(Fluocinolone acetonide, polymyxin B, neomycin and lidocaine hydrochloride)
And dosage form:
Each ml of solution contains:
0.250 mg fluocinolone acetonide
Polymyxin B sulfate equivalent to 10,000 U
Neomycin sulfate equivalent to 3.50 mg
20.00 mg of lidocaine hydrochloride
Vehicle c.b.p. 1.00 ml.
THERAPEUTIC INDICATIONS: Treatment of otitis externa and other inflammatory conditions, allergic and itchy respond to steroids and in whom an infection is present or suspected their existence.
Synalar-O ® combines powerful anti-inflammatory, antiallergic and antipruritic topical fluocinolone acetonide with antibacterial activity of neomycin sulfate.
Pharmacokinetics IN HUMAN preparations Synalar-O ® is highly effective, because of the actions antiinflammatory, antipruritic, antiallergic and vasoconstrictor of fluocinolone acetonide and activity of the antibiotic neomycin sulfate.
The percutaneous penetration of corticosteroids varies 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 their synthetic derivatives exhibit a biologically active double bond at positions 4.5 and a ketone group at C3. As a general rule, the steroid metabolism involves several additions of oxygen atoms or hydrogen, followed by formation of conjugates, which are more water soluble compounds. Reducing the double bond occurs in the liver 4.5 and out of this, producing both inactive compounds. Occurs only in the liver reduction 3-ketone substituent at the 3-hydroxyl derivative forming tetrahydrocortisol. In the liver, most of these steroids are combined by enzymatic reactions with sulfate or glucuronide with the 3-hydroxyl group, these reactions also occur, but to a lesser degree in the kidney.
The water-soluble derivatives (esters of sulfate or glucuronide) and other metabolites resulting predominant eliminated via the urine. In humans, the removal of corticosteroids or fecal biliary tract presents no relevance.
The nonspecific action of corticosteroids may be explained by induction of phospholipase A2 inhibitory proteins (lipocortins) at the cellular level, which decreases 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 involved in the initiation of the responses induced by endogenous chemical mediators above. The application of corticosteroids inhibits the marginalization (accession of small vesicles 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 observed clinically as a reduction of edema, erythema and pruritus.
Antimitotic actions of corticosteroids, especially fluorinated species are related primarily to human skin cells and skin fibroblasts.
Contraindications fungal or viral infections untreated. Herpes simplex and varicella vaccines. Hypersensitivity to a compound of the medication. Perforated eardrum.
Special Precautions: Prolonged use of topical corticosteroids may produce atrophy of the skin and subcutaneous tissues.Glucocorticoids can mask some signs of infection and new infections may appear during their use.
Prolonged treatment may favor the development of non-susceptible organisms and fungi.
Because there has been no systemic activity with therapeutic doses of Synalar ®-O, care should be taken when transferring patients with systemic steroid treatment to Synalar ®-O, if there is reason to suspect that their adrenal function is impaired.
Administration of topical corticosteroids to children should be limited to the shortest period of time and less of the product supports effective therapeutic regimen.
Cross allergic reactions may incur, which would help prevent future use of kanamycin and streptomycin paromycin.
This preparation is not for ophthalmic use.
Use in Pregnancy and Lactation: Not recommended for use Synalar ®-O during the first trimester of pregnancy. If used during the second and third quarter, the expected benefits should be valued in relation to the potential risks to the fetus.
ADVERSE REACTIONS: There have been reported burning, itching, irritation, dryness, folliculosis, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, secondary infection and skin atrophy with the use of topical corticosteroids.
It has been reported ototoxicity and nephrotoxicity with the topical use of neomycin.
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 OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: The use of Synalar-O ® in humans has been linked to effects of carcinogenicity, mutagenicity or teratogenicity.
Also not been associated with impaired fertility.
DOSAGE AND ADMINISTRATION: Otic.
Instillation of 3 to 4 drops into the ear, 2 to 4 times daily.
There is no evidence that exceeding the maximum recommended dose, Synalar ®-O is more effective, in fact, higher doses should not be used.
REPRESENTATIONS AND MANAGEMENT Overdosage: See PRECAUTIONS.
PRESENTATION: 15 ml dropper bottle.
RECOMMENDED STORAGE: Store at room temperature not exceeding 25 ° C.
Keep the bottle tightly closed.
LEGENDS OF PROTECTION:
Its sale requires a prescription. Keep out of reach of children.Exclusive literature for physicians.
For additional information on this product call our Medical Information Centre, Tel: (01) (55) 5258-5099 and 01-800-821-8887, or mexico.info @ roche.com
Made in Mexico by:
Laboratorios Sophia, S. A. C. V.
SYNTEX, S. A. C. V.
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