Propecia Frequently Asked Questions

What is Propecia?

Propecia (finasteride) us the first oral medication that effectively treats male pattern hair loss. Propecia is primarily effective in treating hair loss on the vertex (top of the head) and the mid-scalp area.

How does Propecia work?

Researchers have recently discovered that men who suffer from male pattern hair loss have increased levels of dihydrotestosterone (DHT). DHT is produced from testosterone through the activity of an enzyme called 5-alpha-reductase. Biochemical analysis reveals elevated levels of 5-alpha-reductase in the scalp of balding men and the lack of the hair loss in men with 5-alpha-reductase deficiencies. Propecia inhibits 5-alpha-reductase, thus blocking the formation of DHT. This appears to interrupt a key element in the development of male pattern hair loss.

What is dyihydrotesterone (DHT)?

DHT is one of several male hormones in the body. DHT is responsible for the development of the external genitals in the male fetus, However, as an adult DHT appears to cause:

Male pattern hair lossshortening of the growing phase of hairprogressive miniaturization of hair folliclesdecreasing number of visible hairsProstate enlargementAcne.

What is male pattern hair loss?

Male pattern hair loss is a common condition in which individuals experience a thinning of the hair on the scalp. Often, this results in a receding hairline and/or balding at the vertex of the head. These changes typically begin gradually in men in their early twenties. Physicians believe male pattern hair loss is secondary to a genetic disposition and is dependent on hormones..

What clinical studies have been done concerning Propecia?

Clinical studies were conducted in men age 18 to 41 with mild to moderate degrees of male pattern hair loss. All individuals treated with Propecia received a tar based shampoo (Neutrogena T/Gel shampoo) and were instructed to wash their hair at least once per day. Clinical improvements were seen as early as three months into the treatment with Propecia. In men with vertex hair loss, global photographs revealed hair re-growth in 66 percent of men. Furthermore, hair counts with these men indicated that 83 percent of the recipients had no further hair loss over the two-year clinical trial period.

Will Propecia work for all men?

For most men, Propecia increases the number of scalp hairs, helping to fill in thin areas of the scalp. Men treated with Propecia also noted a slowing of hair loss. Although results will vary, generally men will not re-grow all of the hair they have lost. Male pattern hair loss occurs gradually over time, Propecia can significantly reduce or delay the hair loss process.

How long does it take before individuals start to notice the benefits of Propecia?

Hair naturally grows at a rate of about a half an inch per month, so it may take up to sixth months for the effects of Propecia to be visible. However, most men begin to see some results early in the first three months. These results include a decrease in the amount of hair loss, general improvement in the condition of the hair with noticeable re-growth occurring after sixth months.

What are the side effects of Propecia?

Similar to all prescription medications, Propecia may cause some side effects. In clinical studies, side effects associated with Propecia were uncommon and did no affect most men. In fact, more individuals discontinued the placebo as compare to Propecia secondary to adverse experiences. A very small percentage of men (less than 2 percent) experienced sexual side effects (which may be attributable to the placebo effect).

Resolution occurred in all men who discontinued therapy with Propecia. The side effects also resolved in 58 percent of the men who continued to take the medication.

Is Propecia appropriate for women or children?

No, Propecia is for the treatment of hair loss in men only. Furthermore, women who are or may potentially be pregnant must not use Propecia and should not handle crushed or broken tablets. Propecia may cause a potential risk to the development of the male sex organs in the fetus. Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablet has not been broken or crushed.

Is it safe for a man taking Propecia to conceive a child with his spouse?

Yes, it is quite safe. Propecia does not effect a man's ability to have a child (fertility). There have been no studies that even suggest any risk to the fetus if the father is taking Propecia.

Are there any known drug interactions that occur while taking Propecia?

No dug interactions of clinical importance have been identified. Compounds that have been tested in man include: digoxin, propanolol, theophylline, warfarin, etc. Additionally, although no specific interaction studies were performed on the following medications, finasteride doses of 1 mg or more were concomitantly used in clinical studies with the following: acetaminophen, a-blockers analgesics, angiotension-converting enzymes (ACE) inhibitors, anticonvulsants, benzodiazepines, betablockers, calcium-channel blockers, cardiac nitrates, diuretics H2-antagonists, HMG-Coa reductase inhibitors, prostaglandin synthetase inhibitors (NSAIDS), etc. without evidence of clinically significant adverse interactions.

Does Propecia effect any routine tests?

Yes, men undergoing a prostatic-specific antigen (PSA) test while taking Propecia, consideration should be given to doubling the PSA level. In clinical studies with Propecia men 18-41 years of age, the mean value of 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 percent. Note: There is no correlation between Propecia and Prostate cancer.

What is the recommended dose?

The recommended dose is 1 mg once per day. Propecia may be administered with or without meals. If a dose is missed do not take an extra tablet; just take the medication as usual. There are no added benefits to taking more than the recommended dose.

What about an overdose of Propecia?

Should a significant overdose of Propecia occur, individuals should seek immediate medical attention.

How is Propecia supplied?

Propecia tablets, 1 mg, are tan, octagonal, film coated convex tablets with the code MRK 71 on one side and the Propecia label on the other.

• NDC 0006-0071-31 unit bottle of 30
• NDC 0006-0071-61 Propak carton of 3 unit bottles of 30

How should Propecia be stored?

Propecia should be stored at room temperature, 15-30 C (59-86 F) Keep container closed and out of the reach of children.