INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo RETIN-A® 0,05% cream
RETIN-A® 0,025% gel

SCHEDULING STATUS:
Schedule 3.

PROPRIETARY NAME
(and dosage form):

RETIN-A® 0,05% cream
RETIN-A
® 0,025% gel

COMPOSITION:
Each one gram of cream contains 0,5 mg of the active ingredient
tretinoin and sorbic acid 0,2% m/m as preservative.
Each one gram of gel contains 0,25 mg of the active ingredient, tretinoin.

PHARMACOLOGICAL CLASSIFICATION:
A 13.12 Acne preparations.

PHARMACOLOGICAL ACTION:
Tretinoin has an inflammatory action which is reported to be related to its therapeutic activity. This inflammation appears to consist of an enlargement of vessels in the papillary body and a slight perivascular cellular infiltration. The inflammatory action may result from labialisation of lysosomes and the release of hydralases and proteases which are capable of inciting inflammatory reactions. It has been suggested that the therapeutic activity of tretinoin in the treatment of acne results from it increasing the rate of production of loose horny material. This increased production and resulting flow of dehiscing material to the surface prevents the impaction of horny material into comedones.

INDICATIONS:
RETIN-A is indicated for topical application in the treatment of hyperkeratotic follicular and related conditions such as acne vulgaris, primarily grades 1-111 in which comedones, papules and pustules predominate. It is not effective in most cases of severe pustular and deep cystic nodular varieties (acne conglobata).

CONTRA-INDICATIONS:
Use of RETIN-A should be discontinued if hyper-sensitivity to any of the ingredients is noted.

DOSAGE AND DIRECTIONS FOR USE:
Prior to treatment with RETIN-A, areas being treated should be thoroughly cleansed with water and a mild, non-medicated soap. The treated area should not be washed 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 RETIN-A.
Patients treated with RETIN-A may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
Astringent toiletries should be avoided.
RETIN-A should be applied once daily, before retiring, to the area of the skin where acne lesions occur. Only a sufficient quanity of medication should be applied to cover the affected areas lightly, using a gauze swab, cotton-wool or the tips of clean fingers. Oversaturation should be avoided since excess medication could run into the eyes, angles of the nose or other areas where treatment is not intended.
Application may cause a transitory feeling of warmth or slight stinging. When administered as directed, RETIN-A may produce a slight erythema similar to that of mild sunburn. In cases where it has been necessary to discontinue therapy temporarily, or reduce the frequency of application, therapy may be resumed or the frequency of application increased when the patients become able to tolerate the treatment.
Alterations of vehicle, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
During the early weeks of therapy, 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.
Therapeutic results should be noticed after two to three weeks. Results may not be optimal until after six weeks of therapy. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
It is not recommended to initiate treatment with RETIN-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, RETIN-A may induce severe local erythema, persistent dry skin, swelling, rash, 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. Temporary hyper- or hypo-pigmentation has been reported with repeated application of tretinoin.
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 RETIN-A completely and, if necessary, consult a physician.
Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with RETIN-A. Exposure to sunlight, including ultraviolet sunlamps, should be minimised during the use of RETIN-A and patients with sunburn should be advised not to use the products until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin.
Patients who may be required to have considerable sun exposure due to their occupation should exercise particular caution. When exposure to sunlight cannot be avoided, use of sunscreen products and protective clothing over treated areas is recommended. To date, generally adverse effects have been reversible upon discontinuation of therapy.
Concomitant topical medication should be used with caution, because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing peeling agents (such as sulphur, resorcinol, benzoyl peroxide or salicylic acid) with RETIN-A. It is also advisable to "rest" a patient's skin until the effects of peeling agents subside before use of RETIN-A is begun.
Similar precautions are advisable with regard to the use of medicated or abrasive soaps and cleaners, soaps and cosmetics that have a strong drying effect, permanent wave solutions, waxing preparations and products with high concentrations of alcohol, astringents, spices or lime. Caution should be used so that these products do not come in contact with skin treated with RETIN-A.
Patients will be able to remove hair as usual (e.g. plucking, electrolysis, depilatories), but should avoid these procedures at night before applying RETIN-A, as they might result in skin irritation.
Excessive medication will not produce more rapid or better results, but marked redness, peeling or discomfort may occur. If excess application occurs accidently or through overenthusiastic use, RETIN-A should be discontinued for several days before resuming therapy.
RETIN-A should be kept away from the eyes, the mouth, angles of the nose and mucous membranes.
Oral tretinoin has been shown to be teratogenic in a wide variety of animals. Limited animal data urge caution in the use of preparations containing tretinoin during the first trimester of pregnancy.
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 prospective studies performed in pregnant women and the teratogenic blood level of tretinoin is not known. Topical tretinoin should be used during pregnancy only the potential benefit justifies the potential risk to the foetus. If an eventual pregnancy occurs the patient should inform her doctor.
It is not known whether tretinoin is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when RETIN-A is administered to a nursing mother.
Safety and effectiveness have not been established in children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Topical application of RETIN-A is characterised by little systemic absorption, hence overdosage is unlikely.
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. Oral ingestion of RETIN-A may lead to the same adverse events associated with excessive intake of Vitamin A.

IDENTIFICATION:
Yellow, oil-in-water cream, having a faint waxy odour.
Smooth, clear viscous yellow gel, having an odour of alcohol.

PRESENTATION:
RETIN-A 0,05% cream and 0,025% gel are packed in screw-capped aluminium tubes containing 20 g.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
RETIN-A 0,05% cream: F/13.12/106
RETIN-A 0,025% gel: J/13.12/350

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN - CILAG
Janssen Pharmaceutica (Pty) Ltd
(Reg. No. 80/11122/07)
15th Road,
Halfway House, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
RETIN-A 0,05% cream: 9 October 1973
RETIN-A 0,025% gel: 30 June 1977

® Trademark                Code No.: 023340
                        97B
Britepak

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