|
 |
|
RENOVA
RENOVA ONLINE
Before Using This Medicine
In deciding to use a medicine, the risks of using the medicine
must be weighed against the good it will do. This is a decision
you and your doctor will make. For tretinoin, the following should
be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to acitretin, etretinate,
isotretinoin, tretinoin, or vitamin A preparations. Also tell your
health care professional if you are allergic to any other
substances, such as preservatives or dyes.
Pregnancy—Tretinoin has not been studied in
pregnant women. Topical tretinoin is not recommended during
pregnancy. Topical tretinoin has been shown to cause delayed bone
development in some animal fetuses. Before using this medicine,
make sure your doctor knows if you are pregnant or if you may
become pregnant.
Breast-feeding—It is not known whether
tretinoin passes into the breast milk. Mothers who are using this
medicine and who wish to breast-feed should discuss this with
their doctors.
Children—Studies on this medicine have been
done only in adult patients, and there is no specific information
comparing use of this medicine in children with use in other age
groups. Children are unlikely to have skin problems due to the
sun. In older children treated for acne, tretinoin is not expected
to cause different side effects or problems than it does in other
age groups.
Older adults—Many medicines have not been
studied specifically in older people. Therefore, it may not be
known whether they work exactly the same way they do in younger
adults or if they cause different side effects or problems in
older people. There is no specific information comparing use of
tretinoin in patients 50 years of age and older with use in other
age groups.
Other medicines—Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other
precautions may be necessary. Tell your health care professional
if you are using any other topical prescription or nonprescription
(over-the-counter [OTC]) medicine that is to be applied to the
same area of the skin. When you are using topical tretinoin, it is
especially important that your health care professional know if
you are taking any of the following:
 | Acitretin (e.g., Soriatane) |
| Etretinate (e.g., Tegison) |
| Tretinoin, oral (e.g., Vesanoid)—May increase chance of
getting severe dryness or redness of skin |
Proper Use of This Medicine
It is very important that you use this medicine only as
directed. Do not use more of it, do not use it more often,
and do not use it for a longer time than your doctor ordered. To
do so may cause irritation of the skin.
Do not apply this medicine to windburned or sunburned skin
or on open wounds.
Do not use this medicine in or around the eyes or lips, or
inside of the nose. Spread the medicine away from these areas
when applying. If the medicine accidentally gets on these areas,
wash with water at once.
This medicine usually comes with patient directions. Read them
carefully before using the medicine.
Before applying tretinoin, wash the skin with a mild soap or
cleanser and warm water by using the tips of your fingers. Then
gently pat dry. Do not scrub your face with a sponge or washcloth.
Wait 20 to 30 minutes before applying this medicine to make
sure the skin is completely dry. Applying tretinoin to wet
skin can irritate the skin.
To use the cream or gel form of this medicine:
| Apply just enough medicine to very lightly cover the
affected areas, and rub in gently but well. A pea-sized amount
is enough to cover the whole face. |
To use the solution form of this medicine:
| Using your fingertips, a gauze pad, or a cotton swab, apply
enough tretinoin solution to cover the affected areas. If you
use a gauze pad or a cotton swab for applying the medicine,
avoid getting it too wet. This will help prevent the medicine
from running into areas not intended for treatment. |
After applying the medicine, wash your hands to remove any
medicine that might remain on them.
Dosing—
The dose of topical tretinoin will be different for different
patients. Follow your doctor's orders or the directions on the
label. The following information includes only the average
dose of topical tretinoin. If your dose is different, do not
change it unless your doctor tells you to do so.
| For topical dosage forms (cream, gel, or solution):
| For acne:
| Adults and teenagers—Apply to the affected area(s)
of the skin once a day, at bedtime. |
|
| For cream dosage form (brand name Renova
only):
| For fine wrinkles, dark spots, or rough skin caused by
the sun:
| Adults up to 50 years of age—Apply to the affected
area(s) of the skin once a day, at bedtime.
| Adults 50 years of age and older—Use and dose must
be determined by your doctor. |
|
|
|
|
Missed dose—
If you miss a dose of this medicine, skip the missed dose and
go back to your regular dosing schedule. Do not double doses.
Storage—
To store this medicine:
| Keep out of the reach of children.
| Store away from heat and direct light. The gel product is
flammable and should be kept away from fire or excessive heat.
| Keep the medicine from freezing.
| Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children. |
| | |
Precautions While Using This Medicine
During the first 3 weeks you are using tretinoin, your skin may
become irritated. Also, your acne may seem to get worse before it
gets better. It may take longer than 12 weeks before you notice
full improvement of your acne, even if you use the medicine every
day. Check with your health care professional at any time skin
irritation becomes severe or if your acne does not improve within
8 to 12 weeks.
You should avoid washing the skin treated with tretinoin for at
least 1 hour after applying it.
Avoid using any topical medicine on the same area within 1
hour before or after using tretinoin. Otherwise, tretinoin
may not work properly or skin irritation might occur.
Unless your doctor tells you otherwise, it is especially
important to avoid using the following skin products on the same
area as tretinoin:
| Any other topical acne product or skin product containing a
peeling agent (such as benzoyl peroxide, resorcinol, salicylic
acid, or sulfur)
| Hair products that are irritating, such as permanents or
hair removal products
| Skin products that cause sensitivity to the sun, such as
those containing spices or limes
| Skin products containing a large amount of alcohol, such as
astringents, shaving creams, or after-shave lotions
| Skin products that are too drying or abrasive, such as some
cosmetics, soaps, or skin cleansers |
| | | |
Using these products along with tretinoin may cause mild to
severe irritation of the skin. Although skin irritation can occur,
some doctors sometimes allow benzoyl peroxide to be used with
tretinoin to treat acne. Usually tretinoin is applied at night so
that it does not cause a problem with any other topical products
that you might use during the day. Check with your doctor before
using topical medicines with tretinoin.
During the first 6 months of use, avoid overexposing the
treated areas to sunlight, wind, or cold weather. The skin
will be more prone to sunburn, dryness, or irritation, especially
during the first 2 or 3 weeks. However, you should not stop using
this medicine unless the skin irritation becomes too severe. Do
not use a sunlamp .
To help tretinoin work properly, regularly use sunscreen or
sunblocking lotions with a sun protection factor (SPF) of at least
15. Also, wear protective clothing and hats, and apply creams,
lotions, or moisturizers often.
Check with your doctor at any time your skin becomes too dry
and irritated. Your health care professional can help you choose
the right skin products for you to reduce skin dryness and
irritation and may include the following:
| For patients using tretinoin for the treatment of acne:
| Regular use of water-based creams or lotions helps to
reduce skin irritation or dryness that may be caused by
the use of tretinoin. |
| For patients using tretinoin for the treatment of fine
wrinkling, dark spots, and rough skin caused by the sun:
| This medicine should be used as part of an ongoing
program to avoid further damage to your skin from the
sun. This program includes staying out of the sun when
possible or wearing proper clothing or hats to protect
your skin from sunlight.
| Regular use of oil-based creams or lotions helps to
reduce skin irritation or dryness caused by the use of
tretinoin. |
|
|
|
Side Effects of This Medicine
In some animal studies, tretinoin has been shown to cause skin
tumors to develop faster when the treated area is exposed to
ultraviolet light (sunlight or artificial sunlight from a
sunlamp). Other studies have not shown the same result and more
studies need to be done. It is not known if tretinoin causes skin
tumors to develop faster in humans.
Along with its needed effects, a medicine may cause some
unwanted effects. Although not all of these side effects may
occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the
following side effects occur:
| More common
| Burning feeling or stinging skin (severe);
lightening of skin of treated area, unexpected;
peeling of skin (severe); redness of skin (severe) ;
unusual dryness of skin (severe) |
|
| Rare
| Darkening of treated skin |
|
Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment as your
body adjusts to the medicine. However, check with your doctor if
any of the following side effects continue or are bothersome:
| More common
| Burning feeling, stinging, or tingling of skin
(mild)—lasting for a short time after first applying the
medicine; chapping or slight peeling of skin (mild);
redness of skin (mild); unusual dryness of skin
(mild); unusually warm skin (mild) |
|
The side effects will go away after you stop using tretinoin.
On the rare chance that your skin color changes, this effect may
last for several months before your skin color returns to normal.
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketing for a certain
use, experience may show that it is also useful for other medical
problems. Although this use is not included in product labeling,
tretinoin is used in certain patients with the following medical
conditions:
| Keratosis follicularis (skin disorder of small, red bumps)
| Verruca plana (flat warts) |
|
Other than the above information, there is no additional
information relating to its proper use, precautions, or side
effects for these uses.
|
|
|
