Kutiweit - instructions for use, dose, side effects, contraindications

Active substanceFluticasoneFluticasone

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Kutiveyt®

ointment externally

GlaxoSmithKline Trading, ZAO Russia

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Dosage form: & nbspointment for external use

Composition:

1 g of ointment contains:

Active substance

Fluticasone propionate (micronized) 0.05 mg.

Excipients

Propylene glycol 50.00 mg.

Sorbitan sesquioleate 5.00 mg.

Microcrystalline wax 250.00 mg.

Paraffin liquid up to 1.00 g.

Description:

Homogeneous translucent ointment is white or almost white.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.08 Fluticasone

Pharmacodynamics:

Mechanism of action

Glucocorticosteroids for external use have anti-inflammatory, antipruritic and vasoconstrictive properties.

Anti-inflammatory properties are due to the numerous mechanisms of inhibition of the late phase of allergic reactions, including a decrease in the number of mast cells, weakening of chemotaxis and activation of eosinophils, a decrease in the production of cytokines by lymphocytes, monocytes, mast cells and eosinophils. as well as inhibition of arachidonic acid metabolism.

Fluticasone refers to glucocorticosteroids (GCS) with a pronounced local anti-inflammatory effect. When applied to the skin, the probability of oppression of the hypothalamic-pituitary-adrenal system (GGNS) is negligible. In vitro studies have shown that fluticasone characterized by high selectivity and affinity for glucocorticosteroid receptors. According to clinical studies when entering the systemic circulation fluticasone quickly transformed in the liver to an inactive metabolite (carboxylic acid), followed by rapid elimination from the body. Due to these properties, Kutiveyt® has a high therapeutic index.

Pharmacodynamic effects

Fluticasone does not cause unforeseen hormonal disorders, does not have a significant effect on the central and peripheral nervous system, gastrointestinal tract, cardiovascular and respiratory systems.

Pharmacokinetics:

Suction

Due to the limited absorption of fluticasone through the skin, the bioavailability of the drug for external use is very low.

Bioavailability of fluticasone when taken orally is close to zero due to the verylow level of absorption in the gastrointestinal tract and extensive metabolism during the "first passage" through the liver, which provides a low level of systemic exposure to accidental ingestion of the drug.

Distribution

After entering the systemic circulation fluticasone quickly falls into bile and is excreted through the intestine.

Fluticasone does not accumulate in the tissues and does not bind to melanin.

Metabolism

According to the results of pre-clinical and clinical studies fluticasone has a high metabolic clearance with subsequent rapid removal from the body. Thus, the drug that enters the systemic bloodstream through the skin is rapidly inactivated. The main pathway of metabolism is hydrolysis to a carboxylic acid; this metabolite has a very weak glucocorticosteroid and anti-inflammatory activity.

Excretion

Fluticasone is excreted within 48 hours mainly through the intestines.

Indications:

Treatment of acute and chronic dermatoses

The drug Kutiveyt® containing an effective glucocorticosteroid fluticasone. is used in adults and children aged 6 months and older to stop inflammation and itching in dermatoses sensitive to glucocorticosteroid therapy such as:

atopic dermatitis (including atopic dermatitis in children aged 6 months);
numular dermatitis (discoid eczema);
seborrheic dermatitis;
psoriasis (except for common plaque psoriasis);
simple chronic lichen;
red flat lichen;
contact or allergic contact dermatitis;
discoid lupus erythematosus;
erythroderma (as an adjunct to systemic GCS therapy);
inflammatory reactions to insect bites.

Reducing the risk of recurrence of the disease

Kutiveyt® is used to reduce the risk of relapses in the chronic form of atopic dermatitis if a therapeutic effect is observed in the treatment of the acute phase of the disease.

Contraindications:

Hypersensitivity to the active substance or any other component of the preparation:
primary skin lesions of bacterial, viral and fungal etiology;
pink udree;
common acne;
perioral dermatitis;
perianal and genital itching;
itching without symptoms of inflammation;
children age up to 6 months.

Carefully:

Psoriasis, renal insufficiency, hepatic insufficiency, advanced age, children's age (from 6 months to 12 years).

Pregnancy and lactation:

Fertility

There are no available data for assessing the effect of GCS for external application on human fertility.

Pregnancy

There is a limited amount of data on the use of fluticasone during pregnancy.

As a result of preclinical studies, it was found that external application of corticosteroids in pregnant animals can cause a deviation of embryonic development, however, the significance of this phenomenon for humans has not been established.

The drug Kutiveyt® can be given only if the intended benefit to the mother exceeds any possible risks to the fetus. In this case, it is necessary to apply the ointment in the minimum amount for the shortest period of time, sufficient for the manifestation of the clinical effect.

Breastfeeding period

The safety of GCS therapy for external use during breastfeeding has not been established.

There are no available data to confirm the possibility of systemic absorption of GCS for external application in an amount sufficient for their detection in breast milk.

As a result of preclinical studies, it was found that during breastfeeding with subcutaneous administration in quantities sufficient for determination in plasma, fluticasone was found in milk.

Kutiveyt® can be given during breastfeeding only if the intended benefit to the mother exceeds any potential risks to the child.

When applying Kutiveyt® during breastfeeding, the drug should not be applied to the area of the mammary glands to prevent it from accidentally swallowing the baby.

Dosing and Administration:

Outwardly.

It is shown to adults, elderly people, children from 6 months and older. The general course of therapy is 4 weeks.

The use of ointment is especially indicated for the treatment of dry, lichenic or scaly foci.

Treatment of acute and chronic dermatoses

Apply Kutiveyt® ointment 1 or 2 times a day with a thin layer in an amount not larger than necessary to cover the entire affected area, and rub gently. Duration of treatment - up to 4 weeks before the effect, then reduce the frequency of application or switch to treatment with a less active drug. It is necessary to withstand sufficient time to absorb the Kutiveyt® ointment before applying an emollient. If the condition deteriorates or there is no improvement within 2 weeks, a reassessment of treatment and diagnosis should be made.In the treatment of atopic dermatitis, GCS for external use should be gradually phased out against maintenance therapy with an emollient after the control of the disease is achieved.

Renewal of the initial symptoms of dermatosis can occur when the GSS therapy is suddenly discontinued for external use, especially when using highly active drugs.

Reducing the risk of recurrence of atopic dermatitis

After achieving a therapeutic effect in the acute phase of the disease, the frequency of ointment use is reduced: it is recommended to apply the drug once a week, without applying an occlusive bandage.

The drug Kutiveyt® is applied to all previously affected areas of the skin or to areas where a relapse of the disease can be expected. This dosing regimen should be combined with daily application of emollients. Regular monitoring of the patient's condition is necessary.

Special patient groups

Children 6 months and older

Children are more likely to develop local and systemic side effects while using external GCS, and, in general,children are recommended shorter courses of treatment and the appointment of less active drugs than adults. The course of therapy for children should not exceed 4 weeks.

Care should be taken when applying Kutiveyt cream. ensuring the application of the drug in the minimum amount for the shortest period of time, sufficient for the manifestation of the clinical effect.

Elderly patients

In clinical studies, there was no difference in the results between groups of elderly patients and younger patients. The high prevalence of reduced hepatic or renal function in elderly patients can lead to a delay in the removal of the active substance from the body in the event of its systemic absorption. Thus, Kutiveyt® ointment should be applied in the minimum amount for the shortest period of time, sufficient for the manifestation of the clinical effect.

Patients with impaired renal and / or liver function

In the case of systemic absorption (with prolonged application of the ointment over a large area), the metabolism and excretion of the active substance slows down in patients with impaired renal and / or liver function, which increases the risk of systemic toxicity.Thus, it is necessary to apply the ointment in the minimum amount for the shortest period of time, sufficient for the manifestation of the therapeutic effect.

Side effects:

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥1 / 1,000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000. including individual cases). Frequency categories were formed on the basis of post-registration observation.

Frequency of occurrence of undesirable reactions

Infectious and parasitic diseases

Rarely: opportunistic infections.

Immune system disorders

Rarely: hypersensitivity, itching at the site of application, rash, swelling.

Disorders from the endocrine system

Rarely: inhibition of GHGN: weight gain or obesity, slow weight gain or growth retardation in children, cushingoid traits (eg, lunate face, central obesity), decreased endogenous cortisol, hyperglycemia or glucosuria, hypertension, osteoporosis, cataract, glaucoma.

Often: itching at the site of ointment application.

Infrequently: burning in the place of application of the ointment.

Rarely: thinning of the skin, atrophy, striae, telangiectasia, hypopigmentation, hypertrichosis, allergic contact dermatitis, exacerbation of the symptoms of the underlying disease, pustular psoriasis, erythema, rash, urticaria.

It should be reported to the doctor about any undesirable reactions noted above.

The decision on the further treatment strategy should be made by the doctor.

If any of the unwanted reactions listed in the manual is aggravated, or if you notice any other undesirable reactions not listed in the instructions, tell your doctor.

Overdose:

Symptoms

With external application fluticasone can be absorbed in sufficient quantity to manifest systemic action. The likelihood of an acute overdose is extremely low, but chronic overdose or misuse of Kutiveyt® can develop signs of hypercorticism (Itenko-Cushing syndrome).

Treatment

In case of an overdose of fluticasone, the drug is canceled gradually - by reducing the frequency of its application or switching to a less active GCS in order to avoid the risk of developing glucocorticoid insufficiency.

With the development of a clinical picture of drug overdose, symptomatic therapy is indicated.

Interaction:

Concomitant therapy with drugs that have an inhibitory effect on the isoenzyme CYP3A4 (eg, ritonavir, itraconazole), may lead to inhibition of GCS metabolism, which is accompanied by an increased systemic effect. The degree of clinical significance of such interactions depends on the activity of the inhibitor of the isoenzyme CYP3A4, the dose and method of administration of GCS, but this interaction is unlikely with an external application.

Special instructions:

Caretive® should be used with caution in patients who have a history of local reactions of hypersensitivity to other GCS. Local reactions of hypersensitivity (see section "Side effect") may resemble the symptoms of the underlying disease.

Manifestations of hypercorticism (Itenko-Cushing syndrome) and reversible inhibition of HHH. leading to a glucocorticoid insufficiency, in some cases arise due to increased systemic absorption of GCS for external use.In such cases, it is necessary to gradually stop the treatment, reducing the frequency of application, or replace the drug Kutiveyt® with a less active SCS. A sudden cessation of treatment can lead to glucocorticoid insufficiency (see the "Side effect" section).

Risk factors for the development of severe systemic reactions include the following:

- activity and dosage form of GCS for external use;

- duration of treatment;

- application to large areas of the skin;

- application to the closed areas of the skin, for example, in diaper rash or under occlusive dressings (children may have a diaper as an occlusive dressing);

- increased hydration of the horny layer of the dermis;

- application to areas with thin skin, such as face;

- damaged skin or other conditions potentially accompanied by damage to the skin barrier;

- compared with adults in children, there is a possibility of absorption of more GCS for external use, thus increasing the risk of developing systemic adverse reactions. This is due to the immaturity of the skin barrier and a higher ratio of body surface area to body weight in children compared to adults.

Children from 6 months to 12 years should avoid prolonged continuous treatment with GCS for external use whenever possible, as there is a possibility of suppression of adrenal function.

Caution should be exercised when prescribing GCS for external use in the treatment of psoriasis, as there are reports of early relapses, addiction, the risk of generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function. The use of psoriasis requires careful monitoring of the course of the disease in the patient.

Long-term application of Kutiveyt® ointment on the face area is undesirable, since the skin in this area is more prone to atrophic changes.

When applying Kutiveyt® ointment on the eyelids, care should be taken that the drug does not get into the eyes, as repeated contact of the drug with the mucous membrane of the eye can lead to the development of cataracts and glaucoma.

In the secondary infection Defects of the skin should be prescribed appropriate antibiotic therapy. In case of signs of spread of infection, it is necessary to cancel SCS for external use and to prescribe appropriate antibiotic therapy.

Bacterial infections are easier to develop in warm and humid conditions in natural folds of the skin or under occlusive dressings, therefore, the skin should be thoroughly cleaned before applying a new bandage.

SCS therapy for external use is sometimes used to treat dermatitis developing around chronic ulcers of the lower limbs. However, this may be associated with a higher incidence of local hypersensitivity reactions and infectious complications.

Explicit inhibition of the function of the GGNS (cortisol level in the blood plasma in the morning less than 5 μg / dL) in adults is unlikely with the use of Kutiveyt® in recommended doses, except for the application of the preparation more than 50% of the body surface area and in excess of 20 g per day .

Effect on the ability to drive transp. cf. and fur:

Studies to evaluate the effect of Kutiveyt® on the ability to drive vehicles or mechanisms have not been conducted. Based on the profile of undesirable reactions of the drug Kutiveyt®, no adverse effect on the management of vehicles and mechanisms is expected.

Form release / dosage:

Ointment for external use. 0.005%.

Packaging:

For 15 grams in an aluminum tube, covered from the inside with a varnish, covered with a protective membrane and a plastic lid. On tuba together with instructions for use in cardboard pack.

Storage conditions:

Store below 30 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012556 / 02

Date of registration:16.07.2009 / 13.05.2014

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Pharmaceuticals, S.A. Poland

Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO

Information update date: & nbsp07.02.2018

Illustrated instructions

Instructions

Kutiveyt® (Cutivate®)