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Synalar Simple 0.025% 20gr Cream, Fluocinolone Acetonide

INDICATIONS: Topical Corticosteroid dermal use.

SIMPLE SYNALAR ® is indicated for the treatment of a wide variety of inflammatory conditions, allergic and itchy skin and mucous membranes, photodermatitis, psoriasis, atopic dermatitis, seborrheic dermatitis in severe cases, contact dermatitis, eczematous dermatitis, lichen planus, nummular eczema , pretibial myxedema, necrobiosis lipoidica, erythroderma, neurodermatitis, intertriginous psoriasis, pruritus Nodular, discoid lupus erythematosus, exfoliative dermatitis, lichen simplex chronic intertrigo.

Pharmacokinetics HUMAN SYNALAR ® preparations are highly effective SIMPLE, due to anti-inflammatory, antipruritic, antiallergic and fluocinolone acetonide vasoconstrictor.

The percutaneous penetration of corticosteroids vary depending on the patient and can be modified depending on the vehicle used, the length and area of ​​the application and conditions of the skin, and the skin temperature and the degree of hydration of the patient. After absorption of 90% or more plasma cortisol is bound reversibly to proteins. Only the fraction of free corticosteroid enters cells where it produces its effects corticosteroidales.

All adrenocortical steroids and biologically active synthetic derivatives have a double bond in the positions 4, 5 and a keto group at C3. As a rule, the steroid metabolism involves several additions of oxygen atoms or hydrogen, followed by the formation of conjugates that are more water soluble compounds. Double bond reduction 4, 5 occurs in the liver and off it, causing both inactive compounds. Occurs only in the liver reducing substituent 3-ketone form the 3-hydroxy derivative tetrahydrocortisol. In the liver, the majority of these drugs are combined by enzymatic reactions with sulfate or glucuronide with the 3-hydroxy group, these reactions also occur, but to a lesser extent in kidney.

Soluble derivatives (esters sulfate or glucuronide) and others resulting predominant metabolites are eliminated via the urine. In humans, the removal of corticosteroids or fecal bile tract presents no relevance.

Nonspecific action of corticosteroids can be explained by the induction of phospholipase A2 inhibitory proteins (lipocortins) at the cellular level, which reduces the formation, release and actions of endogenous chemical mediators of inflammation, such as kinins, histamine , liposomal enzymes, prostaglandins and complement systems. Additionally, it is believed that macrophages and leukocytes are involved in the initiation of the responses induced by endogenous chemical mediators mentioned above. The application of corticosteroids inhibits marginalization (small vesicles adhesion to the walls) and the subsequent migration of macrophages and leukocytes to the area. The resulting effect is not only inflammatory, but also a reversal of vascular dilation and permeability of the vesicles in the affected area, which is seen clinically as decreased edema, erythema and pruritus.

Antimitotic actions of corticosteroids, especially fluorinated species, are mainly related to the human skin cells and skin fibroblasts.

Contraindications SIMPLE SYNALAR ® is contraindicated in patients with known hypersensitivity to components in cutaneous tuberculosis and certain viral diseases such as herpes and chickenpox.

PRECAUTIONS: For any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissue. When used on intertriginous or flexor areas, or on the face, this may occur even when used for short periods of time. Significant systemic absorption may result when corticosteroids are applied to areas of the body even when not using occlusive technique. Administration of topical corticosteroids to children should be limited to shorter treatment period and the least amount compatible with an effective therapeutic regimen. In the presence of infection, you should use a antibacterial, antiviral and antifungal proper. If a favorable response does not occur promptly using SIMPLE SYNALAR ® should be discontinued until the infection has been adequately controlled. Occlusive techniques increase the percutaneous absorption of topical steroids. Its use may be useful in the treatment of dermatoses recalcitrant. The use of tight-fitting diapers or rubber pants on a child, can act as an occlusive technique and increase absorption of topical corticosteroids in the underlying skin. Patients (particularly children) receiving a large amount of topical corticosteroids applied to a large surface area or under an occlusive technique should be evaluated for suppression hypothalamic-pituitary-adrenal (urinary free cortisol, ACTH stimulation test). If you are deleting, the dose should be reduced or treatment discontinued.

This presentation is not for ophthalmic use.

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: Although in humans there are no reported side effects attributable to the use of topical corticosteroids during pregnancy, the absolute safety of its use has not been fully established. Therefore, in this case its use is not recommended for large areas or for prolonged periods, especially during the first three months of pregnancy.

ADVERSE REACTIONS: The following have been reported adverse reactions with topical corticosteroids, burning, itching, irritation, dryness, folliculosis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, stretch marks and miliary eruption.

DRUG INTERACTIONS AND OTHER GENDER: No drug interactions have been reported with this product.

CHANGES IN RESULTS OF LABORATORY TESTS: There are no reported changes in laboratory tests with this product.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: The use of Synalar ® SIMPLE in humans has not been associated with effects of carcinogenicity, mutagenicity or teratogenicity. Also, it has been linked to impaired fertility.

DOSAGE AND ADMINISTRATION:

Occlusive dressing: Apply a layer of Synalar ® SIMPLE on injuries and cover them with a sheet of polyethylene dimensions slightly larger than the area to be treated. Fix with tape the edges of the cover to the adjacent normal skin, making sure the dressing is airtight. When settle psoriatic lesions on the hands, cover them with polyethylene gloves. The occlusive dressing kept for 24 hours, after which it is removed and the treatment repeated.

Cure cover: Apply a small amount to the affected area 2 times a day, rubbing gently, when the nature of the injury allows. When the box is under control, the dosage should be tapered gradually.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION: See WARNINGS.
Drug Name: Simple Synalar
Comparative brand: Simple Synalar
Active: fluocinolone acetonide
Presentation: Cream
Concentration: 0.025%
Response time: No
Laboratory GRIMANN, S. A. de CV
Box with tube with 20g
Manufactured in: Mexico