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Alprostadil

Generic Name
Alprostadil
Brand Names
Caverject, Edex, Muse, Prostin Vr
Drug Type
Small Molecule
Chemical Formula
C20H34O5
CAS Number
745-65-3
Unique Ingredient Identifier
F5TD010360

Overview

Alprostadil is a chemically-identical synthetic form of prostaglandin E1 (PGE1), a potent vasodilator produced endogenously. In 1996, the FDA approved the use of alprostadil, administered either with an intracavernosal injection or an intraurethral suppository, for the treatment of erectile dysfunction, and it is used in men for whom oral treatment is either contraindicated or ineffective. After administration, alprostadil promotes smooth muscle relaxation of the corpus cavernosal. Alprostadil is also used in neonatal patients with congenital heart defects that depend on a patent ductus for survival until corrective or palliative surgery can be performed. This drug causes vasodilation by directly affecting vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This results in increased pulmonary or systemic blood flow in infants.

Background

Alprostadil is a chemically-identical synthetic form of prostaglandin E1 (PGE1), a potent vasodilator produced endogenously. In 1996, the FDA approved the use of alprostadil, administered either with an intracavernosal injection or an intraurethral suppository, for the treatment of erectile dysfunction, and it is used in men for whom oral treatment is either contraindicated or ineffective. After administration, alprostadil promotes smooth muscle relaxation of the corpus cavernosal. Alprostadil is also used in neonatal patients with congenital heart defects that depend on a patent ductus for survival until corrective or palliative surgery can be performed. This drug causes vasodilation by directly affecting vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This results in increased pulmonary or systemic blood flow in infants.

Indication

Alprostadil 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. It is also indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology, and as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Associated Conditions

  • Erectile Dysfunction
  • Patent Ductus Arteriosus (PDA)
  • Raynaud's Phenomenon

FDA Approved Products

Caverject
Manufacturer:Pharmacia & Upjohn Company LLC
Route:INTRACAVERNOUS
Strength:41.1 ug in 1 mL
Approved: 2023/03/01
NDC:0009-7686
Caverject Impulse
Manufacturer:U.S. Pharmaceuticals
Route:INTRACAVERNOUS
Strength:20 ug in 0.5 mL
Approved: 2016/10/01
NDC:63539-221
Caverject Impulse
Manufacturer:U.S. Pharmaceuticals
Route:INTRACAVERNOUS
Strength:10 ug in 0.5 mL
Approved: 2016/10/01
NDC:63539-121
MUSE
Manufacturer:Meda Pharmaceuticals Inc.
Route:URETHRAL
Strength:125 ug in 1 1
Approved: 2018/04/25
NDC:0037-8110
MUSE
Manufacturer:Meda Pharmaceuticals Inc.
Route:URETHRAL
Strength:250 ug in 1 1
Approved: 2018/04/25
NDC:0037-8120

Singapore Approved Products

CAVERJECT POWDER FOR INJECTION 20 mcg/ml
Manufacturer:PFIZER MANUFACTURING BELGIUM NV
Form:INJECTION, POWDER, FOR SOLUTION
Strength:20 mcg/ml
Online:Yes
Approved: 1995/03/28
Approval:SIN08097P
PROSTIN VR PAEDIATRIC INJECTION 0.5 mg/ml
Manufacturer:PHARMACIA & UPJOHN CO
Form:INJECTION
Strength:0.5 mg/ml
Online:Yes
Approved: 1988/07/14
Approval:SIN02280P

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