Hydrocortisone (Topical)

Introductory Information

Corticosteroid secreted by the adrenal cortex; topical anti-inflammatory agent.a

Class: 84:06 Anti-inflammatory Agents; or900 (VA primary); rs202 (VA primary); ot250 (VA
primary); de200 (VA primary)

Brands*: Ala-Cort®, Ala-Scalpt®, Analpram-HC® (combination), Anucort-HC®, Anu-Med®

HC, Anusert® HC, Anusol-HC®, Aquanil HC®, Caldecort® Anti-Itch, Carmol® HC
(combination), Cetacort®, CortaGel® Extra Strength, Cortaid® Intensive Therapy, Cortaid®
Maximum Strength, Cortaid® Sensitive Skin Formula, Cortenema®, Corticaine®, Cortifoam®,
Cortisporin® (combination), Cortizone for Kids®, Cortizone®, Cortizone® External Anal Itch
Relief, Cortizone® Scalp Itch Formula, Dermacort®, Dermarest®, DriCort®, DermiCort®,
Dermtex® HC, Enzone® (combination), Epifoam® (combination), Gynecort®, Hemorrhoidal®-
HC, Hemril-HC®, HydroSKIN®, Hytone®, LactiCare®-HC, Lanacort®, Lazersporin-C®
(combination), Locoid®, Mantadil® (combination), Massengill® Medicated Soft Cloth
Towelette®, Nupercainal® Hydrocortisone Anti-Itch, Nutracort®, Orabase® HCA, Pandel®,
Penecort®, Pramosone® (combination), Preparation H® Hydrocortisone, Proctocort®,
proctoCream®-HC (combination), proctoFoam®-HC (combination), Sarnol® HC, Scalp-Aid®,
Scalpcort® Maximum Strength, Texacort®, Westcort®, Zone-A® Cream (combination), Zone-
A® Forte Lotion (combination)
*
also available generically

Generic Name: Hydrocortisone

CAS Number: 50-23-7
Synonym: Cortisol, Compound F

Generic Name: Hydrocortisone Acetate

CAS Number: 50-03-3
Synonym: Cortisol Acetate

Generic Name: Hydrocortisone Butyrate

CAS Number: 13609-67-1

Generic Name: Hydrocortisone Valerate

CAS Number: 57524-89-7
Synonym: Cortisol Valerate

Uses

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.b

Nonprescription preparations used for temporary relief of minor skin irritations, itching, and
rash caused by eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps,
detergents, cosmetics, or jewelry.a
 Adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of
the anorectum: 25 mg in the morning and at night for 2 weeks.a
Severe proctitis: 25 mg 3 times daily or 50 mg twice daily.a
Adjunctive treatment of postirradiation or factitial proctitis: 25 mg in the morning and at
night for 6-8 weeks (or less if an adequate response is attained).a
For internal hemorrhoid symptoms and adjunctive treatment of other anorectal inflammatory
conditions: 10 mg in the morning and at night for 2-6 days.a

Prescribing Limits

Pediatric Patients
Corticosteroid-responsive Dermatoses
>Self-medication
Topical: Maximum 7 days.a

Adults
Corticosteroid-responsive Dermatoses
>Self-medication
Topical: Maximum 7 days.a

Cautions

Contraindications

• Known hypersensitivity to hydrocortisone or any ingredient in the formulation.b, d, e

• Rectal corticosteroid therapy in patients with intestinal obstruction, abscess, impending
perforation, peritonitis, extensive fistulas, and fresh intestinal anastomoses or sinus tracts.b

Warnings/Precautions

Sensitivity Reactions
Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with
other topical preparations that do not contain corticosteroids; confirm with diagnostic patch
testing.e

General Precautions
Hypothalamic-Pituitary-Adrenal Axis Suppression.
Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress
the HPA axis.b

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation,

morning plasma cortisol, urinary free cortisol), especially in patients applying a topical
corticosteroid to a large surface area or to areas under occlusion.b

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application,
and/or substitute a less potent corticosteroid.b

HPA-axis function recovery generally is prompt and complete following drug

discontinuance.b

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.b

Common Adverse Effects

Burning, stinging, itching, irritation, dry skin, erythema, folliculitis, hypopigmentation,

allergic contact dermatitis, secondary infection.b

Interactions

Specific Drugs and Laboratory Tests

Drug or Test Interaction

Corticosteroids
Nitroblue-tetrazolium test for
bacterial infection
Potential pharmacologic interaction with other
corticosteroid-containing preparationsb
Concurrent use of corticosteroids reportedly may result in
false-negative resultsb

Pharmacokinetics

Absorption

Bioavailability
Percutaneous penetration of corticosteroids following topical application to the skin varies
among individuals and may be increased by occlusive dressings, high corticosteroid
concentrations, and certain vehicles.b

Only minimal amounts of topical corticosteroid reach the dermis and subsequently the
systemic circulation after application to most normal skin areas; more absorption occurs from
the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and
sole.b

Absorption is markedly increased by loss of the skin's keratin layer and by inflammation
and/or diseases of the epidermal barrier (e.g., psoriasis, eczema).b

Occlusive dressings used with hydrocortisone for 96 hours substantially enhance

percutaneous penetration;b occlusive dressings used for up to 24 hours do not appear to alter
penetration.b

In healthy individuals, up to 30-90% of hydrocortisone administered rectally as a retention

enema may be absorbed.b Greater amounts of hydrocortisone may be absorbed if the
intestinal mucosa is inflamed.b

Distribution

Extent
Not known whether topical hydrocortisone is distributed into milk.b

Elimination

Metabolism
Once absorbed through the skin, topically applied corticosteroids are metabolized primarily
in the liver.b
 Elimination Route
Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in
the bile.b

Stability

Storage

Topical
Creams, Lotions, Ointments, Solutions, Aerosol Foams
Room temperature; consult product information for specific recommendations.

Rectal
Creams, Suspensions for Retention Enemas, Aerosol Foams, Suppositories
Room temperature; consult product information for specific recommendations.

Actions

• Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part

from steroid receptor binding.b
• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic
benefit in the management of corticosteroid-responsive dermatoses mediated primarily
through anti-inflammatory, antipruritic, and vasoconstrictive actions.b, d, e
• Anti-inflammatory effects may occur through induction of phospholipase A2 inhibitory
proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids.e
Decreased arachidionic acid precursors may downregulate biosynthesis of potent
inflammatory mediators (e.g., prostaglandins, leukotrienes).e
• Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of
destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed
areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall
permeability and edema formation; decreasing complement components; antagonizing
histamine activity and release of kinin from substrates; reducing fibroblast proliferation,
collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms
as yet unknown.b

Advice to Patients

• Importance of using only as directed, only for the disorder for which it was prescribed, and for
no longer than prescribed;b avoid contact with the eyes.d, e (See Topical Administration under
Dosage and Administration.)
• Importance of informing patients that treated areas of the skin should not be bandaged or
otherwise covered or wrapped as to be occlusive unless directed by a clinician.b
• Importance of informing parents of children receiving the drug that if hydrocortisone is
applied in the diaper area, tight-fitting diapers or plastic pants should not be used since they
may act as an occlusive dressing.b
• Importance of reporting any local adverse reactions, especially those occurring under
occlusive dressings, to a clinician.b
• Potential for hydrocortisone acetate suppositories to stain fabric; take appropriate
precautionary measures.b
Evaluasi Sediaan Salep:

Untuk mengetahui kestabilan sediaan pasta, perlu dilakukan beberapa pengujian, yakni:

1. Organoleptik, merupakan pengujian sediaan dengan menggunakan pancaindra untuk

mendiskripsikan bentuk atau konsistensi (misalnya padat, serbuk, kental, cair), warna
(misalnya kuning, coklat) dan bau (misalnya aromatik, tidak berbau). (Anief, 2000).

2. pH, prinsip uji derajat keasaman (pH) yakni berdasarkan pengukuran aktivitas ion
hidrogen secara potensiometri/ elektrometri dengan menggunakan pH meterAnsel,
1989).

3. Viskositas, viskositas adalah suatu pernyataan tahanan dari suatu cairan untuk
mengalir, makin tinggi viskositas, akan makin besar tahanannya (Martin et al., 1993).
Caranya pengujian klik.

4. Penghamburan/ daya sebar, uji penghamburan diartikan sebagai kemampuan untuk

disebarkan pada kulit. Penentuannya dilakukan dengan Extensometer. Caranya yakni
salep dengan volume tertentu dibawa ke pusat antara dua lempeng gelas, lempeng
sebelah atas dalam interval waktu tertentu dibebani oleh peletakan dari anak timbang.
Permukaan penyebaran yang dihasilkan dengan menaiknya pembebanan
menggambarkan suatu karakteristik untuk daya hambur (Voigt, 1993).

5. Resitensi panas, uji ini untuk mempertimbangkan daya simpan suatu sediaan salep atau
gel dalam daerah iklim dengan perubahan suhu (tropen) nyata dan terus menerus.
Caranya yakni salap dalam wadah tertutup diulang dan ditempatkan dalam pertukaran
kontinue suhu yang berbeda-beda (misalnya 20 jam pada 370C dan 4 jam pada 400C)
dan ditentukan waktunya (Voigt, 1994).