Finasteride
Brand names: PROPECIA, PROSCAR, Finasteride
Warnings
Key warnings include: - PROSCAR reduces PSA levels by approximately 50%, though any confirmed PSA increase while taking it may signal prostate cancer and warrants evaluation - Men aged 55+ taking finasteride showed increased high-grade prostate cancer risk (1.8% vs 1.1% placebo) - Pregnant females or those potentially pregnant must not handle crushed/broken tablets due to risk of abnormal male fetal genitalia development - Not indicated for pediatric patients or females - Physicians should evaluate other urological conditions before initiating treatment
Contraindications
4 CONTRAINDICATIONS Finasteride tablets are contraindicated in the following: • Hypersensitivity to any component of this medication. • Pregnancy. Finasteride use is contraindicated in females 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 female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also , , and .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Hypersensitivity to any components of this product (4) . Females who are or may potentially be pregnant (4 , , , .
Overdose
10 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 effects. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m 2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m 2 (400 mg/kg) and 5900 mg/m 2 (1000 mg/kg), respectively.
Drug interactions
7 DRUG INTERACTIONS 7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. 7.2 Other Concomitant Therapy Although specific interaction studies were not performed, finasteride was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, H 2 antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.
Uses
PROSCAR is indicated for treating symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates to "improve symptoms," "reduce the risk of acute urinary retention," and "reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy." When combined with doxazosin, it reduces symptomatic BPH progression risk. The drug is not approved for prostate cancer prevention.
Dosage forms & strengths
2 DOSAGE AND ADMINISTRATION Finasteride tablets may be administered with or without meals. Finasteride tablets may be administered with or without meals (2) . Monotherapy: One tablet (5 mg) taken once a day . Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin . 2.1 Monotherapy The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see ] . 2.2 Combination with Alpha-Blocker The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see ].
All identified pills
714
RED ROUND · Finasteride
2 manufacturers
715
BLUE ROUND · Finasteride
2 manufacturers
93 7355
BLUE OVAL · Finasteride
3 manufacturers
C112
BROWN ROUND · Finasteride
E 61
BLUE ROUND · Finasteride
10 manufacturers
F1 Actavislogo
RED ROUND · Finasteride
7 manufacturers
F1
BROWN ROUND · Finasteride
10 manufacturers
F5
BLUE ROUND · Finasteride
34 manufacturers
H 37
BLUE ROUND · Finasteride
17 manufacturers
H 36
BROWN ROUND · Finasteride
8 manufacturers
IG 412
BLUE ROUND · Finasteride
J 81
WHITE OCTAGON (8 SIDED) · Finasteride
8 manufacturers
J 81
BROWN OCTAGON (8 SIDED) · Finasteride
M 151
WHITE ROUND · Finasteride
7 manufacturers
M F17
BLUE ROUND · Finasteride
MSD 72
BLUE FREEFORM · Finasteride
PROPECIA P
BROWN OCTAGON (8 SIDED) · Finasteride
3 manufacturers
R 171
BROWN ROUND · Finasteride
2 manufacturers
R 172
GREEN OVAL · Finasteride
2 manufacturers
RG 770
WHITE TRIANGLE · Finasteride
ZE 56
BLUE ROUND · Finasteride
2 manufacturers
Side effects
The most frequently reported drug-related adverse effects from the 4-year PLESS study were: "impotence," "decreased libido," "decreased volume of ejaculate," "breast enlargement," "breast tenderness and rash." Sexual dysfunction effects were most prominent in Year 1, stabilizing in subsequent years.