PROSCAR (finasteride)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Pregnancy

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Suicidal ideation

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
High-grade prostate cancer
Malignant tumor of male breast

There are 10 severe adverse reactions.

More Frequent	Less Frequent
None.	High-grade prostate cancer Hypersensitivity drug reaction

Rare/Very Rare
Angioedema Malignant tumor of male breast Rhabdomyolysis Seizure disorder Self-injurious ideation Suicidal Suicidal ideation Urticaria

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Disorder of ejaculation Erectile dysfunction Gynecomastia Libido changes Mastalgia	Decrease ejaculate volume Hypotension Peripheral edema Skin rash

Rare/Very Rare
Depression Hematospermia Muscle weakness Myalgia Myopathy Oligospermia Orgasm disorder Pruritus of skin Testicular pain

Finasteride is not indicated for use in women and is contraindicated in women who are pregnant or may potentially be pregnant. Because of the ability of 5alpha-reductase inhibitors to inhibit the conversion of testosterone to DHT, finasteride may cause abnormalities of the external genitalia of male fetuses exposed to the drug during pregnancy. Studies have shown that low doses of finasteride administered to female rats during pregnancy can produce abnormalities of the external genitalia in male offspring.

If finasteride is administered during pregnancy, the patient should be apprised of the potential fetal hazard. In addition, because of the possibility of drug absorption and subsequent risk to a male fetus, women who are pregnant or who potentially may be pregnant should not handlebrokenorcrushed finasteride tablets; if such contact occurs, the affected area should be washed immediately with soap and water and the woman should inform her clinician. Intact finasteride tablets are coated, and the coating will prevent contact with finasteride during normal handling.

Reproduction studies in pregnant rats receiving finasteride dosages ranging from 100 mcg/kg daily to 100 mg/kg daily (up to 86 times the maximumrecommended human dosage (MRHD)) resulted in dose-dependent development of hypospadias in 3.6-100% of male offspring. Pregnant rats produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation, and transient nipple development when given dosages of 30 mcg/kg daily (0.03times the MRHD) and decreased anogenital distance when given dosages of 3 mcg/kg daily (0.003times the MRHD).

The critical period during which these effects can be induced in male rats has been determined to be days 16-17 of gestation. These effects are expected pharmacologic effects of 5alpha-reductase inhibitors and are similar to those reported in male infants with a genetic deficiency of 5alpha-reductase. No abnormalities were observed in female offspring exposed to any finasteride dosage in utero.

No developmental abnormalities were observed in first filial generation (F1) male or female offspring resulting from mating of male rats receiving finasteride 80 mg/kg daily (61 times the MRHD) with untreated females. Administration of the drug at a dosage of 3 mg/kg daily (30 times the MRHD) during the late gestation and lactation period resulted in slightly decreased fertility in F1 male offspring. No effects were seen in female offspring.

No evidence of malformations was observed in rabbit fetuses exposed to finasteride in utero from days 6-18 of gestation at dosages up to 100 mg/kg daily; however, effects on male genitalia would not be expected as the exposure did not occur during the critical period of genital system development in rabbits. No abnormalities were observed in male fetuses when pregnant rhesus monkeys were given finasteride IV at dosages up to 800 ng daily (143 times the highest estimated exposure of a pregnant woman to finasteride via the semen of a sexual partner receiving finasteride 5 mg daily) during days 20-100 of gestation. However, external genital abnormalities were observed in male rhesus monkey fetuses in studies using an oral finasteride dosage of 2 mg/kg daily (18,000 times the highest estimated blood levels of finasteride from semen in men receiving 5 mg daily). No other abnormalities were observed in male fetuses, and no abnormalities were observed in female fetuses exposed to finasteride at any dosage in utero.

It is not known whether finasteride is distributed into human milk, but the drug is not indicated for use in women.

Because BPH occurs mainly in men 55 years of age or older, efficacy and safety of finasteride in this age group have been established, although only limited data are available on use of the drug in men older than 80 years of age. Of the 3040 patients enrolled in a long-term (4 years) controlled clinical trial of the drug, 1480 (49%) were 65 years of age or older and 105 (3.5%) were 75 years of age or older. No overall differences in efficacy or safety were observed in this trial between geriatric and younger patients, and other clinical experience has revealed no evidence of age-related differences.

Generally, finasteride is well tolerated in geriatric men. The elimination rate of finasteride is decreased in geriatric individuals; however, the findings are not clinically significant anddosage adjustment is not necessary. The mean terminal half-life of finasteride in individuals 70 years of age or older was approximately 8 hours (range: 6-15 hours) compared with 6 hours (range: 4-12 hours) in individuals 45-60 years of age; consequently, the mean daily AUC after 17 days of dosing was 15% higher in individuals 70 years of age or older.