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(alprostadil) Sterile Powder
For Intracavernosal Use
CAVERJECT Sterile Powder contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.
Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116° C. Its solubility at 35° C is 8000 micrograms per 100 milliliter double distilled water. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in four sizes: 5, 10, 20 and 40 micro-grams per vial -When reconstituted as directed with 1 milliliter of bacteriostatic water for injection or sterile water, both preserved with benzyl alcohol 0.945% w/v, gives 1.13 milliliters of reconstituted solution. Each milliliter of CAVERJECT contains 5.4, 10.5, 20.5 or 41.1 micrograms of alprostadil depending on vial strength, 172 milligrams of lactose, 47 micrograms of sodium citrate and 8.4 milligrams of benzyl alcohol. The deliverable amount of alprostadil is 5, 10, 20 or 40 micrograms per milliliter because approximately 0.4 microgram for the 5 microgram strength, 0.5 microgram for the 10 and 20 microgram strengths and 1.1 microgram for the 40 microgram strength is lost due to adsorption to the vial and syringe. When necessary, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.
The structural formula of alprostadil is represented at right:
What are the possible side effects of alprostadil (Caverject, Caverject Impulse, Edex, Muse)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using alprostadil and call your doctor at once if you have a serious side effect such as:
- feeling light-headed, fainting;
- trouble urinating, blood in your urine;
- bleeding, bruising, or swelling where you injected the medication;
- a painful erection that lasts 4 hours or longer;
- severe pain or irritation of your penis or urethra;...
What are the precautions when taking alprostadil sterile powder for injection (Caverject Powder)?
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 (e.g., angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (e.g., leukemia, multiple myeloma), sickle cell anemia.
Use of this drug does not protect against sexually transmitted diseases (e.g., 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...
Last reviewed on RxList: 3/3/2008
This monograph has been modified to include the generic and brand name in many instances.
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