Full Prescribing Info
Fluocinolone acetonide.
APLOSYN-25 CREAM: Each g contains 250 mcg (0.025%) Fluocinolone acetonide in a water-washable aqueous base, with methyl and propyl paraben as preservatives.
APLOSYN-25 OINTMENT: Each g contains 250 mcg (0.025%) Fluocinolone acetonide in an ointment base.
APLOSYN-10 CREAM: Each g contains 100 mcg (0.01%) Fluocinolone acetonide in a water-washable aqueous base, with methyl and propyl paraben as preservatives.
APLOSYN-10 OINTMENT: Each g contains 100 mcg (0.01%) Fluocinolone acetonide in an ointment base.
APLOSYN OINTMENT is a mixture of wool fat, propylene glycol and white soft paraffin.
APLOSYN CREAMS employ a specially formulated hydrophilic base which is odorless, non-staining, and cosmetically appealing to the most particular patient. This finely micronized base provides quick release of the steroid facilitating onset of action. Its pH is close to that of the skin (5.6-5.7) thus preventing irritation and helping the skin renew and heal itself.
APLOSYN OINTMENT provides an emollient and water-protective base.
APLOSYN CREAMS and OINTMENTS provide maximum effectiveness and have shown no demonstrable risk of toxic reactions. The 0.01% and 0.25% Creams are more potent and significantly more effective than hydrocortisone 1.0% Cream. In relation to other corticosteroids used topically, APLOSYN has proved as effective as all and in many instances, effective even in cases where other agents gave an inadequate therapeutic response or other agents have failed. Numerous types of eczematous dermatoses which have not responded to other topical corticosteroids have been reported responsive to application of APLOSYN. With modified techniques of application, as mentioned below, highly refractory lesions such as those of psoriasis and other chronic dermatoses are amenable to treatment with APLOSYN. Repeated insult patch test of the base in the Creams, applied and reapplied to 200 patients over a total of three weeks, did not produce primary or allergic sensitivity. APLOSYN has the chemical formula 6α19α dilluoro - 16α hydroxyprednisolone 16, 17 acetonide. The cream has a water-washable aqueous base of stearic acid, with methyl and propylparaben as preservatives.
Pharmacology: Pharmacodynamics and Pharmacokinetics: Fluocinolone acetonide (Aplosyn) is a synthetic anti-inflammatory corticosteroid that produces vasoconstriction and suppression of membrane permeability, mitotic activity, immune response and release of inflammatory mediators in the body.
Independently of the route of administration, the systemic absorption of Fluocinolone acetonide (Aplosyn) is below 0.1 ng/ml which indicates that the systemic distribution is very minimal and the effect of fluocinolone is mainly local. Following absorption, fluocinolone acetonide (Aplosyn) metabolism is primarily hepatic. The reported half-life of fluocinolone acetonide ranges between 1.3-1.7 hours. Fluocinolone acetonide (Aplosyn) is mainly excreted by the kidneys. Volume of distribution, protein binding and clearance are not relevant as the systemic absorption of Fluocinolone acetonide (Aplosyn) is very minimal and the concentration in urine is lower than the minimum quantitation limit.
Fluocinolone (Aplosyn) are intended for topical use in acute and chronic dermatoses.
APLOSYN-10 CREAM for occlusive dressing therapy, maintenance therapy and for pediatric cases; specifically for wet lesions.
A. Maintenance therapy: The 0.01% Cream is particularly useful in maintenance therapy of large areas in the indications listed above.
B. Occlusive dressing therapy: Closed dressings applied over APLOSYN have been found effective for the management of a number of particularly stubborn chronic dermatoses. These include psoriasis, chronic dermatitis, lichen planus, lichen simplex chronicus, granuloma annulare. Fluocinolone acetonide (Aplosyn) – 10 Cream is sparingly applied to the lesion and gently rubbed in until it disappears. The cream is reapplied, leaving a thin coating over the lesion. This area is then completely covered with a pliable non-porous film such as Sarah Wrap, polyethylene, or a similar material. Frequency of dressing change is best determined on an individual basis. It may be changed, twice daily or once daily, but as a general rule, change of dressing every 24 hours is recommended. Convenience may dictate the use of closed dressings for only part of each day, with the use of bland emollients between dressings for dry, fissured lesions. In general, the rate of response of a given lesion is directly related to the total time the lesion is treated with the closed dressing. In general, the rate of response of a given lesion is directly related to the total time lesion is treated with the closed dressing. Reapplication of fluocinolone acetonide (Aplosyn) in the method given above is essential at each change of dressing. Improvement is noted in three to four days and complete remission, except for residual erythema, usually occurs in one to three weeks.
For those lesions which are essentially dry, it is important that the dressing be made as airtight and watertight as possible. The edges of the covering film preferably are sealed to adjacent normal skin with an adhesive material, thus preventing evaporation. In some instances, it may be advisable to initially increase local water content by briefly soaking the lesion before application. For those lesions which are essentially moist, especially those of the eczematous dermatitis group, complete sealing of the lesion may not be needed. Here, the covering plastic film is useful to keep the medication in place over the lesion and to retain some water, but incomplete sealing of the edges of the film or punctures in the film will allow excess moisture to escape. Patients with eczematous dermatitis may be particularly prone to develop irritation with the use of adhesive materials; hence, it may be preferable to hold the dressings in place with gauze or elastic bandages, stockings, etc. For use in pediatric patients.
APLOSYN-10 OINTMENT for pediatric use, maintenance therapy, occlusive therapy; specifically for dry lesions. This is most suitable when emollient and water protective effect is desired.
APLOSYN-25 CREAM: Topical application is indicated in the following areas of therapy: Atopic dermatitis, neurodermatitis, contact dermatitis, seborrheic dermatitis, eczematous dermatitis, pruritus ani, lichen planus, post-anal surgery, nummular eczema, stasis dermatitis, intertrigo, exfoliative dermatitis, intertriginous psoriasis. A small amount should be applied lightly to the affected area two or three times daily, as needed. The cream should be massaged gently and thoroughly until it disappears. Since the Cream is in a water – washable, vanishing cream base, it is easily applied and leaves no traces. APLOSYN may be used over long periods of time in specific conditions when deemed necessary.
APLOSYN-25 OINTMENT is most suitable when an emollient and water protective effect is desired, as in atopic dermatitis where there is a tendency to fissuring and cracking, in hand dermatoses and during cold weather.
Advantages: Speedy remission of chronic dermatoses when other topical corticosteroids have failed.
Has a very high anti-inflammatory activity.
Effective in sparing amounts and easily applied.
No systemic effects on routine topical application.
Dosage/Direction for Use
Apply lightly to the affected area two or three times daily, as needed. Change dressing every 24 hours.
There are no data available on overdose with Fluocinolone acetonide (Aplosyn).
Topical corticosteroids are contraindicated in tuberculosis, fungal, and most viral lesions of the skin (including herpes simplex, vaccinia and varicella).
This drug is contraindicated in individuals with a history of hypersensitivity to its components.
Special Precautions
APLOSYN preparations are virtually non-sensitizing and non-irritating.
General precautions and limitations: Although side effects are not ordinarily encountered with topically applied corticosteroids, as with all drugs, a few patients may react unfavorably under certain conditions. If reactions or idiosyncrasies are encountered, the agent should be discontinued and appropriate steps taken.
Occlusive dressing method, precautions and limitations. If occlusion of total body or extensive areas is employed, the possibility of systematic absorption of the corticosteroids being used exists and suitable precautions should be taken. For patients with extensive disease it may be preferable to use a sequential approach, treating one portion of the body at a time. Occasionally, patients may shown contact sensitivity to a particular dressing material or adhesive. In such instances, a substitute occlusive dressing material or adhesive should be employed, or the technique discontinued. Malodor, which may be observed upon removal of closed dressing, will usually disappear with simple washing. The lesions should be carefully inspected between dressing to determine whether infection is developing. On infrequent occasions, miliaria, folliculitis, or pyodermas have been seen with the use of this technique. The development of infection requires appropriate local or systematic antibacterial therapy and discontinuation of the occlusive dressing method. Malodor and infection however, both decrease in incidence if dressing is renewed every 24 hours.
In the management of the psoriatic patient, it has been observed that the patient whose disease is in a chronic stabilized phase is the best candidate. While lesion relapses can be expected to occur in most patients upon discontinuation of topical corticosteroid therapy, remissions may persist for several weeks to several months in favorable cases. The patient whose psoriasis is in an active stage, with recent appearance of new lesions may not be a good candidate, and may show very early relapse of lesions, relative resistance to topical corticosteroid, or development of new lesions.
Some plastic films may be flammable and due care should be exercised in their use. Similarly, caution should be employed when such films are used on children or left their proximity, to avoid the possibility of accidental suffocation.
Use In Pregnancy & Lactation
The safety of topical corticosteroids during pregnancy or lactation has not been established. The potential benefit of topical corticosteroids, if used during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Store at temperatures not exceeding 30°C.
Shelf-Life: 36 months.
ATC Classification
D07AC04 - fluocinolone acetonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Aplosyn-10: Cream 100 mcg/g (0.01%) x 5 g. Oint 100 mcg/g (0.01%) x 5 g.
Aplosyn-25: Cream 250 mcg/g (0.025%) x 5 g. Oint 250 mcg/g (0.025%) x 5 g.
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