Pandel^® (hydrocortisone probutate cream) Cream, 0.1%

For Dermatologic Use Only
Rx only
Not for Ophthalmic Use

Pandel Cream contains hydrocortisone probutate, a synthetic adrenocorticosteroid, for dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Hydrocortisone probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11β,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is:

Each gram of Pandel (hydrocortisone probutate cream) Cream, 0.1% contains: 1 mg of hydrocortisone probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.

Pandel (hydrocortisone probutate cream) Cream, 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

Pandel (hydrocortisone probutate cream) Cream, 0.1% is contraindicated in those patients who are hypersensitive to hydrocortisone probutate or to any of the components of the preparation.

The most frequent adverse reactions reported for Pandel (hydrocortisone probutate cream) Cream, 0.1% have included burning in 4, stinging in 2, and moderate paresthesia in 1 out of 226 patients.

The following local adverse reactions are reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are uled in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, miliaria.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS).

Apply a thin film of Pandel (hydrocortisone probutate cream) Cream, 0.1% to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.

Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Pandel (hydrocortisone probutate cream) Cream, 0.1% should not be used with occlusive dressings unless directed by the physician. Pandel (hydrocortisone probutate cream) Cream, 0.1% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Pandel (hydrocortisone probutate cream) Cream, 0.1%, a white to off-white opaque cream is supplied as follows:

15 g tubes NDC 64682-200-15
45 g tubes NDC 64682-200-45
80 g tubes NDC 64682-200-80
Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured for CollaGenex Pharmaceuticals, Inc.
Newtown, PA 18940
by Altana Inc., Melville, New York 11747

I153A CS/IF153A CS
R4/03
#121