Edex 40 ug/mL
alprostadil · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Endo USA, Inc.
Edex is an injectable medication containing alprostadil, a prostaglandin analog used to treat erectile dysfunction in men. The medication is injected directly into the penis to help produce an erection.
Key Facts
- Brand Name
- Edex
- Generic Name
- alprostadil
- NDC Code (Product)
52244-040- Manufacturer
- Endo USA, Inc.
- Strength
- 40 ug/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVERNOUS
- Marketing Status
- Application #
- NDA020649
- Drug Class
- Prostaglandin Analog [EPC]; Prostaglandin E1 Agonist [EPC]
- Marketing Start
- 03/15/2012
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE edex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Dosage & Administration
DOSAGE AND ADMINISTRATION edex ® in the Treatment of Erectile Dysfunction The dosage range of edex ® for the treatment of erectile dysfunction is 1 to 40 mcg. The intracavernous injection should be given over a 5 to 10 second interval. In a study with a dose range of 1 to 20 mcg of edex ® , the mean dose was 10.7 mcg at the end of the dose titration period. In two studies with a dose range of 1 to 40 mcg of edex ® , the mean dose was 21.9 mcg at the end of the dose titration period. Doses greater than 40 mcg have not been studied. A ½-inch, 27- to 30-gauge needle is generally recommended for the intracavernous injection. The patient is advised not to exceed the optimum edex ® dose which was determined in the doctor's office. The lowest possible effective dose should always be used. Initial Titration in Physician's Office Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology : Dosage titration should be initiated at 2.5 mcg of alprostadil. If there is a partial response, the dose may be increased by 2.5 mcg to a dose of 5 mcg and then in increments of 5 to 10 mcg, depending upon erectile response, until the dose that produces an erection suitable for intercours…
Warnings
WARNINGS Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. The incidence of priapism (erections greater than 6 hours in duration) was <1% with long-term use for up to 24 months. In the majority of cases, spontaneous detumescence occurred. Pharmacologic intervention and/or aspiration of blood from the corpora was necessary in 1.6% of 311 patients with prolonged erections/priapism. To minimize the chances of prolonged erection or priapism, edex ® should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION ). The patient must be instructed to immediately report to his prescribing physician or, if unavailable, to seek immediate medical assistance for any erection that persists longer than six hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Contraindications
CONTRAINDICATIONS 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
Drug Interactions
Drug Interactions The pharmacodynamic interaction between heparin (5,000 units) and alprostadil intravenous infusion (90 mcg over 3 hours) was investigated. The results indicate significant changes in partial thromboplastin time (140% increase) and thrombin time (120% increase). Therefore, caution should be exercised with concomitant administration of heparin and edex ® . (Also, see Drug-Drug Interactions in CLINICAL PHARMACOLOGY, Pharmacokinetics .)
Adverse Reactions
ADVERSE REACTIONS edex ® , administered by intracavernous injection in doses ranging from 1 to 40 mcg per injection for periods up to 24 months, has been evaluated in clinical trials for safety in over 1,065 patients with erectile dysfunction. Discontinuation of therapy due to a side effect in clinical trials was required in approximately 9% of patients treated with edex ® and in <1% of patients treated with placebo. Local Adverse Reactions The following local adverse reactions were reported in studies including 1,065 patients treated with edex ® for up to two years. Penile Pain With use of up to 24 months, penile pain was reported at least once by 29% of patients during injection, 35% of patients during erection, and by 30% of patients after erection. On a per injection basis, 15% of injections were associated with penile pain. Penile pain was judged by patients to be mild in intensity for 80% of painful injections, moderate in intensity for 16% of painful injections, and severe in intensity for 4% of painful injections. The frequency of penile pain reports decreased over time; 41% of the patients experienced pain during the first 2 months and 3% of the patients experienced pain d…
Frequently Asked Questions
What is Edex used for?
Edex is an injectable medication containing alprostadil, a prostaglandin analog used to treat erectile dysfunction in men. The medication is injected directly into the penis to help produce an erection.
Is Edex a controlled substance?
Edex is not classified as a controlled substance by the DEA.
What is the generic name for Edex?
The generic name for Edex is alprostadil. There are 7 other brand versions of alprostadil.
What is the NDC code for Edex 40 ug/mL?
The NDC (National Drug Code) for Edex 40 ug/mL is 52244-040, listed by Endo USA, Inc..