Dosing & Uses
Dosage Forms & Strengths
topical cream
- 0.1%
Corticosteroid-Responsive Dermatoses
Medium potency corticosteroid indicated for relief of inflammatory and pruritic manifestations of dermatoses
Apply sparingly to affected area qDay or BID depending on severity of condition
Administration
Apply a thin film to the affected area and massage gently until the cream 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)
Should not be used with occlusive dressings unless directed by the physician
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
<18 years: Safety and efficacy not established
Adverse Effects
1-10%
Burning (2%)
Stinging (1%)
<1%
Paresthesia
Frequency Not Defined
Itching
Irritation
Dryness
Folliculitis
Hypertrichosis
Acneiform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis
Secondary infections
Skin atrophy
Striae
Miliaria
Postmarketing Reports
Rash
Papulovesicular rash
Dryness
Erythema
Pruritus
Warnings
Contraindications
None listed by the manufacturer
Cautions
Systemic absorption of topical corticosteroids may suppress the HPA axis with the potential for glucocorticosteroid insufficiency may occur during or after withdrawal of treatment; factors that predispose to HPA axis suppression include use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age; use of topical corticosteroids may require periodic evaluation for HPA axis suppression; evaluation for HPA axis suppression may be done by using adrenocorticotropic hormone (ACTH) stimulation test
Children are more susceptible to systemic toxicity because of their larger skin surface to body mass ratios
Systemic effects of topical corticosteroids may manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus
Discontinue if irritation develops
If concomitant skin infection is present or develops, use appropriate antibacterial or antifungal agent; discontinuation of topical corticosteroid may be required if infection inadequately controlled
Avoid contact with eyes
Pregnancy & Lactation
Pregnancy
There is no clinical information on pregnant women to inform any drug-associated risk for major birth defects and miscarriage; in animal reproduction studies, hydrocortisone probutate given by subcutaneous route during period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively)
Lactation
There is no information on presence of hydrocortisone probutate in breast milk, or on its effects on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Medium potency corticosteroid Elicits anti-inflammatory, anti-pruritic, and vasoconstrictive actions; acts by the induction of phospholipase A2 inhibitory proteins (lipocortins); these proteins control the biosynthesis of potent mediators of inflammation (eg, prostaglandins, leukotrienes) by inhibiting the release of their common precursor arachidonic acid
Absorption
Extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, integrity of the epidermal barrier, extent surface area
Occlusive dressings
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Pandel topical - | 0.1 % cream | ![]() | |
Pandel topical - | 0.1 % cream | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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