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 Indications, Dosage, Storage, Stability - Tretinoin (topical)
Retin A Indications, Dosage, Storage, Stability - Tretinoin (topical)
INDICATIONS
Cream, Gel, Liquid and Gel with Microspheres: Tretinoin
is indicated for topical
application in the treatment
of acne vulgaris. The safety
and efficacy of this product
in the treatment of
other disorders have not been established.
Emollient Cream: (To understand fully the indication
for this product, please read the entire
INDICATIONS
and USAGE section of the monograph.)
Tretinoin emollient
cream is indicated as
an adjunctive agent (see
second bullet point below)
for use in the mitigation (palliation) of fine wrinkles,
mottled hyperpigmentation, and tactile
roughness of facial skin
in patients who do not achieve such palliation using comprehensive
skin care and sun avoidance
programs alone (see bullet point
3 for populations in which effectiveness
has not been established). TRETINOIN EMOLLIENT CREAM DOES NOT
ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING,
or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN.
Many patients achieve desired palliative
effects on fine wrinkling, mottled hyperpigmentation, and tactile
roughness of facial skin
with the use of comprehensive skin
care and sun avoidance
programs including sunscreens, protective clothing, and emollient
creams NOT containing tretinoin.
- Tretinoin emollient
cream has demonstrated
NO MITIGATING EFFECT on significant signs of chronic
sun exposure such
as coarse or deep wrinkling, skin
yellowing, lentigines, telangiectasia, skin
laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
- Tretinoin emollient
cream should only be
used under medical
supervision as an adjunct
to a comprehensive skin
care and sun avoidance
program that includes
the use of effective sunscreens (minimum SPF of 15) and protective
clothing when desired results on fine wrinkles, mottled hyperpigmentation,
and roughness of facial
skin care have not been
achieved with a comprehensive skin care and sun avoidance
program alone.
- The effectiveness
of tretinoin emollient
cream in the mitigation
of fine wrinkles, mottled hyperpigmentation, and tactile
roughness of facial skin has not been established in people greater
than 50 years of age OR
in people with moderately to heavily pigmented
skin. In addition, patients
with visible actinic
keratoses and patients with a history of skin
cancer were excluded from clinical
trials of tretinoin
emollient cream.
Thus the effectiveness and safety of tretinoin
emollient cream
in these populations are not known at this time.
- Neither the safety nor the effectiveness
of tretinoin emollient
cream for the prevention
or treatment of
actinic keratoses
or skin neoplasms has
been established.
- Neither the safety nor the efficacy of using tretinoin
emollient cream
daily for greater than 48 weeks has been established, and daily
use beyond 48 weeks has not been systemically and histologically
investigated in adequate and well-controlled trials. (See WARNINGS).
DOSAGE AND ADMINISTRATION
Cream, Gel, Liquid and Gel with Microspheres
Tretinoin Gel, Cream or Liquid should be applied once a day, in
the evening, or before retiring, to the skin
where acne lesions appear,
using enough to cover
the entire affected area
lightly.
Liquid: The liquid
may be applied using a fingertip, gauze pad, or cotton
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
treatment is not intended.
Gel: Excessive application results in "pilling"
of the gel, which minimizes the likelihood of over application by
the patient. Application of excessive amounts of gel
may result in “caking” of the gel, and will
not provide incremental efficacy.
Application may cause
a transitory feeling
of warmth or slight stinging. In cases where it has been necessary
to temporarily discontinue therapy or to reduce
the frequency of application, therapy may be resumed or frequency
of application increased when the patients become able to tolerate
the treatment.
Alterations of vehicle, drug
concentration, or dose
frequency should be closely monitored by careful observation of
the clinical therapeutic
response and skin tolerance.
Efficacy has not been established for less than once-daily dosing
frequencies.
During the early weeks of therapy, an apparent increase
in number and exacerbation
of inflammatory acne lesions
may occur. This is due to the action
of the medication
on deep, previously unseen lesions and should not be considered
a reason to discontinue therapy. Therapeutic results should be noticed
after two to three weeks but more than six weeks of therapy may
be required before definite beneficial effects are seen.
Once the acne lesions
have responded satisfactorily, it may be possible to maintain the
improvement with less frequent applications, or other dosage forms.
Patients treated with tretinoin
acne treatment
may use cosmetics, but the areas to be treated should be cleansed
thoroughly before the medication is applied (See PRECAUTIONS).
Therapeutic results may be noticed after two weeks, but more than
seven weeks of therapy are required before consistent beneficial
effects are observed.
Emollient Cream
- Do NOT use tretinoin
emollient cream
if the patient is
pregnant or is attempting
to become pregnant
or is at high risk of
pregnancy.
- Do NOT use tretinoin
emollient cream
if the patient is
sunburned or if the patient
has eczema or other
chronic skin
condition(s).
- Do NOT use tretinoin
emollient cream
if the patient is
inherently sensitive to sunlight.
- Do NOT use tretinoin
emollient cream
if the patient is
also taking drugs known to be photosensitizers (e.g., thiazides,
tetracyclines, fluoroquinolones, phenothiazines, sulfonamides)
because of the possibility of augmented phototoxicity.
Patients require detailed instruction
to obtain maximal benefits and to understand all the precautions
necessary to use this product
with greatest safety. The physician
should review the PATIENT PACKAGE INSERT, Emollient Cream.
Tretinoin emollient
cream should be applied
to the face once a day
before retiring using only enough to cover
the entire affected area
lightly. Patients should gently wash
their face with a mild
soap, pat the skin dry,
and wait 20 to 30 minutes before applying tretinoin
emollient cream. The
patient should apply a pea-sized amount of cream
to cover the entire
face lightly. Special caution
should be taken when applying the cream
to avoid the eyes, ears, nostrils, and mouth.
Application of tretinoin
emollient cream
may cause a transitory
feeling of warmth or slight stinging.
Mitigation (palliation) of facial
fine wrinkling, mottled hyperpigmentation and tactile
roughness may occur gradually over the course of therapy. Up to
6 months of therapy may be required before the effects are seen.
Most of the improvement noted with tretinoin
emollient cream
is seen during the first 24 weeks of therapy. Thereafter, therapy
primarily maintains the improvement realized during the first 24
weeks.
With discontinuation of tretinoin
emollient cream
therapy, a majority of patients will
lose most mitigating effects of tretinoin
emollient cream on
fine wrinkles, mottled hyperpigmentation, and tactile
roughness of facial skin; however, the safety and effectiveness
of using tretinoin
emollient cream for greater than 48 weeks have not been established.
Application of larger amounts of medication
than recommended will not
lead to more rapid or better results, and marked redness, peeling,
or discomfort may occur.
Patients treated with tretinoin
emollient cream
may use cosmetics but the areas to be treated should be cleansed thoroughly
before the medication is applied. (See PRECAUTIONS).
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