sound asleep [40:<15,000 ng/mL: 48 hours 15,000 to> <60,000 ng/mL: 48 hours 60,000 ng/mL: 72 hours Canadian labeling (Caripul): 3,000 to> <15,000 ng/mL: 48 hours 15,000: 48 hours If stored at 2 C to 8 C (36 F to 46 F) for up to 8 days, the following maximum durations of administration at room temperature (25 C [77 F]) according to solution concentration are recommended: 3,000 to> <15,000 ng/mL: 24 hours 15,000 to> <60,000 ng/mL: 48 hours 60,000 ng/mL: 48 hours Short excursions at 40 C (104 F) are permitted as follows: Solution concentration> <15,000 ng/mL: Up to 2 hours Solution concentration 15,000 to> <60,000 ng/mL: Up to 4 hours Solution concentration 60,000 ng/mL: Up to 8 hours The following maximum durations of administration at temperatures >25 C to 40 C (>77 F up to 104 F) administered either immediately or after up to 8 days storage at 2 C to 8 C (36 F to 46 F) according to solution concentration are recommended: Use at temperature >25 C to 30 C (>77 F up to 86 F): US labeling (Veletri):> <60,000 ng/mL: 24 hours 60,000 ng/mL: 48 hours Canadian labeling (Caripul): All concentrations: 24 hours Use at temperature up to 40 C (104 F): US labeling (Veletri): 60,000 ng/mL: 24 hours (immediately administered after preparation) Drug Interactions Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Prostacyclin Analogues may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification Anticoagulants: Prostacyclin Analogues may enhance the adverse/toxic effect of Anticoagulants. Specifically, the antiplatelet effects of these agents may lead to an increased risk of bleeding with the combination. Monitor therapy Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Blood Pressure Lowering Agents: Prostacyclin Analogues may enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Digoxin: Epoprostenol may increase the serum concentration of Digoxin. Monitor therapy DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy Thrombolytic Agents: May enhance the adverse/toxic effect of Prostacyclin Analogues. Specifically, the antiplatelet effects of prostacyclin analogues may lead to an increased risk of bleeding when combined with thrombolytic agents. Monitor therapy Adverse Reactions Note: Adverse events reported during dose initiation and escalation include flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), anxiety/nervousness/agitation (11%), chest pain (11%); dizziness, abdominal pain, bradycardia, musculoskeletal pain, dyspnea, back pain, diaphoresis, dyspepsia, hypoesthesia/paresthesia, and tachycardia are also reported. Although some adverse reactions may be related to the underlying disease state, abdominal pain, anxiety/nervousness/agitation, arthralgia, bleeding, bradycardia, diarrhea, diaphoresis, flu-like syndrome, flushing, headache, hypotension, jaw pain, nausea, pain, pulmonary edema, rash, tachycardia, thrombocytopenia, and vomiting are clearly contributed to epoprostenol. The following adverse events have been reported during chronic administration for idiopathic or heritable PAH: >10%: Cardiovascular: Tachycardia (35% to 43%), flushing (23% to 42%), hypotension (13%) Central nervous system: Dizziness (83%), headache (46% to 83%), chills (25%), fever (25%), flu-like syndrome (25%), sepsis (25%), anxiety (21%), nervousness (21%), tremor (21%), agitation (11%) Dermatologic: Dermal ulcer (39%), eczema (25%), skin rash (25%), urticaria (25%) Gastrointestinal: Nausea ( 67%), vomiting ( 67%), anorexia (66%), diarrhea (37% to 50%) Local: Injection site reactions: Infection (18%), pain (11%) Neuromuscular & skeletal: Arthralgia ( 84%), neck pain ( 84%), pain ( 84%), jaw pain (54% to 75%), myalgia (44%), musculoskeletal pain (35%), hyperesthesia ( 12%), hypoesthesia ( 12%), paresthesia ( 12%)> <1%, postmarketing, and/or case reports: Abdominal pain, anemia, ascites, dyspnea, fatigue, hemorrhage, hepatic failure, hyperthyroidism, pancytopenia, pulmonary edema, pulmonary embolism, splenomegaly, thrombocytopenia Warnings/Precautions Concerns related to adverse effects: Pulmonary edema: Some patients with PAH have developed pulmonary edema during dosing adjustment and acute vasodilator testing (an off-label use), which may be associated with concomitant heart failure (LV systolic dysfunction with significantly elevated left heart filling pressures) or pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis. If pulmonary edema develops during therapy initiation, discontinue and do not readminister. Rebound pulmonary hypertension: Avoid abrupt interruptions or large sudden reductions in dosage; may result in rebound pulmonary hypertension (eg, dyspnea, dizziness, asthenia). A fatal case occurred following interruption. Immediate access to medication or pump and infusion sets is essential to prevent treatment interruptions. Vasodilation: Epoprostenol is a potent pulmonary and systemic vasodilator and can cause hypotension and other reactions such as flushing, nausea, vomiting, dizziness, and headache. Monitor blood pressure and symptoms regularly during initiation and after dose change. Disease-related concerns: Conditions that increase bleeding risk: Epoprostenol is a potent inhibitor of platelet aggregation. Use with caution in patients with other risk factors for bleeding. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: Appropriate Use: Initiation or transition to epoprostenol requires specialized cardiopulmonary monitoring in a critical care setting where clinicians are experienced in advanced management of pulmonary arterial hypertension. To reduce the risk of thromboembolism during chronic use, anticoagulants should be coadministered unless contraindicated. Infection: Chronic continuous IV infusion of epoprostenol via a chronic indwelling central venous catheter (CVC) has been associated with local infections and serious blood stream infections. Monitoring Parameters Monitor for improvements in pulmonary function, decreased exertional dyspnea, fatigue, syncope and chest pain, blood pressure, pulmonary vascular resistance, pulmonary arterial pressure and quality of life. Following establishment of a new chronic infusion rate, measure standing and supine blood pressure for several hours. In addition, the pump device and catheters should be monitored frequently to avoid system related failure. Monitor arterial pressure; assess all vital functions. Hypoxia, flushing, and tachycardia may indicate overdose. Pregnancy Risk Factor B Pregnancy Considerations Adverse events have not been observed in animal reproduction studies. Women with pulmonary arterial hypertension (PAH) are encouraged to avoid pregnancy (McLaughlin 2009; Taichman 2014). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience anxiety, back pain, diarrhea, flushing, lack of appetite, jaw pain, bone pain, muscle pain, joint pain, nausea, vomiting, or flu-like symptoms. Have patient report immediately to prescriber signs of infection, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), shortness of breath, severe dizziness, passing out, severe headache, dark urine, angina, tachycardia, bradycardia, abnormal heartbeat, pale skin, tremors, severe loss of strength and energy, burning or numbness feeling, abdominal edema, skin sores, injection site redness, edema, or severe irritation (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about epoprostenol Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: agents for pulmonary hypertension Consumer resources Epoprostenol Epoprostenol Intravenous (Advanced Reading) Professional resources Epoprostenol Sodium (AHFS Monograph) Epoprostenol (FDA) Other brands: Flolan , Veletri Related treatment guides Pulmonary Hypertension> ]} Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Epoprostenol Rating 2 User Reviews 8.0 /10 2 User Reviews 8.0 Rate it! Manufacturer Teva Pharmaceuticals USA, Inc. 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