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Edex 40 Mcg Crt 6

  • Manufacturer Name : Endo Generic Products
  • MFG # : 52244004006
  • NDC : 52244004006
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description Alprostadil for inj, 1.25 MCG
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category I
Drug Type Code 1
FDA Approval Date 06/12/1997
FDA Therap Equiv AP
HCPCS J0270
Market Entry Date 11/09/1998
Medical Coverage COVERED WITH SPECIAL INSTRUCTIONS
Termination Date -
Unit EA
Units Per Pkg 1
Active Ingredients 704 alprostadil 745653
AHFS Class 24129200 VASODILATING AGENTS, MISCELLANEOUS
DEA Class NC
Dose Form KIT
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 31756 alprostadil INTRACAVER KIT 40 MCG
Inactive Ingredients 18822 rubber, unspecified; 2432 lactose 64044515
OMP Family -
Product Category RX Pharmaceuticals
Strength 40MCG
Common Brand Name COMMON BRAND NAME(S): Caverject
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: "blood thinners" (such as warfarin, heparin).
Allocation Period -
Case Quantity 12
Drug Form Pack Size 6
Form DISPOSABLE CARTRIDG
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AP Injectable aqueous solutions including dry powders, concentrated solutions or ready-to-use solutions are considered pharmaceutically and therapeutically equivalent if they produce the same concentration and are labeled similarly.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 6
How to Use HOW TO USE: 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. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist. This medication is given by injection into the penis as directed by your doctor. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose an injection site on the other side of the penis from the site of the last dose, using a different area each time. After injection, apply pressure to the injection site with an alcohol swab for about 5 minutes to avoid bruising. Do not use a bent needle to inject this medication. If the needle is bent, replace it with a new needle. If the needle breaks during injection, contact your doctor right away. Dosage is based on your medical condition and response to therapy. This medication should usually work within 5 to 20 minutes to produce an erection that lasts for about 1 hour. The manufacturer recommends that this medication be used no more than 3 times a week with at least 1 day between each dose. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist. Tell your doctor if your condition lasts or gets worse (for example, if the drug does not produce an erection or it becomes more difficult to get an erection).
Missed Dose MISSED DOSE: Not applicable.
Notes NOTES: Do not share this medication with others. Keep all regular medical appointments, and have regular checkups to monitor the effectiveness and safety of this medication.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (al-PROS-ta-dil)
Precautions PRECAUTIONS: Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (such as leukemia, multiple myeloma), sickle cell anemia. Use of this drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method such as a latex or polyurethane condom during all sexual activity. Consult your doctor or pharmacist for more details.
Side Effects SIDE EFFECTS: Mild/moderate pain, irritation, or slight bleeding at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: redness/tenderness/swelling of the penis, lumps/unusual curving of the penis. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection. This medication is not for use in women or children. This medication is not recommended for use in men with penile implants.

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Edex 40 Mcg Crt 6 is manufactured by Endo Generic Products.
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