Medication Monitor



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Generic Name (Trade Name—Company)
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  • 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.

  • February 2, 2016

    FDA has approved the first prefilled pen device containing concentrated U-500–strength insulin for patients with diabetes who require more than 200 units per day. The product is designed as a more convenient alternative to the current U-500 vial, which requires use of either a syringe designed for U-100–strength insulin or a volumetric (tuberculin) syringe, both of which require dose conversions.

    Each KwikPen holds 1,500 units of insulin (3 mL, with each mL containing 500 units), the amount contained in five U-100 insulin pens. However, it is the same size as other Eli Lilly KwikPens and dials in five-unit increments.  

    Humulin R U-500 exhibits both basal and prandial properties, allowing it to be used as insulin monotherapy. This effect has been attributed to the high concentration of the preparation.  

    As with other insulins, Humulin R U-500 is contraindicated during hypoglycemic episodes and in patients hypersensitive to Humulin R U-500 or any of its additives or components.  

    Eli Lilly, the manufacturer, offers a savings card program for eligible commercially insured patients to pay as little as $25 per prescription for up to 12 redemptions over a 12-month period.

  • May 12, 2015

    FDA has expanded the indication of moxifloxacin for the treatment of pneumonic plague (infection of the lungs) and septicemic plague (infection of the blood). Moxifloxacin is also approved for prevention of plague in adult patients.

    Plague is extremely rare in most parts of the world, including the United States, with 1,000 to 2,000 cases worldwide each year. The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague, and septicemic plague.

    Plague can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. The bacteria that causes plague, Yersinia pestis, is considered a biological threat agent that could potentially be used as a bioterrorism agent.

    FDA approved moxifloxacin for plague under the agency’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to be used in cases where it is not feasible or ethical to conduct trials in humans. Because plague is such a rare disease, it would not be possible to conduct adequate efficacy trials in humans.

    Moxifloxacin’s approval was based on an efficacy study conducted in African green monkeys that were infected with Y. pestis in a laboratory setting. Animals were randomly selected to receive a 10-day regimen of moxifloxacin or placebo at least 4 hours after the onset of fever following exposure to Y. pestis. The primary endpoint was survival at the end of the study.

    All 10 monkeys treated with moxifloxacin survived. None of the 10 monkeys treated with placebo survived.

    Moxifloxacin’s safety has been characterized in clinical studies and postmarketing information for the drug’s existing clinical uses. Common adverse effects are nausea, diarrhea, headache, and dizziness.

    Moxifloxacin carries a Boxed Warning about an increased risk of tendinitis and tendon rupture and worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis. Other adverse effects include allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm. However, given that plague is a very serious and often deadly condition, the benefit of moxifloxacin for treating plague outweighs these potential risks.

  • March 27, 2015

    FDA has expanded the approved use of aflibercept to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).

    Aflibercept is administered by a physician as an injection into the eye once a month for the first five injections and then once every 2 months. It is intended to be used along with appropriate interventions to control blood glucose, blood pressure, and cholesterol.

    Safety and efficacy of aflibercept to treat DR in patients with DME were evaluated in 679 participants in two clinical studies in which participants were randomly assigned to receive aflibercept or macular laser photocoagulation, a laser-based treatment used to burn small areas of the retina.

    At week 100, participants being treated with aflibercept showed significant improvement in the severity of their DR, compared with patients who did not receive aflibercept.

    The most common adverse effects include bleeding of the conjunctiva, eye pain, cataracts, floaters, increased intraocular pressure, and vitreous detachment.

    Serious adverse reactions include infection within the eye and retinal detachments. 

    FDA granted breakthrough therapy designation to aflibercept for the treatment of DR with DME. The agency also reviewed the new use for aflibercept under the agency’s priority review program.

    FDA previously approved aflibercept to treat wet age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula. Aflibercept is also approved to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula, resulting in blurred vision.

    In February, FDA approved ranibizumab injection 0.3 mg to treat DR in patients with DME.

  • 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.

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