Synalar (Fluocinolone Acetonide)

SYNALAR®

Medicis

Fluocinolone Acetonide

Topical Corticosteroid

Indications And Clinical Uses :

For topical therapy of corticosteroid responsive acute and chronic skin eruptions where an anti-inflammatory, anti-allergenic, and antipruritic activity in the topical management is required.

Topical solution (0.01%) is more appropriate than the fluocinolone acetonide ointment formulation for use in locations such as the scalp

Contra-Indications:

Untreated bacterial, tubercular, fungal and most viral lesions of the skin (including herpes simplex, vaccinia, and varicella). Contraindicated in individuals with a history of hypersensitivity to any of the components.

Warnings in Clinical States:

Pregnancy and Lactation: The safety of topical corticosteroids during pregnancy or lactation has not been established. The potential benefit of topical corticosteroids, if used during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.

Not for ophthalmic use.

Precautions:

Not recommended for use under occlusive dressings.:

Apply cautiously on lesions close to the eye. Severe irritation is possible if these formulations contact the eye. Should this occur, immediate flushings of the eye with a large volume of water is recommended.

Prolonged use of topical corticosteroid products may produce atrophy of the skin and of subcutaneous tissues, particularly on flexor surfaces and on the face. If this is noted, discontinue its use.

Use with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.

If a symptomatic response is not noted within a few days to a week, the local applications of corticosteroids should be discontinued and the patient reevaluated.

During the use of topical corticosteroids secondary infections may occur.

Although hypersensitivity reactions have been rare with topically applied steroid products, the drug should be discontinued and appropriate therapy instituted if there are signs of reaction.

In cases of bacterial infections of the skin, appropriate antibacterial agents should be used as primary therapy. If it is considered necessary, the topical corticosteroid product may be used as an adjunct to control inflammation, erythema and itching.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Significant systemic absorption may result when steroids are applied over large areas of the body. To minimize the possibility, when long-term therapy is anticipated, interrupt treatment periodically or treat one area of the body at a time.

Laboratory Tests: Urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Adverse Reactions:

The following adverse skin reactions have been reported with the use of topical steroids: dryness, burning, itching, local irritation, striae, skin atrophy, atrophy of subcutaneous tissues, telangiectasia, hypertrichosis, change in pigmentation and secondary infection. Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

Symptoms And Treatment Of Overdose :

There is no specific antidote, but gastric lavage should be performed.

In case of hypercorticism and/or adrenal suppression, discontinue therapy.

Dosage & Administration:

Synalar ointment is suitable when an emollient effect is desired. A small amount of ointment should be applied gently on the affected skin area, 2 or 3 times daily, as needed.

Topical solution, 0.01% should be applied to the affected area as thin film, from 2 to 4 times daily, depending on the severity of the condition. On hairy sites, the hair should be parted to allow direct contact with the lesion.

It is recommended that ointment or solution not be used under occlusive conditions.

Availability & Storage:

Ointment: Each g of ointment contains: fluocinolone acetonide 0.025% in a petrolatum base without preservatives. Collapsible tubes of 60 g.

Solution: Each bottle contains: fluocinolone acetonide 0.01% in a propylene glycol vehicle without preservatives. Plastic squeeze bottles with controlled drop tip of 60 mL.

Store at room temperature (15 to 30°C).

SYNALAR® Medicis Fluocinolone Acetonide Topical Corticosteroid

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