Synalar 10/Synalar 25/Synalar HP

Synalar 10: Cream: Each gram contains: Fluocinolone acetonide 100 mcg (in a topical cream base).
Fluocinolone acetonide (Synalar 10) 100 mcg/g (0.01%) Topical cream is odourless and non-staining, and is preserved with methyl and propyl parabens. It is water-protective and emollient.
Ointment: Each gram contains: Fluocinolone acetonide 100 mcg (in an ointment base).
Fluocinolone acetonide (Synalar 10) 100 mcg/g (0.01%) Ointment is odourless and non-staining, and is water-protective and emollient.
Synalar 25: Cream: Each gram contains 250 mcg of fluocinolone acetonide in an emollient cream base.
Fluocinolone acetonide (Synalar 25) emollient cream is odourless and non-staining, and are preserved with methyl and propyl parabens. Fluocinolone acetonide (Synalar 25) emollient cream is water-protective and emollient.
Ointment: Each gram contains: Fluocinolone acetonide, USP 250 mcg.
Fluocinolone acetonide (Synalar 25) 250 mcg/g (0.025%) Ointment is odourless and non-staining, and is water-protective and emollient.
Synalar HP: Each gram contains: Fluocinolone acetonide 2 mg (in a water-washable aqueous cream base preserved with methylparaben and propylparaben).

Synalar 10/Synalar 25: Fluocinolone acetonide (Synalar 10/Synalar 25) is primarily effective because of the anti-inflammatory, antipruritic and vasoconstrictor actions of Fluocinolone acetonide.
Synalar HP: Pharmacology: Pharmacodynamics: Fluocinolone acetonide is primarily effective as anti-inflammatory, antipruritic and vasoconstrictor. It is a glucocorticoid receptor agonist that binds to cytoplasmic glucocorticoid receptor and subsequently translocates to the nucleus where it initiates the transcription of glucocorticoid responsive genes such as lipocortins. Lipocortins inhibit phospholipase A2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandin and leukotrienes. Both are potent mediators of inflammation. It exerts its vasoconstrictive effect through inhibition of nitric oxide synthase thereby blocking nitric oxide production and effectively diminishing the effect of nitric oxide on vascular smooth muscles leading to reduced blood flow.
Pharmacokinetics: Fluocinolone acetonide is well absorbed from the sites of application. When applied to broken skin, sufficient amount may be absorbed that produces systemic effects. Mainly metabolized in the liver, but also in the kidney and is excreted in the urine.

Synalar 10/Synalar 25: Fluocinolone acetonide is suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin and mucosa. It is indicated for topical application in the following conditions: Insect bite reactions, photodermatitis, psoriasis, atopic dermatitis, seborrheic dermatitis, contact dermatitis, eczematous dermatitis, lichen planus, prurigo nodularis, pretibial myxedema, necrobiosis, lipoidica, neurodermatitis, intertriginous psoriasis, nummular eczema, discoid lupus erythematosus, exfoliative dermatitis, pruritus ani et vulvae, lichen simplex chronicus, intertrigo, otitis externa and stasis dermatitis.
Synalar HP: Fluocinolone acetonide (Synalar HP) 2 mg/g (0.2% w/w) Cream is effective for the relief of the inflammatory manifestations of corticosteroid responsive dermatoses. It may be an effective anti-inflammatory agent in dermatoses that have proved to be refractory to other topical corticosteroid preparations.
Fluocinolone acetonide (Synalar HP) 2 mg/g (0.2% w/w) Cream is indicated only for use on small areas and not prolonged periods of time.
It is indicated for topical application in the following conditions: Psoriasis vulgaris, lichen planus, eczematous dermatitis, atopic dermatitis, neurodermatitis keloids, hypertrophic scars and other localized conditions.

Synalar 10/Synalar 25: Open Therapy: A small amount should be applied lightly to the affected skin area two to three times daily with gentle but thorough massage. When the condition is under control, the dosage should be decreased gradually.
Occlusive Dressing Therapy: Closed dressings applied over Fluocinolone acetonide (Synalar 10/Synalar 25 Cream) have been found to be effective for the management of a number of particularly stubborn chronic dermatoses.
Fluocinolone acetonide (Synalar 10/Synalar 25 Cream) is sparingly applied to the lesion and gently rubbed in. A further thin coat is applied and the area is then covered completely with a pliable nonporous film. Frequency of dressing change is best determined by the physician on an individual basis. It may be changed twice daily but as general rule, change of dressing every 24 hours is recommended. Convenience may dictate the use of closed dressings for only part of each day with the use of bland emollients between dressings for dry, fissured lesions.
In general, the rate of response of a given lesion is directly related to the total time the lesion is treated with a closed dressing. Reapplication of Fluocinolone acetonide (Synalar 10/Synalar 25 Cream) in the method given as previously mentioned is essential at each change of dressing. When the condition is under control, the dosage should be reduced gradually.
Synalar HP: Fluocinolone acetonide (Synalar HP) 2 mg/g (0.2% w/w) Cream is indicated for use on small areas and not for extended periods of time. It is recommended that the total daily dose be limited to 2 g. It is estimated that 1 g of cream will cover approximately 80-100 square centimeters of body surface.
A small amount of Fluocinolone acetonide (Synalar HP) 2 mg/g (0.2% w/w) Cream should be applied lightly to the affected skin two or three times daily as needed. The cream should be rubbed in gently and thoroughly until it disappears. When the condition is under control, the dosage should be reduced gradually.

Synalar HP: Topically applied corticosteroids can be absorbed in large amounts to produce systemic effects. Patients (particularly children) receiving a large dose of topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated for evidence of Hypothalamus-Pituitary-Adrenal (HPA) axis suppression. This can be tested through Urinary free cortisol and ACTH Stimulation test. If HPA axis suppression is noted, the dose should be reduced or discontinue the drug or to substitute a less potent steroid.

Fluocinolone acetonide (Synalar 10/Synalar 25/Synalar HP) is contraindicated in those patients with a history of hypersensitivity to any of its components.
Synalar 25: These preparations are not intended for ophthalmic use.

Prolonged use of topical corticosteroid products may produce atrophy of the skin. When used on the face, this may occur even with short term use.
Significant systemic absorption may result when corticosteroids are applied over a large areas of the body, even when occlusion is not used.
This preparation is not for ophthalmic use.
In the presence of an infection, the use of an appropriate antibacterial, antiviral or antifungal agent should be instituted. If a favourable response does not occur promptly, Fluocinolone acetonide (Synalar 10/Synalar 25/Synalar HP) should be discontinued until the infection has been adequately controlled.
Use in Children: Administration of topical corticosteroids to children should be limited to a short period of time and to the smallest amount compatible with an effective therapeutic regimen.
Synalar 10/Synalar 25: Topical corticosteroids should be used with caution on lesions close to the eye.
When used with occlusive dressing, the lesions should be carefully inspected between dressings to determine whether infection is developing. On infrequent occasions, miliaria, folliculitis, or pyodermas have been seen with the use of this technique. The development of infection requires appropriate local or systemic antibacterial therapy and discontinued of the occlusive dressing method.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Synalar HP: Fluocinolone acetonide (Synalar HP) 2 mg/g (0.2% w/w) Cream should not be used for prolonged periods and the quantity per day should not exceed 2 g of formulated material.
If no response is observed during the first week of therapy, medication should be discontinued. However, if a response is noted, therapy may continue for a maximum of three weeks. It is recommended that Synalar 0.025% or 0.01% concentrations be utilized for maintenance therapy beyond this period of time.
Occlusive dressing increases the percutaneous absorption of topical corticosteroids. Its use can be helpful in the treatment of recalcitrant dermatoses. Tight-fitting diapers or plastic pants on a child may also function as an occlusive dressing and increase absorption of topical corticosteroids by the underlying skin.
Patients (particularly children) receiving a large dose of topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, the dose should be reduced or the corticosteroid discontinued.
Use in Children: Fluocinolone acetonide (Synalar HP) 2 mg/g (0.2% w/w) Cream should not be used on infants up to two years of age.

Synalar 10/Synalar 25: The use of any drug in pregnancy, lactation, or in women of childbearing age requires that the potential benefits of the drug be weighed against the possible hazards to the mother and child.
While topical corticosteroids have not been reported to have an adverse effect on human pregnancy, the safety of their use in pregnant women has not been established absolutely. Therefore, drugs of this class should not be used extensively on pregnant patients in large amounts or for prolonged periods of time, especially for the first three months of pregnancy.
Synalar HP: In laboratory animals, increase in incidences of fetal abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some cases at rather low dosage levels. Although topical corticosteroids have not been reported to have an adverse effect on human pregnancy, the safety of their use in pregnant women has not been established absolutely. Therefore, drugs of this class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time, especially during the first three months of pregnancy.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breastmilk. Caution should be exercised when topical corticosteroids are administered to nursing woman.

The following local adverse reactions have been reported with topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

Synalar HP: Prednisone and other corticosteroids taken by mouth.
Hydrocortisone and other corticosteroids applied on skin.
Cyclosporine and other drugs that lower the immune system.

Synalar HP: Handling and Disposal: Properly discard when it is expired or no longer needed.
Consult a pharmacist or local waste disposal company on how to safely discard the product.

Synalar 10 Cream: Store at temperatures not exceeding 30°C.
Synalar 10 Ointment/Synalar 25 Cream: Store at temperatures below 25°C.
Synalar 25 Ointment/Synalar HP: Store at temperatures not exceeding 25°C.

Topical Corticosteroids

D07AC04 - fluocinolone acetonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.

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