What Proscar® does 

Proscar® lowers levels of a key hormone called DHT (dihydrotestosterone), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. Proscar® will help reduce the risk of developing a sudden inability to pass urine and the need for surgery. However, since each case of BPH is different, you should know that: Even though the prostate shrinks, you may NOT notice an improvement in urine flow or symptoms. You may need to take Finasteride 5mg for six (6) months or more to see whether it improves your symptoms. Therapy with Proscar® may reduce your risk for a sudden inability to pass urine and the need for surgery.

Since the beneficial response to Proscar® may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.

Dosage

The recommended dosage is one 5-mg tab daily with or without food. Although early improvement may be seen, a therapeutic trial of at least 6 months may be necessary to assess whether a beneficial response has been achieved.

Renal Insufficiency: Adjustments in dosage are not necessary in patients with varying degrees of renal insufficiency (creatinine clearance as low as 9 mL/min) as pharmacokinetic studies did not indicate any change in the disposition of finasteride. 

Elderly: No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients >70 years.

Prostate Cancer
It is recommended that before initiating therapy with Proscar® and periodically thereafter, patients should be examined for prostatic cancer by digital rectal examination. Finasteride causes a decrease in serum PSA concentrations; therefore, reduction of serum PSA levels in patients with BPH treated with Proscar does not rule out concomitant prostate cancer.  

Storage

Store Proscar® at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Proscar out of the reach of children and away from pets.

Use in pregnancy & lactation:

Proscar® is contraindicated in women who are or may become pregnant (see Precautions). Because of the ability of 5-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male fetus when administered to pregnant women. Proscar® is not indicated for use in women. It is not known whether finasteride is excreted in human milk.

Exposure to Finasteride - Risk to Male Fetus:

Crushed Proscar® tablets should not be handled by women who are or may become pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus (see Use in pregnancy & lactation under Contraindications). Similarly, small amounts of finasteride have been recovered from the semen in subjects receiving Proscar® 5 mg/day. The amount of finasteride measured in ejaculate was at most 1/50 of the minimum oral dose required for a detectable reduction in circulating DHT levels in adult males. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. Therefore, when the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen or discontinue Proscar® (see Use in pregnancy & lactation under Contraindications).

Use in children:

Proscar® is not indicated for use in children. Safety and effectiveness in children have not been established.

Side Effects

As with any medicine, there are possible side effects with Proscar®. However, not everyone who takes this drug will experience side effects. In fact, most people tolerate Proscar well. When side effects do occur, they are generally minor and either require no treatment or can easily be treated by you or your healthcare provider.

Some men taking Proscar® may have changes or problems with ejaculation, such as a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to interfere with normal sexual function. In some cases these side effects went away while the patient continued to take Proscar®.

In addition, some men may have breast enlargement and/or tenderness. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Some men have reported allergic reactions such as rash, itching, hives, and swelling of the lips and face. Rarely, testicular pain has been reported.