Source: Health Products and Food Branch (CA) Revision Year: 2021
STIEVA-A (tretinoin 0.01%, 0.025%, or 0.05% w/w) is indicated in the treatment of acne vulgaris, primarily where comedones, papules and pustules predominate. STIEVA-A is not effective in most cases of severe pustular and deep cystic nodular varieties (acne conglobata).
Safety and effectiveness of STIEVA-A in patients aged 65 years and above have not been established.
Safety and effectiveness of STIEVA-A in patients below the age of 12 years have not been established.
STIEVA-A cream is for topical use only.
Because of increased sensitivity of ultraviolet radiation associated with the use of tretinoin, patients should be instructed to use a broad spectrum sunscreen with an SPF of at least 15, to re-apply sunscreen regularly and to wear protective clothing (see PRECAUTIONS).
STIEVA-A should be applied sparingly to the affected area once a day before bedtime for up to 12 weeks.
Therapeutic results may be noticed after two to three weeks of therapy; however, results may not be optimal until after eight to ten weeks of treatment. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improved state with less frequent applications; however, a maintenance dose has not been studied or established.
Excessive application will not improve efficacy, but may increase the risk of severe irritation.
The efficacy and safety of STIEVA-A has not been studied beyond 12 weeks in acne vulgaris clinical trials.
During the first three weeks of treatment, STIEVA-A may be applied every second day to allow the patient’s skin to adjust to the medication, especially for patients with sensitive skin and/or a fair complexion.
Formulation strength should be selected and adjusted according to the patient’s tolerance.
In case of an apparent exacerbation of the acne lesions during early weeks of therapy, dosing frequency may be reduced or a lower strength of STIEVA-A may be used (see PRECAUTIONS).
Concomitant medicated and non-medicated therapies should be used with caution (see DRUG INTERACTIONS).
In cases of undue skin irritation (redness, peeling, or discomfort), a moisturiser may be used as needed, the frequency of application should be reduced (e.g., application every other day), use a lower strength of the product, if applicable, or temporarily interrupt treatment. The normal frequency of application should be resumed once the skin irritation subsides. Treatment should be discontinued if skin irritation persists.
Renal impairment: No dosage adjustment is necessary.
Hepatic impairment: No dosage adjustment is necessary.
The area under treatment (not just clinical lesions) should be thoroughly cleansed with a mild soap or cleanser, and dried, followed by application of STIEVA-A with a gentle application. Hands should be washed before and after application. Application may be accompanied by a transitory feeling of warmth or a stinging sensation. Patients may also use a moisturiser as needed.
Do not apply STIEVA-A to eyelids or to the skin at the corners of the eyes and mouth. Avoid the angles of the nose, skin fold areas and nasolabial fold. If treatment in these areas is necessary, apply very sparingly. Caution should be used when applying to sensitive areas of skin, such as the neck, abraded or eczematous skin, or in patients with inflammatory skin conditions that coexist with acne (see WARNINGS).
Do not use near an open flame (see PRECAUTIONS).
Patients being treated with STIEVA-A may continue to use water-based, noncomedogenic, hypoallergenic and oil-free cosmetics. Following application of STIEVA-A, the patient should be instructed to allow the skin to dry before applying cosmetics (see DRUG INTERACTIONS).
If combination therapy is required, consideration should be given to applying the products at different times of the day (e.g. one in the morning and the other in the evening (see DRUG INTERACTIONS).
If patients forget to take a dose of STIEVA-A, they should be instructed to apply the next dose at the usual time. Patients should be instructed to not apply a double dose to make up for forgotten doses.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
If topical medication is applied excessively, marked redness, peeling or discomfort may occur. If severe irritation occurs, suspend treatment and appropriate symptomatic measures should be taken.
In case of accidental ingestion, a symptomatic and supportive treatment should be instituted. Inadvertent oral ingestion of STIEVA-A cream may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A including teratogenesis in women of childbearing years. Therefore, in such cases, pregnancy testing should be carried out in women of childbearing years.
Recommendations: Store between 15ºC and 30ºC. Do not freeze. Keep the tube tightly closed when not in use. Keep out of the sight and reach of children.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
