Composition:

Each 100g cream contains 1g Hydrocortisone.

Mechanism of Action:

Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of Hydrocortisone on connective tissue.

Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes in prostaglandin synthesis. The vasoconstrictor action of Hydrocortisone may also contribute to its anti-inflammatory activity

Indications:

Hydrocortisone Domina has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.

Usage:

Use sparingly over a small area once or twice a day for a maximum period of one week. If the condition has not improved, or worsens, consult your doctor.

This product should not be recommended for use on children under 10 years of age without medical advice.

Side Effects:

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately.

Contraindications:

- Bacterial, viral or fungal infections of the skin.

- Hypersensitivity to the active substance or to any of the excipients.

- Use on the eyes and face, Ano-genital region, Broken or infected skin including cold sores, acne and athlete's foot.

Precautions:

• There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions.
• Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
• Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.
• Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systematic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
• Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy especially napkin eruption where the napkin can act as an occlusive dressing and increase absorption. In infants and children, courses of treatment should therefore not normally exceed 7 days
• Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and a systemic administration of antimicrobial agents.
• As with all corticosteroids, prolonged application to the face is undesirable
• Do not use under an occlusive dressing.
• This medicinal product contains chlorocresol, which may cause allergic reactions.
• This medicinal product also contains cetostearyl alcohol in the excipient cetomacrogol emulsifying wax, and may cause local skin reactions (e.g., contact dermatitis).

Pharmacokinetic Properties:

Absorption: Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas, or under occlusive dressings.

Distribution: Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk.

Metabolism: Hydrocortisone is metabolised mainly in the liver, but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.

Elimination: Hydrocortisone is excreted in the urine, mostly conjugated as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.

Drug Interactions:

None known.

Use in Pregnancy or Lactation:

- There is inadequate evidence of safety in human pregnancy. There may therefore be a very small risk of such effects in the human foetus.

- There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers.