Derma-Smoothe/Fs (Fluocinolone Acetonide)

Uses

This Cream and Ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin.

This is particularly suitable for topical application in:

• Eczema and dermatitis: Atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
• Prurigo, Psoriasis, lichen planus.
• Discoid lupus erythematosus.

Derma-Smoothe/Fs (Fluocinolone Acetonide) is also used to associated treatment for these conditions: Acute Otitis Media, Allergy Skin, Anal Fissures, Atopic Dermatitis (AD), Blisters, Chronic Disease of Skin, Dermatosis, Diabetic Macular Edema (DME), External Hemorrhoid, Friction and Pressure Injuries, Hemorrhoids, Internal, Non-infectious Posterior Uveitis Chronic Uveitis, Otitis Externa, Perianal erythema, Pruritus, Psoriasis of the scalp, Purulent Wounds, Scab, Seborrheic dermatitis of the scalp, Skin Infections, Bacterial, Skin Inflammation caused by Bacterial Infections, Skin Inflammation of the ear, Uveitis, Wound Infections, Anal eczema, Chronic eczematous otitis externa, Corticosteroid-responsive dermatoses, Postoperative Care, Perioperative management therapy, Postoperative treatment

How Derma-Smoothe/Fs (Fluocinolone Acetonide) works

Fluocinolone acetonide is a corticosteroid and thus, it can be inferred that it acts by inhibiting the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation.

Some reports have indicated that fluocinolone acetonide presents a high binding affinity for the glucocorticoid receptor. After binding the receptor, the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements in the promoter region of the target genes. This effect promotes the induction of phospholipase A2 inhibitory proteins (lipocortins). Through this mechanism of action, it is thought that fluocinolone induces mainly one of the lipocortins, annexin 1, which will later mediate the synthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of arachidonic acid which is the precursor of all these inflammatory mediators. Hence, the induction of these proteins will prevent the release of arachidonic acid by phospholipase A2.

Dosage

Derma-Smoothe/Fs (Fluocinolone Acetonide) dosage

A small quantity of Derma-Smoothe/Fs (Fluocinolone Acetonide) is applied lightly up to 2 or 3 times a day, and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly.

Side Effects

Side-effects are extremely rare, but as with all topical corticosteroids, patient may show hypersensitivity reaction.

Toxicity

Studies to determine the carcinogenic and its effect in fertility have not been performed. It is important to consider that several corticosteroids have been shown to present genotoxic potential but fluocinolone acetonide was shown to not be genotoxic in the Ames test and mouse lymphoma TK assay.

Precaution

Appropriate anti-infective cover should be given if there is an associated infection. Long term continuous topical steroid therapy can produce atrophic skin changes. Do not apply to the face for prolonged periods. Prolonged use or treatment of extensive areas can produce adrenal suppression, especially in infants and children.

Food Interaction

Volume of Distribution

This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal.

Elimination Route

When administered as an eye implant, fluocinolone acetonide presents a sustained delivery for even 12 months in which there can be observed a sustained release. The concentration of fluocinolone acetonide are generally higher in the vitreous and retina with a little dispersion to the aqueous humor.

There are reports indicating that topical administration of fluocinolone acetonide produces a percutaneous absorption which is determined by the vehicle, integrity of the epidermal barrier and the use of occlusive dressing.

Independently of the route of administration, the systemic absorption of fluocinolone acetonide is below 0.1 ng/ml which indicates that the systemic distribution is very minimal and the effect of fluocinolone is mainly local.

Half Life

The reported half-life of fluocinolone acetonide ranges between 1.3-1.7 hours.

Clearance

This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal and the concentration in urine is lower than the minimum quantitation limit.

Elimination Route

Fluocinolone acetonide is mainly excreted by the kidneys. It is important to mention that the systemically absorbed dose is very minimal.

Pregnancy & Breastfeeding use

Pregnancy: Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate intrauterine growth retardation. There may be a small risk of such effects on the human fetus.

Lactation: When topical steroid treatment is necessary, minimize amount and length of treatment.

Contraindication

Primary infections of the skin and in rosacea, acne, perioral dermatitis, anogenital pruritis and napkin eruption. Also known hypersensitivity to neomycin

Storage Condition

Store at temperature below 30° C.

Innovators Monograph

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