Long-term continuous topical therapy should be avoided, particularly in infants and children. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids. Caution should be exercised if Zeta-Cort® cream is used near the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infection persists. Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance.

Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions.

Zeta-Cort® Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions. 

None known 

Pregnancy

Pregnancy Category C:

Safety for use of Zeta-Cort® during pregnancy has not been established. Studies in animals have not shown teratogenic effects with fusidic acid but studies with corticosteroids have shown teratogenic effects. The potential risk for humans is unknown. Zeta-Cort® cream should not be used during pregnancy unless clearly necessary.

Lactation

No effects on the infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid and betamethasone varlerate is negligible. Zeta-Cort® Cream can be used when breast-feeding but should not be used on the breast. 

Zeta-Cort® has no or negligible influence on the ability to drive or to use machines. 

Based on clinical data for Zeta-Cort® approximately 3% of patients can be expected to experience an undesirable effect.

The most frequently reported undesirable effects are various transient symptoms of application site irritation. Allergic reactions have been reported.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Very common >1/10

Common >1/100 and <1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1,000

Very rare <1/10,000

Immune system disorders

Not known

Allergic reaction

Skin and subcutaneous tissue disorders

Uncommon

Skin irritation Skin burning sensation Pruritus Eczema aggravated Skin stinging sensation Erythema

Rare

Urticaria Dry skin

Not known

Contact Dermatitis Rash Telangiectasia 

Excessive prolonged use of topical corticosteroids may suppress the pituitary adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated. 

ATC code: D07CC01

Zeta-Cort® cream combines the well-known anti-inflammatory and antipruritic effects of betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone valerate is a topical steroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy. More refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against Staphyloccus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia and Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains of S. aureus. The antibacterial activity of fusidic acid is not diminished in the presence of betamethasone. 

There are no data which define the pharmacokinetics of Zeta-Cort® cream, following topical administration in man. 

However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.

Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine. 

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. 

15 gm cream filled in printed Aluminum Collapsible tube packed in a printed carton with folded leaflet.