A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Retin A Patient, Information, Instructions - Tretinoin (topical)
Retin A Patient, Information, Instructions - Tretinoin (topical)
PATIENT INFORMATION
Tretinoin is used to treat acne. It is available in a cream, gel
or topical solutions. Tretinoin may cause
your skin to be sensitive
to the sun, wind and extreme cold. The most common side
effects include skin that
becomes excessively red, edematous, blistered, or crusted. If these
effects occur, the medication
should either be discontinued or the dosage
lowered to something tolerated by your skin. Tretinoin should be
applied lightly to the skin
where the acne is prior
to bedtime. Your skin may
get a warm or tingling feeling
after you apply the medication. You may notice acne worsening when
therapy is started. This occurs when the medication
begins to work on acne
that is not visible
from the surface. Treatment should not be discontinued.
PATIENT PACKAGE INSERT
Cream, Gel, Liquid and Gel with Microspheres
Important, Read Directions Carefully Before Using:
THIS INFORMATION TELLS YOU ABOUT TRETINOIN CREAM, GEL, LIQUID
AND GEL WITH MICROSPHERES FOR TREATMENT OF ACNE AS
PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING
TO YOUR DOCTOR'S INSTRUCTIONS,
AND IT SHOULD NOT BE APPLIED TO
OTHER AREAS OF THE BODY OR
TO OTHER GROWTHS OR
LESIONS. THE SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS
HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO
ASK YOUR DOCTOR.
GELS ARE FLAMMABLE: Note: Keep away from heat
and flame. Keep tube tightly
closed.
Warning and Precautions
The Effects of the Sun on Your Skin: As
you know, overexposure to natural
sunlight or the artificial
light of a sunlamp can
cause sunburn. Overexposure
to the sun over many years may cause
premature aging
of the skin and even skin
cancer. The chances of these effects occurring will vary depending
on skin type, the climate
and the care taken to avoid overexposure to the sun. Therapy with
tretinoin cream, gel,
liquid or gel
with microspheres may make your skin
more susceptible
to sunburn and other
adverse effects of the sun, so unprotected exposure
to natural or artificial
light (such as a sunlamp)
should be minimized.
Laboratory Findings: When laboratory mice are
exposed to artificial
sunlight, they often develop skin
tumors. These sunlight-induced tumors may appear more quickly and
in greater number if
the mouse is also topically
treated with the active ingredient
in the cream, gel, liquid and gel
with microspheres. In some
studies under different conditions, however, when mice treated with
tretinoin were exposed
to artificial sunlight,
the incidence and
rate of development
of skin tumors was reduced.
There is no evidence
to date that tretinoin
alone will cause
the development of skin
tumors in either laboratory animals or humans. However, investigations
in this area are continuing.
Use Caution in the Sun: When outside, even on hazy
days, areas treated with tretinoin
cream, gel, liquid or
gel with microspheres should
be protected. An effective
sunscreen should be
used any time you are outside (consult your physician
for a recommendation of an SPF level which will
provide you with the necessary high level of protection). Protective
clothing, like a hat, should be worn for extended sun exposure.
Do not use artificial
sunlamps while you are using tretinoin
cream, gel, liquid or gel
with microspheres. If you do become sunburned, stop your therapy
with tretinoin cream,
gel, liquid or gel
with microspheres until your skin
has recovered.
Avoid Excessive Exposure to Wind or Cold: Extremes
of climate tend to dry or burn
even normal skin. Skin
treated with tretinoin cream, gel, liquid
or gel with microspheres
may be more vulnerable
to these extremes. Your physician
can recommend ways to manage your acne
treatment under such conditions.
Possible Problems: Although tretinoin
cream, gel, liquid or gel
with microspheres was developed to minimize dermal irritation, the
skin of certain individuals may become excessively dry, red, swollen,
blistered, or crusted. Therefore, you should avoid preparations
that may dry or irritate your skin. These preparations may include
certain astringents, toiletries containing alcohol, spices, or certain
medicated soaps, shampoos and hair permanent solutions. You should
also avoid contact with
the peel of limes. If you experience
severe or persistent irritation, discontinue the use of tretinoin
cream, gel, liquid or
gel with microspheres and
consult your physician.
There have been reports that, in some patients, areas treated with
tretinoin developed a temporary increase or decrease in the amount
of skin pigment (color)
present.
Use Other Medication Only on Your Physician's Advice:
Your physician knows
which other medications may be helpful during treatment and will
recommend them to you if necessary. Follow the physician's instructions
carefully. In addition, you
should avoid preparations that may dry or irritate your skin. These
preparations may include certain astringents, toiletries containing
alcohol, spices or lime, or certain medicated soaps, shampoos and
hair permanent
solutions. Do not allow anyone else to use this medication. Do not
use other medications with tretinoin
which are not recommended by your doctor. The medications you have
used in the past might cause
unnecessary redness or peeling.
If You are Pregnant, Think You are Pregnant, Plan to Become
Pregnant, or are Nursing an Infant: No studies have been
conducted in humans to establish the safety of tretinoin
cream, gel, liquid or
gel with microspheres in
pregnant women. If
you are pregnant, think you are pregnant, or are nursing a baby,
consult your physician
before using this medication.
While You're on Tretinoin Cream, Gel, Liquid or Gel with
Microspheres Therapy
Use a mild, non-medicated soap. Avoid frequent washings and
harsh scrubbing. Acne isn't caused by dirt, so no matter
how hard you scrub, you cannot wash
it away. Washing too frequently (more than 2-3 times per day) or
scrubbing too roughly
may at times actually make your acne
worse. Wash your skin gently
with a mild, bland soap. Pat skin
dry with a towel. Let the face
dry 20 to 30 minutes before applying tretinoin
cream, gel or liquid. Remember, excessive irritation
such as rubbing, too much washing, use of other medications not
suggested by your physician, etc., may worsen your acne.
How To Use Tretinoin Cream, Gel, Liquid or Gel with Microspheres
To get the best results with tretinoin
cream, gel, liquid or
gel with microspheres therapy,
it is necessary to use it properly. Forget about the instructions
given for other products and the advice of friends. Just stick to
the special plan your doctor
has laid out for you and be patient. When tretinoin
gel with microspheres is
used properly, therapeutic results may be noticed after 2
weeks, but more than 4 weeks of therapy are required before consistent
beneficial effects are observed. Remember, when tretinol cream,
gel or liquid
is used properly, many users see improvement by 12 weeks.
AGAIN, FOLLOW INSTRUCTIONS¾BE
PATIENT¾DON'T START AND STOP THERAPY
ON YOUR OWN¾IF YOU HAVE QUESTIONS,
ASK YOUR DOCTOR.
To Help you Use the Medication Correctly, Keep These Simple
Instructions in Mind
Apply tretinoin cream,
gel, liquid or gel
with microspheres once daily before bedtime, or as directed by your
physician. Your physician
may advise, especially if your skin
is sensitive, that you start your therapy by applying tretinoin
every other night. First, wash
with a mild soap and dry
your skin gently. WAIT 20 TO
30 MINUTES BEFORE APPLYING MEDICATION; it is important for skin
to be completely dry in order
to minimize possible irritation.
It is better not to use more than the amount suggested by your
physician or to apply more frequently than instructed. Too much
medication may irritate
the skin, waste medication
and will not give faster
or better results.
Keep the medication
away from the corners of the nose, mouth, eyes and open wounds.
Spread it away from these areas when applying.
Gel with Microspheres: Squeeze about one inch or
less of medication
onto the fingertip. While this should be enough for your whole face,
after you have some experience
with the medication
you may find you need slightly
more or less of tretinoin. Cover the affected area lightly by first
dabbing it on your forehead, chin
and both cheeks, then spreading it over the entire
affected area. Smooth gently into the skin. Some patients may experience
a slight visible residue
of medication after
application.
Cream: Squeeze about a half inch or less of medication
onto the fingertip. While that should be enough for your whole face,
after you have some experience
with the medication
you may find you need slightly
more or less to do the job. The medication
should become invisible almost immediately. If it is still visible,
you are using too much. Cover the affected area
lightly with tretinoin
cream by first dabbing
it on your forehead, chin
and both cheeks, then spreading
it over the entire affected
area. Smooth gently into the skin.
Gel: Squeeze about a half inch or less of medication
onto the fingertip. While that should be enough for your whole face,
after you have some experience
with the medication
you may find you need slightly
more or less to do the job. The medication
should become invisible almost immediately. If it is still visible,
or if dry flaking occurs from the gel within a minute or so,
you are using too much. Cover the affected area lightly with tretinoin
gel by first dabbing it
on your forehead, chin and both cheeks, then spreading
it over the entire affected
area. Smooth gently into the skin.
Liquid: Tretinoin liquid
may be applied to the skin
where acne lesions appear, spreading
the medication over
the entire affected area,
using a fingertip, gauze
pad, or cottons swab. If gauze
or cotton is employed, care should be taken not to oversaturate
it to the extent that the liquid
would run into areas where
the treatment is not
intended (such as the corners of the mouth, eyes, and nose).
Cream, Gel and Liquid and Gel with Microspheres:
It is recommended that you apply a moisturizer or a moisturizer
with sunscreen that will
not aggravate your acne
(noncomedogenic) every morning after you wash.
What to Expect With Your New Treatment
Tretinoin gel works deep
inside your skin and this
takes time. You cannot make tretinoin
cream, gel, liquid, or gel
with microspheres work
any faster by applying more than one dose
each day, but an excess amount of tretinoin cream, gel, liquid
or gel with microspheres
may irritate your skin. Be patient.
There may be some discomfort or peeling
during the early days of treatment. Some patients also notice that
their skin begins to take
on a blush. These reactions do not happen to everyone. If they do,
it is just your skin adjusting
to tretinoin cream,
gel, liquid or gel
with microspheres and this usually subsides within two to four weeks.
These reactions can usually be minimized by following instructions
carefully. Should the effects become excessively troublesome, consult
your doctor.
By 3¾6 weeks, some patients may
notice an appearance
of new blemishes (papules and pustules). At
this stage it is important
to continue using tretinoin
cream, gel, liquid or
gel with microspheres.
If tretinoin is going
to have a beneficial effect
for you, you should notice a continued improvement in your appearance
after 6 to 12 weeks of therapy. Don't be discouraged if you see
no immediate improvement.
Don't stop treatment
at the first signs of improvement.
Once your acne is under
control you should continue
regular application
of tretinoin cream,
gel, liquid or gel
with microspheres until your physician instructs otherwise.
If You Have Questions
All questions of a medical
nature should be taken up with your doctor. For more information
about tretinoin cream,
gel, liquid or gel
with microspheres call the toll-free number: 800-426-7762. Call
between 9:00 a.m. and 3:00 p.m. Eastern Time, Monday through Friday.
Emollient Cream
What is the Most Important Information about Tretinoin Emollient
Cream?
Tretinoin emollient
cream is a serious medication.
It does not eliminate wrinkles or repair
sun-damaged skin. It may help treat fine wrinkles, spotty discoloration,
and rough feeling
skin, but it does not “cure” these conditions. Tretinoin emollient
cream should only be used
under supervision of your health care provider
as party of a broad skin
care program. This program should include avoiding direct sunlight
(by using protective
clothing and sunscreens
with a minimum SPF of
15) and using other moisturizing facial creams that do not contain
tretinoin.
You should use tretinoin
emollient cream
only at bedtime. Do not use drying skin
care products. Use the smallest amount of tretinoin
emollient cream needed and avoid getting it in your eyes, ears,
nose or mouth.
Warning: Do not use tretinoin
emollient cream
if you are pregnant
or attempting to become pregnant. Avoid sunlight and any other medicines
that may increase your sensitivity to sunlight. (See WHAT SHOULD
I AVOID WHILE USING TRETINOIN EMOLLIENT CREAM).
Tretinoin emollient
cream has not been
studied in people who are over 50 years of age
or in people with moderately or darkly pigmented skin.
What is Tretinoin Emollient Cream? (What Can I Expect from
Tretinoin Emollient Cream?)
Tretinoin emollient
cream is a serious medication
that may help treat but will
not “cure” fine wrinkles, spotty skin
discoloration, and rough feeling skin.
Studies wshow that after
24 weeks, about 30% of the people who used tretinoin emollient cream
for fine wrinkles or spotty discoloration had moderate improvement,
another 35% had minimal
improvement and 35% had no improvement. About 16% of the people
who used tretinoin
emollient cream
for rough skin had moderate
improvement, 35% had minimal
improvement, and 49% had no improvement. There is no evidence
that tretinoin emollient
cream treats coarse skin,
deep wrinkles, yellowing skin, or other skin
care problems.
Tretinoin emollient
cream should be used as
party of a broad skin
care program. This program
should include avoiding direct sunlight (by using protective clothing
and sunscreens with a minimum
SPF of 15) and using other moisturizing facial
creams that do not contain tretinoin. Many people can achieve desired
effects by using this program
without using tretinoin emollient cream. You should not use tretinoin
emollient cream
until you have tried a broad skin
treatment program
without tretinoin
emollient cream.
When you use tretinoin
emollient cream, improvement
in fine wrinkling, spotty skin
discoloration and rough
skin is not immediate
and occurs gradually over time. Generally, you may notice some effects
in 3 to 4 months. The effects are usually most noticeable at about
6 months with little additional improvement after that time. If
tretinoin emollient
cream treatment
is stopped, the improvement will
gradually diminish.
The safety of using tretinoin
emollient cream
daily for more than 48 weeks has not been established.
Who Should Not Use Tretinoin Emollient Cream
You should not use tretinoin
emollient cream
if you are sunburned or highly sensitive
to the sun, if you have eczema, or if your skin
is irritated. Tretinoin emollient
cream can cause
increased skin irritation
and increased susceptibility to sunburn.
Since tretinoin emollient
cream may make your skin
more sensitive to
sunlight, you should tell your health
care professional
if you are also using other medicines that increase sensitivity
to sunlight because you should not be using tretinoin
emollient cream
with these medicines. These include but are not limited to: thiazides
(used to treat high blood
pressure), tetracyclines, fluoroquinolones or sulfonamides (used
to treat infection), and phenothiazines
(used to treat serious emotional problems). If you are taking any
prescription medicines,
non-prescription medicines or using any facial
creams, check with a health
care professional
to make sure they do not interact with tretinoin
emollient cream.
Pregnancy Warning: Safe use during pregnancy has
not been shown. There are reports of birth
defects with laboratory animals and humans that were given tretinoin
by mouth. You should not use tretinoin
emollient cream if you are pregnant
or trying to become pregnant.
It is not known if tretinoin
emollient cream
is passed to infants through breast milk. Safe use in children has
not been shown.
The safety and effectiveness
of tretinoin emollient
cream for people over
age 50 or with darker skin
coloration has not been proven.
How Should I Use Tretinoin Emollient Cream
You should apply tretinoin
emollient cream
to your face once a day
before retiring using only enough to cover
the entire affected area
lightly. Gently wash your face
with a mild soap, pat the skin
dry, and wait 20 to 30 minutes before applying tretinoin
emollient cream. Apply
a pea-sized amount of cream to cover
your entire face. You
may feel a warmth or slight stinging when tretinoin
emollient cream
is first applied.
You must be especially careful when applying the cream
to avoid your eyes, ears, nostrils, or mouth. Tretinoin emollient
cream may cause
severe redness, itching, burning, stinging, and peeling
if applied to these areas.
Using larger than necessary amounts of tretinoin
emollient cream
will not speed results and can cause
an overdosage. An overdosage
can result in red and peeling
skin as well as some pain
or discomfort.
You may use cosmetics after applying tretinoin
emollient cream. Make
sure to clean your face
thoroughly before applying tretinoin
emollient cream again.
What Should I Avoid While Using Tretinoin Emollient Cream?
Tretinoin emollient
cream increases your sensitivity
to sunlight. Avoid sunlight as much as possible. Use protective
clothing and a sunscreen
with a minimum SPF of
15. Do not sunbathe or use sunlamps. If you are sensitive to sunlight
or have a job that requires you to be out in the sun for long periods,
you must use extreme caution.
While using tretinoin
emollient cream, avoid
any products that can dry or irritate the skin. For example, avoid
products applied to the skin
that contain alcohol, spices, or lime. Also, avoid cleansers, hair
removal, or other products that can irritate the skin.
What are the Possible Side Effects of Tretinoin Emollient
Cream?
The most common side effects
are skin reactions, itching,
red, and dry skin have been reported. So have burning, stinging,
and peeling skin. These
are most often mild and are most common when treatment
is started.
How Can I Get Additional Information?
This Patient Package Insert summarizes the most important information
about tretinoin emollient
cream. If you would like more information, talk to your doctor
or other health care provider.
There is also a leaflet written for health
care professionals that your pharmacist
can provide for you.
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