- Approval Id
- 9ebbf9efa89f7c6d
- Drug Approval Emc Name
- Fludroxycortide 4 micrograms per square centimetre Tape
- Drug Name
- Fludroxycortide 4 micrograms per square centimetre Tape
- Company Name
- Typharm Limited
- Company Address
- Unit 1, 39 Mahoney Green, Rackheath, Norwich, Norfolk, NR13 6JY
- Company Website
- http://typharm.com
- Company Telephone
- +44 (0)1603 722480
- Company Medical Info Direct Line
- +44 (0)2037 694160
- Company Medical Info Email
- medinfo@typharm.com
- Company Customer Care Direct Line
- +44 (0)1603 722480
- Company Stock Availability
- +44 (0)1603 722480
- Atc Code
- D07AC07
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Typharm Ltd.
First Floor
Unit 1
39 Mahoney Green
Rackheath
Norwich
NR13 6JY
- Authorisation Number
- PL 00551/0014
- Authorisation Date
- Date of first authorisation: 28 February 1999
Date of latest renewal: 24 August 2001
- Instruction Authorisation Holder
- Typharm Ltd.
First Floor
Unit 1
39 Mahoney Green
Rackheath
Norwich
NR13 6JY
- Instruction Authorisation Number
- PL 00551/0014
- Instruction Authorisation Date
- Date of first authorisation: 28 February 1999
Date of latest renewal: 24 August 2001
- Instruction Composition
- The tape is impregnated with 4 micrograms fludroxycortide per square centimetre.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Occlusive tape.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Occlusive topical steroid. Adjunctive therapy for chronic, localised, recalcitrant dermatoses that may respond to topical corticosteroids and particularly dry, scaling lesions.4.2 Posology and method of administration
\*\*Posology\*\*
\*Adults and the Elderly\*
For application to the skin, which should be clean, dry and shorn of hair. In most instances the tape need only remain in place for 12 out of 24 hours.
\*\*Method of administration\*\*
Fludroxycortide Tape is waterproof. Cosmetics may be applied over the tape.
\*Application:\* The tape cannot be torn and must be cut with clean scissors. The tape is cut so as to cover the lesion and a quarter inch margin of normal skin. Corners should be rounded off. After removing the lining paper, the tape is applied to the centre of the lesion with gentle pressure and worked to the edges, avoiding excessive tension of the skin. If longer strips of tape are to be applied, the lining paper should be removed progressively.
If the affected area is likely to be moving constantly, for example, on the hand, finger, knee or elbow, apply the tape while the skin/joint is flexed. Segments can be cut from the tape to allow it to mould around the joint.
If irritation or infection develops, remove tape and consult a physician.
\*Paediatric population\*
If used in children, courses should be limited to five days and occlusion should not be used (see section 4.4).4.3 Contraindications
Chicken pox. Vaccinia. Tuberculosis of the skin. Hypersensitivity to any of the components. Facial rosacea. Acne vulgaris. Perioral dermatitis. Perianal and genital pruritus. Dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Not advocated for acute and weeping dermatoses.
Local and systemic toxicity of medium and high potency topical corticosteroids is common, especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression (see section 4.8). Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete on discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.
Long-term continuous therapy should be avoided in all patients irrespective of age. Application under occlusion should be restricted to dermatoses in very limited areas. If used on the face, courses should be limited to five days and occlusion should not be used.
In the presence of skin infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, fludroxycortide should be discontinued until the infection has been adequately controlled.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
The label will state strong steroid.
\*\*Paediatric population\*\*
Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Children may also demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than do mature patients because of a larger skin surface to body weight ratio. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There is inadequate evidence of safety in human pregnancy. There may be a very small risk of cleft palate and intra-uterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals.
Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for mother and child.
\*\*Breast-feeding\*\*
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in the breast milk of nursing mothers. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to nursing mothers.4.7 Effects on ability to drive and use machines
Not relevant.4.8 Undesirable effects
The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilatations of superficial blood vessels producing telangiectasia.
Prolonged use of large doses to extensive areas can result in sufficient systemic absorption to produce generalised manifestations of steroid toxicity and may result in depression of HPA function on discontinuing treatment.
Manifestations of Cushing's syndrome, hyperglycaemia and glycosuria have occurred in some patients.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Intracranial hypertension including bulging fontanelles, headaches and bilateral papilloedema have also been reported in children receiving topical corticosteroids.
Infected skin lesions, viral, bacterial or fungal, may be substantially exacerbated by topical steroid therapy. Wound healing is significantly retarded.
Hypersensitivity reactions may occur.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.4.9 Overdose
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see section 4.4).
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, potent (group III), dermatological preparations, ATC code: D07AC07
Fludroxycortide is a fluorinated, synthetic, potent, topical corticosteroid. As with other topical steroids, the therapeutic effect is primarily the result of its anti-inflammatory, antimitotic and antisynthetic activities.5.2 Pharmacokinetic properties
When applied topically, particularly to large areas, when the skin is broken, or under occlusive dressings, corticosteroids may be absorbed in sufficient amounts to cause systemic effects.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber in addition to that summarised in other sections of the Summary of Product Characteristics.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Acrylate copolymer adhesive
Low-density polyethylene backing
Silicone coated paper release liner6.2 Incompatibilities
None known.6.3 Shelf life
24 months.6.4 Special precautions for storage
Keep the plastic container tightly closed in order to protect from moisture.
Store in a dry place, below 25°C.6.5 Nature and contents of container
Polypropylene dispenser and silica gel desiccant sachet in a polypropylene container, with a polyethylene lid, packed in a cardboard box, containing 20cm, 50cm or 200cm of translucent, polythene adhesive film, 7.5cm wide, protected by a removable paper liner.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal and handling.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
The tape is impregnated with 4 micrograms fludroxycortide per square centimetre.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Occlusive tape.
## Clinical Particulars
4.1 Therapeutic indications
Occlusive topical steroid. Adjunctive therapy for chronic, localised, recalcitrant dermatoses that may respond to topical corticosteroids and particularly dry, scaling lesions.4.2 Posology and method of administration
\*\*Posology\*\*
\*Adults and the Elderly\*
For application to the skin, which should be clean, dry and shorn of hair. In most instances the tape need only remain in place for 12 out of 24 hours.
\*\*Method of administration\*\*
Fludroxycortide Tape is waterproof. Cosmetics may be applied over the tape.
\*Application:\* The tape cannot be torn and must be cut with clean scissors. The tape is cut so as to cover the lesion and a quarter inch margin of normal skin. Corners should be rounded off. After removing the lining paper, the tape is applied to the centre of the lesion with gentle pressure and worked to the edges, avoiding excessive tension of the skin. If longer strips of tape are to be applied, the lining paper should be removed progressively.
If the affected area is likely to be moving constantly, for example, on the hand, finger, knee or elbow, apply the tape while the skin/joint is flexed. Segments can be cut from the tape to allow it to mould around the joint.
If irritation or infection develops, remove tape and consult a physician.
\*Paediatric population\*
If used in children, courses should be limited to five days and occlusion should not be used (see section 4.4).4.3 Contraindications
Chicken pox. Vaccinia. Tuberculosis of the skin. Hypersensitivity to any of the components. Facial rosacea. Acne vulgaris. Perioral dermatitis. Perianal and genital pruritus. Dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Not advocated for acute and weeping dermatoses.
Local and systemic toxicity of medium and high potency topical corticosteroids is common, especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression (see section 4.8). Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete on discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.
Long-term continuous therapy should be avoided in all patients irrespective of age. Application under occlusion should be restricted to dermatoses in very limited areas. If used on the face, courses should be limited to five days and occlusion should not be used.
In the presence of skin infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, fludroxycortide should be discontinued until the infection has been adequately controlled.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
The label will state strong steroid.
\*\*Paediatric population\*\*
Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Children may also demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than do mature patients because of a larger skin surface to body weight ratio. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There is inadequate evidence of safety in human pregnancy. There may be a very small risk of cleft palate and intra-uterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals.
Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for mother and child.
\*\*Breast-feeding\*\*
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in the breast milk of nursing mothers. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to nursing mothers.4.7 Effects on ability to drive and use machines
Not relevant.4.8 Undesirable effects
The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilatations of superficial blood vessels producing telangiectasia.
Prolonged use of large doses to extensive areas can result in sufficient systemic absorption to produce generalised manifestations of steroid toxicity and may result in depression of HPA function on discontinuing treatment.
Manifestations of Cushing's syndrome, hyperglycaemia and glycosuria have occurred in some patients.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Intracranial hypertension including bulging fontanelles, headaches and bilateral papilloedema have also been reported in children receiving topical corticosteroids.
Infected skin lesions, viral, bacterial or fungal, may be substantially exacerbated by topical steroid therapy. Wound healing is significantly retarded.
Hypersensitivity reactions may occur.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.4.9 Overdose
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see section 4.4).
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, potent (group III), dermatological preparations, ATC code: D07AC07
Fludroxycortide is a fluorinated, synthetic, potent, topical corticosteroid. As with other topical steroids, the therapeutic effect is primarily the result of its anti-inflammatory, antimitotic and antisynthetic activities.5.2 Pharmacokinetic properties
When applied topically, particularly to large areas, when the skin is broken, or under occlusive dressings, corticosteroids may be absorbed in sufficient amounts to cause systemic effects.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber in addition to that summarised in other sections of the Summary of Product Characteristics.
## Pharmaceutical Particulars
6.1 List of excipients
Acrylate copolymer adhesive
Low-density polyethylene backing
Silicone coated paper release liner6.2 Incompatibilities
None known.6.3 Shelf life
24 months.6.4 Special precautions for storage
Keep the plastic container tightly closed in order to protect from moisture.
Store in a dry place, below 25°C.6.5 Nature and contents of container
Polypropylene dispenser and silica gel desiccant sachet in a polypropylene container, with a polyethylene lid, packed in a cardboard box, containing 20cm, 50cm or 200cm of translucent, polythene adhesive film, 7.5cm wide, protected by a removable paper liner.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal and handling.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
