TRETINOIN CREAM USP
Retino - A O.05%
COMPOSITION
RETINO-A® 0.05% Cream contains
Tretinoin - 0.05%
PHARMACEUTICAL FORM
RETINO-A® 0.05% is a white cream.
Therapeutic Indications
RETINO-A® 0.05% is indicated as topical therapy for the treatment of acne vulgaris.
Method of Administration
Adults
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 treate with RETINO-A® 0.05% 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 compleleiy without rubbing it. Areas of the skin being treated should be allowed tO dry ro at least 20 to 30 minutes before application of RETINO-A® 0.05% Cream.
Application of RETINO-A® 0.05% may cause a feeling of warmth and transitory stinging. When administered according to recommended guidelines,
RETINO-A® 0.05% 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
of the clinical therapeutic response and skin tolerance.
Excess application of RETINO-A® 0.05% 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® 0.05% 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® 0.05% may use cosmetics and moisturizers, but the areas of the skin to be treated should be cleansed thoroughly before application of RETINO-A® 0.05% Cream.
Children
Safety and effectiveness have not been established in children.
Contraindications
Hypersensitivity to any component of this product.
Special Warnings and Special Precautions for Use Local Irritation
It is not recommended to initiate treatment with RETINO-A® 0.05% cream 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® 0.05% cream 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® 0.05% cream completely, and if necessary, consult
a physician. in order to minimize the potential for additional skin irritation, RETINO-A® 0.05% cream 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® 0.05% cream 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® 0.05% cream 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 RETINO-A® 0.05% cream.
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 recommended.
Interactions with Other Medicinal Products and Other Forms of Interaction
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® 0.05% cream is begun :
- Concomitant topical medication;
- Preparations containing benzoyl peroxide, sulfur, 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 borm 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 fetus.
[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® 0.05% cream is administered to a nursing woman.
Effects on Ability to Drive and Use Machines
Use of RETINO-A® 0.05% cream is not known to affect the ability to drive a motor vehicle
or operate machinery.
Undesirable Effects
Clinical Trial Data
The safety of tretinoin topical formulations including RETINO-A® 0.05% cream was
evaluated in 4160 patients (of whom 3035 were treated with topical tretinoin
and 1125 received placebo) who participated in 23 clinical trials, including
4 open-label and 19 double-blind, placebo-controlled clinical trials. The 23 clinical
trials evaluated the safety of tretinoin in male and female patients, 10 to 79 years
of age with photodamaged skin or acne vulgaris.
Skin and Subcutaneous Tissue Disorders
Swelling face
Blister
Skin discolouration
Skin hyperpigmentation
Skin hypopigmentation
Skin burning sensation
General Disorders and Administration Site Conditions
Feeling hot
Overdose
RETINO-A® 0.05% cream is intended for topical use only. Excessive application of
RETINO-A® 0.05% cream does not improve the results of treatment and may induce of
marked irritation, e.g., erythema, peeling, pruritus, etc. Oral ingestion of large
amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A (e.g., pruritus, dry skin, arthralgias, anorexia, vomiting). In the event of accidental ingestion, if the ingestion is
recent, the stomach should be emptied immediately by gastric lavage or by
induction of emesis. All other treatment should be appropriately supportive.
PHARMACOLOGICAL PROPERTIES
Tretinoin, all-trans-retinoic acid, is a derivative of vitamin A.
Shelf Life : See on pack
Special Precautions for Storage :
Store below 25°C, protected from light. Do not Freeze. Replace Cap immediately.
FOR EXTERNAL USE ONLY
Presentation :
20 g Aluminium collapsible tube
Marketed by :
Johnson & Johnson Private Limited
Registered Trademark of Johnson & Johnson U.S.A.
Retino - A O.05%
COMPOSITION
RETINO-A® 0.05% Cream contains
Tretinoin - 0.05%
PHARMACEUTICAL FORM
RETINO-A® 0.05% is a white cream.
Therapeutic Indications
RETINO-A® 0.05% is indicated as topical therapy for the treatment of acne vulgaris.
Method of Administration
Adults
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 treate with RETINO-A® 0.05% 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 compleleiy without rubbing it. Areas of the skin being treated should be allowed tO dry ro at least 20 to 30 minutes before application of RETINO-A® 0.05% Cream.
Application of RETINO-A® 0.05% may cause a feeling of warmth and transitory stinging. When administered according to recommended guidelines,
RETINO-A® 0.05% 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
of the clinical therapeutic response and skin tolerance.
Excess application of RETINO-A® 0.05% 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® 0.05% 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® 0.05% may use cosmetics and moisturizers, but the areas of the skin to be treated should be cleansed thoroughly before application of RETINO-A® 0.05% Cream.
Children
Safety and effectiveness have not been established in children.
Contraindications
Hypersensitivity to any component of this product.
Special Warnings and Special Precautions for Use Local Irritation
It is not recommended to initiate treatment with RETINO-A® 0.05% cream 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® 0.05% cream 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® 0.05% cream completely, and if necessary, consult
a physician. in order to minimize the potential for additional skin irritation, RETINO-A® 0.05% cream 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® 0.05% cream 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® 0.05% cream 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 RETINO-A® 0.05% cream.
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 recommended.
Interactions with Other Medicinal Products and Other Forms of Interaction
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® 0.05% cream is begun :
- Concomitant topical medication;
- Preparations containing benzoyl peroxide, sulfur, 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 borm 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 fetus.
[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® 0.05% cream is administered to a nursing woman.
Effects on Ability to Drive and Use Machines
Use of RETINO-A® 0.05% cream is not known to affect the ability to drive a motor vehicle
or operate machinery.
Undesirable Effects
Clinical Trial Data
The safety of tretinoin topical formulations including RETINO-A® 0.05% cream was
evaluated in 4160 patients (of whom 3035 were treated with topical tretinoin
and 1125 received placebo) who participated in 23 clinical trials, including
4 open-label and 19 double-blind, placebo-controlled clinical trials. The 23 clinical
trials evaluated the safety of tretinoin in male and female patients, 10 to 79 years
of age with photodamaged skin or acne vulgaris.
Skin and Subcutaneous Tissue Disorders
Swelling face
Blister
Skin discolouration
Skin hyperpigmentation
Skin hypopigmentation
Skin burning sensation
General Disorders and Administration Site Conditions
Feeling hot
Overdose
RETINO-A® 0.05% cream is intended for topical use only. Excessive application of
RETINO-A® 0.05% cream does not improve the results of treatment and may induce of
marked irritation, e.g., erythema, peeling, pruritus, etc. Oral ingestion of large
amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A (e.g., pruritus, dry skin, arthralgias, anorexia, vomiting). In the event of accidental ingestion, if the ingestion is
recent, the stomach should be emptied immediately by gastric lavage or by
induction of emesis. All other treatment should be appropriately supportive.
PHARMACOLOGICAL PROPERTIES
Tretinoin, all-trans-retinoic acid, is a derivative of vitamin A.
Shelf Life : See on pack
Special Precautions for Storage :
Store below 25°C, protected from light. Do not Freeze. Replace Cap immediately.
FOR EXTERNAL USE ONLY
Presentation :
20 g Aluminium collapsible tube
Marketed by :
Johnson & Johnson Private Limited
Registered Trademark of Johnson & Johnson U.S.A.