Cutivate cream 0.05 %, 15 g — Made in Poland — Free Delivery

Pharmacological properties

Pharmacodynamics. Fluticasone propionate is a GCS preparation with high anti-inflammatory activity and a very low level of suppression of the hypothalamic-pituitary-adrenal system when applied topically, therefore its therapeutic index is one of the broadest of all topical steroids presented today.

Fluticasone propionate has high systemic activity when administered s / c, but very low activity when administered orally, possibly due to metabolic inactivation. According to in vitro studies, its high affinity for human corticosteroids receptors has been established.

Fluticasone propionate does not exhibit an unpredictable hormonal effect and a noticeable effect on the central nervous system and peripheral nervous system, digestive, cardiovascular or respiratory systems.

Pharmacokinetics

Absorption. With local and oral administration, bioavailability is very low due to the limited absorption of the preparation through the skin or in the gastrointestinal tract and due to the intensive metabolism of the first pass. Oral bioavailability approaches zero, therefore, the systemic effect of fluticasone propionate with accidental use of a cream / ointment inside will be low.

Distribution. Studies have shown that a very small amount of orally taken fluticasone propionate reaches the systemic circulation, which is rapidly excreted in the bile and excreted in the feces. Fluticasone propionate is not retained in any body tissues and does not bind to melanin.

Metabolism. According to pharmacokinetic studies in animals, fluticasone propionate is rapidly excreted and undergoes extensive metabolic clearance. In humans, metabolic clearance is wide and, accordingly, excretion is rapid. The preparation, penetrating the skin into the systemic circulation, is quickly inactivated. The main metabolic mechanism is hydrolysis to carboxylic acid, which exhibits very low glucocorticoid and anti-inflammatory activity.

Excretion. According to animal studies, the route of elimination does not depend on the method of application of fluticasone propionate. It is excreted mainly in the feces, and this process is completely completed within 48 hours.

Indications

Dermatoses sensitive to corticosteroid treatment, such as:

• atopic dermatitis;
• numular dermatitis (discoid eczema);
• nodular itching;
• psoriasis (with the exception of common plaque psoriasis);
• simple chronic lichen (neurodermatitis), lichen planus;
• seborrheic dermatitis;
• contact or allergic dermatitis;
• discoid lupus erythematosus;
• generalized erythroderma (as an additional remedy);
• reaction to insect bites;
• red prickly heat.

Children. Treatment of atopic dermatitis in children aged 3 months and older in the absence of the effect of treatment with less potent corticosteroids.

Application

Cutivate, cream

Adults and children from the age of 3 months. The cream is especially beneficial for the treatment of damp or weeping skin surfaces. The preparation is applied in a thin layer to the affected skin 1 or 2 times a day. The duration of treatment with daily use is up to 4 weeks until the condition improves, then the frequency of applying the cream should be reduced or the treatment should be changed with a less powerful preparation. After applying the cream, allow enough time for absorption before the subsequent application of the emollient.

Once the disease is under control, the frequency of topical corticosteroids should be gradually reduced until complete withdrawal, and emollients should be used as maintenance therapy.

Resumption of symptoms of an existing disease is possible with a sudden cessation of the use of topical corticosteroids, especially potent ones.

Duration of treatment for adults and elderly patients. If the condition worsens or there is no improvement within 2-4 weeks, the diagnosis and treatment should be reviewed.

Children aged 3 months. Children are more likely to experience local or systemic adverse reactions with topical corticosteroids, so they are generally given shorter courses of treatment and less potent preparations than adults.

Cutivate cream should be used with caution to ensure that the minimum effective amount of the preparation is applied.

Duration of treatment for children. If, when using the cream in children, no improvement occurs within 7-14 days, the treatment should be discontinued and the child should be further examined. If control of the disease is achieved within 7-14 days of treatment, then the minimum effective dose should be used for as little time as possible. The duration of treatment with daily use should not exceed 4 weeks.

Cutivate, ointment

Adults and children from the age of 3 months. The ointment is especially beneficial for the treatment of dry skin surfaces as well as skin with lichen or scaly lesions. The preparation is applied in a thin layer to the affected skin 1 or 2 times a day. The duration of treatment with daily use is up to 4 weeks until the condition improves, then the frequency of applying the ointment should be reduced or the treatment should be changed with a less powerful preparation. After applying the ointment, allow enough time for the preparation to be absorbed before the subsequent application of the emollient.

Once the disease is under control, the frequency of topical corticosteroids should be gradually reduced until complete withdrawal, and emollients should be used as maintenance therapy.

Resumption of symptoms of an existing disease is possible with sudden cessation of topical corticosteroids, especially potent ones.

Duration of treatment for adults and elderly patients. If the condition worsens or there is no improvement within 2-4 weeks, the diagnosis and treatment should be reviewed.

Children aged 3 months. Children are more likely to experience local or systemic adverse reactions with topical corticosteroids, so they are generally given shorter courses of treatment and less potent preparations than adults.

Cutivate ointment should be used with caution to ensure that the minimum effective amount of the preparation is applied.

Duration of treatment for children. If, when using the ointment in children, there is no improvement within 7-14 days, the treatment should be discontinued and the child should be further examined. If control of the disease is achieved within 7-14 days of treatment, then the minimum effective dose should be used for the shortest possible time. The duration of treatment with daily use should not exceed 4 weeks.

Cutivate, cream and ointment

Elderly patients. According to clinical studies, there was no difference in response to treatment between elderly patients and younger patients. Since elderly patients are more likely to deteriorate renal or hepatic function, which can cause a delay in the release of the preparation during systemic absorption, the minimum effective dose of the preparation should be used and during the shortest period of treatment to achieve the desired result.

Hepatic / renal impairment. In the case of systemic absorption (when used on a large surface and for a long time), the metabolism and elimination of the preparation may slow down and the risk of systemic toxicity increases. Therefore, to achieve the desired result, the minimum effective dose should be used for the shortest possible time.

Children. Cutivate cream and ointment are used to treat children aged 3 months and older.

Contraindications

Hypersensitivity to the active substance or any component of the preparation. untreated skin infections. rosacea. common acne. perioral dermatitis. perianal and genital itching. itching without inflammation. dermatoses in children under the age of 3 months, including dermatitis and diaper rash.

Side effects

Side effects are classified according to organs and systems and frequency of occurrence. the frequency of side effects is determined by the following criteria: very often (≥1 / 10), often (≥1 / 100, 1/10), infrequently (≥1 / 1000, 1/100), rarely (≥1 / 10,000, 1/1000), very rarely (1/10 000), including isolated cases.

Infections and invasions: very rarely, opportunistic infections.

From the immune system: very rarely - hypersensitivity.

From the endocrine system: very rarely - suppression of the hypothalamic-pituitary-adrenal system: weight gain / obesity; delayed weight gain / growth retardation in children; cushingoid signs (moonlike face, central obesity); a decrease in the level of endogenous cortisol; hyperglycemia / glucosuria; AG; osteoporosis; cataract; glaucoma.

On the part of the skin and subcutaneous tissue: often - itching; infrequently - a sensation of local burning of the skin; very rarely - thinning of the skin, atrophic striae, telangiectasias, hypertrichosis, changes in pigmentation, allergic contact dermatitis, exacerbation of the main symptoms, pustular psoriasis, erythema, rashes, urticaria.

Special instructions

The preparation is used with caution to treat patients with a local hypersensitivity reaction to corticosteroids or any excipients in history. local hypersensitivity reactions (see side effects) may resemble the symptoms of the disease being treated.

The manifestation of hypercortisolism (Cushing's syndrome) and inverse suppression of the hypothalamic-pituitary-adrenal system with suppression of adrenal function in some individuals may result from increased systemic absorption of topical steroids. If any of the above symptoms appear, the preparation should be gradually discontinued by reducing the frequency of application or replacing it with a less potent corticosteroid. Sudden discontinuation of treatment may cause GCS deficiency (see SIDE EFFECTS).

Risk factors for systemic effects are:

• the power and composition of the topical steroid;
• duration of use;
• application to a large area of ​​the body;
• application on skin surfaces that are in contact, for example, in areas of diaper rash or at the site of application of an occlusive dressing (in infants, diapers can play the role of an occlusive dressing);
• increased hydration of the stratum corneum;
• use on areas with thin skin, for example, on the face;
• use on areas of damaged skin or in other conditions where the skin barrier is broken.

Compared to adults, children and adolescents can absorb proportionally more topical corticosteroids and are therefore more prone to systemic side effects. This is due to the fact that children have an underdeveloped skin barrier and a larger skin surface in relation to body weight compared to adults.

Children. Long-term daily use of topical corticosteroids in children under 12 years of age should be avoided, where possible, as they are more likely to develop adrenal suppression.

Psoriasis treatment. The use of topical corticosteroids for the treatment of psoriasis should be done with caution, since in some cases it has been reported that relapses, the development of tolerance, the risk of generalization of pustular psoriasis and the development of symptoms of local or systemic toxicity caused by a violation of the skin barrier function have been reported. If used for the treatment of psoriasis, the patient should be under close medical supervision.

Applying cream / ointment to the face. Prolonged application of the cream / ointment to the skin of the face is undesirable, since this area is more vulnerable to the development of atrophic changes.

Application on the eyelids. When applying the cream / ointment to the eyelids, avoid getting the preparation in the eyes, as this can cause cataracts and glaucoma with repeated use.

Concomitant infections. Appropriate antibacterial preparations should be prescribed each time an infected inflammatory lesion is treated. If the infection spreads, topical corticosteroids should be discontinued and appropriate antibiotic therapy given.

The risk of infection when applying an occlusive dressing. The risk of developing bacterial infections increases in warm and humid conditions, which can occur under occlusive dressings, therefore, the skin must be carefully cleaned each time before applying a new dressing.

Chronic ulcers of the lower extremities. Topical corticosteroids are sometimes used to treat dermatitis that occurs around chronic leg ulcers. However, this use is associated with an increased incidence of local hypersensitivity reactions and the risk of developing local infections.

Explicit suppression of the function of the adrenal cortex (morning plasma cortisol level of 5 μg / dl) is unlikely when using Cutivate cream / ointment in therapeutic doses, unless 50% of the body surface is treated in adults and 20 g of the preparation per day is used.

The composition of Cutivate cream as an excipient includes imidourea, the metabolic product of which is formaldehyde in trace amounts. Formaldehyde can cause allergic sensitization or irritation by skin contact.

The composition of Cutivate cream contains cetostearyl alcohol and propylene glycol as auxiliary substances, which can cause local skin reactions.

Use during pregnancy and lactation

Pregnancy. Data on the use of fluticasone propionate in pregnant women are limited. Topical use of corticosteroids in pregnant animals can lead to fetal abnormalities, although the relevance of these data to humans has not been established. However, fluticasone propionate should be prescribed during pregnancy only when the expected benefit from the preparation to the mother is higher than the possible risk to the fetus and child. Apply the minimum effective dose of the preparation for the shortest possible period.

Lactation. The safety of topical corticosteroids during breastfeeding has not been established. It is not known whether the use of topical corticosteroids can result in systemic absorption such that a measurable amount of the drug will be detected in breast milk. In the course of a study on laboratory rats, when a certain level of the preparation in the blood plasma after subcutaneous administration was reached, signs of the presence of fluticasone propionate in breast milk were revealed. Prescribe fluticasone propionate cream / ointment during breastfeeding only when the expected benefit from the preparation  to the mother outweighs the possible risk to the child. If administered during breastfeeding, the cream / ointment should not be applied to the breast in order to avoid accidental ingestion of the cream / ointment in the baby's mouth.

Fertility There are no data available to evaluate the effect of topical corticosteroids on human fertility.

The ability to influence the reaction rate when driving or working with other mechanisms. No studies have been conducted to examine this effect. Given the profile of adverse reactions, the effect on the reaction rate when driving or working with other mechanisms is not expected.

Interactions

It has been established that the simultaneous use with preparations that can inhibit cyp 3a4 (for example, ritonavir, itraconazole) inhibits the metabolism of corticosteroids, which may be the cause of a systemic effect. this interaction is clinically significantly dependent on the dose of the preparation, the route of administration of the corticosteroid, and the potency of the cyp 3a4 inhibitor.

Overdose

Symptoms Fluticasone propionate, when applied topically, can be absorbed in an amount sufficient to cause a systemic effect. acute overdose is very unlikely. in case of chronic overdose or abuse, signs of hypercortisolism may occur (see side effects).

Treatment. In case of an overdose, the use of the cream / ointment should be gradually discontinued by reducing the frequency of application or replacing it with a less powerful topical corticosteroid, taking into account the risk of developing GCS deficiency. Further treatment is carried out according to the patient's clinical condition.

Storage conditions

At temperatures below 30 ° c, do not freeze.