Agencia Lei Va Hong
Full Prescribing Info
Fluticasone propionate.
Each gram of CUTIVATE Cream 0.05% contains 500 micrograms of fluticasone propionate.
Excipients/Inactive Ingredients: Liquid Paraffin, Isopropyl Myristate, Cetosteraryl Alcohol, Macrogol Cetostesaryl Ether, Propylene Glycol, Imidurea, Disodium Phosphate Dodecahydrate, Citric Acid Monohydrate, Purified Water.
Treatment of inflammatory dermatoses: Adults: Fluticasone propionate cream is a potent topical corticosteroid indicated for adults, children and infants aged 3 months and older for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; these include the following: Atopic dermatitis (including infantile atopic dermatitis); Nummular dermatitis (discoid eczemas); Prurigo nodularis; Psoriasis (excluding widespread plaque psoriasis); Lichen simplex chronicus (neurodermatitis) and lichen planus; Seborrhoeic dermatitis; Irritant or allergic contact dermatitis; Discoid lupus erythematosus; An adjunct to systemic steroid therapy in generalised erythroderma; Insect bite reactions; Miliaria (prickly heat).
Reduction of the risk of relapse: Cutivate is indicated for the reduction of the risk of relapse of chronic recurrent atopic dermatitis, once an acute episode has been treated effectively.
Dosage/Direction for Use
Creams are especially appropriate for moist or weeping surfaces.
Adults, children and infants aged 3 months and over: Treatment of inflammatory dermatoses: Apply a thin layer and gently rub in using only enough to cover the entire affected area. Perform the treatment once or twice daily for up to 4 weeks until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Atopic dermatitis: Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical steroids especially with potent preparations.
Reduction of the risk of relapse: Once an acute episode has been treated effectively, application frequency should be reduced to once daily application, twice weekly, without occlusion. Application should be continued to all previously affected sites or to known sites of potential relapse. This regime should be combined with routine daily use of emollients. The condition must be re-evaluated on a regular basis.
Paediatric population: Children over 3 months: Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Safety and efficacy of the product for longer than 4 weeks in paediatric patients is not established.
Care should be taken when using fluticasone propionate to ensure the amount applied is the minimum that provides therapeutic benefit.
Elderly: Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal / Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Symptoms and Signs: Topically applied fluticasone propionate may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may appear (see Adverse Reactions).
Treatment: In the event of overdose, fluticasone propionate should be withdrawn gradually by reducing the frequency of application, or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Given the risk of acute adrenal suppression, further management should be as clinically indicated.
The following conditions should not be treated with fluticasone propionate: Rosacea; Acne vulgaris; Perioral dermatitis; Untreated cutaneous infections; Perianal and genital pruritus; Pruritus without inflammation; Dermatoses in infants under three months, including dermatitis and nappy rash.
Special Precautions
Fluticasone propionate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation (see Description). Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing's Syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the previously mentioned 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 Adverse Reactions). Risk factors for increased systemic effects are: Potency and formulation of topical steroid; Duration of exposure; Application to a large surface area; Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing); Increasing hydration of the stratum corneum; Use on thin skin areas such as the face; Use on broken skin or other conditions where the skin barrier may be impaired; In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Overt suppression of the HPA-axis (morning plasma cortisol less than 5 micrograms/dL) is very unlikely to result from therapeutic use of fluticasone propionate Cream unless treating more than 50% of an adult's body surface and applying more than 20 g per day.
Infection risk with occlusion: Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in psoriasis: Topical steroids should be used with caution in psoriasis as rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis, careful patient supervision is important.
Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to the eyelids: If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as cataract and glaucoma might result from repeated exposure.
Concomitant infection: Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
Chronic leg ulcers: Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
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 or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Excipients: CUTIVATE Cream contains the excipient propylene glycol as which may cause skin irritation. CUTIVATE Cream also contains cetostearyl alcohol and imidurea. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Imidurea releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitisation or irritation upon contact with the skin.
Effect on ability to drive and use machines: There have been no studies to investigate the effect of fluticasone propionate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile.
Use in Children: In infants and small children aged 3 months to 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression is more likely to occur.
Use In Pregnancy & Lactation
Fertility: There are no data in humans to evaluate the effect of topical corticosteroids on fertility.
Pregnancy: There are limited data from the use of fluticasone propionate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. The minimum quantity should be used for the minimum duration.
Lactation: The safe use of topical corticosteroids during lactation has not been established. It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration, there was evidence of fluticasone propionate in the milk. Administration of fluticasone propionate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation, fluticasone propionate should not be applied to the breasts to avoid accidental ingestion by the infant.
Adverse Reactions
Adverse events are listed as follows by organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports.
Infections and infestations: Very rare: Opportunistic infection.
Immune system disorders: Very rare: Hypersensitivity.
Endocrine disorders: Very rare: Hypothalamic-pituitary-adrenal (HPA) axis suppression: Increased weight / obesity; Delayed weight gain/growth retardation in children; Cushingoid features (e.g. moon face, central obesity); Decreased endogenous cortisol levels; Hyperglycaemia/glucosuria; Hypertension; Osteoporosis; Cataract; Glaucoma.
Eye disorders: Not known: Vision, blurred (see Precautions).
Skin and subcutaneous tissue disorders: Common: Pruritus.
Uncommon: Local burning sensation.
Very rare: Skin thinning, atrophy, striae, telangiectasias, pigmentation changes, hypertrichosis, allergic contact dermatitis, exacerbation of underlying symptoms, pustular psoriasis, erythema, rash, urticaria.
Drug Interactions
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
Do not freeze.
ATC Classification
D07AC17 - fluticasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Cream 0.05% x 15 g.
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