Fusidic Acid + Hydrocortisone

Pharmacologic Category

Antibiotic, Topical; Corticosteroid, Topical

Dosing: Adult

Atopic dermatitis: Topical: Apply 3 times/day for ≤14 days

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Atopic dermatitis: Topical: Children ≥3 years and Adolescents: Refer to adult dosing.

Use: Labeled Indications

Note: Not approved in the US

Atopic dermatitis: Treatment of mild to moderately severe atopic dermatitis caused by susceptible organisms (eg, staphylococcus aureus).

Administration: Topical

For external use only; not for use in or near the eye. Use only as directed and for the duration prescribed.

Administration: Pediatric

Topical: For external use only; apply sparingly to affected areas; not for use in or near the eye. Use only as directed and for the duration prescribed.

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat certain skin problems when a skin infection is present.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss.

• Severe skin irritation

• Skin changes like acne, stretch marks, slow healing, or hair growth.

• Skin thinning

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Medication Safety Issues

​Pediatric patients: High-risk medication:

Contraindications

Hypersensitivity to fusidic acid, hydrocortisone acetate, or any component of the formulation; fungal infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations and viral diseases of the skin

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Appropriate use: Avoid use with occlusive dressings. Do not use near the eye; conjunctival irritation may occur. Do not use for >14 days without clinical improvement.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Pregnancy Considerations

See individual agents.

Breast-Feeding Considerations

See individual agents.

Briggs' Drugs in Pregnancy & Lactation

• Hydrocortisone

Adverse Reactions

Frequency not always defined.

Dermatologic: Dermatitis (exacerbation: 2%), acne rosacea, atrophic striae, burning sensation of skin, dyschromia, hypertrichosis, pruritus, secondary skin infection, skin atrophy, subcutaneous atrophy, telangiectasia, xeroderma

Hypersensitivity: Hypersensitivity reaction

Local: Local irritation (2%)

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions Open Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Product Availability

Not available in the US

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Fucidin H: Fusidic acid 2% and hydrocortisone acetate 1% (30 g)

Anatomic Therapeutic Chemical (ATC) Classification

• D07CA01

Generic Available (US)

No

Mechanism of Action

See individual agents.

Pharmacodynamics/Kinetics

Absorption: Fusidic acid: ~2%; hydrocortisone acetate: 1% to 5% (may be higher if integrity of skin is compromised).

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Related Information

• Fusidic Acid (Topical)
• Hydrocortisone (Topical)

Index Terms

Hydrocortisone acetate and Fusidic Acid; Hydrocortisone and Fusidic Acid

References

Fucidin H (fusidic acid and hydrocortisone acetate) [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; October 2012.

Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191.[PubMed 32265601]

Brand Names: International

Curoderm-H (PK); Disuf-H (LK); Foban Hydro (HK, MY); Fucidin H (AE, AR, BH, CH, CL, CO, CZ, EC, EE, GB, HK, HU, IL, IN, IT, JO, KW, LB, LT, LV, MT, MY, PE, PH, RO, RU, SA, SG, SK, TH, VN, ZA); Fucidin Hydrocortison (LU, NO); Fucidin Hydrocortisone (BE); Fucidin-H (LK); Fucidin-Hydrocortison (SE); Fucidine H (DE, ES, PT); Fucil-hc (PK); Fucudin H (GR); Fusac-H (PK); Fusicort (BD); Fusidate H (BD, HK); Fusiderm HC (CO); Fusitrim (BD); Fuson-H (IN)

Last Updated 10/13/20