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DP Lotion-HC 1%: Hydrocortisone 1% w/w, lanolin 0.6% w/v and mineral oil 15.9% w/v in a uniformly white, glossy, moderately viscous lotion.
DP Hydrocortisone Cream 1%: A white smooth and glossy cream.
Hydrocortisone is a corticosteroid that, when applied topically, often produces dramatic suppression of lesions having inflammation as a prominent feature. Such lesions include: eczema, various forms of dermatitis, psoriasis and intertrigo. Lanolin is a substance obtained from sheep's wool that, when mixed with mineral oil, gives an emollient lotion that facilitates the absorption of hydrocortisone.
When applied topically, hydrocortisone is absorbed through the skin allowing penetration to deeper layers. Absorption is aided by the presence of lanolin and mineral oil and also by use of occlusive dressings due to the hydration of the skin layers that results. Very little hydrocortisone reaches the systemic circulation unless the skin is broken or denuded.
DP LOTION-HC 1% and DP Hydrocortisone Cream are indicated as adjunctive therapy for the symptomatic relief of the inflammatory manifestations of corticosteroid responsive dermatoses.
Apply a thin, even layer two to four times a day.
DP LOTION-HC 1% and DP Hydrocortisone Cream are contraindicated when viral, fungal, bacterial or parasitic infections are present at the lesion site. Use is also contraindicated where pruritus is due to psychogenic or internal organ disease, or skin cancer is present. A history of lanolin sensitivity is also a contraindication to use of DP LOTION-HC 1%.
Although the absorption of hydrocortisone into the systemic circulation is small, the amount absorbed may be increased significantly if prolonged administration occurs or extensive areas are treated. This is particularly so in infants and young children. The use of occlusive dressings may also increase the amount of hydrocortisone reaching the systemic circulation.
Use in Pregnancy: The safe use of topical corticosteroids during pregnancy has not been established, therefore, the decision to use either Hydrocortisone preparation to treat a pregnant woman must be decided on the basis of benefit versus potential risk.
Adverse effects associated with topical application of DP LOTION-HC 1% and DP Hydrocortisone Cream are unlikely, significant abuse of the product being required. If effects occur, they are likely to be topical such as cutaneous atrophy, petechiae and steroid acne.
Systemic effects may occur when relatively large amounts of hydrocortisone are absorbed. Absorption is influenced by: amount used, duration of treatment and nature of the skin.
Nil.
Overdosage may result in cutaneous atrophy, petechiae, steroid acne or systemic effects of glucocorticoid overdose. The preparation should be stopped immediately and the patient monitored for signs of withdrawal and treated appropriately.
Store tightly closed below 25°C. Protect from light and moisture. Keep out of reach of children. Shelf-life one year.
Prescription Medicine.
DP Lotion HC-1%: 100mL and 250mL.
DP Hydrocortisone Cream: 500g.
Hydrocortisone is 11β,17α,21-trihydroxy-pregn-4-ene-3,20-dione. It has a chemical formula and molecular weight of C21H30O5 and 362.5 respectively.
Other ingredients are:
DP Lotion HC-1%: Cetyl alcohol 95%, Paraffin oil light, Polysorbate 60, Sorbitan monostearate, Liquid lanolin, Propyl paraben, Glycerine, Methyl paraben, Triethanolamine 99% and Water.
DP Hydrocortisone Cream: Paraffin oil light, Cetamacrogol 1000, Butylated hydroxyanisole, Cetostearyl alcohol, Propyl paraben, Methyl paraben, Glycerine and Water.
Douglas Pharmaceuticals Ltd
PO Box 45-027
Lincoln
Auckland 8
New Zealand
Ph: (09) 835-0660
Fax: (09) 835-0665
27 April 1999