RETINO-A" Cream contains tretinoin in the following strengths by weight
0.025% & 0.05%
RETINO-A is a white cream.
RETINO-A is indicated as topical therapy for the treatment of acne vulgaris.
Posology and Method of Administration
RETINO-A should be applied once daily in the evening before bedtime in only
a sufficient quantity to lightly cover the entire affected areas. Prior to treatment
with RETINO-A areas being treated should be thoroughly cleansed with water
and a mild, non-medicated Soap. The treated area should be washed no more
than twice a day. After washing the skin should be dried gently and completely
without rubbing it. Areas of the Skin being treated should be allowed to dry for
at least 20 to 30 minutes before application of RETINO-A
Application of RETINO-A may cause a feeling of warmth and transitory
stinging. When administered according to recommended guidelines,
RETINO-A may produce a slight erythema similar to that of mild sunburn.
In cases where it is necessary to temporarily discontinue therapy or reduce
the frequency of application, therapy should be resumed or the frequency of
application increased when the patient becomes able to tolerate the treatment.
Frequency of application should be closely monitored by careful observation
or the clinical therapeutic response and skin tolerance
Excess application of RETINO-A" does not provide more rapid or better results.
In fact, marked redness, peeling or discomfort can occur. If excess application
occurs accidentally or through over-enthusiastic use, RETINO-A should be
discontinued for several days before resuming therapy
Therapeutic effects may be noticed after two to three weeks of use but more
than six weeks of therapy may be required before definite beneficial effects
are seen. During the early weeks of treatment, an apparent exacerbation of
inflammatory 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, Once a satisfactory response has been obtained, it may
be possible to maintain this improvement with less frequent applications.
Patients treated with RETINO-A may use cosmetics and moisturizers, but
the areas of the skin to be treated should be cleansed thoroughly before
application of RETINO-A (see section on Special warnings and special
precautions for use).
Safety and effectiveness have not been established in children.
Hypersensitivity to any component of this product.
Special Warnings and Special Precautions for Use
It is not recommended to initiate treatment with RETINO-A® or continue its
use in the presence of skin irritation (e.g. erythema, peeling. pruritus,
sunburn, etc.) until these symptoms subside.
In certain sensitive individuals, RETINO-A may induce severe local
erythema, swelling, pruritus, warmth, burning or stinging, blistering, crusting
and/or peeling at the site of application. If the degree of local irritation warrants
the patient should be instructed to either apply the medication less frequently
or discontinue its use temporarily
Tretinoin has been reported to cause severe irritation on eczematous skin and
should be used with utmost caution in patients with this condition. If a patient
experiences severe or persistent irritation, the patient should be advised to
discontinue application of RETINO-A completely, and if necessary, consult
In order to minimize the potential for additional skin irritation, RETINO-A
should be kept away from the eyes, the mouth, paranasal creases of the nose,
and mucous membranes or other areas where treatment is not intended.
Weather extremes, such as wind, cold and low humidity may be irritating to
skin treated with RETINO-A and may increase its dryness.
Patients will be able to remove hair as usual (e.g. plucking. electrolysis,
depilatories) but should avoid these procedures at night before applying
RETINO-A as they might result in skin irritation.
Permanent wave solutions, waxing preparations, medicated soaps and
Shampoos can sometimes irritate even normal skin. Caution should be used
so that these products do not come into contact with skin treated with
Exposure to Sunlight
Exposure to sunlight, including ultraviolet sunlamps, may provoke additional
irritation. Therefore, exposure should be avoided or minimized during the use
of Tretinoin. Patients with sunburn should be advised not to use the product
until fully recovered because of potential severe irritation to sensitive skin.
Patients who may be required to have considerable sun exposure due to their
Occupation, and those with inherent sensitivity to the sun, should exercise
particular caution. When exposure to sunlight cannot be avoided, use of
sunscreen products and protective clothing over treated areas is
Interactions with Other Medicinal Products and Other Forms of
The following products or medications should be used with caution because of possible interaction with Tretinoin. It is advised to allow the effects of such
preparations to subside before use of RETINO-A is begun:
Concomitant topical medication;
Preparations containing benzoyl peroxide, sulphur, resorcinol, or salicylic acid,
Toiletry preparations having an abrasive, drying, or desquamative effect,
including soaps, shampoos, cosmetics, and products with high
concentrations of alcohol, astringents, spices or lime
Pregnancy and Lactation
Use during pregnancy
Topical Tretinoin has not been shown to be teratogenic in Wistar rats and
rabbits when given in doses 1000 and 320 times the topical human dose,
respectively, assuming that a 50 kg adult applies 250 mg of 0.1% RETINO-A
cream topically. At these topical doses, however, a delayed ossification of
several bones occurred in rabbits. In rats, a dose-dependent increase of
supernumerary ribs was observed. These changes are considered variants of
normal development. The ossification changes are usually spontaneously
corrected after weaning.
There have been isolated reports of birth defects among babies born. to
women exposed to topical Tretinoin during pregnancy. To date, there have been
no adequate and well-controlled studies performed in pregnant women, and
the teratogenic blood level of Tretinoin is not known. However, a well-conducted
retrospective cohort study of babies born to women exposed to topical Tretinoin
during the first trimester of pregnancy found no excess birth defects among
these babies when compared to babies born to women in the same cohort
who were not similarly exposed. Nevertheless, topical Tretinoin should be
used during pregnancy only if the potential benefit justifies the potential risk
to the foetus (see section on Preclinical safety data).
[Oral Tretinoin has been shown to be teratogenic and fetotoxic in rats when
given in doses 2000 and 500 times the topical human dose, respectively
Use during lactation
It is not known whether this drug is excreted in human milk. Since many
drugs are excreted in human milk, caution should be exercised when
RETINO-A is administered to a nursing woman.
Effects on Ability to Drive and Use Machines
or operate machinery.
Use of RETINO-A is not known to affect the ability to drive a motor vehicle