foundation [1%:<1 mcg/kg (MRHD is 40 mcg and the calculation assumes a 60 kg subject). Pregnancy, Nursing Mothers and Pediatric Use edex is not indicated for use in women or pediatric patients. Geriatric Use Of the approximately 1,065 patients who entered the in-office dose-titration period in clinical studies, 25% were 65 years or older. 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). Overall differences in safety were not observed between these geriatric patients and younger patients. Geriatric patients should be dosed and titrated according to the same DOSAGE AND ADMINISTRATION recommendations as younger patients, and the lowest possible effective dose should always be used. 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. 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. 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; forty-one percent of the patients experienced pain during the first 2 months and 3% of the patients experienced pain during months 21-24. In placebo-controlled studies, penile pain was reported by 31% of patients after edex and by 9% of patients after placebo injection. Prolonged Erection/Priapism Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. In placebo-controlled studies, 3% of patients treated with edex and> <1% of patients treated with placebo reported prolonged erections greater than four hours. 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. 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 .) Hematoma/Ecchymosis 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. In placebo-controlled studies, the frequency of local bleeding was 6% with injection of edex and 3% with injection of placebo. In most cases, these reactions were attributed to faulty injection technique. Local Adverse Reactions Reported by ≥1% of Patients All Study Periods * Local Reaction edex Local Reaction edex N = 1065 n (%) N = 1065 n (%) * Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653. † Penile pain reported without an association to injection site or erection, such as pain in penis and scrotum, pain in glans penis, and burning penile pain. ‡ Examples include injection into glans penis, urethra or subcutaneously. Penile pain during injection 305 (29) Ecchymosis 44 (4) Penile pain during erection 368 (35) Penile angulation 72 (7) Penile pain after erection 317 (30) Penile fibrosis 52 (5) Penile pain (other) † 116 (11) Cavernous body fibrosis 20 (2) Prolonged erection Peyronie's disease 11 (1) > 4 6 Hours 44 (4) Faulty injection technique ‡ 59 (6) > 6 Hours 6 (> <1) Penis disorder 28 (3) Bleeding 158 (15) Erythema 17 (2) Hematoma 56 (5) Systemic Adverse Experiences The following systemic adverse experiences were reported in controlled and uncontrolled studies in ≥1% of patients treated for up to 24 months with edex . Systemic Adverse Experiences Reported by ≥1% of Patients * BODY SYSTEM Adverse Experience edex N = 1065 n (%) BODY SYSTEM Adverse Experience edex N = 1065 n (%) BODY SYSTEM Adverse Experience edex N = 1065 n (%) * Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653. RESPIRATORY CARDIOVASCULAR UROGENITAL Upper respiratory tract Hypertension 17 (2) Prostate disorder 15 (1) infection 58 (5) Myocardial infarction 13 (1) Testicular pain 13 (1) Sinusitis 14 (1) Abnormal ECG 12 (1) Inguinal hernia 11 (1) BODY AS A WHOLE Influenza-like symptoms 35 (3) METABOLIC/NURITIONAL DERMATOLOGIC Headache 20 (2) Hypertriglyceridemia 17 (2) Skin disorder 14 (1) Infection 18 (2) Hypercholesterolemia 12 (1) SPECIAL SENSES Pain 16 (2) Hyperglycemia 12 (1) Abnormal vision 11 (1) MUSCULOSKELETAL Back pain 23 (2) Leg pain 13 (1) Hemodynamic changes, manifested as increases or decreases in blood pressure and pulse rate, were observed during clinical studies but did not appear to be dose-dependent. Four patients (> <1%) reported clinical symptoms of hypotension such as dizziness or syncope. edex had no clinically important effect on serum or urine laboratory tests. Post-Marketing Adverse Experiences Needle breakage. Overdosage Limited data are available in regard to edex overdose in humans. Systemic reactions are uncommon with intracavernous injection of edex . Hypotension occurred in less than 1% of patients treated with edex . 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 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 Injection 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 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 micrograms of alprostadil. If there is a partial response, the dose may be increased by 2.5 micrograms to a dose of 5 micrograms and then in increments of 5 to 10 micrograms, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. If there is no response to the initial 2.5-microgram dose, the second dose may be increased to 7.5 micrograms, followed by increments of 5 to 10 micrograms. The patient must stay in the physician's office until complete detumescence occurs. It there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given. Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury) Dosage titration should be initiated at 1.25 micrograms of alprostadil. The dose may be increased by 1.25 micrograms to a dose of 2.5 micrograms, followed by an increment of 2.5 micrograms to a dose of 5 micrograms, and then in 5-microgram increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. The patient must stay in the physician's office until complete detumescence occurs. If there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given. At-Home (Maintenance Therapy) Dosing Instructions The first injections of edex must be done at the physician's office by medically trained personnel. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. The physician should instruct the patient to discard any needles which become bent during the self-injection procedure as these needles may break. The physician should make a careful assessment of the patient's skills and competence with the self-injection procedure. The intracavernous injection must be done under sterile conditions. The site of injection is usually along the lateral aspect of the proximal third of the penis. Visible veins should be avoided. The side of the penis that is injected and the site of injection must be alternated. The injection site must be cleansed with an alcohol swab before injection. 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. If the duration of erection is longer than 1 hour, the dose of edex should be reduced. The lowest effective dose should be used at home. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office. Dose adjustment may be required and should be made only after consultation with the physician. Careful and continuous follow-up of the patient while in the self-injection program must be exercised. This is especially true for the initial self-injections, since adjustments in the dose of edex may be needed. The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. The reconstituted edex cartridge and needle are intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the needles and cartridges. While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of edex should be adjusted, if needed. The patient is instructed to follow the enclosed patient information pamphlet. Preparation of Solution The edex injection device is used to reconstitute the single-dose, dual-chamber cartridge. The plunger is used to force the sterile 0.9% sodium chloride (1.075 mL) in one chamber into the chamber containing alprostadil. After reconstitution, the edex injection device is used to administer the intracavernous injection of alprostadil. The reusable edex injection device is for use only with the cartridges and needles included in the edex Cartridge Packs. Prepare the edex solution immediately before use. Do not administer unless solution is clear. Do not add any drugs or solutions to the edex solution. Discard any unused solution remaining in the cartridge. The reconstituted solution should not be stored. The edex cartridge contains a solid layer or lyophilized cake of dry white powder approximately 3/8" in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, contains precipitates, or is discolored. CAUTION: Do not reuse any solution remaining in the cartridge due to the possibility of bacterial contamination. Administration edex is given as an intracavernous injection over a 5 to 10 second interval. See patient information for edex . Stability The single-dose, dual-chamber cartridge should be reconstituted only when it is certain that the patient is ready to administer the drug. The reconstituted drug solution should be used immediately after reconstitution. Any solution remaining in the cartridge should be discarded. How is Edex Injection Supplied edex (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex injection device. One chamber of the cartridge contains 10.75, 21.5 or 43.0 mcg of alprostadil as a white, sterile, lyophilized powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. 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 micrograms, respectively. edex Cartridge 2 Pack contains one reusable edex injection device, two single-dose, dual-chamber cartridges, two inch, 29 gauge (0.33 mm 12.7 mm) needles, and four alcohol swabs. edex Cartridge 6 Pack contains one reusable edex injection device, six single-dose, dual-chamber cartridges, six inch, 29 gauge (0.33 mm 12.7 mm) needles, and twelve alcohol swabs. The edex cartridges are supplied in the following packages: edex Cartridge 2 Pack (includes one injection device, two cartridges, two needles and four alcohol swabs) 10 mcg 1 2 Pack NDC 52244-010-02 20 mcg 1 2 Pack NDC 52244-020-02 40 mcg 1 2 Pack NDC 52244-040-02 edex Cartridge 6 Pack (includes one injection device, six cartridges, six needles and twelve alcohol swabs) 10 mcg 1 6 Pack NDC 52244-010-06 20 mcg 1 6 Pack NDC 52244-020-06 40 mcg 1 6 Pack NDC 52244-040-06 Store at 25 C (77 F); excursions permitted between 15 - 30 C (59 - 86 F). Manufactured in Germany for: Actient Pharmaceuticals, LLC Lake Forest, Illinois 60045 Rev 2 03/15 edex (alprostadil for injection) For Intracavernous Use Only Sterile Powder and Diluent (sterile 0.9% sodium chloride) in Cartridges PATIENT INFORMATION FOR edex CARTRIDGES Please read carefully before using. Rx Only Rev. 2 03/2015 Please read carefully before using. edex can only be obtained with a prescription from your doctor. You or your partner should be fully trained on the proper injection technique before using edex at home. Be sure to use only the dose prescribed by your doctor. This leaflet provides a summary of information about your medicine. Please read this information carefully before you prepare the edex solution. The reusable edex injection device is used to prepare and administer the edex solution. A convenient carrying case is provided for the reusable edex injection device. Carefully follow the instructions for administration which are described below. For further information or advice, ask your doctor or pharmacist. Please keep this information in case you need to refer to it again. Erectile Dysfunction: Causes and Treatments There are several causes of erectile dysfunction, commonly known as impotence. These include impaired blood circulation in the penis, nerve damage, hormonal imbalances, excessive alcohol use, emotional problems, and certain medications that you may be taking for other conditions. 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. Erectile dysfunction is often due to more than one of these causes. Treatment for erectile dysfunction includes penile injections, medical devices that produce an erection, surgical procedures (e.g. penile bypass or implants), hormone treatment, psychological counseling, lifestyle changes, or a change in medication. You should not stop taking any prescription medications, unless told to do so by your doctor. Your doctor has prescribed edex , a penile injection, to treat your erectile dysfunction. Use of edex edex is injected into a specific area of the penis (see injection directions below) and should produce an erection in 5 to 20 minutes. The erection can be expected to last up to one hour. You should not use edex more than 3 times a week. Injections should be administered at least 24 hours apart. Ideally, the injection should be administered just prior to foreplay. If your partner experiences insufficient vaginal lubrication or painful vaginal sensations during intercourse, the use of a lubricant may be helpful. Who should NOT use edex ? Men who have conditions that might result in long-lasting erections should not use edex . Some of these conditions include sickle cell anemia or trait, leukemia, and tumor of the bone marrow (multiple myeloma). If you have any of these conditions, consult your doctor. Men with penile implants, severe penile curvature, or those who have been advised not to engage in sexual activity should not use edex . edex should not be used by women or children. What are the risks of using edex ? Erections that last more than 6 hours can cause serious damage to the penile tissue and may result in permanent impotence. Call the prescribing physician or, if unavailable, seek professional help immediately if you still have an erection 6 hours after injection. Various treatment options for reversing a prolonged erection are available. A common side effect of edex is mild to moderate pain during injection. The erection may also be associated with a painful sensation. If you experience severe pain, contact the prescribing physician. Call your doctor if you notice any redness, lumps, swelling, tenderness or curvature of the erect penis. A small amount of bleeding at the injection site may occur. To prevent bruising, apply firm pressure to the injection site for 5 minutes. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting. There is a possibility of needle breakage with use of edex . To best avoid breaking the needle, you should pay careful attention to your doctor's instructions and try to handle the injection device properly. 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. If you cannot see or cannot grasp the broken end, you should promptly contact your doctor. NOTE: edex offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Small amounts of bleeding at the injection site can increase the risk of transmission of blood-borne diseases between partners. There is no approved injectable treatment using multiple medications. In addition, there are no data on the efficacy and safety of these combinations. edex Cartridge 2 Pack contains enough supplies for two injections. The 2 Pack contains the following items: One reusable edex injection device One reusable carrying case Two single-dose, dual-chamber cartridges (one per injection) Two inch, 29 gauge (0.33 mm x 12.7 mm) sterile needles (one per injection) Four alcohol swabs (two per injection) Patient Information for edex Cartridges edex Cartridge 6 Pack contains enough supplies for six injections. The 6 Pack contains the following items: One reusable edex injection device One reusable carrying case Six single-dose, dual-chamber cartridges (one per injection) Six inch, 29 gauge (0.33 mm x 12.7 mm) sterile needles (one per injection) Twelve alcohol swabs (two per injection) Patient Information for edex Cartridges Storage and Handling 1. Store at 25 C (77 F); temperature variations between 15 - 30 C (59 - 86 F) are allowed. As with any drug product, extremes in temperature should be avoided. When traveling, do not store in checked luggage during air travel or leave in a closed automobile. 2. edex solution should be used immediately after reconstitution. IMPORTANT: To maintain sterility and avoid contamination, follow these directions carefully. Each needle and cartridge should be used only once. Safely discard the supplies (see the Discard Injection Supplies section of these instructions). The edex cartridges contain a solid layer or cake of dry white powder approximately 3/8 in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. Self-Injection Procedure Before using edex , you should be properly trained by your doctor. Mix edex just prior to injection. Your dose has been customized for your individual needs. Use only the dose prescribed by your doctor. Have a clean area available to assemble the items necessary for your edex injection. 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. READ THE INSTRUCTIONS COMPLETELY BEFORE STARTING YOUR SELF-INJECTION PROCEDURE Prepare edex Solution 1. Wash your hands thoroughly with soap and water and dry them with a clean towel. 2. Check to see if the seal on the base of the needle is intact. Remove the seal from the base of the needle. Do not touch the exposed needle (Figure B). 3. Attach the needle to the tip of the edex injection device by turning clockwise until tight (Figure C). Note: Always attach the needle to the injection device before inserting the cartridge into the injection device. 4. Turn the blue portion of the plunger counterclockwise to unscrew it from the injection device (Figure D). 5. Pick up the cartridge and wipe the tip of the cartridge with an alcohol swab. Do not touch the tip of the cartridge after it has been cleansed with the alcohol swab (Figure E). 6. Insert the cartridge into the injection device with the tip facing toward the attached needle (Figure F). The ridge on the cartridge will need to fit into the groove on the injection device. 7. Attach the plunger to the injection device by turning the blue portion of the plunger clockwise until tight (Figure G). 8. Hold the injection device in an upright position with the needle pointing up. 9. To prepare the drug solution, slowly push the plunger until the two gray rubber stoppers touch (Figure H). Gently move the injection device in a back and forth motion until the drug has dissolved and the solution is clear. The solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, is colored, or contains particles. 10. 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). Do not turn the protective caps counterclockwise as this will loosen the needle. Do not discard the large external protective cap; you will need to use it later. Do not touch the exposed needle or allow the needle to touch anything. 11. Gently tap the cartridge so that air bubbles float to the top of the solution (Figure J). Carefully push the plunger until a drop of solution appears at the end of the needle (Figure K). Note: The plunger pushes the rubber stoppers forward; the rubber stoppers cannot be pulled back with the plunger. 12. Push the plunger until the upper rim of the top stopper reaches the correct volume mark for your prescribed dose. Excess solution will be expelled through the needle. 13. Set the injection device down on a clean, level surface and do not allow the needle to touch anything. Select Injection Site 14. Choose an injection site mid-shaft on one side of the penis. Avoid visible blood vessels. With each use of edex , alternate the side of the penis and vary the site of the injection (Figure L). If your penis is not circumcised, pull the foreskin back. 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. Wipe the injection site with a new alcohol swab. Do not discard this swab; you will need to use it later. Inject edex 15. Pick up the injection device and reposition the penis as in Step 14 to keep it from moving during the injection. 16. Hold the injection device as shown in Figure M. Do not touch the plunger at this time. 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). Now place your thumb on the plunger and inject the solution slowly over a period of 5 to 10 seconds (Figure N). 17. 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. 18. Withdraw needle from penis. Immediately apply firm but gentle pressure with the alcohol swab to the injection site for five minutes to prevent bruising (Figure O). Continue to apply firm pressure until bleeding stops. If bleeding continues or recurs after applying pressure, abstain from intercourse. Discard Injection Supplies 19. Carefully place the large external protective cap on the needle. Remove the needle from the injection device by turning counterclockwise. 20. Remove the cartridge from the injection device by turning the blue portion of the plunger counterclockwise. 21. Discard your needle in a special container for disposal of sharp medical supplies. Ask your doctor or pharmacist where you can obtain these special containers. Follow the directions on your disposal container for proper disposal procedures. Do not reuse or share needles. 22. Clean the reusable injection device with warm water and a mild soap after each use. Once the injection device is dry, place it in the carrying case. As with all prescription medicines, do not allow anyone else to use your medication. Proper injection technique and individual dose titration are essential for the safe use of this product. Manufactured in Germany for: Actient Pharmaceuticals, LLC Lake Forest, Illinois 60045 Rev 2 03/2015 Pincipal Display Panel - 10 mcg edex 10 mcg NDC 52244-110-01 (alprostadil for injection) sterile powder and diluent (sterile 0.9% sodium chloride injection) in cartridge for intracavernous injection Rx only NDC 52244-010-06 Rx only edex 10 mcg (alprostadil for injection) cartridge 6 pack sterile powder and diluent (sterile 0.9% sodium chloride) in cartridges for intracavernous injection contains edex injection device and supplies for 6 single-doses Principal Display Panel - 20 mcg edex 20 mcg NDC 52244-120-01 (alprostadil for injection) sterile powder and diluent (sterile 0.9% sodium chloride injection) in cartridge for intracavernous injection Rx only NDC 52244-020-06 Rx only edex 20 mcg (alprostadil for injection) cartridge 6 pack sterile powder and diluent (sterile 0.9% sodium chloride) in cartridges for intracavernous injection contains edex injection device and supplies for 6 single-doses Principal Display Panel - 40 mcg edex 40 mcg NDC 52244-140-01 (alprostadil for injection) sterile powder and diluent (sterile 0.9% sodium chloride injection) in cartridge for intracavernous injection Rx only NDC 52244-040-06 Rx only edex 40 mcg (alprostadil for injection) cartridge 6 pack sterile powder and diluent (sterile 0.9% sodium chloride) in cartridges for intracavernous injection contains edex injection device and supplies for 6 single-doses EDEX alprostadil injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52244-010 Route of Administration INTRACAVERNOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPROSTADIL (ALPROSTADIL) ALPROSTADIL 10 ug in 1 mL Inactive Ingredients Ingredient Name Strength ALFADEX LACTOSE SODIUM CHLORIDE WATER Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:52244-010-02 2 BLISTER PACK (BLISTER PACK) in 1 CARTON 1 1 CARTRIDGE (CARTRIDGE) in 1 BLISTER PACK 1 1 mL in 1 CARTRIDGE 2 NDC:52244-010-06 6 BLISTER PACK (BLISTER PACK) in 1 CARTON 2 1 CARTRIDGE (CARTRIDGE) in 1 BLISTER PACK 2 1 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020649 04/15/2012 EDEX alprostadil injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52244-020 Route of Administration INTRACAVERNOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPROSTADIL (ALPROSTADIL) ALPROSTADIL 20 ug in 1 mL Inactive Ingredients Ingredient Name Strength ALFADEX LACTOSE SODIUM CHLORIDE WATER Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:52244-020-02 2 BLISTER PACK (BLISTER PACK) in 1 CARTON 1 1 CARTRIDGE (CARTRIDGE) in 1 BLISTER PACK 1 1 mL in 1 CARTRIDGE 2 NDC:52244-020-06 6 BLISTER PACK (BLISTER PACK) in 1 CARTON 2 1 CARTRIDGE (CARTRIDGE) in 1 BLISTER PACK 2 1 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020649 01/15/2012 EDEX alprostadil injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52244-040 Route of Administration INTRACAVERNOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPROSTADIL (ALPROSTADIL) ALPROSTADIL 40 ug in 1 mL Inactive Ingredients Ingredient Name Strength ALFADEX LACTOSE SODIUM CHLORIDE WATER Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:52244-040-02 2 BLISTER PACK (BLISTER PACK) in 1 CARTON 1 1 CARTRIDGE (CARTRIDGE) in 1 BLISTER PACK 1 1 mL in 1 CARTRIDGE 2 NDC:52244-040-06 6 BLISTER PACK (BLISTER PACK) in 1 CARTON 2 1 CARTRIDGE (CARTRIDGE) in 1 BLISTER PACK 2 1 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020649 03/15/2012 Labeler - Actient Pharmaceuticals, LLC (962685223) Establishment Name Address ID/FEI Operations Aesica Pharmaceuticals GmbH 341737465 ANALYSIS(52244-010, 52244-020, 52244-040) Establishment Name Address ID/FEI Operations Kremers Urban Pharmaceuticals, Inc 006422406 ANALYSIS(52244-010, 52244-020, 52244-040) Establishment Name Address ID/FEI Operations Lancaster Laboratories 069777290 ANALYSIS(52244-010, 52244-020, 52244-040) Establishment Name Address ID/FEI Operations SGS Life Science Services 062491980 ANALYSIS(52244-010, 52244-020, 52244-040) Establishment Name Address ID/FEI Operations Vetter Pharma-Fertigung GmbH & Co. KG 344217323 MANUFACTURE(52244-010, 52244-020, 52244-040) Establishment Name Address ID/FEI Operations Vetter Pharma-Fertigung GmbH & Co. KG 316126754 ANALYSIS(52244-010, 52244-020, 52244-040) Revised: 03/2015 Actient Pharmaceuticals, LLC Next Interactions Print this page Add to My Med List More about Edex (alprostadil) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 28 Reviews Add your own review/rating Drug class: impotence agents Consumer resources Edex injectable a offers you
special effects Edex Injection try and
EmoticonEmoticon