EPOPROSTENOL injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

EPOPROSTENOL SODIUM (UNII: 4K04IQ1OF4) (EPOPROSTENOL - UNII:DCR9Z582X0)

Доступна с:

Sun Pharmaceutical Industries, Inc.

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Epoprostenol for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. A large study evaluating the effect of epoprostenol on survival in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving epoprostenol plus conventional therapy than in those receiving conventional therapy alone. The chronic use of epoprostenol for injection in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated. Some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with

Обзор продуктов:

Epoprostenol for injection is supplied as a sterile lyophilized material in 10 mL vials. 10 mL vial with an orange flip top containing epoprostenol sodium equivalent to 0.5 mg (500,000 ng) epoprostenol, is packaged in carton of 1 vial (NDC 62756-059-40 ). 10 mL vial with a purple flip top containing epoprostenol sodium equivalent to 1.5 mg (1,500,000 ng) epoprostenol, is packaged in carton of 1 vial (NDC 62756-060-40 ). Store the vials of epoprostenol for injection at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Unopened vials of epoprostenol for injection are stable until the date indicated on the package when stored at 68° to 77°F (20° to 25°C). The unopened vial should be kept in the carton and not exposed to direct sunlight. Use after reconstitution and immediate dilution to final concentration can be found in DOSAGE AND ADMINISTRATION (2.4) Reconstitution, Table 1: Maximum duration of administration (hours) at room temperature (77°F /25°C) of fully diluted solutions in the drug delivery reservoir. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. If either occurs, do not administer.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

EPOPROSTENOL - EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPOPROSTENOL FOR INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPOPROSTENOL FOR
INJECTION.
EPOPROSTENOL FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Epoprostenol sodium is a prostanoid vasodilator indicated for the
treatment of pulmonary arterial hypertension (PAH)
(WHO Group 1) to improve exercise capacity. Studies establishing
effectiveness included predominantly patients with
NYHA Functional Class III-IV symptoms and etiologies of idiopathic or
heritable PAH or PAH associated with connective
tissue diseases. (1)
DOSAGE AND ADMINISTRATION
Dosage
Infusion of epoprostenol for injection should be initiated at 2
ng/kg/min and increased in increments of 2 ng/kg/min
every 15 minutes or longer until dose-limiting pharmacologic effects
are elicited or until a tolerance limit to the drug
is established. (2.1)
If symptoms of pulmonary hypertension persist or recur after improving
- the infusion should be increased by 1- to
2-ng/kg/min increments at intervals sufficient to allow assessment of
clinical response; these intervals should be at
least 15 minutes. (2.2)
Administration
Epoprostenol for injection is administered by continuous intravenous
infusion via a central venous catheter using an
ambulatory infusion pump. (2.3)
Do not mix with any other parenteral medications or solutions prior to
or during administration. (2.4)
Re constitution
Reconstituted in vial with only 5 mL of either Sterile Water for
Injection or Sodium Chloride 0.9% Injection.
Epoprostenol for injection solution reconstituted and immediately
diluted to the final concentration in the drug
delivery reservoir can be administered per the conditions of use as
outlined in Table 1. (2.4)
Solution for chronic delivery should be prepared in a drug delivery
reservoir appropria