1. Name Of The Medicinal Product
CLARELUX 500 microgram/g cutaneous foam in pressurised container.
2. Qualitative And Quantitative Composition
Each gram contains 500 microgram clobetasol propionate.
For a full list of excipients, see section 6.1.
Excipients: also includes cetyl alcohol 11.5 mg/g, stearyl alcohol 5.2 mg/g and propylene glycol 20.9 mg/g.
3. Pharmaceutical Form
Cutaneous foam in pressurised container.
White foam that breaks down upon contact with skin.
4. Clinical Particulars
4.1 Therapeutic Indications
Short-course treatment of steroid responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids.
4.2 Posology And Method Of Administration
CLARELUX is a highly potent topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.
Note: for proper dispensing of foam, hold the container upside down and depress the actuator.
Route of administration: for cutaneous use.
Avoid contact with eyes, nose and mouth. Do not use near a naked flame.
Use in adults
CLARELUX should be applied to the affected area twice daily. There are no data from clinical studies evaluating the efficacy of once daily application.
The foam application has been designed so that the preparation spreads easily without being too fluid and allows easy application direct to the affected area.
Invert the container and dispense a small amount (of the size of a walnut or one teaspoon) of CLARELUX directly on the lesions, or dispense a small amount into the cap of the container, onto a saucer or other cool surface, taking care to avoid contact with eyes, nose, and mouth. Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Gently massage into affected area until the foam disappears and is absorbed. Repeat until entire affected area is treated. Move the hair away from the affected area so that the foam can be applied to each affected area.
Use in Children and Adolescents
As there are no data regarding the use of CLARELUX in children and adolescents, use in these patients is not recommended.
4.3 Contraindications
CLARELUX is contraindicated in patients with hypersensitivity to clobetasol propionate, to other corticosteroids, or to any of the excipients.
CLARELUX is contraindicated in patients with burns, rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus.
The use of CLARELUX is contraindicated in the treatment of primary infected skin lesions caused by infection with viruses, fungi or bacteria.
CLARELUX should not be used on the face.
4.4 Special Warnings And Precautions For Use
Long-term continuous topical therapy should be avoided as adrenal suppression can occur readily even without use with an occlusive dressing. Upon clearing of lesions or after a maximum treatment period of two weeks, change to intermittent therapy or consider replacing with a weaker steroid. With chronic intermittent use, Hypothalamic-Pituitary-Adrenal (HPA) axis function should be assessed periodically.
Secondary infection may develop, requiring the withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial products.
Special caution should be exercised if liver impairment is proven.
Topical corticosteroids may be hazardous because rebound relapses can follow development of tolerance. Patients may also be exposed to the risk of developing generalised pustular psoriasis and local or systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
Unless supervised by a physician, CLARELUX should not be used with occlusive dressings.
There have been a few reports in the literature of the development of cataracts in patients who have been using corticosteroids for prolonged periods of time. Although it is not possible to rule out systemic corticosteroids as a known factor, prescribers should be aware of the possible role of corticosteroids in cataract development.
This medicinal product contains propylene glycol, which may cause skin irritation. This medicinal product also contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
As there are no data regarding the use of CLARELUX in children and adolescents, use in these patients is not recommended.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed using CLARELUX.
4.6 Pregnancy And Lactation
Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see 5.3 Preclinical Safety Data). There are no adequate and well-controlled studies of clobetasol propionate in pregnant women. Epidemiological studies in pregnant women following use of oral corticosteroids have indicated little or no risk with regard to an association with cleft palate.
CLARELUX should not be used during pregnancy unless clearly necessary.
The safe use of clobetasol propionate during lactation has not been established. Glucocorticosteroids are excreted in breast milk, therefore CLARELUX should not be used in breast-feeding women unless clearly necessary.
4.7 Effects On Ability To Drive And Use Machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable Effects
The most commonly observed adverse reactions associated with the use of clobetasol propionate cutaneous foam formulations in clinical trials were application site reactions including burning (5%) and other non
Adverse reactions observed with clobetasol propionate cutaneous foam formulations in clinical trials are classified in body systems and listed below as very common (>10%), common (1-10%), uncommon (0.1 - 1%), rare (0.01 - 0.1%) and very rare (<0.01%), including isolated reports.
Nervous system disorders - Very rare: paraesthesia.
Eye disorders - Very rare: eye irritation.
Vascular disorders - Very rare: vein distended.
Skin and subcutaneous tissue disorders - Very rare: dermatitis not otherwise specified (NOS), dermatitis contact, psoriasis aggravated, skin irritation, skin tenderness, skin tightness.
General disorders and administration site conditions - Common: application site burning, application site reaction NOS; very rare: application site erythema, application site pruritus, pain NOS.
Investigations - Very rare: blood urine present, mean cell volume increased, protein urine present, urine nitrogen.
As with other topical corticosteroids, prolonged use of large amounts, or treatment of extensive areas can result in adrenocortical suppression. This is likely to be transient if the weekly dosage does not exceed 50g in adults.
Prolonged and intensive treatment with a highly active corticosteroid preparation may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease (see 4.4 Special warning and precautions for use).
There are reports of pigmentation changes and hypertrichosis with topical steroids.
If signs of hypersensitivity appear, applications should be stopped immediately. Exacerbation of symptoms may occur.
Additional local adverse events associated with glucorticosteroids include perioral dermatitis, rosacea-like dermatitis, delayed wound healing, rebound phenomenon which can lead to dependence on corticosteroids, and effects on the eyes. Raise of intraocular pressure and increased risk for cataract are known side effects for glucocorticosteroids. Contact allergy to CLARELUX or one of the excipients may also occur. If the product is not used properly, bacterial, viral, parasitic, and fungal infections may be masked and/or aggravated. Folliculitis has also been reported.
4.9 Overdose
No overdoses have been reported. Topically applied CLARELUX can be absorbed in sufficient amounts to produce systemic effects. If features of hypercorticoidism appear topical steroids should be discontinued gradually and, because of the risk of acute adrenal suppression, this should be done under medical supervision.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Corticosteroids, very potent (group IV)
ATC code: D07A D01
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
A vasoconstrictor study has shown that CLARELUX has a comparable potency, based upon skin blanching response, as other clobetasol propionate formulations.
5.2 Pharmacokinetic Properties
Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.
In a controlled pharmacokinetic study, 3 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of CLARELUX therapy to at least 20% of the body surface area.
5.3 Preclinical Safety Data
Parenteral administration of corticosteroids, including clobetasol propionate, to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. Animal studies have indicated that intrauterine exposure to corticosteroids may contribute to the development of cardiovascular and metabolic diseases in adult life, but there is a lack of evidence for the occurrence of such effects in humans (see 4.6 Pregnancy and Lactation).
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ethanol anhydrous
Purified water
Propylene glycol
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Citric acid anhydrous
Potassium citrate
Propellant: propane/n-butane/isobutane
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25ºC. Do not refrigerate. Store upright.
The canister contains a pressurised, flammable liquid. Do not use near a naked flame. Do not expose to temperatures higher than 50ºC or to direct sunlight. Do not pierce or burn the canister, even when empty.
6.5 Nature And Contents Of Container
Pressurised aluminium container closed with an inverted valve, containing 50g or 100g of foam. The inside of the can is lined with a double coated, clear epoxy-phenolic lacquer. Each filled canister is fitted into a spout actuator with dust cap.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Pierre Fabre Dermatologie
45 place Abel Gance
92100 Boulogne
France
8. Marketing Authorisation Number(S)
PL 20693/0004
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 23rd March 2005
Date of last renewal : 12/06/2008
10. Date Of Revision Of The Text
12 June 2008
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