Each film-coated tablet of PROPECIA contains 1 mg of finasteride.
Excipients/Inactive Ingredients: Each film-coated tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, hydroxypropyl methylcellulose, hydroxypropylcellulose, titanium dioxide, talc, yellow ferric oxide, and red ferric oxide.
Pharmacology: PROPECIA (finasteride, MSD) 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).
Pharmacodynamics: Results of Clinical Studies: The effect of PROPECIA on male pattern hair loss has been demonstrated in 3 studies in more than 1,800 men. Two of these studies were done over a 5-year period in men with different amounts of hair loss and with balding at the top of the head. The third study was conducted for 1 year in men with balding at the front of the head.
A special photographic method was used to count the number of hairs in a balding area of the scalp. In general, men who took PROPECIA maintained or showed an increase in the number of hairs and noticed improvement in their hair, with benefit continuing with long term use. At the same time, those who did not take PROPECIA continued to lose their hair.
At each clinic visit, men in the studies were also asked to fill out a questionnaire and rate the change in appearance of their hair and their satisfaction with the treatment result. For every question asked, men treated with PROPECIA reported greater improvement than those who did not receive PROPECIA. Men who took PROPECIA reported improvements as early as 3 months after beginning treatment. Improvements continued throughout the 5 years of treatment.
These men were also rated by physicians who determined whether there was an increase or decrease in scalp hair. The ratings were based on a balding scale and on photographs of the patient's head taken before, during, and at the end of the studies. Almost all men treated with PROPECIA for 5 years had no further hair loss and many of these men had improved hair growth as rated by physicians.
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 or children.
PROPECIA is not effective in postmenopausal women with androgenetic alopecia.
PROPECIA is not approved for the prevention of prostate cancer.
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 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%.
Mood alterations and depression: Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 1 mg. Patients should be monitored for psychiatric symptoms and if these occur, treatment with finasteride should be discontinued and the patient advised to seek medical advice.
Driving or operating machinery while using PROPECIA: PROPECIA should not affect the ability to drive or operate machinery.
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 3,200 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.
Other Long Term Data: 5α-reductase inhibitors may increase the risk of high-grade prostate cancer. In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving finasteride 5 mg and 1147 (24.4%) men receiving placebo. In the finasteride 5 mg group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the finasteride 5 mg group may be explained by a detection bias due to the effect of finasteride 5 mg on prostate volume. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (clinical stage T1 or T2) at diagnosis. The clinical significance of the Gleason 7-10 data is unknown.
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. Post-marketing cases of male breast cancer have been reported with the use of finasteride. 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; 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.
Propecia FC tab 1 mg
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