Skinalar-N Cream 0.025%+0.5%

Uses

This cream is used for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment.

Skinalar-N Cream 0.025%+0.5% 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 Skinalar-N Cream 0.025%+0.5% 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

Skinalar-N Cream 0.025%+0.5% dosage

This cream is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Sincethis cream is a water-washable vanishing cream, it is easily applied and leaves no traces

Side Effects

Dry skin, pruritus, irritation, mild to moderate transient burning or stinging sensation. Local atrophic skin changes (prolonged & intensive treatment). Hypercorticism (systemic absorption on prolonged use). Itching, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of skin, secondary infections, striae & miliaria.

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

Avoid prolonged use in infant & children. Pregnancy. Appropriate anti-infective cover should be given if there is an associated infection.

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 Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Contraindication

Viral diseases & skin TB, acne vulgaris, scabies, perioral dermatitis, ringworm, bacteria & fungal infections unless appropriate chemotherapy given. Extensive or prolonged usage in pregnancy.

Special Warning

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmicpituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalmic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Acute Overdose

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

Storage Condition

Store at room temperature 15-25°C ; avoid freezing and excessive heat above 40°C

Innovators Monograph

You find simplified version here Skinalar-N Cream 0.025%+0.5%