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Rx Item-Edex 10Mcg Alprostadil Kit 2 By Endo Lab

Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01  UPC No.:352244010025 352244-010025 NDC No. 5Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01  UPC No.:352244010025 352244-010025 NDC No. 5Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Edex 10Mcg Alprostadil Kit 2 By Endo Lab

$498.76$199.99

Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01 UPC No.:352244010025 352244-010025 NDC No. 52244-0010-02 UPC/GTIN No. 3-52244-01002-5 MPN 1002 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item

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Clinical Information
Gen. Code and Des.
23797 alprostadil INTRACAVER KIT 10 MCG
GCN and Des.
2294 alprostadil INTRACAVER KIT 10 MCG
Strength
10MCG
Dose Form
KIT
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24129200 VASODILATING AGENTS, MISCELLANEOUS
Active Ingredients
704 alprostadil 745653
Inactive Ingredients
18822 rubber, unspecified
2432 lactose 64044515






EDEX- alprostadil injection, powder, lyophilized, for solution
Actient Pharmaceuticals, LLC

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 (?-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1 ). 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 ?-cyclodextrin, 51.06 mg lactose); 20 mcg cartridge (21.5 mcg alprostadil, 695.2 mcg ?-cyclodextrin, 51.06 mg lactose); 40 mcg cartridge (43.0 mcg alprostadil, 1,390.3 mcg ?-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 C20 H34 O5 and the molecular weight is 354.49. The chemical structure is:

alprostadil chemical structure
The ?-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of ?-cyclodextrin is C36 H60 O30 and the molecular weight is 972.85.

The chemical structure is:

?-cyclodextrin chemical structure
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 active ingredient, alprostadil, immediately dissociates from the ?-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5 or 43.0 mcg of alprostadil is placed into the edex� injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively.

CLINICAL PHARMACOLOGY

Alprostadil (PGE1 ) is one of the prostaglandins, a family of naturally occurring acidic lipids with various pharmacological effects. Endogenous PGE1 is derived from dihomo-gamma-linolenic acid, a fatty acid found within the phospholipids of cellular membranes. As an endogenous substance, PGE1 exerts its biological effects either directly or indirectly by regulating and modifying the synthesis and effects of other hormones and mediators.

Mode of Action
Alprostadil is a smooth muscle relaxant. Precontracted isolated preparations of the human corpus cavernosum, corpus spongiosum and cavernous artery are relaxed by alprostadil. Alprostadil has been shown to bind to specific receptors in human penile tissue. Two types of receptors that differ in their PGE1 binding affinity have been identified. The binding of alprostadil to its receptors is accompanied by an increase in intracellular cAMP levels. Human cavernous smooth muscle cells respond to alprostadil by releasing intracellular calcium into the surrounding medium. Smooth muscle relaxation is associated with a reduction of the cytoplasmic free calcium concentration. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum which is essential for the maintenance of a flaccid and non-erect penis.

Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernous arteries. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.

Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01  UPC No.:352244010025 352244-010025 NDC No. 5
RX ITEM-Edex 10Mcg Kit 2 By Endo Lab
Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01 UPC No.:352244010025 352244-010025 NDC No. 5

Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01  UPC No.:352244010025 352244-010025 NDC No. 5
Edex 10Mcg Kit 2 By Endo Lab
Item No.:RX165035 165035 NDC No.52244001002 5224401002 52244-010-02 52244-0010-02 52244-0010-02 Each NDC 52244-0010-01 52244001001 5224401001 52244-010-01 UPC No.:352244010025 352244-010025 NDC No. 5

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ALPROSTADIL INTRACAVER KI
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.