REMODULIN SUMMARY
REMODULIN® (treprostinil sodium) Injection
Remodulin® (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3.0 mg metacresol, 6.3 mg sodium citrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.
Remodulin® is indicated as a continuous subcutaneous infusion or intravenous infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms (see CLINICAL PHARMACOLOGY: Clinical Effects) to diminish symptoms associated with exercise.
Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan®; the risks and benefits of each drug should be carefully considered prior to transition.
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