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NRA-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: • NRA-FINASTERIDE (finasteride tablets) is a Type II 5α-reductase inhibitor, indicated as monotherapy for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to: - Reduce the risk of acute urinary retention; - Reduce the risk of surgery including transurethral…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • NRA-FINASTERIDE as monotherapy is indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to: • Reduce the risk of acute urinary retention; • Reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy.
• NRA-FINASTERIDE causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH. • NRA-FINASTERIDE administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progress of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score).
2 Recommended Dose and Dosage Adjustment The recommended dosage of NRA-FINASTERIDE is one 5 mg tablet daily with or without food (see 14 CLINICAL TRIALS; and, for information on doxazosin, see a doxazosin Product Monograph). 15 mL/s [9 mL/min]) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
3 Pharmacokinetics). 4 Administration NRA-FINASTERIDE is for oral administration. 5 Missed Dose If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual.
). 1%). 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 finasteride tablets, appropriate evaluation should be conducted to rule out other urological conditions, including prostate cancer that might mimic BPH. Monitoring and Laboratory Tests Effects on PSA and Prostate Cancer Detection In clinical studies, finasteride tablets 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 tablets, 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 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 therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with finasteride tablets 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. Finasteride tablets 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.
1 Pregnant Women, Exposure to Finasteride - Risk to Male Fetus); • Hypersensitivity to any component of this product. NRA-FINASTERIDE is not indicated for use in women or children. 1 Dosing Considerations • NRA-FINASTERIDE as monotherapy is indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to: • Reduce the risk of acute urinary retention; • Reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy.
• NRA-FINASTERIDE causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH. • NRA-FINASTERIDE administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progress of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score).
2 Recommended Dose and Dosage Adjustment The recommended dosage of NRA-FINASTERIDE is one 5 mg tablet daily with or without food (see 14 CLINICAL TRIALS; and, for information on doxazosin, see a doxazosin Product Monograph). 15 mL/s [9 mL/min]) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
3 Pharmacokinetics). 4 Administration NRA-FINASTERIDE is for oral administration. 5 Missed Dose If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual. 5 OVERDOSAGE Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse reactions.
For management of a suspected drug overdose, contact your regional poison control centre. NRA-FINASTERIDE (finasteride) Page 6 of 36 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Film-coated Tablet / 5 mg microcrystalline cellulose, hydroxyl propyl methyl cellulose, polyethylene glycol, coloring agents (FD&C blue 2 aluminum lake, titanium dioxide, iron oxide yellow), pregelatinized starch, lauroyl macrogoglycerides, lactose monohydrate, magnesium stearate and sodium starch glycolate.
1 Pregnant Women, Exposure to Finasteride - Risk to Male Fetus); • Hypersensitivity to any component of this product. NRA-FINASTERIDE is not indicated for use in women or children.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 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, 1 All other trademarks are the property of their respective owners. NRA-FINASTERIDE (finasteride) Page 8 of 36 consideration should be given to the fact that PSA levels decrease in patients treated with finasteride tablets.
Psychiatric There have been post-marketing reports of serious psychiatric symptoms in patients being treated with finasteride that sometimes continued after treatment discontinuation. 5 Post-Market Adverse Reactions). It is recommended that all patients be screened for suicidal ideation, self-harm, and depression and/or associated risk factors before treatment initiation.
Clinical monitoring of all patients for signs and symptoms of psychiatric disorder should continue throughout treatment and after. If these occur, patients should be advised to seek medical advice, as soon as possible. 1 Pregnant Women NRA-FINASTERIDE is contraindicated for use in women when they are or may potentially be pregnant (see 2 CONTRAINDICATIONS).
Because of the ability of Type II 5α-reductase inhibitors such as finasteride tablets 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.
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 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
2 Breast-feeding). NRA-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. 2 Breast-feeding It is not known whether finasteride is excreted in human milk.
3 Pediatrics (< 18 years of age) NRA-FINASTERIDE (finasteride) Page 9 of 36 No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use (see 14 CLINICAL TRIALS). Safety and effectiveness in children have not been established.
4 Geriatrics Evidence from clinical studies and experience suggests that use in geriatric populations is associated with no significant differences in safety or effectiveness. 1 Adverse Reaction Overview The following clinically significant adverse effects may be associated with the treatment of finasteride tablets (see 7 WARNINGS AND PRECAUTIONS): • Male breast cancer • […]
NRA-FINASTERIDE are blue colored, modified apple shaped, biconvex, film-coated tablets, debossed with ‘F’ on one side and ‘5’ on the other side. Available in blister packages of 30 tablets and bottle packages of 30, 100 and 500 tablets.
7 WARNINGS AND PRECAUTIONS General Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. NRA-FINASTERIDE is not indicated for those patients who are candidates for immediate surgery.
No studies have been conducted to determine if finasteride tablets can be used for the control of prostatic hyperplasia in asymptomatic patients. The long term (>10 years) beneficial and adverse effects of finasteride tablets have not yet been established.
Prior to treatment with finasteride tablets, 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