hydrocortisone probutate topical (Rx)

Brand and Other Names:Pandel
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream

  • 0.1%
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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

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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

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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

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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.

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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

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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