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Details with Side Effects
Limited data are available in regard to edex® (alprostadil for injection) overdose in humans. Systemic reactions are uncommon with intracavernous injection of edex® (alprostadil for injection) . Hypotension occurred in less than 1% of patients treated with edex® (alprostadil for injection) . A single dose rising tolerance study in healthy volunteers indicated that single intravenous doses of alprostadil from 1 to 120 mcg were well tolerated. Beginning with a 40 mcg bolus intravenous dose, the frequency of drug-related systemic adverse events increased in a dose-dependent manner, characterized mainly by facial flushing.
The primary symptom of an edex® (alprostadil for injection) overdose is a prolonged erection or priapism. Because of the potential for tissue hypoxia and possible necrosis, it is strongly recommended to treat an erection lasting more than 6 hours. The patient is strongly encouraged to go to the nearest emergency room if his personal physician is not available.
In the event of an overdose, supportive therapy according to the presence of other symptoms is recommended.
edex® (alprostadil for injection) should not be used in patients who have a known hypersensitivity to alprostadil or other prostaglandins, in patients who have conditions that might predispose them to priapism, such as sickle cell anemia or trait, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease. Patients with penile implants should not be treated with edex® (alprostadil for injection) .
edex® (alprostadil for injection) should not be used in men for whom sexual activity is inadvisable or contraindicated.
edex® (alprostadil for injection) should not be used in women and children and is not for use in newborns.
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Edex Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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