Finasteride tablets USP are contraindicated in the following:
• Hypersensitivity to any component of this medication.
• Pregnancy. Finasteride use is contraindicated in women when they are
or may potentially be pregnant. Because of the ability of Type II
5α-reductase inhibitors to inhibit the conversion of testosterone to
5α-dihydrotestosterone (DHT), Finasteride may cause abnormalities of the
external genitalia of a male fetus of a pregnant woman who receives
Finasteride. If this drug is used during pregnancy, or if pregnancy
occurs while taking this drug, the pregnant woman should be apprised of
the potential hazard to the male fetus. [See also Warnings and
Precautions (5.3), Use in Specific Populations (8.1), How
Supplied/Storage and Handling (16)and Patient Counseling Information
(17.2).] In female rats, low doses of Finasteride administered during
pregnancy have produced abnormalities of the external genitalia in male
offspring.
In clinical studies, Finasteride tablets USP reduced serum PSA
concentration by approximately 50% within six months of treatment. This
decrease is predictable over the entire range of PSA values in patients
with symptomatic BPH, although it may vary in individuals.raw Finasteride powder
For interpretation of serial PSAs in men taking Finasteride tablets USP, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on Finasteride tablets USP may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance with Finasteride tablets USP therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with Finasteride tablets USP for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. These adjustments preserve the utility of PSA to detect prostate cancer in men treated with Finasteride tablets USP.
Finasteride tablets USP may also cause decreases in serum PSA in the presence of prostate cancer.
The ratio of free to total PSA (percent free PSA) remains constant
even under the influence of Finasteride tablets USP. If clinicians elect
to use percent free PSA as an aid in the detection of prostate cancer
in men undergoing Finasteride therapy, no adjustment to its value
appears necessary.
Men aged 55 and over with a normal digital rectal examination and PSA
≤3.0 ng/mL at baseline taking Finasteride 5 mg/day in the 7-year
Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason
score 8 to 10 prostate cancer (Finasteride 1.8% vs placebo 1.1%). [See
Indications and Usage (1.3) and Adverse Reactions (6.1).] Similar
results were observed in a 4-year placebo-controlled clinical trial with
another 5α-reductase inhibitor (dutasteride, AVODART) (1% dutasteride
vs 0.5% placebo). 5α-reductase inhibitors may increase the risk of
development of high-grade prostate cancer. Whether the effect of
5α-reductase inhibitors to reduce prostate volume, or study-related
factors, impacted the results of these studies has not been established.
Women should not handle crushed or broken Finasteride tablets USP when they are pregnant or may potentially be pregnant because of the possibility of absorption of Finasteride and the subsequent potential risk to a male fetus. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. [See Contraindications (4), Use in Specific Populations (8.1), Clinical Pharmacology (12.3), How Supplied/Storage and Handling (16)and Patient Counseling Information (17.2).]
