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PMS-FINASTERIDE is a brand name for Finasteride, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
pms-FINASTERIDE is not indicated for use in women or children. pms-FINASTERIDE is contraindicated in the following: Pregnant Women - Use in women when they are or may potentially be pregnant (see WARNINGS AND PRECAUTIONS, Exposure to Finasteride - Risk to Male Fetus); Hypersensitivity to any component of this product.
WARNINGS AND PRECAUTIONS General Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. pms-FINASTERIDE is not indicated for those patients who are candidates for immediate surgery.
No studies have been conducted to determine if finasteride can be used for the control of prostatic hyperplasia in asymptomatic patients. The long-term (> 10 years) beneficial and adverse effects of finasteride have not yet been established.
Prior to treatment with pms-FINASTERIDE, the patient should undergo a thorough urological evaluation to determine the severity of the condition, and to exclude the need for immediate surgery or the possibility of carcinoma of the prostate.
Periodic follow-up evaluations should be performed to determine whether a clinical response has occurred. Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge.
Breast changes including breast enlargement, tenderness and neoplasm have been reported (see ADVERSE REACTIONS). Effects on PSA and Prostate Cancer Detection In clinical studies, finasteride 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. For interpretation of serial PSAs in men taking finasteride, 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 may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range pms-FINASTERIDE Product Monograph Page 5 of 31 for men not taking a 5α-reductase inhibitor.
Non-compliance with pms-FINASTERIDE therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with finasteride for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These adjustments preserve the utility of PSA to detect prostate cancer in men treated with finasteride. Finasteride 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.
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. 8% vs. 1%) (see INDICATIONS AND CLINICAL USE and ADVERSE REACTIONS).
Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride) (1% dutasteride vs. 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. Prior to initiating therapy with pms-FINASTERIDE, appropriate evaluation should be conducted to rule out other urological conditions, including prostate cancer that might mimic BPH.
Special Populations Pregnant and Nursing Women pms-FINASTERIDE is contraindicated for use in women when they are or may potentially be pregnant (see CONTRAINDICATIONS). Because of the ability of Type II 5α-reductase inhibitors such as finasteride to inhibit conversion of testosterone to dihydrotestosterone, finasteride may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
It is not known whether finasteride is excreted in human milk. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Therefore, if this drug is used during pregnancy or if pregnancy occurs while taking or exposed to this drug, the pregnant woman should be apprised of the potential hazard to the male fetus (see TOXICOLOGY, Developmental Studies).
Exposure to Finasteride – Risk to Male Fetus Women should not handle crushed or broken tablets of pms-FINASTERIDE when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus (see WARNINGS AND PRECAUTIONS, Pregnant and Nursing Women).
pms-FINASTERIDE tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. pms-FINASTERIDE Product Monograph Page 6 of 31 Pediatrics pms-FINASTERIDE is not indicated for use in children.
Safety and effectiveness in children have not been established. Monitoring and Laboratory Tests Effect on Levels of PSA Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age.
When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with pms-FINASTERIDE. ADVERSE REACTIONS Adverse Drug Reaction Overview Finasteride is well-tolerated.
Clinical Trial Adverse Drug Reactions In PLESS, 1,524 patients treated with finasteride 5 mg daily and 1,516 patients treated with placebo […]