TM Owner Organon LLC
Proscar 5mg Tablet
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Indications & Clinical Uses
- Proscar 5 mg tablets contain finasteride, a 5-alpha-reductase inhibitor, and are used in men with an enlarged prostate (benign prostatic hyperplasia, BPH).
- They improve symptoms, reduce the risk of acute urinary retention and reduce the need for prostate surgery.
- Proscar may also be used together with the alpha-blocker doxazosin to reduce the risk of BPH symptoms getting worse.
- The dose is one 5 mg tablet by mouth once daily, with or without food, alone or with doxazosin.
- Proscar is not indicated for women or children.
- Formulation check: finasteride is also sold under other brand names and strengths (for example Propecia), so do not swap between finasteride products; Proscar is the 5 mg tablet.
- The US label holder is Organon LLC.
Side Effects
- Side effects seen more often than with placebo in BPH trials include impotence (8.1% in year 1), decreased libido (6.4%), decreased ejaculate volume (3.7%), breast enlargement (0.5%), breast tenderness (0.4%) and rash (0.5%).
- Depression and suicidal thoughts have been reported after marketing.
- Breast cancer has been reported in men.
- The US label carries no boxed warning.
- Contact your healthcare provider about breast changes, mood changes or thoughts of self-harm.
- Sexual side effects should be discussed with your healthcare provider before stopping treatment.
- Sexual side effects were reported most often in the first year of treatment and generally became less frequent in later years of the 4-year study.
Precautions & Warnings
- Do not take Proscar if you are allergic to finasteride.
- Women who are or may be pregnant must not handle crushed or broken tablets, because the medicine can cause abnormal external genitalia in a male baby.
- Proscar lowers PSA (prostate specific antigen) by about 50%, so any confirmed PSA rise needs evaluation even within the normal range.
- Men on finasteride had more high-grade (Gleason 8 to 10) prostate cancers than with placebo in prevention trials.
- Use with caution if your liver function is abnormal, as finasteride is metabolized extensively in the liver.
- Store below 30°C, protected from light, with the container tightly closed.
Avoid Interactions
- The US label identifies no clinically important drug interactions, and finasteride does not affect cytochrome P450 enzymes.
- In studies it was used together with acetaminophen (paracetamol), aspirin, alpha-blockers, ACE inhibitors, beta-blockers, diuretics and NSAIDs without problems.
- Nothing is listed that increases or reduces its effect.
- The main interaction is with testing: Proscar lowers PSA levels by about 50%, which can mask or change prostate cancer screening results.
- Tell any doctor who orders a PSA test that you take Proscar, and tell your healthcare provider about all medicines and supplements you use.
References
Frequently Asked Questions
Proscar (finasteride) 5 mg treats symptoms of an enlarged prostate (BPH) in men, lowers the risk of acute urinary retention and reduces the need for prostate surgery. It can be combined with doxazosin. It is not for women or children.
Take one Proscar 5 mg tablet by mouth once daily, with or without food. Proscar (finasteride) can be used alone or with doxazosin. Follow your prescribed schedule. The dose stays the same whether you take it alone or with doxazosin.
Proscar side effects include impotence (8.1% in year 1), reduced sex drive (6.4%), less semen (3.7%), breast enlargement or tenderness and rash. Depression and breast cancer have been reported. Tell your healthcare provider about mood changes or breast lumps. The US label carries no boxed warning.
Women who are or may be pregnant must not handle crushed or broken Proscar tablets, as finasteride can harm a male baby. No important drug interactions are listed. Tell your healthcare provider about Proscar before any PSA blood test. Proscar is not for women or children.
Take Proscar as soon as you remember on the same day, then continue once daily. If it is almost time for the next dose, skip the missed one. Do not take two tablets at once. Ask your healthcare provider if unsure.
Yes. Proscar (finasteride) lowers PSA levels by about 50%, so any confirmed PSA rise needs evaluation even if the number looks normal. Men taking finasteride also had more high-grade prostate cancers than placebo in prevention trials. Tell any doctor ordering a PSA test.
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