Propecia 1 mg
Images for reference only. Packaging will vary.
Seventy-seven percent of men who took Propecia were rated as "improved" by doctors.
Sixty-six percent of men who took Propecia in clinical trials regrew hair as determined by hair count.
Merck & Co., which makes Propecia, is also responsible for the Merck Manuals used by healthcare professionals.
Nine of ten men who took Propecia in clinical trials reported either the cessation of hair loss or new hair growth.
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Propecia from online pharmacy: South Africa
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100 tabs for $91.22 ($0.91 per tab)
Finasteride from online pharmacy: India
Propecia 1 mg is available from our online pharmacy for less money than you'd spend locally. If you like the convenience of ordering from your home, you can order your prescription online, or speak with one of our customer service representatives on the phone. Call us, The Drug Company, toll free at 1-888-254-3038. Prior to taking Propecia 1 mg, please consult with your doctor or health professional to see if this medication is right for you. Many customers have saved even more money by speaking with their doctor about a generic substitute.
PROPECIA IS FOR USE BY MEN ONLY.
What Propecia is used for
Your physician has prescribed PROPECIA because you have male pattern hair loss (also known as androgenetic alopecia).
Note: PROPECIA is not for use by women or children.
In whom is PROPECIA expected to work?
Men with mild to moderate, but not complete, hair loss can expect to benefit from the use of PROPECIA. In post-menopausal women who were studied, PROPECIA was not effective in the treatment of hair loss (androgenetic alopecia).
In most men, PROPECIA prevented further hair loss during five years of use. Moreover, for the majority of men PROPECIA increased the number of scalp hairs, helping to fill in thin or balding areas of the scalp. Although results will vary, in general you will not be able to grow back all of the hair you have lost.
What is Male Pattern Hair Loss?
Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp. Often, this results in a receding hairline and/or balding on the top of the head. This condition is thought to be caused by a combination of heredity and a particular hormone, DHT (dihydrotestosterone).
DHT contributes to shortening of the growth phase and thinning of the hair (see package insert for illustrations). This process leads to male pattern hair loss. These changes typically start to occur in some men in their 20's and become more common with age. Once hair loss has occurred over a long period of time, the hair may be permanently lost.
How does scalp hair grow?
On average, your hair grows about 1 cm each month. Hairs grow from hair follicles, which are located beneath the skin.
A single scalp hair grows continuously for 2 to 4 years (growth phase) and then stops growing for 2 to 4 months (rest phase). After that time the hair falls out. In its place a new healthy hair begins to grow, and the cycle is repeated. The hairs on your scalp are always in different stages of this cycle so it is normal to lose scalp hair every day.
What Propecia does
PROPECIA blocks an important enzyme (Type II 5-alpha reductase) involved in the regulation of the hair follicle and lowers the levels of dihydrotestosterone (DHT) in the scalp, a major cause of male pattern hair loss.
When Propecia should not be used
PROPECIA should not be taken by women or children.
Do not take PROPECIA if you:
are or may potentially be pregnant (see Pregnancy:).
think you are allergic to any ingredient in PROPECIA.
What the medicinal ingredient is
What the important nonmedicinal ingredients for Propecia are
Docusate sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, methylhydroxypropylcellulose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, red ferric oxide and yellow ferric oxide.
What dosage forms Propecia comes in
PROPECIA is a tan-colored, 8-sided, film-coated tablet. It contains 1 mg of finasteride as the active ingredient.
Warnings and Precautions
PROPECIA is for use in male pattern hair loss only.
BEFORE you use PROPECIA talk to your physician or pharmacist about any medical problems you have or have had, especially liver disease, and about any allergies.
PROPECIA is for the treatment of male pattern hair loss in men only. Women who are or may potentially be pregnant must not us PROPECIA. They should also not handle crushed or broken tablets of PROPECIA. If the active ingredient in PROPECIA is absorbed after oral use or through the skin by a woman who is pregnant with a male baby, it may cause the male baby to be born with abnormalities of the sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a physician should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
Can I drive or operate machinery while using PROPECIA?
PROPECIA should not affect your ability to drive or operate machinery.
If you have questions, ask your physician.
Interactions with Propecia
PROPECIA usually does not interfere with other medicines. However, you should always tell your physician about all medicines you are taking or plan to take, including those obtained without prescription.
Can I continue my current hair care routine?
There should be no need to change your current hair care routine (for example, shampooing or haircuts).
PROPECIA can affect a blood test called PSA (prostate-specific antigen) used for the screening of prostate cancer. If you have a PSA test done, you should tell your physician that you are taking PROPECIA.
Proper Use of Propecia
THIS MEDICINE IS PRESCRIBED FOR YOUR SPECIFIC MEDICAL CONDITION AND FOR YOUR OWN USE. USE ONLY AS SPECIFICALLY DIRECTED AND DO NOT GIVE TO OTHER PEOPLE.
Take one tablet of PROPECIA every day, with or without food. Follow your physician's advice.
If you take too many tablets, contact your physician promptly.
Try to take PROPECIA as your physician has prescribed. However, if you miss a dose, do not take an extra one. Just take the next tablet as usual.
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 finasteride is used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Until further information is gathered in men >41 years of age without BPH, consideration should be given to doubling the PSA level in men undergoing this test while taking PROPECIA.
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.
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect significantly the cytochrome P450-linked drug metabolizing enzyme system. Compounds which have been tested in man have included antipyrine, digoxin, glyburide, propranolol, theophylline, and warfarin and no interactions were found. However, patients on medication with narrow therapeutic indices, such as phenytoin, should be carefully monitored when treatment with PROPECIA is initiated.
Information for the Patient
Special Handling Instructions
Crushed or broken Tablets PROPECIA should not be handled by women when they are or may potentially be pregnant (see Warnings and Precautions, Special Populations, Exposure to Finasteride—Risk to Male Fetus).
Dosage and Administration
Adjustments in dosage are not necessary in patients with varying degrees of renal insufficiency (creatinine clearances as low as 0.15 mL/s [9 mL/min]) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
The recommended dosage is one 1 mg tablet daily. PROPECIA (finasteride, USP) may be taken with or without food.
In general, daily use for three months or more is necessary before hair growth is increased and/or further hair loss is prevented. Continued use is recommended to obtain maximum benefit. Withdrawal of treatment leads to reversibility of effect within 12 months.
If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual.
Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3200 men and is generally well tolerated. In three 12-month, placebo-controlled, double-blind, multicenter studies of comparable design, the overall safety profiles of PROPECIA (finasteride, USP) 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 or placebo, respectively: decreased libido (1.8%, 1.3%), erectile dysfunction (1.3%, 0.7%) and ejaculation disorder (1.2%, 0.7%; primarily decreased volume of ejaculate: [0.8%, 0.4%]). Integrated analysis of clinical adverse experiences showed that during treatment with PROPECIA, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution of these adverse reactions occurred in men who discontinued therapy with PROPECIA and in most 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 above side effects decreased to ≤0.3% by the fifth year of treatment with PROPECIA.
A sexual function questionnaire was self-administered by patients participating in the two vertex baldness trials to detect more subtle changes in sexual function. At Month 12, statistically significant differences were found in 3 of 4 domains (sexual interest, erections, and perception of sexual problems) when compared to placebo. However, no significant difference was seen in the question on overall satisfaction with sex life.
The following adverse experiences have been reported in postmarketing use: ejaculation disorder; breast tenderness and enlargement; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; and testicular pain.
No difference in standard laboratory parameters was observed between patients treated with placebo or PROPECIA.
Indications and Clinical Use
PROPECIA (finasteride, USP) is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men who have mild to moderate scalp hair loss of the vertex and anterior mid-scalp. Clinical studies were conducted in men between 18 to 41 years of age.
PROPECIA is not indicated for use in women (see Warnings and Precautions) or children.
For management of a suspected drug overdose, CPhA recommends that you contact your regional Poison Control Centre. See the eCPS Directories section for a list of Poison Control Centres.
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 reactions.
No specific treatment for overdosage with PROPECIA (finasteride, USP) is recommended.
Dosage Forms, Composition and Packaging
Each tan-colored, 8-sided, film-coated convex tablet, with the code “P” logo on one side and PROPECIA on the other, contains: finasteride 1 mg. Nonmedicinal ingredients: docusate sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, methylhydroxypropylcellulose, microcrystalline cellulose, pregelatinized starch, red ferric oxide, sodium starch glycolate, talc, titanium dioxide and yellow ferric oxide. Blister packages of 28.
Warnings and Precautions
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 (see Pregnant Women). 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.
Clinical studies with PROPECIA have not been conducted in elderly men with male pattern hair loss.
Results of a one year placebo-controlled study, enrolling 137 healthy postmenopausal women with androgenetic alopecia (age range: 41-60 years), showed no benefit of treatment with PROPECIA 1 mg daily on scalp hair growth.
Caution should be used in the administration of PROPECIA (finasteride, USP) in patients with liver function abnormalities, as finasteride is metabolized in the liver.
Other causes of alopecia should be ruled out prior to prescribing PROPECIA. Efficacy and duration of treatment should be assessed periodically by the treating physician.
PROPECIA is not indicated for use in children.
PROPECIA (finasteride, USP) is not indicated for use in women. Women should not handle crushed or broken PROPECIA tablets when they are or may potentially be pregnant (see Contraindications). Because of the ability of Type II 5 alpha-reductase inhibitors such as finasteride to inhibit conversion of testosterone to dihydrotestosterone, PROPECIA may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
It is not known whether PROPECIA is excreted in human milk.
Storage and Stability
Store at room temperature 15-30°C and protect from moisture.
Action and Clinical Pharmacology
In a study in 15 healthy male subjects, the mean bioavailability of finasteride 1 mg tablets was 65% (range, 26-170%), based on the ratio of AUC relative to a 5 mg intravenous dose infused over 60 minutes. Following the intravenous infusion, mean plasma clearance was 165 mL/min (range, 70-279 mL/min) and mean steady-state volume of distribution was 76 L (range, 44-96 L). In a separate study, the bioavailability of finasteride was not affected by food.
Approximately 90% of circulating finasteride is bound to plasma proteins. Finasteride has been found to cross the blood-brain barrier.
PROPECIA (finasteride, USP) is a competitive and specific inhibitor of Type II 5 alpha-reductase, an intracellular enzyme that converts the androgen testosterone into dihydrotestosterone (DHT). Two distinct isozymes of 5 alpha-reductase are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5 alpha-reductase is predominant in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5 alpha-reductase is responsible for approximately one-third of circulating DHT. The Type II 5a-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.
In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type II isozyme. Using native tissues (scalp and prostate), in vitro binding studies examining the potential of finasteride to inhibit either isozyme revealed a 100-fold selectivity for the human Type II 5 alpha-reductase over Type I isozyme (IC50=500 and 4.2 nM for Type I and II, respectively). For both isozymes, the inhibition by finasteride is accompanied by reduction of the inhibitor to dihydrofinasteride and adduct formation with NADP+. The turnover for the enzyme complex is slow (t1/2 approximately 30 days for the Type II enzyme complex and 14 days for the Type I complex).
Finasteride has no affinity for the androgen receptor and has no androgenic, antiandrogenic, estrogenic, antiestrogenic, or progestational effects. Inhibition of Type II 5 alpha-reductase blocks the peripheral conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations. Finasteride produces a rapid reduction in serum DHT concentration, reaching 65% suppression within 24 hours of oral dosing with a 1 mg tablet.
In men with male pattern hair loss (androgenetic alopecia), the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp. Administration of finasteride decreases scalp and serum DHT concentrations in these men. By this mechanism, finasteride interrupts a key factor in the development of androgenetic alopecia in those patients genetically predisposed.
PROPECIA (finasteride, USP) is contraindicated in the following:
Pregnancy: Use in women when they are or may potentially be pregnant (see Warnings and Precautions, Exposure to Finasteride—Risk to Male Fetus);
Hypersensitivity to any component of this product.
PROPECIA is not indicated for use in women or children.