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PROSTIN VR®(alprostadil)

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PROSTIN VR® Quick Finder

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...

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INDICATIONS AND USAGE

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...

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DOSAGE AND ADMINISTRATION

The preferred route of administration for PROSTIN VR PEDIATRIC Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, PROSTIN VR PEDIATRIC may be administered through...

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CONTRAINDICATIONS

None.

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WARNINGS

See

PRECAUTIONS

General Precautions

Cortical proliferation of the long bones, first observed in dogs, has also been observed in...

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ADVERSE REACTIONS

Central Nervous System

Apnea has been reported in about 12% of the neonates treated. (See

Cardiovascular System...

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OVERDOSAGE

Apnea, bradycardia, pyrexia, hypotension, and flushing may be signs of drug overdosage. If apnea or bradycardia occurs, discontinue the infusion, and provide appropriate medical treatment. Caution should be used in...

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DESCRIPTION

PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol.

The...

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CLINICAL PHARMACOLOGY

Alprostadil (prostaglandin E1) is one of a family of naturally occurring acidic lipids with various pharmacologic effects. Vasodilation, inhibition of platelet aggregation, and...

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HOW SUPPLIED

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.

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500 micrograms per mL

Rx only...

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