Clarelux 500 инструкция по применению крем

CLARELUX should be applied to the affected scalp area twice a day, morning and evening, as follows:
Attention: For proper foam extraction it is important to hold the can upside down!

1. Shake the can well
2. Holding the can vertically upside down, pour a small amount (the size of a walnut) either directly onto the affected scalp area or into the cap and then onto the scalp. CLARELUX should always be applied thinly. Therefore, use as little as possible when affecting the affected scalp areas
treat. How much you need depends on the size of the affected area. Do not apply on the eyelids. Respect, think highly of
Make sure the foam does not come into contact with your eyes, nose or mouth. Do not put the foam directly on the hand, as the foam begins to melt immediately when it comes into contact with warm skin
3. Brush the hair to one side and gently massage the foam into the scalp until the foam is dissolved and absorbed by the skin. If necessary, repeat this process to treat the entire affected area

If you stop using CLARELUX
Do not abruptly abort the application, as this could be harmful. Your doctor may end your treatment slowly and you may need to have regular check-ups.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

About Medicine

One gram of cutaneous foam contains 500 micrograms of clobetasol propionate.

500 micrograms of clobetasol propionate are equivalent to 440 micrograms of clobetasol.

Excipient(s) with known effect

One gram of cutaneous foam contains 604.3 mg of ethanol, 20.9 mg of propylene glycol, 11.5 mg of cetyl alcohol and 5.2 mg of stearyl alcohol.

For the full list of excipients, see section 6.1.

Cutaneous foam in pressurised container.

White foam that breaks down upon contact with skin.

Clobetasol propionate belongs to the most potent class of topical corticosteroids (group IV) and prolonged use may result in serious undesirable effects (see section 4.4). If treatment with a local corticosteroid is clinically justified beyond 2 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).

Posology

Use in adults

CLARELUX 500 micrograms/g, cutaneous foam in pressurised container 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.

Route of administration: for cutaneous use.

CLARELUX 500 micrograms/g, cutaneous foam in pressurised container should be applied to the affected area twice daily. There are no data from clinical studies evaluating the efficacy of once daily application.

Paediatric population

CLARELUX is not recommended for use in children less than 12 years old (see section 5.1).

Method of administration

For cutaneous use

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.

Note: for proper dispensing of foam, hold the container upside down and depress the actuator.

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.

Avoid contact with eyes, nose and mouth.

Do not use near a naked flame.

CLARELUX is contraindicated in patients with:

• hypersensitivity to clobetasol propionate, to other corticosteroids, or to any of the excipients listed in section 6.1;

• ulcerated lesions, 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 parasites, viruses, fungi or bacteria.

CLARELUX 500 micrograms/g, cutaneous foam in pressurised container:

• must not be used on the face

• is contra-indicated in infants under 2 years old (see section 4.3)

• must not be applied to the eyelids (risk of glaucoma and cataract).

Special warnings

Hypersensitivity

CLARELUX should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see section 4.8) may resemble symptoms of the condition under treatment.

Stop using immediately if signs of hypersensitivity appear.

Adrenal suppression

Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals, particularly in children as a result of increased systemic absorption of topical steroids.

If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see section 4.8).

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.

Long term use

Cases of osteonecrosis, serious infections (including necrotizing fasciitis), and systemic immunosuppression (sometimes resulting in reversible Kaposi’s sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses (see section 4.2). In some cases, patients used concomitantly other potent oral/topical corticosteroids or immunosuppressors (e.g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 2 weeks, a less potent corticosteroid preparation should be considered

Infections and infestations

The use of CLARELUX^® on wounds or ulcerations is not recommended.

Secondary infection may develop; bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.

Visual disturbance

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 (see Precautions for use) or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Precautions for use

Increased systemic absorption of topical steroids

Increased systemic absorption of topical steroids can lead to occurrence of systemic adverse reactions (i.e., adrenal suppression, immunosuppression). Increased systemic absorption of topical steroids can be facilitated by:

— long term exposure,

— application to a large surface area,

— use on occluded skin areas (e.g. on intertriginous areas or under occlusive dressings),

— use on thin areas (e.g. face),

— use on broken skin or other conditions where the skin barrier may be impaired,

— and increasing hydration of the stratum corneum.

Unless supervised by a physician, CLARELUX should not be used with occlusive dressings.

Rebound phenomenon

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal reaction). 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. This rebound phenomenon is more likely to occur when delicate skin sites such as the face and flexures are treated and may be seen in the event of sudden discontinuation after long-term use. This can be minimised by withdrawing treatment gradually or by substituting a less potent corticosteroid.

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 advice is recommended in these cases or other treatment options should be considered.

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.

Eye disorders

Systemic corticosteroids therapy is associated with glaucoma and cataract formation. This risk has also been reported during ophthalmic treatment, and during regular local corticosteroid application to the eyelids. Additionally there have been reports of cataracts and glaucoma in patients following prolonged potent topical corticosteroid overuse on the face and/or the body. Although hypertensive effect of topical steroid is usually reversible after cessation of treatment, the visual defects resulting from glaucoma and cataracts are irreversible.

CLARELUX should not be applied on the eyelids.

Patients should wash their hands after each application to avoid eye contamination with CLARELUX. If CLARELUX becomes in contact with the eye, the affected eye should be bathed in copious amounts of water.

Patients on prolonged courses of potent topical steroids should be screened for cataract and glaucoma on a regular basis, especially patients with known risk factors for cataract (e.g. diabetes, smokers) or for glaucoma (e.g. personal or family history of glaucoma).

Paediatric population

CLARELUX is not recommended for use in children less than 12 years old (see section 5.1).

Excipients with known effect

This medicinal product contains:

˗ 2145 mg of ethanol in each application, which may cause burning sensation on damaged skin,

— 74 mg of propylene glycol in each application,

— cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Pregnancy

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see section 5.3). 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. Limited evidence suggests a small risk for low birth weight when using large amounts of potent/very potent topical corticosteroids such as clobetasol propionate in pregnancy.

CLARELUX in pressurised container should not be used during pregnancy unless clearly necessary.

Breast-feeding

The safe use of clobetasol propionate during lactation has not been established. Glucocorticosteroids are excreted in breast milk, therefore CLARELUX 500 micrograms/g, cutaneous foam in pressurised container should not be used in breast-feeding women unless clearly necessary.

Fertility

There are no data in humans to evaluate the effect of topical corticosteroids on fertility.

Clobetasol administered subcutaneously to rats decreased fertility in females at the highest dose (see section 5.3).

Summary of the safety profile

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 changes in the skin such as skin atrophy, ecchymoses secondary to skin atrophy, skin fragility, telangiectasia, especially on the face, striae particularly affecting the proximal limbs.

Additional local adverse events associated with glucocorticosteroids include perioral dermatitis, rosacea-like dermatitis, delayed wound healing, rebound phenomenon (topical steroid withdrawal reactions) which can lead to dependence on corticosteroids, and effects on the eyes. Rise of intraocular pressure and increased risk for cataract are known side effects for glucocorticosteroids (see section 4.4).

In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease (see section 4.4).

Secondary infection may develop; bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied. If the product is not used properly, bacterial, viral, parasitic, and fungal infections may be masked and/or aggravated (see section 4.4). Folliculitis has also been reported.

Contact allergy to CLARELUX or one of the excipients may occur. If signs of hypersensitivity appear, applications should be stopped immediately. Exacerbation of symptoms may occur.

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-specified reactions (2%).

Tabulated list of adverse reactions

The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data)”.

*Topical steroid withdrawal reactions: reactions resulted from the long term or inappropriate use (redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules).

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; Website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

Pharmacotherapeutic group: Corticosteroids, very potent (group IV)

ATC code: D07A D01

Mechanism of action

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.

Pharmacodynamic effects

A vasoconstrictor study has shown that CLARELUX has a comparable potency, based upon skin blanching response, as other clobetasol propionate formulations.

Clinical efficacy and safety

The efficacy and safety of clobetasol propionate (CP) foam 0.05% has been demonstrated in a double-blind placebo and active comparator (CP solution) controlled study: 188 adult participants were treated for moderate to severe psoriasis of the scalp during 2 weeks. Products were applied twice a day over the entire scalp area. Pruritus, scaling, erythema and plaque thickness were evaluated after 2 weeks of treatment. 74% of participants using CP foam were rated completely clear or almost clear compared 6-10% of the placebo group and 61% of the CP solution group. All disease signs and symptoms were significantly improved after 2 weeks and also following 2 weeks off treatment.

Clinical data in children and adolescents established that Clobetasol foam is safe and effective for treatment of mild-to-moderate plaque-type psoriasis in patients aged 12 years or older. A double-blind randomised placebo vehicle-controlled trial was performed in 497 patients aged 12 years or older. (253 were given clobetasol EF foam, 123 received vehicle foam, and 121 received clobetasol ointment, each for two weeks). About 27% of the participants were adolescents. Compared with the vehicle foam, clobetasol foam was almost 4 times more effective in treating mild-to-moderate plaque-type psoriasis in the total population (47% vs 12%). Efficacy was similar between adolescents and adults and the incidence of AEs was comparable between clobetasol foam and vehicle foam for adults and paediatric participants as young as 12 years.

Absorption and distribution

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the carrier, the integrity of the epidermal barrier, the severity of the disease and the area treated. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Topical corticosteroids can be absorbed from intact healthy skin.

Metabolism and elimination

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.

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and genotoxicity. No topical studies were performed to assess the safety, pharmacology and the carcinogenic potential of clobetasol.

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 section 4.6).

In fertility studies, subcutaneous administration of clobetasol propionate to rats at doses of 6.25 to 50 micrograms/kg/day produced no effects on male fertility. In females, increased embryofetal loss and growth suppression and thymic atrophy in the litters were observed at the highest dose.

Ethanol anhydrous

Purified water

Propylene glycol

Cetyl alcohol

Stearyl alcohol

Polysorbate 60

Citric acid anhydrous

Potassium citrate

Propellant: propane/n-butane/isobutane

Do not store above 25°C. 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 50°C or to direct sunlight. Do not pierce or burn the canister, even when empty.

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.

Pierre Fabre Limited

250 Longwater Avenue

Green Park

Reading

RG2 6GP

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Clarelux,

Clarelux, Cream is a multiple combination cream which exhibits anti-bacterial, anti-protozoal, anti-fungal and steroid properties to control inflammation. Ofloxacin is a broad-spectrum antibiotic that acts against many gram-positive and gram-negative bacteria. Ornidazole belongs

to the nitroimidazole group of antibiotics and is used to treat amoeba and trichomonas infections. Terbinafine is a topical antifungal and antiparasitic drug. Clobetasol is a potent corticosteroid which exhibits anti-inflammatory, anti-pruritic and vasoconstrictive properties.

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Clobetasol propionate is generally applied twice daily so the duration of action is long. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

Uses

Clarelux, is used for:

• Initial control of all forms of hyperacute eczema in all age groups
• Chronic hyperkeratotic eczema of the hands and feet and patches of chronic lichen simplex
• Chronic hyperkeratotic psoriasis of any area of the body
• Severe acute photosensitivity
• Hypertrophic lichen planus
• Localized bullous disorders
• Keloid scarring
• Pretibial myxoedema
• Vitiligo
• Suppression of reaction after cryotherapy
• Scalp Solution is used for the topical therapy of recalcitrant corticosteroid-responsive dermatoses of the scalp, including recalcitrant cases of psoriasis and seborrheic dermatitis.

Clarelux, is also used to associated treatment for these conditions:

Alopecia, Severe Plaque psoriasis, Corticosteroid responsive, Inflammatory Dermatosis, Corticosteroid responsive, pruritic Dermatosis, Moderate Plaque psoriasis, Moderate Scalp Psoriasis, Severe Scalp Psoriasis

How Clarelux, works

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.

Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.

Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

Table Of contents

• Clarelux,
• Uses
• Dosage
• Side Effect
• Precautions
• Interactions
• Uses during Pregnancy
• Uses during Breastfeeding
• Accute Overdose
• Food Interaction
• Half Life
• Volume of Distribution
• Clearance
• Interaction With other Medicine
• Contradiction
• Storage

Dosage

Clarelux, dosage

Nyclobate Cream & Ointment

Adults and children over 1 year:

• Apply sparingly to cover the affected area, and gently rub into the skin. Frequency of application is 2 to 3 times daily according to the severity of the condition. The total dose applied should not exceed 50 g weekly.

• Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient\\\’s condition being reviewed.

• Repeated short courses of Clobetasol may be used to control exacerbations

Children below 1 year: Under 1 year this preparation is not recommended

Nyclobate Scalp Application

• It should be applied to the affected scalp areas twice daily, once in morning and once at night.

• Total dosage should not exceed 50 ml per week.

• As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved

Children: Under 1 year this preparation is not recommended.

Nyclobate Shampoo

• It should be applied to the dry (not wet) scalp once a day to the affected areas only.

• It should be massaged gently into the lesions and left in place for 15 minutes before lathering and rinsing.

• Treatment should be limited to 4 consecutive weeks.

• Total dosage of shampoo should not exceed 50 g per week.

• Under 18 years this preparation is not recommended.

Side Effects

Generally Clarelux, is well tolerated. However, few side effects after prolonged and intensive treatment may cause local atrophic changes in the skin such as Burning, itching, irritation, dry skin eczema.

Toxicity

Data regarding acute overdoses of glucocorticoids are rare. Overdoses of clobetasol propionate can lead to reversible HPA axis suppression and glucocorticoid insufficiency. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency.[A188405] Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.[A188405]

Precaution

Do not swallow. For external use only.

Interaction

No hazardous interactions have been reported with use of Clarelux,.

Food Interaction

No interactions found.

Volume of Distribution

Data regarding the volume of distribution of clobetasole propionate are not readily available.

Elimination Route

Twice daily application of clobetasol foam leads to a C_max of 59±36pg/mL with a T_max of 5 hours. Clobetasol cream showed an increase in clobetasol concentrations from 50.7±96.0pg/mL to 56.3±104.7pg/mL.

Half Life

Data regarding the half life of clobetasol propionate are not readily available.

Clearance

Data regarding the clearance of clobetasol propionate are not readily available.

Elimination Route

Corticosteroids are eliminated predominantly in the urine.

Pregnancy & Breastfeeding use

The safe use of Clarelux, during pregnancy & lactation has not been established.

Contraindication

Contraindicated in Cutaneous infections such as impetigo, tinea corporis and herpes simplex, Infestations such as scabies, Acne vulgaris, Hypersensitivity, Rosacea, Gravitational ulceration, Perioral dermatitis, Children under 1 year

Special Warning

Use in Paediatrics: The drug may be used in paediatrics patients in appropriate dosage, but large quantities for prolonged period should be avoided. It is contraindicated in children less than one year.

Acute Overdose

Acute overdosage is very unlikely to occur. However, in the case of chronic overdose or misuse the features of hypercortisolism may appear.

Interaction with other Medicine

No hazardous interactions have been reported

Storage Condition

Do not store above 30 0 C. Keep away from light and out of the reach of children. Do not freeze.

Innovators Monograph

You find simplified version here Clarelux,

What is clobetasol propionate used for?

How does clobetasol propionate work?

How is clobetasol propionate applied?

What are the side effects of clobetasol propionate?

Can clobetasol propionate be used on the face?

Can clobetasol propionate be used during pregnancy?

Can clobetasol propionate be used in children?

How long can clobetasol propionate be used for?

Substance: clobetasol

Date of last drug list: 01-07-2013

Commercial code: W53332002

Concentration:
500mcg/g

Pharmaceutical form:
ointment

Quantity: 1

Product type: generic

Prescription restrictions:
P-RF —
Medicines prescription that is retained in the pharmacy (not renewable).

Pharmaceutical forms available for clobetasol

Concentrations available for clobetasol

0.05%, 0.5mg/g, 0.5mg/ml, 500mcg/g