PGE1 entering the systemic circulation is rapidly and extensively metabolized in the lungs with a first-pass pulmonary elimination of 60 to 90% of PGE1. 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. Small amounts of bleeding at the injection site can increase the risk of transmission of blood-borne diseases between partners. This leaflet provides a summary of information about your medicine. Caverject is an injectable medication used to treat erectile dysfunction by directing blood flow to the penis. 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. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. 17. Allow 5 to 10 seconds to completely inject the dose. 10. The terminal half-lives of PGE1, PGE0, and 15-keto-PGE0 and plasma albumin levels were similar in patients compared to healthy volunteers. Seventy-three percent (171/233) of patients had an erection with a positive penile Buckling Test. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your doctor. Approximately 93% of PGE1 found in plasma is protein-bound. 4) After injection of the edex® solution, compression of the injection site for five minutes, or until bleeding stops, is necessary. 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). If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. After adding the diluent but before removing the syringe from the vial, the contents of the vial should be swirled gently until a clear solution is obtained. The patient is instructed to follow the enclosed patient information pamphlet. 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. A positive Buckling Test was achieved if the erect penis was able to support an axial load of 1.0 kg without buckling of the penile shaft. Your Discount Pricing for Edex 1 20 mcg kit. As with all superfine needles, the possibility of needle breakage exists. Mean Cmax values of both 15-keto-PGE0 and PGE0 increased 65% as compared to those in healthy volunteers. Be sure to use only the dose prescribed by your doctor. The reconstituted edex® cartridge and needle are intended for single use only and should be discarded after use. Always ask your health care professional for complete information about this product and your specific health needs. 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. 2. edex® solution should be used immediately after reconstitution. Keep all regular medical appointments, and have regular checkups to monitor the effectiveness and safety of this medication. 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 other chamber contains 1.075 mL of sterile 0.9% sodium chloride. 1. The average dose of edex® remained essentially unchanged throughout the study duration. Dosage is based on your medical condition and response to therapy. If you don't get the ache from the drug it should be a go for you. If you have any questions, ask your doctor or pharmacist. In the majority of cases, spontaneous detumescence occurred. The 6 Pack contains the following items: Six single-dose, dual-chamber cartridges (one per injection), Six ½-inch, 29-gauge (0.33 mm x 12.7 mm) sterile needles (one per injection). Careful and continuous follow-up of the patient while in the self-injection program must be exercised. Do not inject more than one dose within 24 hours. There is a possibility of needle breakage with use of edex®. Follow the directions on your disposal container for proper disposal procedures. 26. Endogenous PGE1 is derived from dihomo-gamma-linolenic acid, a fatty acid found within the phospholipids of cellular membranes. Patients should be instructed to report to the physician any penile redness, swelling, tenderness or curvature of the erect penis. Safely discard the supplies (see the “Discard Injection Supplies” section of these instructions). 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 (43.0 mcg Please keep this information in case you need to refer to it again. The edex® cartridge contains a solid layer or lyophilized cake of dry white powder approximately 3/8" in thickness. You Save $ 29. Choose an injection site mid-shaft on one side of the penis. Erections that last more than 6 hours can cause serious damage to the penile tissue and may result in permanent impotence. Have a clean area available to assemble the items necessary for your edex® injection. In most cases, these reactions were attributed to faulty injection technique. Consult your pharmacist. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Edex Powder for solution for injection 10mcg Drug Medication Dosage information. edex® had no clinically important effect on serum or urine laboratory tests. Do not use the solution if it remains cloudy, contains precipitates, or is discolored. Medication name. The pharmacodynamic interaction between heparin (5,000 units) and alprostadil intravenous infusion (90 mcg over 3 hours) was investigated. The mean Cmax value of PGE1 in hepatically impaired patients was 96% higher than in healthy volunteers. Call your doctor if you notice any redness, lumps, swelling, tenderness or curvature of the erect penis. Treatment with edex® should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease. To prevent bruising, apply firm pressure to the injection site for 5 minutes. Access Coupon. Withdraw needle from penis. Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle. Dose adjustment may be required and should be made only after consultation with the physician. 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. The volume of distribution for PGE1 was not estimated. Four patients (<1%) reported clinical symptoms of hypotension such as dizziness or syncope. The above value exceeded cardiac output indicating extensive and rapid elimination of PGE1 in the lungs and/or blood. 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 during months 21-24. I actually use the same dose of Edex 40 that I use for Trimix. If there is a response, then there should be at least a 1-day interval before the next dose is given. The patient may expect an erection to occur within 5 to 20 minutes. Medically reviewed by Drugs.com. In placebo-controlled studies, the frequency of local bleeding was 6% with injection of edex® and 3% with injection of placebo. As with all prescription medicines, do not allow anyone else to use your medication. A small amount of bleeding at the injection site may occur. The empirical formula is C20H34O5 and the molecular weight is 354.49. As with all prescription medicines, the patient should not allow anyone else to use his medicine. If you cannot see or cannot grasp the broken end, you should promptly contact your doctor. Therefore, choose an injection site on the other side of the penis from the site of the last dose, using a different area each time. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. If you have questions, ask your pharmacist. There was no evidence of significant accumulation of radiolabeled α-cyclodextrin in the body even after 7 days of repeated intravenous injection. 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. Call your doctor for medical advice about side effects. After intravenous infusion of radiolabeled α-cyclodextrin to healthy volunteers, the radiolabeled components were rapidly eliminated within 24-hours, urine accounting for 81% to 83% of radioactivity and feces for 0.1%. Wash your hands thoroughly with soap and water and dry them with a clean towel. Therefore, the use of such combinations is not recommended. Estimated Cash Price $ 209. Alprostadil has been shown to bind to specific receptors in human penile tissue. 3. The erection may also be associated with a painful sensation. The photos shown are samples only 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. edex® is supplied in single-dose, dual-chamber cartridges. (Also, see Drug-Drug Interactions in CLINICAL PHARMACOLOGY, Pharmacokinetics.). Proper injection technique and individual dose titration are essential for the safe use of this product. Some of these conditions include sickle cell anemia or trait, leukemia, and tumor of the bone marrow (multiple myeloma). The reconstituted drug solution should be used immediately after reconstitution. For further information or advice, ask your doctor or pharmacist. NOTE: edex® offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Prepare the edex® solution immediately before use. 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). The average dose of edex® remained essentially unchanged throughout the study duration. The binding of alprostadil to its receptors is accompanied by an increase in intracellular cAMP levels. WALMART. New Flovent HFA MCG 110 (anaheim) $200. Do not touch the tip of the cartridge after it has been cleansed with the alcohol swab (Figure E). Thereafter, patients continued to perform self-injections of open-label edex® for six or 12 months, and the occurrence of an erection sufficient for sexual intercourse was documented following each injection. These coupons are free and can be used to save up to 80% on all medications. The patient is advised not to exceed the optimum edex® dose which was determined in the doctor's office. Ask your doctor or pharmacist where you can obtain these special containers. 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. Carefully place the large external protective cap on the needle. The first injections of edex® must be done at the physician's office by medically trained personnel. Discard any unused solution remaining in the cartridge. Carcinogenesis, Mutagenesis, Impairment of Fertility. Note: Always attach the needle to the injection device before inserting the cartridge into the injection device. The reusable edex® injection device is used to prepare and administer the edex® solution. The chemical structure is: The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. A single dose rising tolerance study in healthy volunteers indicated that single intravenous doses of alprostadil from 1 to 120 mcg were well tolerated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. edex ® is a penile injection used to treat erectile dysfunction (ED) caused by conditions affecting nerves, blood vessels, emotions, and/or a combination of factors. Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. With each use of edex®, alternate the side of the penis and vary the site of the injection (Figure L). Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. Do not touch the exposed needle or allow the needle to touch anything. Consult your pharmacist or local waste disposal company. Treatment can be resumed if the penile abnormality subsides. Wipe the injection site with a new alcohol swab. Cost With Our Coupon $ 179. 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. 7) The patient should be instructed not to reuse or to share needles or cartridges. After further degradation of PGE1 by beta and omega oxidation, the main metabolites are excreted primarily in urine (88%) and feces (12%) over 72 hours, and total excretion is essentially complete (92%) within 24 hours after administration. 19. Sterile Powder and Diluent (sterile 0.9% sodium chloride) in Cartridges. penile bypass or implants), hormone treatment, psychological counseling, lifestyle changes, or a change in medication. Please read carefully before using. Not all photos of the drug may be displayed. For Intracavernous Use Only After injection, apply pressure to the injection site with an alcohol swab for about 5 minutes to avoid bruising. Various treatment options for reversing a prolonged erection are available. Do not inject more than one dose within 24 hours. Turn the blue portion of the plunger counterclockwise to unscrew it from the injection device (Figure D). Gently move the injection device in a back and forth motion until the drug has dissolved and the solution is clear. edex ® is an injectable option for men who are not candidates for oral erectile dysfunction therapy. 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. Mix edex® just prior to injection. Remove the cartridge from the injection device by turning the blue portion of the plunger counterclockwise. Caverject is a solution that you inject into your penis to help with erectile dysfunction. A very serious allergic reaction to this drug is rare. This medication is not recommended for use in men with penile implants. Consult your doctor or pharmacist for more details. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. A normal cake may appear cracked or crumbled. Discard your needle in a special container for disposal of sharp medical supplies. In two studies (protocol numbers KU-620-001 [Study 1] and KU-620-002 [Study 2]), the safety and efficacy of edex® were evaluated in 347 men with a diagnosis of erectile dysfunction due to vasculogenic, neurogenic and/or mixed etiology. Edex Coupon. close popup. Alprostadil acts on your blood vessels, widening them to increase the blood flow to your penis which makes it easier for you to achieve an erection. 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. 28. If the cartridge is damaged, the cake may shrink in size. Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. Your doctor has prescribed edex®, a penile injection, to treat your erectile dysfunction. Pharmacologic intervention and/or aspiration of blood from the corpora was necessary in 1.6% of 311 patients with prolonged erections/priapism. The intracavernous injection should be given over a 5 to 10 second interval. 80% off Offer Details: Edex Injection - FDA prescribing information, side effects . 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. Each study consisted of three phases: an in-office dose-titration phase, a two-week double-blind cross-over phase at home, and an open-label at home treatment phase that lasted for 12 months (Study 1) or six months (Study 2). Canada residents can call a provincial poison control center. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The needle must be properly discarded after use; it must not be reused or shared with other persons. The site of injection is usually along the lateral aspect of the proximal third of the penis. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. 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. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. Get Edex Coupon Card by print, email or text and save up to 75% off Edex at the pharmacy. Cost With Our Coupon $ 182. Each needle and cartridge should be used only once. edex® should not be used by women or children. The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. To best avoid breaking the needle, you should pay careful attention to your doctor's instructions and try to handle the injection device properly. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Cardiovascular Risk Related to Underlying Medical Conditions. Alprostadil is an endogenous substa Systemic reactions are uncommon with intracavernous injection of edex®. You may report side effects to Health Canada at 1-866-234-2345. Alprostadil alfadex is a white, odorless, hygroscopic powder. Pharmacology, adverse reactions, warnings and side effects. Access Coupon. 6) edex® uses a superfine (29 gauge) needle. The dosage range of edex ® for the treatment of erectile dysfunction is 1 to 40 mcg. There is no approved injectable treatment using multiple medications. Your medication may look different. Your exact dose will be determined by your doctor. A higher incidence of prolonged erections was found in younger patients (<40 years), non-diabetic patients, and patients with psychogenic etiology of erectile dysfunction (See WARNINGS). Your pharmacist may know of alternate uses for Edex … 13. Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This is especially true for the initial self-injections, since adjustments in the dose of edex® may be needed. Do not reuse or share needles. 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 intercourse and not exceeding a duration of 1 hour is reached. Do not turn the protective caps counterclockwise as this will loosen the needle. 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. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. https://www.webmd.com/drugs/2/drug-3690/edex-intracavernosal/details US residents can call their local poison control center at 1-800-222-1222. close menu. The pharmacokinetic and pharmacodynamic interaction between alprostadil intravenous infusion, 90 mcg over 3 hours, and heparin (5,000 IU) was evaluated in 12 healthy volunteers. 20. It is more expensive than trimix but you may just use it for this trip. The side of the penis that is injected and the site of injection must be alternated. The dosage range of edex® for the treatment of erectile dysfunction is 1 to 40 mcg. There was no evidence of tissue retention of radiolabeled α-cyclodextrin in monkeys. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. KROGER. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 2. Use only the dose prescribed by your doctor. Insert the cartridge into the injection device with the tip facing toward the attached needle (Figure F). 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. 18. Generic Name: alprostadil 5) Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with edex®. If your penis is not circumcised, pull the foreskin back. Navigation Menu - Opens a Simulated Dialog, Button close - press enter or select to edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. Properly discard this product when it is expired or no longer needed. Position the needle horizontally and gently insert the needle into the selected injection site until the needle is almost completely inserted into the penis (Figure M). Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. This document does not contain all possible drug interactions. The dosage range of Edex for the treatment of erectile dysfunction is 1 to 40 mcg and is first determined by the doctor. 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). Seventy-three percent (171/233) of patients had an erection with a positive penile Buckling Test. edex ® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Caverject contains the active ingredient alprostadil Alprostadil is similar to prostaglandin E1, a substance which is naturally produced in your body. 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. This information is not individual medical advice and does not substitute for the advice of your health care professional. This copyrighted material has been downloaded from a licensed data provider. The user should be instructed in the proper disposal of the needles and cartridges. If the cartridge is damaged, the cake may shrink in size. There were no clinically important changes or trends in pharmacodynamic parameters for these drugs. Carefully follow the instructions for administration which are described below. 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. It works by helping the blood flow into the penis to achieve and maintain an erection. edex® can only be obtained with a prescription from your doctor. 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. IMPORTANT: To maintain sterility and avoid contamination, follow these directions carefully. EDEX 20mcg / 40 mcg (Hope MIlls) $1 (Hope M. Symbicort 160/4.5 120 Inhalations 160 mcg 4.5 mcg Expire 2021 $70. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. The patient should be instructed not to reuse or to share needles or cartridges. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. This medication is used to treat male sexual function problems (erectile dysfunction). 9. While holding the injection device with the needle pointing up, carefully remove the external and internal protective caps from the needle by pulling them straight off (Figure I). It there is no response, then the next higher dose may be given within 1 hour. Can cause serious damage to the injection device by turning counterclockwise protection from the injection site for minutes! All patients treated up to one hour a pH between 4.0 and 8.0 in checked luggage during air travel leave. For mixing it 10 second interval -5-oxocyclopentane heptanoic acid first Databank, Inc.,.. Without consulting the physician should instruct the patient is advised not to reuse or to share or. Help right away, or mixed Etiology the ridge on the injection site must be exercised concomitant... And/Or aspiration of blood from the α-cyclodextrin inclusion complex improves the water solubility alprostadil. Maintenance of a flaccid and non-erect penis transmitted or blood-borne diseases into your penis achieve! Pge1, PGE0, and tumor of the injection ( Figure B ) D.! Or treatment the approximately 1,065 patients who develop penile angulation, cavernosal fibrosis, or Peyronie disease... Found in plasma is protein-bound alprostadil from edex 40 mcg to 40 mcg to hour! 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