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What is PROPECIA ®?
PROPECIA® is a
medical breakthrough. The first pill that effectively
treats male pattern hair loss on the vertex (at top of
head) and anterior mid-scalp area.
Does
PROPECIA® really work?
Based on vertex studies at
24 months of men 18 to 41 with mild to moderate hair
loss, the clinical results of PROPECIA® are impressive:
83% maintained their hair based on hair count
(vs. 28% with placebo), 66% had visible regrowth as
rated by independent dermatologists (vs. 7% with
placebo), 80 % were rated as improved by clinical
doctors (vs. 47% with placebo), and most men reported an
increase in the amount of hair, a decrease in hair loss,
and improvement in appearance.
Only a doctor can
determine if PROPECIA® is right for you. PROPECIA® is
for men only. Further, women who are or may potentially
be pregnant must not use PROPECIA® and should not handle
crushed or broken tablets because it may cause
abnormalities of a male baby's sex organs. PROPECIA®
tablets are coated and will prevent contact with the
active ingredient during normal handling.
You
may need to take PROPECIA® daily for 3 months or more to
see visible results. PROPECIA® may not regrow all your
hair. And if you stop using this product, you will
gradually lose the hair you have gained. There is not
sufficient evidence that PROPECIA®works for recession at
the temporal areas. If you haven't seen results after 12
months of using PROPECIA®, further treatment is unlikely
to be of benefit.
Like all prescription
products, PROPECIA® may cause side effects. In clinical
studies, a very small number of men experienced certain
side effects, such as: less desire for sex, difficulty
in achieving an erection, and a decrease in the amount
of semen. Each of these side effects occurred in less
than 2% of men. These side effects were reversible and
went away in men who stopped taking the PROPECIA®. They
also disappeared in most men (58%) who continued taking
PROPECIA®.
Taken once a day in tablet form,
PROPECIA® is simple, easy, and -most important-
clinically demonstrated to be effective in most men.
PROPECIA® helps grow natural hair not just "peach fuzz"
and is as convenient to take as a vitamin: one pill a
day.
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How does PROPECIA®
work?
Scientist have recently discovered that men
who suffer from male pattern hair loss have an increased
level of a substance called DHT in their scalps.
PROPECIA® blocks the formation of DHT and in this way
appears to interrupt a key factor in the development of
male pattern hair loss in men. Most important, PROPECIA
® helps grow natural hair, not just "peach fuzz," and is
as convenient to take as a vitamin: one pill a day.
What is DHT?
DHT is one of many male
hormones in the body. DHT is developmentally important
early in a man's life; however, it appears to be a cause
of hair loss as men get older. DHT shrinks the hair
follicle until it no longer produces visible hair.
Who should not take
PROPECIA®?
PROPECIA®is for the treatment of male
pattern hair loss in MEN ONLY. Further, women who are or
may potentially be pregnant must not use PROPECIA® and
should not handle crushed or broken tablets of PROPECIA®
because it may cause abnormalities of a male baby's sex
organs. PROPECIA® tablets are coated and will prevent
contact with the active ingredient during normal
handling.
Does PROPECIA® work for all
men?
At the conclusion of a 24-month study of men
age 18 to 41 with mild to moderate hair loss at the top
of the head, 83% treated with PROPECIA® maintained their
hair as determined by hair count (vs. 28% with placebo).
Most men reported an increase in the amount of hair, a
decrease in hair loss, and improvement in appearance.
Although results will vary, generally men will not be
able to grow back all of the hair they have lost.
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Will PROPECIA work for me?
For most men, PROPECIA increases the
number of scalp hairs in the first year of treatment,
helping to fill in thin or balding areas of the scalp.
In addition, men taking PROPECIA may note a slowing of
hair loss. Although results will vary, generally you
will not be able to grow back all of the hair you have
lost. There is not sufficient evidence that PROPECIA
works in the treatment of receding hairline in the
temporal area on both sides of the head.
Male pattern hair loss occurs
gradually over time. On average, healthy hair grows only
about half an inch each month. Therefore, it will take
time to see any effect.
You may need to take PROPECIA
daily for three months or more before you see a benefit
from taking PROPECIA. PROPECIA can only work over the
long term if you continue taking it. If the drug has not
worked for you in twelve months, further treatment is
unlikely to be of benefit. If you stop taking PROPECIA,
you will likely lose the hair you have gained within 12
months of stopping treatment. You should discuss this
with your doctor.
PROPECIA is not effective in
the treatment of hair loss due to androgenetic alopecia
in postmenopausal women. PROPECIA should not be taken by
women.
Can PROPECIA® help
maintain my hair count?
PROPECIA® is proven to
maintain hair count in most men. It's the medical
breakthrough men have been waiting for. In clinical
studies, hair count was maintained in men taking
PROPECIA®, while men taking a placebo (a pill with no
medication) continued to show progressive hair loss.
Imagine looking in the mirror two years from now
and seeing essentially the same amount of hair you saw
this morning! Now, PROPECIA® makes this possible for the
vast majority of men.
Can PROPECIA® increase
as well as maintain my hair count?
At 24 months,
66% of the men in our studies regrew hair at the top of
the head (vs. 7% with placebo) as determined by an
expert panel of dermatologists. An assessment by the
study investigators rated 80% of men on PROPECIA® as
improved (vs. 47% with placebo). This was not just
"peach fuzz", but real hair and growth occurred on both
the vertex (at top of the head) and anterior mid-scalp
area. There is not sufficient evidence that PROPECIA®
works for recession at the temporal areas.
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How long will it take for PROPECIA® to
work?
PROPECIA® begins to block the formation of
DHT almost immediately; however, because hair grows
slowly, visible results from PROPECIA ® take some time.
In clinical trials, most men began to see the first
benefit of PROPECIA® slowing hair loss as early as 3
months. After 6 months, men may begin to experience
regrowth. If PROPECIA® does not work within 12 months,
further treatment is unlikely to be of benefit.
How long do I have to take
PROPECIA®?
You need to take PROPECIA® for as long
as you want to continue to benefit from use. If you stop
taking PROPECIA®, you will likely lose any hair you have
gained within 12 months of stopping treatment.
What about long-term use of
PROPECIA®?
PROPECIA® has been tested for 2 years
in clinical studies of 1,200 men.
Does
PROPECIA® have any side effects?
Like all
prescription drugs, PROPECIA® may cause side effects. In
clinical studies, side effects from PROPECIA® were
uncommon and did not affect most men. A very small
number of men experienced certain sexual side effects,
such as: less desire for sex; difficulty in achieving an
erection; and a decrease in the amount of semen. Each of
these side effects occurred in less than 2% of men.
These side effects were reversible and went away in men
who stopped taking PROPECIA®. These side effects also
disappeared in most men (58%) who continued taking
PROPECIA®.
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If a man is taking PROPECIA®,
is it present in his semen?
What effect does
PROPECIA® have on semen?
Semen levels have been measured in 35 men taking
PROPECIA® daily for 6 months. In 60% of the samples,
PROPECIA® levels were undetectable. The mean PROPECIA®
level was 0.26 ng/mL, and the highest level measured was
1.52 ng/mL. Using the highest semen level measured and
assuming 100% absorption from a 5 mL ejaculate per day
volume, human exposure through vaginal absorption would
be 750 times lower than the exposure from the no-effect
dose for developmental abnormalities in male Rhesus
monkeys. There were no developmental abnormalities seen
in male Rhesus monkey fetuses when PROPECIA ® was given
intravenously (into the blood stream) to pregnant Rhesus
monkeys at 750 times the estimated exposure of pregnant
women from men taking 1 mg/day.
You should
discuss this with your doctor and follow your doctor's
instructions.
How does
PROPECIA® compare with other products available for the
treatment of hair loss?
PROPECIA® is the only
pill indicated for male pattern hair loss. Merck has not
conducted clinical trials comparing PROPECIA® with other
medicines and therefore cannot make any comments. You
should discuss this issue with your doctor.
How is PROPECIA® supplied?
PROPECIA®
is available as a 1-mg tablet. This tablet is tan in
color and is octagonal (has eight sides), film-coated,
rounded, somewhat elevated surface. Each PROPECIA®
tablet is marked with a code of MRK 71 on one side and
PROPECIA® 1 on the other. The tablets are supplied as
individual bottles of 30 tablets and in PRO PAK"! , a
carton of 3 bottles each containing 30 tablets for a
total of 90 tablets.
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How should I take
PROPECIA®?
The recommended dosage for PROPECIA®
in men with male pattern hair loss is a single 1-mg
tablet taken by mouth once a day. PROPECIA® may be taken
with or without meals. You may need to take PROPECIA®
daily for three or more months before you see a benefit
from taking PROPECIA®. PROPECIA ® can only work over the
long term if you continue taking it. Continued use is
recommended to obtain maximum benefit. If you stop
taking PROPECIA®, you will likely lose the hair you have
gained within 12 months of stopping treatment. You
should discuss this with your doctor, and follow your
doctor's instructions.
Follow your doctor's
instructions.
- Take one tablet by mouth each day.
- You may take PROPECIA with or without food.
- If you forget to take PROPECIA, do not take
an extra tablet. Just take the next tablet as usual.
PROPECIA will not work
faster or better if you take it more than once a
day.
What are the possible
side effects of PROPECIA?
Like all prescription
products, PROPECIA may cause side effects. In clinical
studies, side effects from PROPECIA were uncommon and
did not affect most men. A small number of men
experienced certain sexual side effects. These men
reported one or more of the following: less desire for
sex; difficulty in achieving an erection; and, a
decrease in the amount of semen. Each of these side
effects occurred in less than 2% of men. These side
effects went away in men who stopped taking PROPECIA.
They also disappeared in most men who continued taking
PROPECIA.
In general use, the following
have been reported: allergic reactions including rash,
itching, hives and swelling of the lips and face;
problems with ejaculation; breast tenderness and
enlargement; and testicular pain.
Tell your doctor promptly
about these or any other unusual side
effects.
- PROPECIA can affect a
blood test called PSA (Prostate-Specific Antigen) for
the screening of prostate cancer. If you have a PSA
test done, you should tell your doctor that you are
taking PROPECIA.
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PRECAUTIONS
General
Caution should be used in the
administration of PROPECIA in patients with liver
function abnormalities, as finasteride is metabolized
extensively in the liver.
Information for
Patients
Women should not handle
crushed or broken PROPECIA tablets when they are
pregnant 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. (See also
CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN - RISK TO
MALE FETUS; PRECAUTIONS, Pregnancy; and HOW
SUPPLIED, Storage and Handling.)
WARNINGS
PROPECIA is not indicated for
use in pediatric patients (see INDICATIONS AND USAGE;
and PRECAUTIONS, Pediatric Use) or women (see
also PRECAUTIONS, Information for Patients and
Pregnancy; and HOW SUPPLIED, Storage and
Handling).
EXPOSURE OF WOMEN - RISK TO
MALE FETUS
Women should not handle crushed or broken
PROPECIA tablets when they are pregnant 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. (See also CONTRAINDICATIONS;
PRECAUTIONS, Information for Patients and
Pregnancy; and HOW SUPPLIED, Storage and
Handling.)
A warning about PROPECIA
and pregnancy.
- Women who are or may potentially be pregnant:
| - must not
use PROPECIA |
| - should
not handle crushed or broken tablets of
PROPECIA. |
If a woman who is pregnant
with a male baby absorbs the active ingredient in
PROPECIA, either by swallowing or through the skin, it
may cause abnormalities of a male baby. s sex organs. If
a woman who is pregnant comes into contact with the
active ingredient in PROPECIA, a doctor 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.
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