Each gram of Hydrocortisone, topical ointment 1%, contains:

active ingredient: Hydrocortisone – 10 mg;

excipients: paraffin liquid, propylparaben, petrolatum (vaseline) white, ethanol (1.62%).

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

Short-acting glucocorticoid that depresses formation, release, and activity of endogenous mediators of inflammation including prostaglandins, kinins, histamine, liposomal enzymes, and complement system. Also modifies body’s immune response.

Hydrocortisone is a corticosteroid with both glucocorticoid and to a lesser extent mineralocorticoid activity. As cortisol it is the most important of the predominantly glucocorticoid steroids secreted by the adrenal cortex. Hydrocortisone is used, usually with a more potent mineralocorticoid, for replacement therapy in adrenocortical insufficiency. It may also be used for its glucocorticoid properties in other conditions for which corticosteroid therapy is indicated but drugs with fewer mineralocorticoid effects tend to be preferred for the long-term systemic therapy of auto-immune and inflammatory disease.

Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. Hydrocortisone readily crosses the placenta.

Although it is considered that Hydrocortisone has fewer side-effects on the skin and is less liable to cause adrenal suppression than the more potent topical corticosteroids, it should be borne in mind, that this property may be considerably modified both by the type of formulation or vehicle used and by the type of esterification present; other factors that may also influence the degree of absorption include the site of application, use of an occlusive dressing, the degree of skin damage, and the size of the area to which the preparation is applied.

Administration

Hydrocortisone is generally applied to the affected area as a thin film one or four times a day depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

• Hydrocortisone is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
• Children up to 1 years of age.

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Pregnancy: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

Hypersensitivity reactions have occurred with corticosteroids, mainly when applied topically.

Adverse effects occur, in general, fairly equally with all systemic corticosteroid preparations and their incidence rises steeply if dosage increases much above physiological values. Short courses at high dosage for emergencies appear to cause fewer adverse effects than prolonged courses with lower doses.

Most topically applied corticosteroids may, under certain circumstances, be absorbed in sufficient amounts to produce systemic effects. Application of corticosteroids to the skin has led to loss of skin collagen and subcutaneous atrophy; local hypopigmentation of deeply pigmented skins has been reported after both the intradermal injection and topical application of potent corticosteroids.

It should also be remembered that corticosteroid-induced adrenal suppression has been associated not only with systemic therapy, but has followed topical application of corticosteroid preparations, particularly those containing potent corticosteroids. Some degree of adrenal suppression is also associated with the use of high dose inhalants and nasal preparations, and has followed the topical application of eye drops and eye ointments.

Avascular necrosis has also been associated with topical application of corticosteroids

This increased susceptibility to infection and masking of symptoms may also be caused by topical or local corticosteroid therapy. Thus, topical application to the skin has led to unusual changes such as atypical ringworm infection.

Topical corticosteroids are associated with a number of local adverse effects on the skin, principally due to their antiproliferative effects on keratinocytes and fibroblasts (leading to skin thinning and atrophy), and to possible interference with the skin flora (leading to increased risk of superinfection or opportunistic infection). Skin thinning is more likely if corticosteroids are applied under occlusion (this is especially true of halogenated corticosteroids, which are more resistant to inactivation by enzymes in the epidermis). Striae, which occur usually in intertriginous areas such as axillae and groin where skin is thin, moist, and occluded, are the most readily appreciable manifestation of skin atrophy, and are irreversible, unlike more minor degrees of atrophy. Other local adverse effects include telangiectasias and purpura. Acneform pustules at the site of application have occurred.

The balance between benefit and the likelihood of local or systemic adverse effects on topical application of corticosteroids will depend on the chemical structure of the drug (i.e. its lipophilicity and resistance to enzymic degradation), the formulation of the vehicle, the way in which it is applied, and the nature of the skin to be treated.

The adverse skin effects arising from systemic corticosteroids also include striae and skin thinning as well as acneform eruptions. Somewhat counter-intuitively a case-control study has suggested an increased risk of Stevens-Johnson syndrome or toxic epidermal necrolysis in patients receiving corticosteroids, particularly in the period shortly after beginning therapy.

Patients using topical corticosteroids should receive the following information and instructions:

• This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
• Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
• The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
• Patients should report any signs of local adverse reactions especially under occlusive dressing.
• Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Hydrocortisone topical ointment, 1% is supplied in a aluminum tube (15 g).

2 years. Do not use after the expiration date.

To be dispensed with prescription.

Store at a room temperature, in a dry place, out of the reach of children. Protect from light.