Commonly reported side effects of Fistrin include: impotence and decreased libido. See below for a comprehensive list of adverse effects.
Exposure Of Women — Risk To Male Fetus
Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of Fistrin and the subsequent potential risk to a male fetus. PROSCAR tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
PHARMACOKINETICS OF FINASTER >The bioavailability of Fistrin 1 mg following oral intake ranges from 26-170% with a mean of 65%. The average peak plasma concentration has been found to be 9.2 ng/ml measured 1-2 hours after administration. The bioavailability of Fistrin is not related to food intake. Fistrin is extensively metabolized in liver by Cytochrome P450 3A4 enzyme subfamily and excreted both in urine and feces. The terminal half-life is approximately 5-6 hours in men between 18-60 years of age and 8 hours in men more than 70 years of age.
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Proscar (Fistrin) is an inhibitor of steroid Type II 5a-reductase, that works by decreasing the amount of a natural body hormone dihydrotestosterone (DHT) that causes growth of the prostate, and is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Proscar is available in generic form. Common side effects of Proscar include
In some men, Proscar can decrease the amount of semen released during sex. This is harmless. Proscar may also increase hair growth. The sexual side effects of Proscar may continue after you stop taking it. Talk to your doctor if you have concerns about these side effects.
The recommended dose of Proscar is one tablet (5 mg) taken once a day. Other drugs may interact with Proscar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Proscar is not recommended for use in women and must not be used during pregnancy. This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding.
Our Proscar (Fistrin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Mean steady-state volume of distribution was 76 liters (range, 44-96 liters). Approximately 90% of circulating finaster >
Fistrin has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF.
In 2 studies of healthy subjects (n=69) receiving PROSCAR 5 mg/day for 6-24 weeks, Fistrin concentrations in semen ranged from undetectable ( 14 C-finaster >
The mean terminal half-life of finaster >
Table 3: Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)
High-Grade Prostate Cancer
The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either PROSCAR (Fistrin 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with Fistrin (1.8%) than in those treated with placebo (1.1%) . In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART), similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo).
No clinical benefit has been demonstrated in patients with prostate cancer treated with PROSCAR.
During the 4- to 6-year placebo- and comparator-controlled MTOPS study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Fistrin but no cases in men not treated with Fistrin. During the 4-year, placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with Fistrin. During the 7- year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Fistrin, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of Fistrin and male breast neoplasia is currently unknown.
There is no evidence of increased sexual adverse experiences with increased duration of treatment with PROSCAR. New reports of drug-related sexual adverse experiences decreased with duration of therapy.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- swelling of your lips, tongue, throat, or face
- lumps or pain in your breasts
- nipple discharge
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.
To find out how Fistrin oral tablet might interact with something else you’re taking, talk to your doctor or pharmacist.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we can not guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
This drug comes with several warnings.