PROSTIN VR PEDIATRIC- alprostadil injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmacia and Upjohn Company LLC

INN (International Name):

ALPROSTADIL

Composition:

ALPROSTADIL 500 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

PROSTIN VR PEDIATRIC Sterile Solution is available in a package of 5 ×1 mL ampoules (NDC 0009-3169-06). 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).

Authorization status:

New Drug Application

Summary of Product characteristics

PROSTIN VR PEDIATRIC- ALPROSTADIL INJECTION, SOLUTION
PHARMACIA AND 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 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
pulmonar