Alprostadil Injection USP Rx only

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

ALPROSTADIL (UNII: F5TD010360) (ALPROSTADIL - UNII:F5TD010360)

Mevcut itibaren:

Teva Parenteral Medicines, Inc.

INN (International Adı):

ALPROSTADIL

Kompozisyon:

ALPROSTADIL 500 ug in 1 mL

Uygulama yolu:

INTRAVASCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Alprostadil injection USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. Alprostadil injection USP should be administered only by trained personnel in facilities that provide pediatric intensive care. None.

Ürün özeti:

Each mL contains 500 micrograms alprostadil in dehydrated alcohol. NDC 0703-1501-02 500 micrograms/mL 1 mL Single Dose Vial shelf pack of 5 vials Store alprostadil injection USP in a refrigerator at 2° to 8°C (36° to 46°F). Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. B 2/2020

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ALPROSTADIL- ALPROSTADIL INJECTION, SOLUTION, CONCENTRATE
TEVA PARENTERAL MEDICINES, INC.
----------
ALPROSTADIL INJECTION USP
RX ONLY
WARNING
Apnea is experienced by about 10 to 12% of neonates with congenital
heart defects treated with
alprostadil injection. Apnea is most often seen in neonates weighing
less than 2 kg at birth and
usually appears during the first hour of drug infusion. Therefore,
respiratory status should be
monitored throughout treatment, and alprostadil injection should be
used where ventilatory
assistance is immediately available.
DESCRIPTION
Alprostadil injection USP for intravascular infusion contains 500
micrograms alprostadil, more
commonly known as prostaglandin E , in 1 mL dehydrated alcohol.
The chemical name for alprostadil is
(1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-
oxocyclopentane heptanoic acid, and the molecular weight is 354.49.
Alprostadil is a white to off-white crystalline powder with a melting
point between 110° and 116°C. Its
solubility at 35°C is 8000 micrograms per 100 mL double distilled
water. Alprostadil has a molecular
formula of C
H O .
CLINICAL PHARMACOLOGY
Alprostadil (prostaglandin E ) is one of a family of naturally
occurring acidic lipids with various
pharmacologic effects. Vasodilation, inhibition of platelet
aggregation, and stimulation of intestinal and
uterine smooth muscle are among the most notable of these effects.
Intravenous doses of 1 to 10
micrograms of alprostadil per kilogram of body weight lower the blood
pressure in mammals by
decreasing peripheral resistance. Reflex increases in cardiac output
and rate accompany the reduction in
blood pressure.
Smooth muscle of the ductus arteriosus is especially sensitive to
alprostadil, and strips of lamb ductus
markedly relax in the presence of the drug. In addition,
administration of alprostadil reopened the
closing ductus of new-born rats, rabbits, and lambs. These
observations led to the investigation of
1
20
34
5
1
alprostadil in infants who had congenital defects which restricted the
pu