TREPROSTINIL injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Teva Parenteral Medicines, Inc.

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Treprostinil Injection 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 Injection 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

Bidhaa muhtasari:

Treprostinil Injection is supplied in 20 mL multidose vials as sterile, clear, colorless to pale yellow solutions in Water for Injection, individually packaged in cartons. Unopened vials of Treprostinil Injection are stable until the date indicated when stored at 25°C (77°F), with excursions permitted to 2° to 30°C (36° to 86°F). 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: 20-mL vial containing 20 mg treprostinil (1 mg treprostinil per mL), carton of 1 (NDC 0703-0666-01). 20-mL vial containing 50 mg treprostinil (2.5 mg treprostinil per mL), carton of 1 (NDC 0703-0676-01). 20-mL vial containing 100 mg treprostinil (5 mg treprostinil per mL), carton of 1 (NDC 0703-0686-01). 20-mL vial containing 200 mg treprostinil (10 mg treprostinil per mL), carton of 1 (NDC 0703-0696-01). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

TREPROSTINIL- TREPROSTINIL INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, 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 Injection is a prostacyclin mimetic 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 Injection 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 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)
CO