individual components

    When compared with all dual combinations of its components in a study involving 1,181 patients with moderately to severely elevated blood pressure, the triple-combination tablet reduced both systolic and diastolic blood pressures. Amturnide is taken once daily and will be available in five strengths of aliskiren/amlodipine/hydrochlorothiazide: 150/5/12.5 mg, 300/5/12.5 mg, 300/5/25 mg, 300/10/12.5 mg, and 300/10/25 mg.

  • January 1, 2011

    Uses:

    Treatment of mild to moderate pain and moderate to severe pain with adjunctive opioid analgesics and for the reduction of fever in patients 2 years and older

    This is the first and only I.V. form of acetaminophen approved by FDA. It can be given as a single dose or as repeated doses. The recommended dose for adults and adolescents weighing 50 kg or more is 1,000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4,000 mg/d. For adults and adolescents weighing less than 50 kg, and for children 2–12 years old, the recommended dose is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg/d. This new formulation will be marketed in 100-mL glass vials containing 1,000 mg of acetaminophen.

  • July 7, 2002

    Uses:

    Management of seizures and a variety of pain conditions

    Lupin Pharmaceuticals announced that it has received FDA approval to market its generic version of Pfizer’s Lyrica capsules. The pregabalin capsules are AB rated to Pfizer's product and will be available in 25-, 50-, 75-, 100-, 150-, 200-, 225-, and 300-mg strengths.

    Pregabalin is indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures, neuropathic pain associated with spinal cord injury, and fibromyalgia.

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