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This page was prepared by Lynn Kash, RN, Internet Nursing Guide Pennsylvania Nurses,Emergency Department http://www.nursefriendly.com/kash/ ******************************************************
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Treprostinil, New treatment for people with connective tissue disease-associated heart and lung problems, November 11, 2001, American College of Rheumatology:"Treprostinil, a structural analogue of naturally occurring prostacyclin, has been shown to be safe and effective in the treatment of patients with pulmonary hypertension associated with various forms of connective tissue disease, according to research presented at the American College of Rheumatology Annual Scientific Meeting Nov. 10 - 15 in San Francisco, California." ******************************************************
Remodulin(Treprostinil), General Information, Center Watch:"Remodulin (treprostinil sodium) injection is a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class II-IV symptoms. Remodulin is intended to diminish the symptoms, such as shortness of breath, associated with physical activity in PAH patients.
Remodulin is supplied in concentrations of 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL and 10.0 mg/mL. The standard infusion rate is 1.25 ng/kg/min, but can be reduced in the event that the original dose cannot be tolerated.
Pulmonary arterial hypertension (PAH) is a disease in which blood pressure is abnormally high in the arteries between the heart and lungs. PAH is characterized by symptoms of shortness of breath during physical exertion. The condition can ultimately lead to heart failure." ******************************************************
Remodulin(UT-15 or Treprostinil Sodium), Treating Pulmonary Hypertension, CHFpatients:"It was approved in July of 2002. It is a strong vasodilator and slows scarring and cell growth inside the lungs' blood vessels. It increases cardiac output and improves exercise ability. The drug's action lasts from 4 to 6 hours instead of the 2 to 6 minute action of Flolan, and Remodulin is stable at room temperature for up to 5 years.
Remodulin is injected under the skin instead of through an IV catheter. This under-the-skin delivery works with a pager-sized infusion pump. This reduces infection risk because there is no "indwelling" catheter. Remodulin does not require mixing - it comes ready to use in glass vials. Every 3 days, the injection site is changed (usually in the stomach area). The chief drawback to Remodulin is pain at the injection site, which can be severe." ******************************************************
Treprostinil Sodium, New Introductions, Cipladoc.com:"Treprostinil sodium is a prostaglandin (epoprostenol analog) approved by the FDA for the treatment of NYHA class II-IV pulmonary arterial hypertension in May 2002. Treprostinil exhibits potent antiproliferative activity in human pulmonary artery smooth muscle cells. For the treatment of primary or secondary pulmonary hypertension, treprostinil is given via continuous subcutaneous infusion using a microinfusion pump. A dose of 1.25 to 2.5 ng/kg/min is administered initially by continuous subcutaneous infusion, with gradual upward titration based on clinical response. It possesses a longer plasma half-life than intravenous epoprostenol." ******************************************************
Remodulin(Treprostinil Sodium), United Therapeutics Receives FDA Approval For Remodulin (Treprostinil Sodium) To Treat Pulmonary Arterial Hypertension, May 23,2002, Doctor's Guide:"United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Remodulin (treprostinil sodium) Injection as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise." ******************************************************
Treprostinil, Description, Drugs.com:"Treprostinil causes dilation (widening) of the arteries. Treprostinil also decreases aggregation of platelets (substances in the blood necessary for blood clotting). These effects decrease pressure in the pulmonary artery (artery from the heart to the lungs)." ******************************************************
Treprostinil(Remodulin), Parenteral Vasodialators, eMedicine.com:"Treprostinil (Remodulin) -- Used to treat pulmonary arterial hypertension. Structuraly very similar to epoprostenol, but stable at room temperature, and with a much longer half-life, so that it can be given as a subcutaneous continuous infusion via a much smaller pump (see below). Elicits direct vasodilation of pulmonary and systemic arterial vessels and inhibits platelet aggregation. The vasodilation reduces right and left ventricular afterload and increases cardiac output and stroke volume." ******************************************************
Remodulin(Treprostinil), New Drugs 2002, Global RX:"United Therapeutics - Remodulin is the second drug approved for the treatment of pulmonary artery hypertension. It is given by constant infusion via a mini pump connected to a subcutaneous catheter implanted in various locations in the stomach. The duration is 4-6 hours. Side effects include jaw pain, headache, flushing, nausea, and pain at the subcutaneous injection site." ******************************************************
Treprostinil Sodium, Information, Mosby's DRUG Consult:"The major pharmacological actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation. In animals, the vasodilatory effects reduce right and left ventricular afterload and increase cardiac output and stroke volume. Other studies have shown that treprostinil causes a dose-related negative inotropic and lusitropic effect. No major effects on cardiac conduction have been observed." ******************************************************
Remodulin(Treprostinil Sodium), News, Pharmalicensing.com:"The FDA has proposed drug labeling for pulmonary arterial hypertension consistent with the treatment of both primary and secondary pulmonary hypertension in patients with NYHA Class II-IV symptoms. The approvable letter also stated that the FDA intends to approve Remodulin with a requirement that United Therapeutics subsequently conduct a post-marketing controlled clinical trial to verify and further describe the drug's clinical benefit. United Therapeutics is in final discussions with the FDA, the outcomes of which are expected to form the basis for approval of Remodulin in accordance with the FDA's accelerated approval regulations. Upon approval, Remodulin will be the first FDA-approved therapy for NYHA Class II pulmonary arterial hypertension patients." ****************************************************** ******************************************************
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