PROSTIN VR PEDIATRIC- alprostadil injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Pharmacia & Upjohn Company LLC

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

PROSTIN VR PEDIATRIC Sterile Solution 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. PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care. None.

Ringkasan produk:

PROSTIN VR PEDIATRIC Sterile Solution is available in a package of 5 ×1 mL ampoules (NDC 0009-0215-05). Each mL contains 500 micrograms alprostadil in dehydrated alcohol. Store PROSTIN VR PEDIATRIC Sterile Solution in a refrigerator at 2° to 8°C (36° to 46°F).

Status otorisasi:

New Drug Application

Karakteristik produk

PROSTIN VR PEDIATRIC- ALPROSTADIL INJECTION, SOLUTION
PHARMACIA & UPJOHN COMPANY LLC
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PROSTIN VR PEDIATRIC
ALPROSTADIL INJECTION, USP
500 MICROGRAMS PER ML
WARNING
Apnea is experienced by about 10 to 12% of neonates with congenital
heart
defects treated with PROSTIN VR PEDIATRIC Sterile Solution. 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 PROSTIN VR PEDIATRIC should be used where
ventilatory assistance is immediately available.
DESCRIPTION
PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion
contains 500
micrograms alprostadil, more commonly known as prostaglandin E , in
1.0 mL
dehydrated alcohol.
The chemical name for alprostadil is (11α,13E,15S)-11,15
dihydroxy-9-oxo-prost-13-en-
1-oic 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.
STRUCTURAL FORMULA
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
®
1
1
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 alprostadil in infants who
had congenital defects
which restricted the pu