TREPROSTINIL injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

TREPROSTINIL (UNII: RUM6K67ESG) (TREPROSTINIL - UNII:RUM6K67ESG)

Fáanlegur frá:

Par Pharmaceutical, Inc.

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Treprostinil is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to -pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%) [see Clinical Studies (14.1) ]. In patients with PAH requiring transition from epoprostenol, treprostinil is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition. None Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see Clinical Considerations) . In animal studies, no adverse reproductive and developmental effects were seen

Vörulýsing:

Treprostinil Injection is supplied in 20 mL multidose vials as sterile solutions in water for injection, individually packaged in cartons. Unopened vials of Treprostinil Injection are stable until the date indicated when stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. A single vial of Treprostinil Injection should be used for no more than 30 days after the initial introduction into the vial. Treprostinil Injection is supplied as: Treprostinil Concentration NDC Number: 20 mg/20 mL 1 mg/mL 42023-206-01 50 mg/20 mL 2.5 mg/mL 42023-207-01 100 mg/20 mL 5 mg/mL 42023-208-01 200 mg/20 mL 10 mg/mL 42023-209-01

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TREPROSTINIL- TREPROSTINIL INJECTION, SOLUTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TREPROSTINIL
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TREPROSTINIL
INJECTION.
TREPROSTINIL INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: MAY 2002
INDICATIONS AND USAGE
Treprostinil is a prostacyclin vasodilator indicated for:
Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to
diminish symptoms associated
with exercise. Studies establishing effectiveness included patients
with NYHA Functional Class II-IV
symptoms and etiologies of idiopathic or heritable PAH (58%), PAH
associated with congenital
systemic-to-pulmonary shunts (23%), or PAH associated with connective
tissue diseases (19%) (1.1)
Patients who require transition from epoprostenol, to reduce the rate
of clinical deterioration. The risks
and benefits of each drug should be carefully considered prior to
transition. (1.2)
DOSAGE AND ADMINISTRATION
PAH WHO Group 1 in patients with NYHA Class II-IV symptoms:
Initial dose for patients new to prostacyclin infusion therapy: 1.25
ng/kg/min; increase based on clinical
response (increments of 1.25 ng/kg/min per week for the first 4 weeks
of treatment, later 2.5 ng/kg/min
per week). Avoid abrupt cessation. (2.2, 2.4)
Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625
ng/kg/min.
Severe hepatic insufficiency: No studies performed. (2.5)
Transition from Epoprostenol:
Increase the Treprostinil dose gradually as the epoprostenol dose is
decreased, based on constant
observation of response. (2.7)
Administration:
Continuous subcutaneous infusion is the preferred mode. Use
intravenous (IV) infusion if subcutaneous
infusion is not tolerated. (2.1, 2.6)
DOSAGE FORMS AND STRENGTHS
Treprostinil Injection is supplied in 20 mL vials containing 20 mg, 50
mg, 100 mg, or 200 mg of
treprostinil (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL). (3)
CONTRAINDICATIONS
Non