Aquacort (Hydrocortisone)

AQUACORT®

Spectropharm Dermatology

Hydrocortisone

Topical Corticosteroid

Action And Clinical Pharmacology: Topical corticosteroids are synthetic derivatives of cortisone which are effective when applied locally to control many types of inflammatory, allergic and pruritic dermatoses.

They are thought to act by controlling the rate of synthesis of proteins. The primary action of the corticosteroid is to interfere with the synthesis of arachidonic acid by inhibiting the phospholipase A2 synthesis. The overall effect of corticosteroids is a catabolic one.

Corticosteroid responsive dermatoses may be divided into those which are very responsive and those which require higher concentrations of corticosteroids, occlusion of the drug under a plastic film or intralesional administration. Attention must be paid to the concentration of topical corticosteroid used.

Although effectiveness is enhanced by the application of the corticosteroid preparation under a transparent plastic wrapping, systemic absorption is also enhanced, occasionally sufficiently to suppress the pituitary-adrenal axis.

Indications And Clinical Uses: For inflammatory manifestations of corticosteroid responsive dermatoses, where an anti-inflammatory, anti-allergenic and antipruritic activity in topical management is required.

Contra-Indications: Untreated tubercular, bacterial and fungal infections involving the skin and in certain viral diseases such as herpes simplex, chickenpox and vaccinia. Hypersensitivity to any of the components of the preparation. Not for ophthalmic use.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: The safety of topical corticosteroids during pregnancy and lactation has not been established. The potential benefit should be weighed in these conditions against possible hazard to the fetus or the nursing infant.

Adrenal suppression and other systemic effects may occur after application to extensive areas and prolonged usage.

Should not be used under occlusive dressings.

Precautions: Topical corticosteroids should be used with caution on lesions close to the eye.

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

Prolonged use of topical corticosteroid products may produce atrophy of the skin and subcutaneous tissues, particularly on flexor surfaces and on the face. If this is noted, discontinue the use of these products. In cases of bacterial infections of the skin, appropriate antibacterial agents should be used as primary therapy. If necessary, the topical corticosteroid may be used as an adjunct to control inflammation, erythema and itching.

These products should be used 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 corticosteroid should be discontinued and the patient re-evaluated.

During the use of topical corticosteroids secondary infections may occur.

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

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Not for ophthalmic use.

Adverse Reactions: The following adverse skin reactions have been reported with the use of topical corticosteroids; dryness, itching, burning, 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 use of corticosteroids.

These side effects have been very rarely observed, even under occlusive conditions, with low potency topical glucocorticosteroid preparations such as hydrocortisone.

Dosage: Apply sparingly to affected areas 2 to 3 times daily. When favorable response is obtained, reduce frequency of application and eventually discontinue altogether.

Availability And Storage: Each mL of white, odorless, washable lotion contains: hydrocortisone 2.5%. Nonmedicinal ingredients: amphisol, carbopol, cetyl alcohol, coconut oil, EDTA, glyceryl stearate, Germall, isopropyl myristate, panthenol, propylene glycol and water. Plastic bottles of 60 mL. Protect from excessive heat. Store at room temperature. Avoid freezing.

AQUACORT® Spectropharm Dermatology Hydrocortisone Topical Corticosteroid

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