Loading…
SANDOZ HYDROCORTISONE is a brand name for Hydrocortisone, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Post-Marketing Adverse Drug Reactions The following adverse reactions have been identified during the post-approval use of hydrocortisone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
g. moon face, central obesity), increased weight /obesity, delayed weight gain/growth retardation in children, decreased endogenous cortisol levels, hyperglycemia/glucosuria, hypertension, osteoporosis, and steroid withdrawal syndrome.
Eye Disorders:
Cataract, glaucoma.
General Disorders and Administrative Site Reactions:
Application site irritation/pain.
Immune System Disorders:
Local hypersensitivity.
Infections and Infestations:
Secondary infection.
Skin and Subcutaneous Tissue Disorders:
Contact dermatitis /dermatitis, erythema, rash, urticaria, pruritus, skin burning, skin pain, skin exfoliation, skin atrophy*, atrophy of subcutaneous tissues, skin dryness*, skin striae*, change in pigmentation*, hypertrichosis, telangiectasia*, and exacerbation of underlying symptoms.
The following have been observed with the use of occlusive dressings: pustules, miliaria, folliculitis, and pyoderma. *Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
DRUG INTERACTIONS Overview No clinical trials were specifically designed to assess potential drug-drug, drug-food, drug-herb, or drug-laboratory interactions with hydrocortisone. , ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor. Page 9 of 19 Drug-Drug Interactions Interactions with other drugs have not been established.
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the PRESCRIBING INFORMATION. • Patients who are hypersensitive to other corticosteroids.
• Patients with bacterial, tubercular, or fungal infections involving the skin, viral diseases (such as herpes simplex, chicken pox, and vaccinia), parasitic infections, skin manifestations relating to tuberculosis or syphilis, eruptions following vaccinations, rosacea, acne vulgaris, and pruritus without inflammation.
• Topical application to the eye. WARNINGS AND PRECAUTIONS General Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. SANDOZ HYDROCORTISONE should not be used under occlusion due to increased risk of systemic exposure and infection.
When used under occlusive dressing, over extensive areas, on the face, scalp, axillae, or scrotum, sufficient absorption may occur to result in adrenal suppression and other systemic effects (see WARNINGS AND PRECAUTIONS - Endocrine and Metabolism, Immune and Ophthalmologic) Cardiovascular Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases associated with impaired circulation.
Use of corticosteroids around chronic leg ulcers may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection. Endocrine and Metabolism Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic- pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency can occur in some individuals as a result of increased systemic absorption of topical corticosteroids.
Hyperglycemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids (see ADVERSE REACTIONS). Conditions which augment systemic absorption include the formulation and potency of the topical corticosteroid, the application of topical corticosteroids over large body surface areas, application to intertriginous areas (such as the axillae), frequency of application, prolonged use, or the use of occlusive dressings.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrocortisone in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Drug-Food Interactions Interactions with food have not been established. Drug-Herb Interactions Interactions with herbal products have not been established. Drug-Laboratory Interactions Interactions with laboratory tests have not been established.
DOSAGE AND ADMINISTRATION Dosing Considerations • Patients/caregivers should be instructed to use the minimum quantity of SANDOZ HYDROCORTISONE for the shortest duration of time necessary to achieve the desired therapeutic benefit because of the potential for corticosteroids to suppress the hypothalamic-pituitary-adrenal (HPA) axis and cause skin atrophy (see WARNINGS AND PRECAUTIONS).
• If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated. • SANDOZ HYDROCORTISONE is for topical use only and not for ophthalmic use. • Pediatric patients may be more susceptible to local and systemic toxicity from equivalent doses of topical corticosteroids because of their larger skin surface to body weight ratios, and may require shorter courses of treatment than adults.
• Geriatric patients may be more susceptible to percutaneous absorption and the potential effects of systemic absorption. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs.
Recommended Dose and Dosage Adjustment A thin layer should be applied to affected areas once or twice a day for a maximum of 4 weeks. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Avoid abrupt discontinuation of topical corticosteroids when control is achieved, as rebound of pre-existing dermatoses can occur. Continue an emollient as maintenance therapy.
Pediatrics (<18 years of age):
Care should be taken when using SANDOZ HYDROCORTISONE in pediatric patients. The minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS — Special Populations, Pediatrics (< 18 years of age)).
Page 10 of 19 Geriatrics (>65 years of age):
SANDOZ HYDROCORTISONE should be used with caution in geriatric patients due to increased risk of renal or hepatic impairment in this population. The minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS — Special Populations, Geriatrics (> 65 years of age)).
Renal/Hepatic Impairment:
In patients with renal or hepatic impairment, the minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS — Special Populations, Patients with renal / hepatic impairment).
Missed Dose In the event of missed dose, SANDOZ HYDROCORTISONE should be applied as soon as possible after the missed dose is remembered. If this is close to the scheduled application time or the next dose, the patient should wait and apply the next scheduled dose.
The usual schedule should be resumed thereafter. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS AND PRECAUTIONS).
Excessive prolonged use or misuse may suppress hypothalamic-pituitary-adrenal (HPA) axis function, resulting in secondary adrenal insufficiency. If symptoms of HPA axis suppression occur, SANDOZ HYDROCORTISONE should be withdrawn gradually by reducing the frequency of application.
Further management should be as clinically indicated. If toxic effects occur, SANDOZ HYDROCORTISONE treatment should be discontinued and symptomatic therapy should be administered. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action SANDOZ HYDROCORTISONE belongs to a class of topical drugs called topical corticosteroids.
It is considered to be a mild or low potency corticosteroid. Topical […]
Other risk factors for increased systemic effects include increasing hydration of the stratum corneum, use on thin skin areas (such as the face), and use on broken skin or in conditions where the skin barrier may be impaired. Page 5 of 19 If patients must be treated over large body surface areas, they should be evaluated periodically for evidence of HPA axis suppression (see WARNINGS AND PRECAUTIONS - Monitoring and Laboratory Tests).
If HPA axis suppression or Cushing's syndrome is observed, an attempt should be made to withdraw the drug by reducing the frequency of application. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see ADVERSE REACTIONS).
Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic corticosteroid supplementation, see the prescribing information for those products.
Pediatric patients may absorb larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface to body mass ratios as compared with adult patients (see WARNINGS AND PRECAUTIONS - Special Populations, Pediatrics).
Immune Topical corticosteroids may increase the risk of infections including aggravation of cutaneous infection, masked infection, and secondary infections. In particular, bacterial infection is encouraged by the warm, moist conditions within skin-fold areas, or caused by occlusive dressings.
If concomitant skin infections develop, SANDOZ HYDROCORTISONE should be discontinued and antimicrobial therapy should be administered. Ophthalmologic Topical corticosteroids should be used with caution on lesions close to the eye because systemic absorption may cause increased intraocular pressure, cataract, or glaucoma.
Sensitivity Local hypersensitivity reactions (see ADVERSE REACTIONS) may resemble symptoms of the condition under treatment. If hypersensitivity reactions occur, SANDOZ HYDROCORTISONE should be discontinued and appropriate therapy should be initiated.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.
Skin If significant irritation develops, SANDOZ HYDROCORTISONE should be discontinued and appropriate therapy should be instituted. Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue.
Topical corticosteroids should be used with caution on lesions of the face, groin, and axillae as these areas are more prone to atrophic changes than other areas of the body. Page 6 of 19 Frequent observation is important if these areas are to be treated.
If skin atrophy is observed, treatment should be discontinued.
Special Populations Pregnant Women:
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development (see TOXICOLOGY). Subcutaneous administration of hydrocortisone to mice at doses of ≥30 mg/kg/day, to rabbits at a dose of 675 mcg/kg/day, and the administration of a single intramuscular injection of ≥25 mg to hamsters during pregnancy produced fetal abnormalities including cleft palate.
The relevance of this finding to human beings has not been established. There are no adequate and well-controlled studies of hydrocortisone in pregnant women. Administration of SANDOZ HYDROCORTISONE during pregnancy should only be considered if the expected benefit to the mother […]