It is indicated for topical application in the treatment of acne.

Avotin-A Cream is used once daily to the area of skin where acne lesions occur.
The area of skin to be treated should be washed with water and a mild non-medicated soap. But not 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 completely by waiting for 20-30 minutes before application of Avotin-A 0.05% Cream.
Cosmetics and moisturizers may be used during the treatment with Avotin-A 0.05% Cream but the areas of the skin to be treated should be washed thoroughly before the application. Astringent cosmetics should be avoided.Avotin-A 0.05% Cream is applied in a thin layer once daily. Medication is applied to the entire area, not just to individual lesions. An amount of a pea is enough for a full facial application. Patient with a sensitive skin or those living in cold, dry climates may start with an application every other or every third day. The corners of nose, the mouth and the eyes should be avoided; these areas are the most sensitive and the most easily irritated. Tretinoin is applied to the chin less frequently during the initial stages of therapy; the chin is sensitive and is usually the first area to become red and scaly. Sunscreens should be used during the summer months if exposure is anticipated.
Response to Treatment:
Therapeutic effect 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 on deep, previously unseen lesions and should not be consider a reason to discontinue therapy.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of Avotin-A cream, and patients with sunburn should be advised not to use the product 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 occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with Avotin-A cream.
Avotin-A cream acne treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with Avotin-A Cream. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with Avotin-A Cream. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of Avotin-A Cream is begun.

Pregnancy:
Oral tretinoin has been shown to be teratogenic in rats when given in doses 1000 times the topical human dose. Oral tretinoin has been shown to be fetotoxic in rats when given in doses 500 times the topical human dose. Topical tretinoin has not been shown to be teratogenic in rats and rabbits when given in doses of 100 and 320 times the topical human dose, respectively (assuming a 50 kg adult applies 250 mg of 0.1% cream topically). However, at these topical doses, delayed ossification of a number of bones occurred in both species. These changes may be considered variants of normal development and are usually corrected after weaning. There are no adequate and well-controlled studies in pregnant women. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breast-feeding:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when Avotin-A cream is administered to a nursing woman.

None stated.

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical Avotin-A Cream is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of Avotin-A Cream . Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with Avotin-A Cream.
To reports any side effect(s):
- Saudi Arabia:
The National Pharmacovigilance Centre (NPC) :
• SFDA call center: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa
• Other GCC States:
- Please contact the relevant competent authority

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

None Known

Long-term animal studies to determine the carcinogenic potential of tretinoin have not been performed. Studies in hairless albino mice suggest that tretinoin may accelerate the tumorigenic potential of weakly carcinogenic light from a solar simulator. In other studies, when lightly pigmented hairless mice treated with tretinoin were exposed to carcinogenic doses of UVB light, the incidence and rate of development of skin tumors was reduced. Due to significantly different experimental conditions, no strict comparison of these disparate data is possible. Although the significance of these studies to man is not clear, patients should avoid or minimize exposure to sun.

Ceteareth -6 and Stearyl Alcohol
Ceteareth 25
Glyceryl Monostearate
Cetyl Alcohol
Vaseline
Yellow Beeswax
Cetearyl Octanoate
Imidurea
Methylparaben
Propylparaben
Propylene Glycol
Titanium Dioxide
Butylated Hydroxyanisole
Purified Water

Not Applicable.

Store below 30°C,away from direct light.

Collapsible aluminum tubes with HDPE plastic screw cap.
Pack size: 30g

No special requirements
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.