Epoprostenol Sodium

A to Z Drug Facts

 Action Direct vasodilation of pulmonary and systemic arterial vascular beds; inhibition of platelet aggregation.

 Indications Long-term IV treatment of primary pulmonary hypertension in NYHA Class III and IV patients.

 Contraindications Chronic use in patients with CHF due to severe left ventricular systolic dysfunction.

 Route/Dosage

ADULTS: ACUTE DOSE RANGING IV Mean maximum dose that did not elicit dose-limiting pharmacological effects is 8.6 ng/kg/min. CONTINUOUS CHRONIC INFUSION: IV Initiate chronic infusions at 4 ng/kg/min less than the maximum tolerated infusion (MTI) rate determined during the acute dose ranging. If the MTI is < 5 ng/kg/min, start chronic infusion at one-half the MTI rate. INCREMENTS: Increase infusion by 1 to 2 ng/kg/min increments at intervals sufficient to allow assessment of clinical response (³ 15 mins). DECREMENTS: Gradually make 2 ng/kg/min decrements every 15 mins or longer until dose-limiting effects resolve.

 Interactions

Antiplatelet drugs, anticoagulants: May increase risk of bleeding. Diuretics, antihypertensives, vasodilators: May cause additional reductions in blood pressure. INCOMPATIBILITIES: Reconstitute with sterile epoprostenol diluent. Do not reconstitute or mix with any other parenteral medications or solutions.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hypotension (acute and chronic dosing); chest pain (acute and chronic dosing); tachycardia; flushing (acute and chronic dosing); syncope; arrhythmia; bradycardia (acute and chronic dosing); supraventricular tachycardia; pallor cyanosis; palpitations; cerebrovascular accident; hemorrhage. CNS: Headache (acute and chronic dosing); anxiety (acute and chronic dosing); nervousness (acute and chronic dosing); agitation (acute dose ranging); tremor; dizziness (acute and chronic dosing); hypesthesia; hyperesthesia; paresthesia convulsions. DERM: Pruritis; rash; sweating. EENT: Amblyopia; vision abnormality. GI: Nausea (acute and chronic dosing); vomiting (acute and chronic dosing); diarrhea; abdominal pain; constipation. META: Hypokalemia; weight reduction; weight gain. RESP: Hypoxia; cough increase; dyspnea (acute and chronic dosing); epistaxis; pleural effusion. OTHER: Jaw pain; myalgia; musculoskeletal pain; chills; fever; sepsis; flu-like symptoms; arthralgia; chest pain; asthenia; local infection; pain at injection site.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly patients: Use caution in dose selection, reflecting greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy. Abrupt withdrawal: May result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness and asthenia. Pulmonary edema: May result during dose ranging in patients with primary pulmonary hypertension. If this occurs, the medication should not be continued.

 Administration/Storage

• Available for IV administration only.
• Store unopened vials at room temperature (59°–77° F), protected from light.
• Reconstitute as directed using sterile diluent for epoprostenol.
• Must not be mixed with other medications or solutions.
• Reconstituted medication may be stored for up to 40 hrs in refrigerator (36°–46° F). Do not freeze. Protect from light.
• Discard any solution that has been refrigerated for > 48 hrs or has been frozen.
• A single dose can be administered over 8 hrs at room temperature, then must be discarded.
• Cold pouch administration can be used up to 24 hrs.
• Do not expose to direct sunlight. Insulate solution from temperature > 77° F and < 32° F.
• Must be administered through a central venous catheter only. Temporary peripheral IV infusions may be used until central access is established.
• Avoid abrupt withdrawal of the medication to prevent rebound pulmonary hypertension.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor blood pressure and pulse frequently during initial dosage adjustment period and periodically throughout therapy.
• Monitor patient for signs and symptoms of adverse effects. Notify physician if noted. Be prepared to adjust infusion rate if indicated.
• Perform routine catheter care per policy. Closely observe catheter site for evidence of infection or inflammation.
• Ensure that infusion is not interrupted except for replacement of infusion pouch.

 Patient/Family Education

• Instruct patient and family that therapy for PPH may be required for months and even years and that commitment is required for drug reconstitution, drug administration and proper care of the permanent central venous catheter.
• Instruct patients that the medication is infused continuously through a permanent indwelling central venous catheter by an infusion pump.
• Warn patient that even brief interruptions in the delivery of the medication will result in rapid return of symptoms.
• Provide appropriate instructions for home administration (mixing, administration, rate, catheter care, etc).
• Instruct patient and family that therapy for PPH may be required for months or even years and that commitment to required for drug reconstitution, drug administration and proper care of the permanent central venous catheter.
• Advise patient that this therapy is added to, and does not replace other therapy that has been prescribed for PPA.
• Advise patient to not change the dose or discontinue therapy unless advised to do so by their physician.
• Advise patient to not take any other medications (prescription, otc, natural product) without consulting with their physician.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts