PROPECIA tablets, each containing Finasteride 1 mg.
Therapeutic Class: PROPECIA (finasteride) is a synthetic 4-azasteroid compound that is a specific inhibitor of Type II 5α-reductase, an intracellular enzyme that metabolizes the androgen testosterone into dihydrotestosterone (DHT).
PROPECIA is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.
PROPECIA is not indicated for use in women (see Pregnancy under Use in Pregnancy & Lactation) or children.
PROPECIA is not effective in postmenopausal women with androgenetic alopecia.
The recommended dosage is one 1-mg tablet daily. PROPECIA may be taken with or without food.
In general, daily use for 3 months or more is necessary before increased hair growth and/or prevention of further hair loss is observed. Continued use is recommended to obtain maximum benefit. Withdrawal of treatment leads to reversibility of effect within 12 months.
In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in side effects.
No specific treatment for overdosage with PROPECIA is recommended.
PROPECIA is contraindicated in the following: Use in women when they are or may potentially be pregnant (see Pregnancy under Use in Pregnancy & Lactation).
Hypersensitivity to any component of this product.
PROPECIA is not indicated for use in women or children.
In clinical studies with PROPECIA in men 18-41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. When PROPECIA is used for treatment of male pattern hair loss in older men who also have benign prostatic hyperplasia (BPH), consideration should be given to the fact that, in older men with BPH, PSA levels are decreased by approximately 50%.
Use in Children: PROPECIA is not indicated for use in children.
Use in the Elderly: Clinical studies with PROPECIA have not been conducted in elderly men with male pattern hair loss.
Pregnancy: PROPECIA is contraindicated for use in women when they are or may potentially be pregnant.
Because of the ability of Type II 5α-reductase inhibitors to inhibit conversion of testosterone to DHT in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
Women should not handle crushed or broken tablets of PROPECIA 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. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
Nursing Mothers: PROPECIA is not indicated for use in women.
It is not known whether finasteride is excreted in human milk.
PROPECIA is generally well tolerated. Side effects, which usually have been mild, generally have not required discontinuation of therapy.
Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3200 men. In three 12 month, placebo-controlled, double-blind, multicenter studies of comparable design, the overall safety profiles of PROPECIA and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 1.7% of 945 men treated with PROPECIA and 2.1% of 934 men treated with placebo.
In these studies, the following drug-related adverse experiences were reported in ≥1% of men treated with PROPECIA: Decreased libido (PROPECIA, 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with PROPECIA and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with PROPECIA and in many who continued therapy. In a separate study, the effect of PROPECIA on ejaculate volume was measured and was not different from that seen with placebo.
The incidence of each of the previously mentioned side effects decreased to ≤0.3% by the fifth year of treatment with PROPECIA.
Breast Cancer: Finasteride has also been studied in men with prostate disease at 5 times the dosage recommended for the treatment of male pattern hair loss. During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride 5 mg but no cases in men not treated with finasteride 5 mg. 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 finasteride 5 mg. 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 finasteride 5 mg, and 1 case of breast cancer in men treated with placebo. There have been postmarketing reports of male breast cancer with the use of finasteride 1 mg and 5 mg. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
Postmarketing Experience: The following additional adverse experiences have been reported in postmarketing use. Because these reactions are reported voluntarily from a population of uncertain size. It is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Immune system disorders: Hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face).
Psychiatric disorders: Depression; suicidal ideation; decreased libido that continued after discontinuation of treatment.
Reproductive system and breast disorders: Sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment; breast tenderness and enlargement; testicular pain; hematospermia; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.
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, glyburide, propranolol, theophylline, and warfarin and no interactions were found.
Although specific interaction studies were not performed, in clinical studies finasteride doses of 1 mg or more were used concomitantly with ACE inhibitors, acetaminophen, alpha blockers, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (NSAIDs), and quinolones, without evidence of clinically significant adverse interactions.
D11AX10 - finasteride ; Belongs to the class of other dermatologicals.
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