Hydrocortisone-17-Valerate (HydroVal)

1. Health Canada Product Monograph — Hydrocortisone-17-Valerate

• Used for the topical treatment of acute and chronic corticosteroid-responsive dermatoses.
• Provides anti-inflammatory, anti-allergic, and antipruritic (itch-relieving) effects when applied to affected skin.

• Corticosteroids have shown teratogenic potential in animal studies even at relatively low systemic doses, so HydroVal should be used during pregnancy, especially in the first trimester, only if the expected benefit justifies the potential risk to the fetus.
• This corticosteroid class should not be applied extensively, in large amounts, or for prolonged periods during pregnancy, and infants born to mothers who received substantial corticosteroid exposure during pregnancy should be monitored for signs of adrenal underactivity.

• Corticosteroids absorbed systemically are known to pass into breast milk and could theoretically suppress infant growth, interfere with the infant's own corticosteroid production, or cause other unwanted effects, so caution is advised when using this product while nursing.

• No specific dosing guidance for older adults is provided in the product monograph, but as with all topical corticosteroids, aging skin is thinner and more prone to bruising and atrophic changes, so cautious, limited-duration use is reasonable in elderly patients.

• Safety and effectiveness in infants and children have not been established.
• Children absorb proportionally more drug through the skin because of their higher skin-surface-to-body-mass ratio, putting them at greater risk of adrenal suppression, Cushingoid features, and growth interference with prolonged use, so treatment should be limited to the smallest amount needed for the shortest effective time.

• A small amount of the 0.2% cream or ointment is applied to the affected skin two to three times daily as needed, rubbed in gently and completely.
• If there is no improvement within a few days to about a week, the product should be stopped and the patient reassessed, and treatment should be discontinued once the lesions have healed.
• The product should not be used under occlusive dressings or wraps unless specifically directed by a physician, since this significantly increases absorption into the body.

• A burning or stinging sensation at the application site may occur.
• Itching may occur.
• Local skin irritation may occur.
• Dryness of the treated skin may occur.
• Folliculitis (inflammation of hair follicles) may occur.
• Increased hair growth (hypertrichosis) at the application site may occur.
• Acne-like eruptions may occur.
• Lightening of skin color (hypopigmentation) at the treated area may occur.
• A rash resembling perioral dermatitis may develop around the mouth if used on the face.
• A prickly-heat-like rash (miliaria) may occur, especially under occlusion.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Allergic contact dermatitis to the product itself can occur, and is usually recognized by a treated lesion failing to heal rather than by an obvious flare.
• Thinning (atrophy) of the skin or underlying tissue can develop with prolonged use, particularly on the face, groin, and underarms.
• Permanent stretch marks (striae) can develop with prolonged use.
• Secondary skin infection or worsening of an existing infection can occur, particularly under occlusive dressings.
• With extensive, prolonged, or occluded use, enough drug can be absorbed into the body to suppress the adrenal glands' own hormone production, with the potential for adrenal insufficiency after stopping treatment.
• Signs of excess corticosteroid in the body, such as a rounded facial appearance, high blood sugar, and sugar in the urine, can develop with significant systemic absorption.
• Worsening of chronic plaque psoriasis into a pustular form has been reported after stopping or reducing potent topical corticosteroid treatment.
• Clouding of the lens of the eye (posterior subcapsular cataracts) has been reported with significant systemic corticosteroid exposure.

• Use with caution on the face, groin, and underarms, since these areas are more prone to atrophic skin changes.
• Use with caution near the eyes, since absorption in this area may raise pressure inside the eye and contribute to glaucoma or cataracts.
• Use with caution in patients with stasis dermatitis or other conditions involving poor circulation to the skin.
• If a bacterial or fungal skin infection is present or develops during treatment, an appropriate antimicrobial should be used, and HydroVal should be stopped if the infection does not respond promptly.
• Use with caution over large body surface areas, for prolonged periods, or under occlusive dressings, since these conditions increase systemic absorption and the risk of body-wide effects.
• Use with particular caution in children, who are more susceptible to systemic absorption and its effects than adults.

• Contraindicated in patients with a known hypersensitivity to hydrocortisone valerate or to any other ingredient in the cream or ointment.
• Contraindicated in the presence of untreated bacterial or fungal skin infections.
• Contraindicated in cutaneous tuberculosis.
• Contraindicated in syphilitic skin lesions.
• Contraindicated in chickenpox.
• Contraindicated in skin eruptions following vaccination.
• Contraindicated in viral skin diseases generally, such as herpes simplex or shingles.
• Not intended for ophthalmic (eye) use.

• The product monograph does not identify specific drug-drug interactions for this topical formulation, and because systemic absorption is normally minimal with recommended use, clinically significant interactions with other medications are not expected.
• Patients should avoid receiving vaccinations without first checking with their physician while using this medication, since topical corticosteroid exposure can theoretically blunt the immune response to a vaccine if absorption is substantial.

• No food interactions are expected, as this is a topical product applied to the skin rather than taken by mouth.

• Apply to the affected skin two to three times daily as needed, rubbing in a small amount gently and completely.

• Store at controlled room temperature, between 15 and 25 degrees C.

• HydroVal is a topical corticosteroid cream or ointment used to calm inflamed, itchy, or allergic skin conditions.
• Apply a thin layer to the affected area two to three times daily as directed, and stop once the skin has healed.
• Common effects include mild burning, itching, dryness, or irritation at the application site.
• Contact your doctor's office or prescriber promptly if the treated skin fails to heal, develops thinning, stretch marks, or signs of infection, or if you notice signs of excess steroid effect such as unusual weight gain or a rounded face.
• Use for external skin application only, avoid contact with the eyes, and do not cover with airtight dressings or bandages unless your physician has specifically told you to.
• Store at room temperature and tell your physician if you are pregnant, planning pregnancy, or breastfeeding before using this product.