Synalar-C .01% 3% 40g Tube, Flocinolone, Clioquinol
Topical corticosteroid, antifungal and antimicrobial. With clioquinol SYNALAR-C is indicated in the treatment of a variety of local inflammatory disorders, pruritic, allergic, bacterial and / or fungal skin and mucous membranes. Is suitable for topical application to the following conditions: psoriasis, atopic dermatitis, contact dermatitis, eczematous dermatitis, lichen planus, neurodermatitis, psoriasis Intertriginous, nummular eczema, exfoliative dermatitis, lichen simplex chronicus, intertrigo and otitis externa.
SYNALAR preparations with clioquinol-C are highly effective due to the actions inflammatory, antipruritic, vasoconstrictive allergic and fluocinolone acetonide as bacterial and antifungal activity of clioquinol.
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, 90% or more of 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, has no relevance.
Topical corticosteroids are effective in a wide range of acute and chronic inflammatory diseases including dermatitis most sensitive to corticosteroids, regardless of etiology.
Anti-inflammatory activity produced by the topical application of steroid known as nonspecific because they act against the majority of cases of inflammation causes including mechanical, chemical, microbiological and immunological.
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. Antimitotic this action may be responsible for the use of corticosteroids in treating scaly dermatitis and psoriasis.
The mechanism of action of corticosteroids in squamous dermatosis is not cell cycle specific and is probably secondary to a general reduction in the synthesis of macromolecules.
The mechanism of action of corticosteroids in the treatment of patients with psoriasis is associated with the reduction in DNA synthesis.
The effects on the suppression of DNA synthesis can be shown not only in proliferative disorders such as psoriasis, can also be demonstrated in normal skin.
Clioquinol SYNALAR-C is contraindicated in patients with known hypersensitivity to components in cutaneous tuberculosis and some diseases such as herpes simplex virus and varicella.
As with 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.
Significant systemic absorption may result when applying corticosteroids on areas of the body, even when not in use occlusion. Administration of topical corticosteroids to children should be limited to shorter period and less product, consistent with an effective therapeutic regimen.
In the presence of viral infection should be instituted using an appropriate agent. If you do not get a favorable response quickly, you should discontinue using Synalar-C with clioquinol, until the infection has been adequately controlled.
Prolonged use or large amounts of this product should be avoided in the treatment of skin disorders secondary to extensive burns, ulceration, atrophic and other conditions in which it is possible the absorption of clioquinol. Spotting can occur due to the disintegration of clioquinol.
You can use a protective cover on the application to prevent staining of clothing. It is recommended that clioquinol SYNALAR-C is not used under occlusive compresses. The diapers or rubber pants of a child may act as an occlusive technique and increase SYNALAR-C absorption by the underlying skin.
Patients (particularly children) who receive a lot of topical corticosteroids applied to a large area must be evaluated for suppression of the hypothalamic-pituitary-adrenal (urinary free cortisol, ACTH stimulation test).
If HPA axis is suppressed, the dose should be reduced or discontinued.
As with other antibacterial and antifungal agents, prolonged use can cause the development of non-susceptible organisms. If superinfection occurs appropriate action should be taken.
This preparation is not for ophthalmic use.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING
Although not reported that topical corticosteroids have an adverse effect on pregnancy in humans, the safety of its use has not been established definitively. Therefore, these drugs should not be used extensively on pregnant women, especially during the first three months of pregnancy.
Have been reported following local adverse reactions with topical corticosteroids: burning, itching, irritation, dryness, folliculosis, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliary eruption. Local application of clioquinol may occasionally cause irritation.
DRUG INTERACTIONS AND OTHER GENDER
No drug interactions have been reported with this product.
CHANGES IN RESULTS OF LABORATORY TESTS
No alterations have been reported in laboratory tests.
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility
Using SYNALAR-C in humans has not been associated with carcinogenicity, mutagenicity or teratogenicity. Also, it has been linked to impaired fertility.
DOSAGE AND ADMINISTRATION
Topically. Should apply a small amount to the affected area of the skin for three times a day with a gentle but firm massage. When the alteration is under control, the dose should be tapered gradually.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION
Box with tube with 40 g 0.01%.
Store at room temperature not exceeding 30 ° C. Keep the tube tightly closed.
Drug Name: Synalar-C
Comparable drug patent: Synalar-C
Active substance: Fluocinolone / Clioquinol
Concentration: 01% / 3%
Extended-release tablets: No
Box with tube with 40g
Made in Mexico