As with all superfine needles, the possibility of needle breakage exists. A standard treatment goal is to produce an erection lasting no longer than 1 hour. Hypotension occurred in less than 1% of patients treated with edex®. Check the product package for instructions on how to store your brand, or ask your pharmacist. This document does not contain all possible drug interactions. Any solution remaining in the cartridge should be discarded. Keep all medications away from children and pets. edex 40 MCG in 1 ML Cartridge injectable is a powder medicine that comes with a sterile liquid for mixing it. The edex. As with any injection, infection is possible. Set the injection device down on a clean, level surface and do not allow the needle to touch anything. Note: Individuals who are sexually active should be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). The pulmonary extraction of alprostadil following intravascular administration was reduced by 15% (66 ± 3.6% vs 78 ± 2.3%) in patients with acute respiratory distress syndrome (ARDS) compared with a group of patients with normal respiratory function who were undergoing cardiopulmonary bypass surgery. In clinical trials, concomitant use of agents such as antihypertensive drugs, diuretics, antidiabetic agents (including insulin), or nonsteroidal anti-inflammatory drugs had no apparent effect on the efficacy or safety of edex®. If the solution does not inject easily, or if you immediately experience a burning pain at the injection site, reposition the needle by advancing it slightly or by partially withdrawing it until the solution can be injected easily and painlessly. Attach the needle to the tip of the edex® injection device by turning clockwise until tight (Figure C). Alprostadil had a significant effect on the pharmacodynamics of heparin resulting in a 140% increase in partial thromboplastin time and a 120% increase in thrombin time. Alprostadil alfadex is a white, odorless, hygroscopic powder. At that time, the efficacy and safety of the therapy should be assessed, and the dose of edex® should be adjusted, if needed. Therefore, caution should be exercised with concomitant administration of heparin and edex®. Do not discard the large external protective cap; you will need to use it later. A ½ inch, 27 to 30 gauge needle is generally recommended for the intracavernous injection. If you experience severe pain, contact the prescribing physician. Do not inject more than one dose within 24 hours. After intracavernous injection of 20 mcg of edex® to 24 patients with erectile dysfunction, mean systemic plasma 15-keto-PGE0 levels increased within 7 minutes from endogenous levels of 12.9 ± 11.8 pg/mL to a Cmax of 421 ± 337 pg/mL (corrected for baseline) followed by a decrease to baseline levels in several hours. The dose of edex® that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse and that is maintained for no longer than 1 hour. The patient must stay in the physician's office until complete detumescence occurs. Mean systemic plasma PGE0 levels increased within 20 minutes from endogenous levels of 0.6 ± 0.5 pg/mL to a Cmax of 3.9 ± 2.3 pg/mL (corrected for baseline) followed by a decrease to baseline levels in several hours. There is a possibility of needle breakage with use of edex®. Because of the potential for tissue hypoxia and possible necrosis, it is strongly recommended to treat an erection lasting more than 6 hours. Edex Coupon. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Pulmonary clearance was found to vary as a function of cardiac output and pulmonary intrinsic clearance in a group of 14 patients with ARDS or at risk of developing ARDS following trauma or sepsis. If you have questions, ask your pharmacist. The physician should instruct the patient to discard any needles which become bent during the self-injection procedure as these needles may break. Inject this medicine very slowly into your penis as shown to you by your doctor 10 to 30 minutes before intercourse. You Save $ 29. Seventy-three percent (171/233) of patients had an erection with a positive penile Buckling Test. The needle must be properly discarded after use; it must not be reused or shared with other persons. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 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 mcg, respectively. 3) The safety and efficacy of combinations of edex® and other vasoactive agents have not been systematically studied. This medication is not for use in women or children. Four patients (<1%) reported clinical symptoms of hypotension such as dizziness or syncope. Among the 71% (81/114) of patients who entered the placebo-controlled phase, an erection sufficient for sexual intercourse was achieved in 74% (60/81) of patients following edex® injection compared to 7% (6/81) of patients following placebo injection. 15-keto-PGE1 has only been detected in vitro in homogenized lung preparations, whereas 15-keto-PGE0 and PGE0 have been measured in plasma. If you cannot see or cannot grasp the broken end, you should promptly contact your doctor. If there is no response to the initial 2.5-mcg dose, the second dose may be increased to 7.5 mcg, followed by increments of 5 to 10 mcg. Access Coupon. Do not administer unless solution is clear. Discard your needle in a special container for disposal of sharp medical supplies. Consult your pharmacist. You Save $ 30. The patient should follow the instructions in the patient information pamphlet to limit the possibility of bacterial contamination. In patients treated with edex® for up to 24 months, local bleeding, hematoma, and ecchymosis were observed in 15%, 5%, and 4% of patients, respectively. close popup. Each needle and cartridge should be used only once. 4) After injection of the edex® solution, compression of the injection site for five minutes, or until bleeding stops, is necessary. Canada residents can call a provincial poison control center. After intracavernous administration in monkeys, radiolabeled α-cyclodextrin was rapidly distributed from the injection site with less than 0.1% of the dose remaining in the penis 1 hour after administration. If the cartridge is damaged, the cake may shrink in size. Do not use the solution if it remains cloudy, is colored, or contains particles. New Flovent HFA 110 MCG (Anaheim) $200. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum which is essential for the maintenance of a flaccid and non-erect penis. Simply bring the coupon below to the pharmacy, and save on Edex at CVS, Walgreens, Walmart, Safeway, Albertsons, Rite Aid, Target, Kroger, and many other drug stores! Hold the injection device as shown in Figure M. Do not touch the plunger at this time. Consult your doctor or pharmacist for more details. WALMART. If your penis is not circumcised, pull the foreskin back. edex 40 MCG in 1 ML Cartridge is a brand of edex 40 MCG in 1 ML Cartridge injectable supplied as a needle and syringe that contains both the powder medicine and the sterile liquid. CAUTION: Do not reuse any solution remaining in the cartridge due to the possibility of bacterial contamination. Caverject contains the active ingredient alprostadil Alprostadil is similar to prostaglandin E1, a substance which is naturally produced in your body. The pharmacokinetic profiles of aspirin, warfarin, digoxin, and glyburide were not affected by concomitant administration of alprostadil. Study 2: Two hundred thirty-three men with a mean age of 59.8 years (range 23 to 74 years) were enrolled in the first phase. Wipe the injection site with a new alcohol swab. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. 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. Mean Cmax values of both 15-keto-PGE0 and PGE0 increased 65% as compared to those in healthy volunteers. Access Coupon. The binding of alprostadil to its receptors is accompanied by an increase in intracellular cAMP levels. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Ask your doctor or pharmacist where you can obtain these special containers. Unlike the 15-keto metabolites which are less pharmacologically active than the parent compound, PGE0 is similar in potency to PGE1 in vitro using isolated animal organs. The mean Cmax value of PGE1 in hepatically impaired patients was 96% higher than in healthy volunteers. Learn how to store and discard needles and medical supplies safely. Grasping the head of the penis with your thumb and forefinger, stretch it lengthwise along your thigh so that you can clearly see the selected injection site. The dose may be increased by 1.25 mcg to a dose of 2.5 mcg, followed by an increment of 2.5 mcg to a dose of 5 mcg, and then in 5-mcg increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Be sure to use only the dose prescribed by your doctor. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Alprostadil (PGE1) is one of the prostaglandins, a family of naturally occurring acidic lipids with various pharmacological effects. edex® is given as an intracavernous injection over a 5- to 10-second interval. A convenient carrying case is provided for the reusable edex® injection device. Men with penile implants, severe penile curvature, or those who have been advised not to engage in sexual activity should not use edex®. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Insert the cartridge into the injection device with the tip facing toward the attached needle (Figure F). Tell your doctor right away if you have any serious side effects, including: Rarely, males may have a painful or prolonged erection lasting 4 or more hours. In placebo-controlled studies, penile pain was reported by 31% of patients after edex® and by 9% of patients after placebo injection. There were no clinically important changes or trends in pharmacodynamic parameters for these drugs. To minimize the chances of prolonged erection or priapism, edex® should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. For further information or advice, ask your doctor or pharmacist. For more information, call Endo Pharmaceuticals Inc. at 1-800-462-3636. In a study in symptomatic subjects with end-stage renal disease undergoing hemodialysis and age/weight/sex-matched healthy volunteers, 120 mcg of alprostadil was administered by intravenous infusion over 2 hours. In placebo-controlled studies, 3% of patients treated with edex® and <1% of patients treated with placebo reported prolonged erections greater than four hours. Discard any unused solution remaining in the cartridge. Call the prescribing physician or, if unavailable, seek professional help immediately if you still have an erection 6 hours after injection. The terminal half-lives of PGE1, PGE0, and 15-keto-PGE0 and plasma albumin levels were similar in these patients vs healthy volunteers. The side of the penis that is injected and the site of injection must be alternated. The dose of edex® that is established in the physician's office should not be changed by the patient without consulting the physician. Smooth muscle relaxation is associated with a reduction of the cytoplasmic free calcium concentration. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. The reusable edex® injection device is for use only with the cartridges and needles included in the edex® Cartridge Packs. Before injecting each dose, clean the injection site with rubbing alcohol. Therefore, caution should be exercised with concomitant administration of heparin and edex®. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. penile bypass or implants), hormone treatment, psychological counseling, lifestyle changes, or a change in medication. The patient must visit the physician's office for regular checkups for assessment of the therapeutic benefit and safety of treatment with edex®. Of the approximately 1,065 patients who entered the in-office dose-titration period in clinical studies, 25% were 65 years or older. 13. KROGER. Endogenous PGE1 is derived from dihomo-gamma-linolenic acid, a fatty acid found within the phospholipids of cellular membranes. Available for Android and iOS devices. In clinical studies, geriatric patients required, on average, higher minimally effective doses and had a higher rate of lack of effect (optimum dose not determined). Alprostadil has been shown to bind to specific receptors in human penile tissue. Safely discard the supplies (see the “Discard Injection Supplies” section of these instructions). Avoid visible blood vessels. 80% off Offer Details: 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. Call your doctor if you notice any redness, lumps, swelling, tenderness or curvature of the erect penis. See patient information for edex®. 17. 3. The above value exceeded cardiac output indicating extensive and rapid elimination of PGE1 in the lungs and/or blood. Gently move the injection device in a back and forth motion until the drug has dissolved and the solution is clear. During the subsequent two-week double-blind, cross-over phase, patients self-injected edex® or placebo at home. Mean total body clearance of PGE1 in patients with erectile dysfunction was calculated to be around 115 L/min after an intravenous infusion of 20 mcg alprostadil. This medication is given by injection into the penis as directed by your doctor. Caverject is a solution that you inject into your penis to help with erectile dysfunction. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85. Your medication may look different. You may report side effects to Health Canada at 1-866-234-2345. Edex has the same component medication as does Caverject (prostaglandin E1 or PGE1) Trimix is another injectable preparation that can be used for the treatment of erectile dysfunction in men. Do not touch the tip of the cartridge after it has been cleansed with the alcohol swab (Figure E). Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for bleeding after intracavernous injection. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. If you contact our Customer Support by one of the methods below, we will be able to assist you in locating the product you are looking for. Injections should be administered at least 24 hours apart. Your exact dose will be determined by your doctor. Alprostadil showed no evidence of mutagenicity in three in vitro assays including the AMES bacterial reverse mutation assay, a forward gene mutation assay in Chinese hamster lung (V79) cells, and a chromosome aberration assay in human peripheral lymphocytes. If you have questions, ask your pharmacist. Turn the blue portion of the plunger counterclockwise to unscrew it from the injection device (Figure D). The volume of distribution for PGE1 was not estimated. 28. Among the 65% (74/114) of patients who entered the open-label treatment phase, the mean rate of response with an erection sufficient for sexual intercourse was 88.9% through 12 months. The human dose of edex® is <1 mcg/kg (MRHD is 40 mcg and the calculation assumes a 60-kg subject). Cajun Jeff (alprostadil for injection) HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. Several drug-drug interaction studies have been conducted with alprostadil alone or in combination with aspirin, digoxin or warfarin in healthy volunteers and with glyburide in subjects with stable, non-insulin dependent diabetes mellitus. 11. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. Doses greater than 40 mcg have not been studied. My doctor wants to give me 20m 1ml injection 6 injections. Curt: Edex works great for me.. The reconstituted solution may initially appear cloudy due to small air bubbles. 7) The patient should be instructed not to reuse or to share needles or cartridges. The edex® cartridge contains a solid layer or Iyophilized cake of dry white powder approximately 3/8" in thickness. If oral medication isn't helping with your erectile dysfunction, penile injections may be the way to go! The terminal half-life of PGE1 in healthy volunteers was calculated to be around 9 to 11 minutes which is consistent with that reported in the literature (8 minutes). edex® (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. 10. The physician should make a careful assessment of the patient's skills and competence with the self-injection procedure. The first injections of edex® must be done at the physician's office by medically trained personnel. edex® is supplied in single-dose, dual-chamber cartridges. Inject this medicine very slowly into your penis as shown to you by your doctor 10 to 30 minutes before intercourse. Access Coupon. Before using this medication, tell your doctor or pharmacist your medical history, especially of: Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernous arteries. Drug interactions may change how your medications work or increase your risk for serious side effects. SAFEWAY. Do not use the solution if it remains cloudy, contains precipitates, or is discolored. Offer Details: 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. Cost With Our Coupon $ 179. 16. 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. 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). The patient must stay in the physician's office until complete detumescence occurs. A potentially serious adverse reaction with intracavernous therapy is priapism. 43. It would make traveling a bit easier. The physician should make a careful assessment of the patient's skills and competence with the self-injection procedure. This medication is used to treat male sexual function problems (erectile dysfunction). Alprostadil is an endogenous substa edex® is not indicated for use in women or pediatric patients. Do not touch the exposed needle (Figure B). Not all photos of the drug may be displayed. alprostadil injection, powder, lyophilized, for solution, We comply with the HONcode standard for trustworthy health information -, in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia, for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as cavernosal fibrosis or Peyronie’s disease. The solution may initially appear cloudy due to small air bubbles. The patient should report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis to his physician as soon as possible. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The absolute bioavailability of alprostadil estimated from systemic exposure was about 98% as compared to the same dose given by a short-term intravenous infusion. The patient is instructed to follow the enclosed patient information pamphlet. 19. edex® can only be obtained with a prescription from your doctor. During the dose-titration phase, individualized optimum doses of edex® were established. edex ® is an injectable option for men who are not candidates for oral erectile dysfunction therapy. Enzymatic oxidation of the C15-hydroxy group followed by reduction of the C13, 14-double bond produces the primary metabolites, 15-keto-PGE1, 15-keto-PGE0, and PGE0. Properly discard this product when it is expired or no longer needed. In patients infected with blood-borne diseases, this could increase the risk of transmission of blood-borne diseases between partners. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). If there is a response, then there should be at least a 1-day interval before the next dose is given. 1. At-Home (Maintenance Therapy) Dosing Instructions. Pick up the cartridge and wipe the tip of the cartridge with an alcohol swab. Smoking has an adverse effect on erectile function by accentuating the effects of other risk factors such as blood vessel disease or high blood pressure. How to Use edex ® To help ensure proper use of edex ®, you should be properly instructed and trained in the self-injection technique before you begin treatment with edex ® at home. JLA FORUMS - … Note: Always attach the needle to the injection device before inserting the cartridge into the injection device. NOTE: edex® offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Some products that may interact with this drug include: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. A patient information pamphlet is included in each package of edex® cartridges. Erectile dysfunction is often due to more than one of these causes. If either is present, do not use the liquid. The patient is advised not to exceed the optimum edex® dose which was determined in the doctor's office. Geriatric: The potential effect of age on the pharmacokinetics of alprostadil has not been formally evaluated. Edex is 195.00 compare to caverject 85.00. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office. 1) Intracavernous injections of edex® can lead to increased peripheral blood levels of PGE1 and its metabolites, especially in those patients with significant corpora cavernosa venous leakage. At home treatments require specific instructions given to the patient by the prescribing doctor. https://www.webmd.com/drugs/2/drug-3690/edex-intracavernosal/details Alprostadil is a smooth muscle relaxant. Sterile Powder and Diluent (sterile 0.9% sodium chloride) in Cartridges PATIENT INFORMATION FOR edex® CARTRIDGES Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. The overall incidence of penile fibrosis, including Peyronie's disease, reported in clinical studies up to 24 months with edex® was 7.8%. The site of injection is usually along the lateral aspect of the proximal third of the penis. The intracavernous injection should be given over a 5 to 10 second interval. Cost With Our Coupon $ 182. The reusable edex® injection device is for use only with the single-dose, dual-chamber cartridges and needles included in the edex® Cartridge 2 Pack or 6 Pack. Loading... View more photos. In placebo-controlled studies, the frequency of local bleeding was 6% with injection of edex® and 3% with injection of placebo. Do not start, stop, or change the dosage of any medicines without your doctor's approval. If the duration of erection is longer than 1 hour, the dose of edex® should be reduced. Mild/moderate pain, irritation, or slight bleeding at the injection site may occur. Seventy-three percent (171/233) of patients had an erection with a positive penile Buckling Test. If you don't get the ache from the drug it should be a go for you. edex® had no clinically important effect on serum or urine laboratory tests. The reconstituted edex® cartridge and needle are intended for single use only and should be discarded after use. Estimated Cash Price $ 208. There was no evidence of tissue retention of radiolabeled α-cyclodextrin in monkeys. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. In the event of an overdose, supportive therapy according to the presence of other symptoms is recommended. Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Do not turn the protective caps counterclockwise as this will loosen the needle. The reusable edex® injection device is used to prepare and administer the edex® solution. In Canada - Call your doctor for medical advice about side effects. edex® Cartridge 6 Pack contains enough supplies for six injections. As with all prescription medicines, do not allow anyone else to use your medication. edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Adverse reactions were reported in studies including 1,065 patients who develop penile angulation, cavernosal fibrosis, or or. Figure F ) not store in checked luggage during air travel or in!, digoxin, and glyburide were not observed between these geriatric patients and younger patients dose! If this occurs, stop, or appropriate for you with soap water. 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Trained by your doctor has prescribed edex®, alternate the side of the penis at injection. Learn how to use his medicine Etiology ( Spinal Cord Injury ): dosage titration be. Particulate matter and discoloration prior to administration flush medications down the toilet or pour them a... Bleeding continues or recurs after applying pressure, abstain from intercourse combinations of for... Pharmaceuticals Inc. at 1-800-462-3636 presynaptic noradrenaline release in the physician should instruct the patient 's and. To you by your doctor or pharmacist if you have any questions ask. Water solubility of alprostadil as a single dose once a day home treatments require specific instructions given to injection! Contains alprostadil, immediately dissociates from the injection device is used to administer the cartridge... Worse, tell your doctor that this product is safe, effective, or is discolored self-injection treatment, counseling. For oral erectile dysfunction by directing blood flow to the injection of edex® and by dilation of cavernous.! The terminal half-lives of PGE1 and its metabolites may lead to hypotension and/or.... Or pediatric patients contains the active edex 40 mcg, alprostadil, immediately dissociates from the α-cyclodextrin inclusion improves...