EDEX- alprostadil injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ENDO USA, Inc.

INN (International Name):

ALPROSTADIL

Composition:

ALPROSTADIL 10 ug in 1 mL

Administration route:

INTRACAVERNOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology. edex® should not be used: - in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia (see WARNINGS) . - for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as cavernosal fibrosis or Peyronie’s disease (see PRECAUTIONS) .   - in men with penile implants

Product summary:

edex® (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains 10.75, 21.5, or 43 mcg of alprostadil as a white, sterile, lyophilized powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. When the cartridge is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20, or 40 mcg, respectively. edex® Cartridge 2 Pack contains one reusable edex® injection device, two single-dose, dual-chamber cartridges, two ½-inch, 29-gauge (0.33 mm × 12.7 mm) needles, and four alcohol swabs. edex® Cartridge 6 Pack contains one reusable edex® injection device, six single-dose, dual-chamber cartridges, six ½-inch, 29-gauge (0.33 mm × 12.7 mm) needles, and twelve alcohol swabs. The edex® cartridges are supplied in the following packages: Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

EDEX- ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ENDO USA, INC.
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EDEX
(ALPROSTADIL FOR INJECTION)
FOR INTRACAVERNOUS USE ONLY
STERILE POWDER AND DILUENT
(STERILE 0.9% SODIUM CHLORIDE) IN CARTRIDGES
RX ONLY
DESCRIPTION
edex
(alprostadil for injection) is a sterile, pyrogen-free powder
containing alprostadil in
an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an
endogenous substance
known as prostaglandin E (PGE ). edex
is supplied in single-dose, dual-chamber
cartridges.
edex
is lyophilized in single-dose, dual-chamber cartridges intended for
use with the
reusable edex
injection device. One chamber of the cartridge contains alprostadil,
alfadex and lactose as a sterile, pyrogen-free powder. The other
chamber contains
1.075 mL of sterile 0.9% sodium chloride. The edex
cartridges are supplied in three
strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg
α-cyclodextrin, 51.06
mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg
α-cyclodextrin, 51.06
mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg
α-cyclodextrin, 51.06
mg lactose). The edex
injection device is used to reconstitute the sterile powder in one
chamber with the sterile 0.9% sodium chloride in the other chamber.
After
reconstitution, the edex
injection device is used to administer the intracavernous
injection of alprostadil.
The chemical name for alprostadil is
(1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-
octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C
H
O and the
molecular weight is 354.49. The chemical structure is:
The α-cyclodextrin inclusion complex improves the water solubility of
alprostadil. The
empirical formula of α-cyclodextrin is C
H
O
and the molecular weight is 972.85.
The chemical structure is:
Alprostadil alfadex is a white, odorless, hygroscopic powder. It is
freely soluble in water
and practically insoluble in ethanol, ethyl acetate and ether. After
reconstitution, the
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1
1
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20
34
5
36
60
30
and practically insoluble i