Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: LEO Pharma Ltd, Auckland, New Zealand, Ph: 0800 497 456
Long-term continuous topical therapy with Fucicort should be avoided.
Although rare, hypersensitivity reactions to fusidic acid have been reported. Should hypersensitivity occur, applications should be stopped immediately.
When steroids and particularly fluorinated steroids are applied for long periods of time (more than four weeks) the occurrence of atrophic striae is likely.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucicort.
Due to the content of corticosteroid, Fucicort should be used with care near the eyes. Avoid getting Fucicort into the eyes (see section 4.8).
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids, especially under occlusion with weekly doses of over 30g. Routine steroid precautions must be observed particularly if the patient is stressed (e.g. following surgery).
Due to the content of betamethasone valerate, prolonged topical use of Fucicort may cause skin atrophy.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroid.
Prolonged use on flexures and intertriginous areas is undesirable.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, Fucicort may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment.
Fucicort contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions
No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.
No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible.
There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity.
Fucicort should not be used during pregnancy unless the clinical condition of the woman requires treatment with fusidic acid and betamethasone valerate.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of topically applied fusidic acid and betamethasone valerate to a limited area of skin of the breastfeeding woman is negligible.
Fucicort can be used during breastfeeding but it is recommended to avoid applying Fucicort on the breast.
There are no clinical studies with Fucicort regarding fertility.
Fucicort has no or negligible influence on the ability to drive and use machines.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritus.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
| Immune system disorders | |
| Uncommon (≥1/1,000 and <1/100) | Hypersensitivity |
| Skin and subcutaneous tissue disorders | |
| Uncommon (≥1/1,000 and <1/100) | Dermatitis contact, Eczema (condition aggravated), Skin burning sensation, Pruritus, Dry skin |
| Rare (≥1/10,000 and <1/1,000) | Erythema, Urticaria, Rash (including rash erythematous and rash generalised) |
| General disorders and administration site conditions | |
| Uncommon (≥1/1,000 and <1/100) | Application site pain, Application site irritation |
| Rare (≥1/10,000 and <1/1,000) | Application site swelling, Application site vesicles |
Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration (see section 4.4).
Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma (see section 4.4).
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (incl. dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhydrosis, and depigmentation. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for Fucicort as described in the frequency listing above.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.
Not applicable.
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