Epoprostenol Sodium
Generic Name: epoprostenol sodium
Brand Names:
Flolan
11 DESCRIPTION FLOLAN (epoprostenol sodium) for injection is sterile sodium salt that is a white or off-white powder formulated for intravenous (IV) administration. Each vial of FLOLAN contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol, 3.76 mg glycine, 50 mg mannitol, and 2.93 mg sodium chloride. Sodium hydroxide may have been added to adjust pH.
Overview
11 DESCRIPTION FLOLAN (epoprostenol sodium) for injection is sterile sodium salt that is a white or off-white powder formulated for intravenous (IV) administration. Each vial of FLOLAN contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol, 3.76 mg glycine, 50 mg mannitol, and 2.93 mg sodium chloride. Sodium hydroxide may have been added to adjust pH.
Uses
1 INDICATIONS AND USAGE FLOLAN is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). FLOLAN is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Studies establishing effectiveness included predominantly (97%) patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Initiate intravenous infusion through a central venous catheter at 2 ng/kg/min. ( 2.2 , 2.3 ) • Change dose in 1- to 2-ng/kg/min increments at intervals of at least 15 minutes based on clinical response. ( 2.2 ) • Avoid sudden large dose reductions. ( 2.2 , 5.2 ) 2.1 Reconstitution Each vial is for single use only; discard any unused diluent or unused reconstituted solution. Select a concentration for the solution of FLOLAN that is compatible with the infusion pump being used with respect to minimum and maximum flow rates, reservoir capacity, and the infusion pump criteria listed below [see Dosage and Administration ( 2.3 )] . Using aseptic technique, reconstitute FLOLAN only with pH 12 STERILE DILUENT for FLOLAN.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions are dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting, and are generally associated with vasodilation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions are shown in Table 2 and are generally related to vasodilatory effects. Table 2.
Warnings
5 WARNINGS AND PRECAUTIONS • Pulmonary edema: Discontinue therapy if pulmonary edema occurs. ( 5.1 ) • Rebound pulmonary hypertension: Do not abruptly discontinue or decrease the dose. ( 5.2 ) • Vasodilation reactions: Monitor blood pressure and symptoms regularly during initiation and after dose change. ( 5.3 ) • Increased risk for bleeding: Increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding. ( 5.4 ) 5.1 Pulmonary Edema If the patient develops pulmonary edema during initiation with FLOLAN, discontinue therapy and do not readminister. Consider the possibility of associated pulmonary veno-occlusive disease in such patients. 4 CONTRAINDICATIONS FLOLAN is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see Clinical Studies ( 14.3 )] . FLOLAN is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients. • Heart failure with reduced ejection fraction. ( 4 ) • Hypersensitivity to FLOLAN or any of its ingredients. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Limited published data from case series and case reports have not established an association with FLOLAN and major birth defects, miscarriage or adverse maternal or fetal outcomes when FLOLAN is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Considerations) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied FLOLAN for injection is supplied as a sterile freeze‑dried powder in 17‑mL flint glass vials with gray butyl rubber closures. pH 12 STERILE DILUENT for FLOLAN is supplied in plastic vials containing 50‑mL diluent with fluororesin‑faced butyl rubber closures with aluminum overseal and lavender plastic flip-off cap.
Frequently Asked Questions
What is Epoprostenol Sodium used for?▼
1 INDICATIONS AND USAGE FLOLAN is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). FLOLAN is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Studies establishing effectiveness included predominantly (97%) patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). ( 1 )
What are the side effects of Epoprostenol Sodium?▼
6 ADVERSE REACTIONS The most common adverse reactions are dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting, and are generally associated with vasodilation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions are shown in Table 2 and are generally related to vasodilatory effects. Table 2.
Can I take Epoprostenol Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary Limited published data from case series and case reports have not established an association with FLOLAN and major birth defects, miscarriage or adverse maternal or fetal outcomes when FLOLAN is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Considerations) .
What are the important warnings for Epoprostenol Sodium?▼
5 WARNINGS AND PRECAUTIONS • Pulmonary edema: Discontinue therapy if pulmonary edema occurs. ( 5.1 ) • Rebound pulmonary hypertension: Do not abruptly discontinue or decrease the dose. ( 5.2 ) • Vasodilation reactions: Monitor blood pressure and symptoms regularly during initiation and after dose change. ( 5.3 ) • Increased risk for bleeding: Increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding. ( 5.4 ) 5.1 Pulmonary Edema If the patient develops pulmonary edema during initiation with FLOLAN, discontinue therapy and do not readminister. Consider the possibility of associated pulmonary veno-occlusive disease in such patients. 4 CONTRAINDICATIONS FLOLAN is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see Clinical Studies ( 14.3 )] . FLOLAN is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients. • Heart failure with reduced ejection fraction. ( 4 ) • Hypersensitivity to FLOLAN or any of its ingredients. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.