How to use Prostasax
Read the Patient Information Leaflet provided by your pharmacist before you start taking Prostasax and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth, with or without food, usually once a day, or as directed by your doctor.
If the tablet is crushed or broken, it should not be handled by a woman who is pregnant or by a woman who may become pregnant (see also Precautions section).
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not stop taking this medication without consulting your doctor.
It may take 6-12 months to notice a benefit.
Inform your doctor if your condition persists or worsens.
Commonly reported side effects of Prostasax include: impotence and decreased libido. See below for a comprehensive list of adverse effects.
What are the uses for Prostasax-oral (hair growth)?
: Prostasax (Propecia) is used for the treatment of male pattern baldness or androgenetic alopecia in males only.
Prostasax hides higher-grade cancer
The trouble with Prostasax dates back to 2003 when the original article was published in the New England Journal of Medicine. The authors of that article studied 18,000 men who randomly were assigned to receive either 5 mg of Prostasax (then used mainly to treat benign enlargement of the prostate) or a placebo.
The men in the Prostasax group had a 25 percent lower risk of being diagnosed with prostate cancer, but a 68 percent higher risk of being diagnosed with a high-grade disease defined by a Gleason score of 7 to 10. (This high-grade type of cancer is usually more difficult to cure.) Since then, the authors of the article have tried to erase these results and encourage urologists to prescribe Prostasax for prostate cancer prevention. When these attempts failed, they started approaching patients and physicians directly.
Consideration Of Other Urological Conditions
Prior to initiating treatment with PROSCAR, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist. Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for Prostasax therapy.
No Decrease in Positive Biopsies
During the first seven years of the study, the patients had a biopsy if they had an abnormal finding on a digital rectal exam or if their PSA became elevated. But because this was a double-blind study, the patients taking Prostasax did not know that their PSA levels were artificially low.
Therefore, fewer patients taking the drug who were told to have a biopsy followed that advice. Were there fewer cancers in these patients because Prostasax actually prevents cancer or because fewer men got a biopsy in the first place? Did their low PSA levels fool them into thinking they couldn’t possibly have cancer? In this study, 15 percent fewer men on Prostasax underwent a biopsy because they were lulled into a false sense of security by their low PSA level.
Thus, the major effect of this drug was to keep patients from knowing that they even needed a biopsy. Of the men in the study who actually had a biopsy, the frequency of positive biopsies for cancer was statistically the same in patients in both test groups.
Dr. Walsh is very concerned about the increase in high-grade disease and the possibility that this presents an unacceptable risk for a form of treatment that has little or no value.
Among Prostasax’s critics is Stewart Justman, who wrote a book called Do No Harm: How a Magic Bullet for Prostate Cancer Became a Medical Quandary. In his review of the publication for the New England Journal of Medicine, Dr. Walsh noted that when patients on Prostasax are diagnosed with prostate cancer, they are more likely to have dangerous, high-grade disease.
The real danger is that many patients will be lulled into a false sense of security. If you are told that you’re on a drug that will prevent cancer, and your PSA falls, you aren’t going to be on your guard.
What are the side effects of Prostasax-oral (hair growth)?
The most common side effects associated with Prostasax are:
Serious side effects include increased risk of high-grade prostate cancer, and increased risk for male breast cancer.
Propecia (1 mg Prostasax) was approved by the FDA for the treatment of male pattern baldness in December 1997. Another Prostasax oral dosage form, Proscar or 5 mg Prostasax tablets are FDA approved only for the treatment of benign prostatic hyperplasia (BPH) and should not be used for androgenetic alopecia. Do not confuse these Prostasax tablets.
Finaster >About Prostasax
- Prostasax (OS: BAN, USAN, JAN)
- Finastéride (OS: DCF)
- MK 906 (MerckSharpD) (IS)
- Prostasax (PH: BP 2018, Ph. Eur. 9, USP 41)
- Finasteridum (PH: Ph. Eur. 9)
Exposure Of Women — Risk To Male Fetus
Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken PROSCAR tablets because of the possibility of absorption of Prostasax and the subsequent potential risk to the male fetus. PROSCAR tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken PROSCAR tablets, the contact area should be washed immediately with soap and water .
PROSCAR is not indicated for use in women.
It is not known whether Prostasax is excreted in human milk.
The following additional adverse events have been reported in postmarketing experience with PROSCAR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- hypersensitivity reactions, such as pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face)
- testicular pain
- sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, decreased libido and ejaculation disorders (e.g. reduced ejaculate volume). These events were reported rarely in men taking PROSCAR for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of PROSCAR in these events is unknown.
- male infertility and/or poor seminal quality were reported rarely in men taking PROSCAR for the treatment of BPH. Normalization or improvement of poor seminal quality has been reported after discontinuation of Prostasax. The independent role of PROSCAR in these events is unknown.
- male breast cancer
The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with Prostasax at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure:
Read the entire FDA prescribing information for Proscar (Prostasax)
Before taking Prostasax
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Prostasax it is important that your doctor knows:
- If you have ever had an allergic reaction to a medicine.
- If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
Is Prostasax safe to take if I'm pregnant or breastfeeding?
Prostasax causes abnormal development of the sexual organs of the male fetus. Therefore, women who are pregnant or are likely to be pregnant should not handle crushed or broken Prostasax tablets in order to prevent absorption through the skin.
Prostasax is not prescribed for women.