Active ingredients: Betamethasone (betamethasone valerate)
ECOVAL 0.1% cream
ECOVAL 0.1% ointment
Ecoval package inserts are available for packs: - ECOVAL 0.1% cream, ECOVAL 0.1% ointment
- ECOVAL 0.1% skin emulsion
Indications Why is Ecoval used? What is it for?
Ecoval contains a medicine called betamethasone valerate. Betamethasone valerate belongs to a group of medicines called corticosteroids, which help reduce swelling and irritation caused by skin problems such as:
- Eczema (atopic dermatitis)
- seborrheic dermatitis (itching that develops on the face, scalp, chest and back with red scaly formations);
- allergic contact or irritative dermatitis
- lichen ((skin diseases characterized by skin lesions with a dry, crusty and flaking appearance)
- psoriasis (thickened patches of inflamed red skin, often covered with silvery scales)
- neurodermatitis (skin condition characterized by chronic itching or peeling)
- treatment of itching
Contraindications When Ecoval should not be used
Do not use Ecoval cream and ointment:
- if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Ecoval
- in children under one year of age
- to treat any of the following skin problems: Untreated skin infections
- viral skin infections (herpes simplex, chicken pox)
- tuberculous infections (caused by fungi or bacteria)
- acne
- severe redness of the skin especially in the central area of the face (acne rosacea)
- red spots and rash around the mouth (perioral dermatitis)
- itching in the anal and genital area
- itchy skin without inflammation
- skin lesions (skin ulcers)
Do not use this medicine if any of these apply to you. If you are not sure talk to your doctor or pharmacist before using Ecoval.
Precautions for use What you need to know before taking Ecoval
Talk to your doctor or pharmacist before taking this medicine if:
- have had a previous allergic reaction to other steroids;
- you are applying cream or ointment with an occlusive dressing (in children, the diaper can act as an occlusive dressing). The bandage can facilitate the passage of the active ingredient through the skin, in this way you can accidentally use too much drug; you have psoriasis, your doctor will want to see you more frequently;
- you are applying the cream or ointment to a "chronic ulcer in the leg. This may increase the risk of local allergic reactions or infections;
- want to apply the cream or ointment over a large area;
- you are applying cream or ointment to skin that is not intact or in skin folds;
- you are applying cream or ointment near the eyes or eyelids, repeated entry of the cream into the eyes can cause cataracts and glaucoma;
- you are applying cream or ointment to thin skin such as the face or to children who have thinner skin than adults and may absorb higher amounts of the drug as a result.
- you are elderly and / or suffer from reduced kidney / liver function. In this case it is advisable to use the smallest amount of drug for the shortest time required to obtain the desired clinical benefit.
Do not use dressings or bandages on the face of children where you have applied the cream or ointment, use on children or on the face should be limited to 5 days.
If you are not sure if any of the above applies to you or your child, talk to your doctor or pharmacist before using this drug.
Interactions Which drugs or foods can modify the effect of Ecoval
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be especially careful if you are taking ritonavir and itraconazole as these medicines increase the effect of the drug.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Administration of betamethasone valerate during pregnancy should be considered in cases of real need and under the direct supervision of the physician.
Use the least amount of medication for the shortest time possible
Pregnancy
Topical administration of betamethasone valerate during lactation should be considered in cases of real need.
If you use betamethasone valerate while breastfeeding, avoid applying it to the breast to prevent the baby from ingesting it.
Driving and using machines
There are no known negative effects on these activities
Ecoval cream contains chlorocresol and cetostearyl acid
Ecoval cream contains chlorocresol which can cause allergic reactions and cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis)
Dosage and method of use How to use Ecoval: Dosage
Always use Ecoval exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Cream - The application of the cream is indicated in lesions at any location and is preferable in the treatment of delicate and moist skin surfaces.
Ointment - Dry skin irritations are most beneficial with the application of the ointment.
- Gently apply a small amount of cream or ointment to the surface to be treated 2-3 times a day. When it notices a significant improvement, it will be able to thin the applications up to suspend them
If your condition worsens or does not clear up in four weeks, talk to your doctor who will reevaluate your treatment and diagnosis.
Topical corticosteroid therapy should be gradually discontinued as the disease is under control and treatment should be continued with an emollient cream as maintenance therapy.
Following the sudden interruption of the application of topical corticosteroids, particularly powerful ones, a relapse of pre-existing dermatoses may occur.
Use in children
In children, do not use the treatment for more than 5 days without medical supervision and do not use occlusive dressing.
Application on the face.
Apply Ecoval to your face only if advised by your doctor. The applications on the face cannot be continued for a long time because the skin on the face thins easily. Do not apply the cream or ointment to the eyes.
Overdose What to do if you have taken an overdose of Ecoval
If you use more Ecoval than necessary
If, by mistake, you sometimes use more Ecoval than you should, don't worry. If you accidentally swallow the drug, you may feel unwell. Talk to your doctor or go to a hospital as soon as possible.
If you forget to use Ecoval
- If you forget to use Ecoval apply it as soon as you remember, then continue as before
- Do not apply an extra dose to make up for the forgotten one
If you stop using Ecoval
If you use Ecoval regularly make sure you speak to your doctor before you stop using it
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Ecoval
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ecoval and contact your doctor immediately if:
- your skin conditions worsen, a generalized rash develops or your skin swells during treatment. You may be allergic to Ecoval, have an infection or need other treatments.
- suffer from psoriasis with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.
Other side effects you may notice when using Ecoval:
Common (may affect up to 1 in 10 people)
- burning sensation, pain, irritation or itching when applying the product
Very rare (may affect up to 1 in 10,000 people)
- an increased risk of infection
- allergic skin reactions in the area treated with the cream (local hypersensitivity)
- rash, irregular itchy skin or redness of the skin
- thinning and dryness of the skin which can make wrinkles appear more easily
- striae
- thinning of the skin which can highlight the veins under the skin
- increase or decrease in hair growth or hair loss and change in skin color
- weight gain, rounding of the face (moon face)
- delayed weight gain or slowed growth in children
- thinning of the bones which can become weaker and break
- cataract or increased pressure in the eye (glaucoma)
- increased blood and urine sugar levels
- increased blood pressure
- application site irritation and pain
The following side effects may also occur locally:
redness, edema, peeling of the skin, acne-like eruptions, dilation of the small vessels of the skin (capillaries) especially in the face, fragility of blood vessels, purpura, dermatitis with pustules. Prolonged use and / or high doses can lead to hypertension blood pressure, tiredness and weakness, heart rhythm disturbances, low blood potassium levels, metabolic alkalosis.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Cream: Do not store above 30 ° C
Ointment: No storage conditions
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Ecoval contains
The active ingredient is betamethasone valerate
Cream
- 100 g contain 0, 122 g of betamethasone valerate equal to 0.100 g betamethasone. (0.1% w / w).
The other ingredients are: Chlorocresol, Eterepolyoxyethylene methylstearyl alcohol, White petroleum jelly, Liquid paraffin, Monobasic sodium phosphate, Phosphoric acid or Sodium hydroxide, Purified water.
Ointment
- 100 g contain 0, 122 g of betamethasone valerate equal to 0.100 g betamethasone. (0.1% w / w).
The other ingredients are: liquid paraffin, white petroleum jelly.
Description of how Ecoval looks and contents of the pack
Cream in 30 g tube. Ointment in 30 g tube.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ECOVAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
0.1% Cream - 100 grams contain:
Betamethasone valerate 0.122 g
equal to Betamethasone 0.100 g
Excipients with known effects: chlorocresol, cetostearyl alcohol.
0.1% Skin emulsion - 100 grams contain:
Betamethasone valerate 0.122 g
equal to Betamethasone 0.100 g
Excipients with known effects: E218 Methylhydroxybenzoate, cetostearyl alcohol.
0.1% Ointment - 100 grams contain:
Betamethasone valerate 0.122 g
equal to Betamethasone 0.100 g
0.05% Cutaneous solution - 100 grams contain:
Betamethasone valerate 0.061 g
equal to Betamethasone 0.050 g
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
- Cream
- Ointment
- Skin emulsion
- Skin solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
ECOVAL cream, ointment and skin emulsion
Skin diseases sensitive to corticosteroids such as: seborrheic dermatitis; Atopic dermatitis; allergic or irritative contact dermatitis; lichen; psoriasis (excluding diffuse plaque psoriasis); neurodermatitis and others.
Symptomatic treatment of itching.
ECOVAL Cutaneous solution
Dermatosis of the hairy parts and in particular of the scalp: eczematous dermatitis, seborrheic eczema, psoriasis (excluding diffuse plaque psoriasis); alopecia areata; dry pityriasis and in particular that seborrheic state with oily desquamation of the scalp commonly known as dandruff.
04.2 Posology and method of administration
Adults, the elderly and children over 1 year of age
ECOVAL cream, ointment and skin emulsion
Gently apply a small amount of the ointment, cream or skin emulsion product to the surface to be treated, 2-3 times a day. When a significant improvement has been obtained, the applications can be thinned out until they are suspended.
Ointment - Dry scaly dermatoses with lichenoid and hyperkeratotic imprint are most affected by the application of the ointment. The fat base in fact exerts an advantageous emollient effect that allows the cortisone to act in depth.
Cream - The application of the cream is indicated in all lesions with any localization. The hydrodispersible vehicle makes the cream preferable in the treatment of delicate and moist skin surfaces.
Skin emulsion - The preparation in the form of an emulsion is indicated when small amounts of corticosteroid have to be applied on large skin surfaces or for application in difficult to access areas such as hairy ones. Pay attention during application given the flammable nature of the product ( see section 4.4).
ECOVAL cutaneous solution
Apply a small amount 2-3 times a day on the area to be treated, massaging it gently, until an appreciable improvement is obtained; to prolong and complete the effect a single daily application or at longer intervals will suffice. Pay attention during application given the flammable nature of the product (see section 4.4).
In the seborrheic state with flaking of the scalp (dandruff), the preparation can be conveniently applied immediately after washing the hair.
Due to the rapid evaporation of the hydroalcoholic vehicle, the preparation is non-greasy and leaves no trace on the hair.
Use in children: In children, treatment should not be continued for more than 5 days without medical supervision and occlusive dressing should not be used.
In cases where the doctor sees the need, the effect of ECOVAL can be increased, by means of an occlusive bandage with polyethylene film, of the surface to be treated.
Bandaging for the whole night alone is generally adequate to achieve a satisfactory response, and in such injuries, later, improvement can be maintained by regular application without bandaging.
In the case of occlusive dressings, it is a good rule that the skin is well cleansed before each renewal of the occlusive bandage, to avoid bacterial infections that can easily occur in the warm humid environment induced by the occlusion.
If conditions worsen or do not resolve within four weeks, treatment and diagnosis should be reassessed.
In atopic eczema therapy with betamethasone valerate should be gradually discontinued as the disease is under control and treatment should continue with an emollient cream as maintenance therapy.
A relapse of pre-existing dermatoses may occur following the sudden interruption of the application of betamethasone valerate.
04.3 Contraindications
ECOVAL cream, ointment and skin emulsion
Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1.
Betamethasone valerate is contraindicated in children under the age of 1 year.
The following conditions should not be treated with betamethasone valerate:
• Untreated skin infections.
• Tuberculous and viral infections of the treated skin (herpes, chicken pox, etc.).
• Acne rosacea.
• Acne vulgaris.
• Perioral dermatitis.
• Itching without inflammation.
• Perianal and genital itching.
• Skin ulcers.
It is contraindicated in the treatment of infected primary skin lesions caused by fungal or bacterial infections; primary or secondary infections caused by yeasts.
It is contraindicated in the treatment of dermatoses in children under 1 year of age including dermatitis and diaper rashes.
Occlusive dressing is contraindicated in exudative lesions and skin infections.
The product is not for ophthalmic use.
ECOVAL cutaneous solution
Hypersensitivity to the active substance or to any of the excipients.
The product is contraindicated in individuals suffering from cutaneous tuberculosis and herpes simplex; in dermatoses in children under 1 year of age including dermatitis and diaper rash; in case of scalp infections. The product is not for ophthalmic use.
04.4 Special warnings and appropriate precautions for use
Betamethasone valerate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients of the drug. Local hypersensitivity reactions (see section 4.8 Undesirable Effects) may resemble symptoms of the disease being treated.
In some individuals, manifestations of hypercortisolism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal axis (HPA), leading to glucocorticoid insufficiency, may occur due to increased systemic absorption of topical steroids. observed one of the above effects, the application of the drug should be gradually reduced by decreasing the frequency of applications or by replacing it with a less potent corticosteroid. Abrupt discontinuation of treatment may lead to glucocorticosteroid insufficiency (see section 4.8 Undesirable Effects).
The risk factors for increased systemic effects are:
• Topical steroid potency and formulation
• Duration of exposure
• Application on a large surface area
• Use on occluded areas of skin for example on intertriginous areas or under occlusive dressing (in children the diaper can act as an occlusive dressing)
• Increased hydration of the stratum corneum
• Use on thin skin areas such as the face
• Use on skin that is not intact or in other conditions where the skin barrier may be damaged
• Compared to adults, children may absorb proportionally more topical corticosteroids and thus be more susceptible to systemic side effects. This is due to the fact that children have an immature skin barrier and a higher surface area to body weight ratio than adults.
Children
Children are much more likely to develop local and systemic side effects typical of topical corticosteroids and children in general require shorter and less potent corticosteroid treatments than adults.
Betamethasone valerate should be used with caution to ensure the application of the lowest amount that gives therapeutic benefit.
The use of the product in children should not exceed 5 days of treatment and occlusive dressing should not be used.
As with other topical corticosteroids, prolonged use of high doses or treatment of large areas may cause sufficient systemic absorption to induce suppression of the hypothalamic-pituitary-adrenal axis. This effect is more likely to occur in infants and children and if occlusive dressings are used. In infants, the diaper can act as an occlusive dressing.
In early childhood use only in case of real need, under the direct supervision of the doctor.
Children can absorb proportionally higher doses of corticosteroid than adults, making them more sensitive to systemic effects.
In infants and children under 12 years, continuous, long-term therapy with topical corticosteroid should be avoided where possible, as suppression of adrenal activity is more likely, with or without clinical signs of hypercortisolism, even without the use of an occlusive dressing (see sections 4.8 Undesirable Effects and 4.9 Overdose).
Senior citizens
Clinical studies have revealed no differences in response between elderly and younger patients. Decreased hepatic or renal function, which is very common in the elderly, may lead to a delay in elimination of the drug, in case of systemic absorption. Therefore, the minimum quantity should be used for the shortest time required to obtain the desired clinical benefit.
Population with renal / hepatic insufficiency
In case of systemic absorption (when the application is extended to a large body surface for a prolonged period) the metabolism and elimination of the drug may be delayed, thus increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest time required to obtain the desired clinical benefit.
Risk of infection in case of occlusion
Hot humid conditions in skin folds or those caused by occlusive dressing promote bacterial infections. If an occlusive dressing is used, the skin surface must be thoroughly cleansed before each renewal of the dressing.
Psoriasis
Topical corticosteroids should not be used in diffuse plaque psoriasis and can be dangerous in other varieties of the disease for various reasons, including rebound relapse, the development of tolerance, the risk of generalized pustular psoriasis, and the development of local or systemic toxicity. due to impaired skin barrier function. It is important to monitor the patient closely during psoriasis treatment.
Cream, ointment and skin emulsion
Application on the face.
Prolonged application to the face is not recommended as this area of the body is more susceptible to atrophic changes than other skin areas. This should be considered when treating psoriasis, discoid lupus erythematosus and severe eczema.
The application of the product on the face should not exceed 5 days of treatment and occlusive dressing should not be used.
Application on the eyelids
If the drug is applied to the eyelids, extreme caution must be used to ensure that the drug does not get into the eyes, because prolonged exposure can cause cataracts, glaucoma, ptosis of the eyelids, rebound effect.
Adequate antimicrobial therapy should be employed if the inflammatory lesions being treated become infected. Any spread of infection requires discontinuation of topical corticosteroid therapy. Systemic chemotherapy is required if bacterial infection persists.
Superinfections
In the case of superinfection of inflammatory lesions, appropriate antimicrobial therapy is required. If infection spreads, topical corticosteroid therapy should be discontinued and appropriate antibacterial therapy administered.
Chronic leg ulcers
In some cases, topical corticosteroids are used to treat dermatitis near chronic leg ulcers. However, this use may be associated with a higher frequency of local hypersensitivity reactions and an increased risk of local infections.
Skin solution and skin emulsion
Due to the flammable nature of betamethasone valerate cutaneous solution and skin emulsion, patients should avoid smoking or being near open flames during and immediately after use (see section 4.2).
Skin solution
Keep the preparation away from the eyes.
If concomitant antibiotic treatment is inappropriate, only an apparent improvement in the clinical situation may occur due to the anti-inflammatory effect of steroids.
Locally applied corticosteroids can reduce skin resistance to bacteria, viruses and fungi.
The prolonged or repeated use of products for topical use can give rise to sensitization phenomena or the development of bacterial or fungal infections.
Important information about some of the ingredients
ECOVAL 0.1% Cream contains chlorocresol. It can cause allergic reactions.
ECOVAL 0.1% Cream contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).
Ecoval 0.1% Skin emulsion contains methyl E218 methyl hydroxybenzoate which may cause allergic reactions (even delayed).
Ecoval 0.1% Skin emulsion contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).
04.5 Interactions with other medicinal products and other forms of interaction
Co-administration of drugs that can inhibit CYP3A4 (eg ritonavir and itraconazole) has been shown to inhibit the metabolism of corticosteroids resulting in 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.
04.6 Pregnancy and lactation
Fertility
There are no human data to evaluate the effect of topical corticosteroids on fertility.
Pregnancy
There are limited data on the use of betamethasone valerate in pregnant women.
Topical administration of corticosteroids during pregnancy in laboratory animals may cause abnormalities in fetal development (see section 5.3 Preclinical safety data).
The relevance of this experimental finding to humans has not been established; however, the administration of betamethasone valerate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus, therefore in cases of actual need and under the direct supervision of the physician.The minimum amount should be used for a minimum period of time.
Feeding time
It has not been established whether the use of topical corticosteroids while breastfeeding is safe.
It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities of the active substance in breast milk.
Topical administration of betamethasone valerate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the baby.
If used during breastfeeding, betamethasone valerate should not be applied to the breast to avoid accidental ingestion by the baby.
04.7 Effects on ability to drive and use machines
Ecoval does not affect the ability to drive or use machines.
No studies on the ability to drive and use machines have been performed.
04.8 Undesirable effects
Side effects are listed below by MedDRA organ, system / system, and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and
Data after marketing
Infections and infestations
Very rare: opportunistic infections
Disorders of the immune system
Very rare: local hypersensitivity.
If signs of hypersensitivity appear, the application must be discontinued immediately.
Endocrine pathologies
Very rare: suppression of the hypothalamic-pituitary-adrenal axis
Cushingoid characteristics (e.g. moon face, middle body obesity), weight gain / growth retardation in children, osteoporosis, glaucoma, hyperglycemia / glycosuria, cataracts, hypertension, weight gain / obesity, decreased blood levels endogenous cortisol, alopecia, tricorressi.
As with other topical corticosteroids, prolonged use of high doses or treatment of large areas may cause sufficient systemic absorption to induce suppression of the hypothalamic-pituitary-adrenal axis. This effect is more likely to occur in infants and children and if occlusive dressings are used. In infants, the diaper can act as an occlusive dressing.
Skin and subcutaneous tissue disorders
Common: local skin burning / skin pain, itching.
Very rare: skin thinning * / skin atrophy *, skin wrinkling *, dry skin *, striae *, telangiectasia *, pigmentation changes *, hypertrichosis, allergic contact dermatitis / dermatitis, erythema, rash, urticaria, psoriasis pustular, exacerbation of latent symptoms.
* Skin characteristics secondary to local and / or systemic effects of suppression of the hypothalamic-pituitary-adrenal axis.
Prolonged, high-dose use of highly active corticosteroid preparations may cause local atrophic skin changes such as thinning and striae particularly if occlusive bandages are used or if skin folds are involved.
Prolonged and high-dose use of highly active corticosteroid preparations can cause dilation of superficial capillaries, particularly if occlusive bandages are used or if skin folds are involved.
In very rare cases, corticosteroid treatment of psoriasis (or its withdrawal) is thought to have caused the pustular form of the disease.
General disorders and administration site conditions
Very rare: application site irritation / pain
ECOVAL preparations are usually well tolerated but application should be discontinued immediately if signs of hypersensitivity appear.
Symptoms may be exacerbated.
This effect typically occurs in infants and children and if occlusive dressings are used. In infants, the diaper can act as an occlusive dressing.
Locally there may be redness, edema, desquamation, itching with signs of hypersensitivity to the product; other effects include acneiform eruptions, telengectasias (especially on the face), vascular fragility, purpura after prolonged treatments (especially on the face), rebound pustular dermatitis which, being sensitive to steroids, become evident only when they are suspended.
Prolonged and / or high dose use can induce an excess syndrome with arterial hypertension, asthenia, adynamia, heart rhythm disturbances, hypokalaemia and metabolic alkalosis.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Symptoms and signs:
Topically applied betamethasone valerate can be absorbed in sufficient quantities to give systemic effects.
Acute overdose is very unlikely, however signs of hyperadrenalism may occur in the event of chronic overdose or abuse (see section 4.8 Undesirable Effects).
Treatment: in the event of overdose, the application of betamethasone valerate should be discontinued gradually by reducing the frequency of applications or by replacing the drug with a less potent corticosteroid, to avoid the risk of adrenal insufficiency.
Further medical evaluation should be undertaken as clinically indicated or as recommended by the National Poisons Center, if information is available.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: active corticosteroids, (group III).
ATC code: D07AC01.
Betamethasone valerate is an active corticosteroid with anti-inflammatory activity.
Mechanism of action
Topical corticosteroids act as anti-inflammatory agents through a multiple mechanism aimed at inhibiting delayed phase allergic reactions which include decreased mast cell density, decreased chemotaxis and activation of eosinophils, decreased cytokine production by lymphocytes, monocytes, mast cells and eosinophils and inhibition of arachidonic acid metabolism.
Pharmacodynamic effects
Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.
05.2 Pharmacokinetic properties
Absorption
Topical corticosteroids can be absorbed systemically through intact skin. The level of percutaneous absorption of topical corticosteroids is determined by several factors, including the vehicle and the integrity of the skin barrier. Occlusion, inflammation and / or other skin disease processes may also increase percutaneous absorption.
However, many factors can favor greater absorption: the area and extent of the skin to be treated, the type of lesion, the duration of the treatment, any occlusive bandage. In this regard, it should be borne in mind that certain areas of the skin (scrotum, face, eyelids, hair) absorb them more easily than others (skin of the knees, elbows, palm of the hand and soles of the feet).
Distribution
The use of pharmacodynamic endpoints to assess the systemic exposure of topical corticosteroids is necessarily due to the fact that the circulating levels are well below the level of detection.
Metabolism
Once absorbed through the skin, topical corticosteroids are metabolised via pharmacokinetic pathways similar to those of systemically administered corticosteroids which are metabolised primarily by the liver.
Elimination
Corticosteroids are eliminated through the kidneys. Some corticosteroids and their metabolites are also excreted via the bile.
05.3 Preclinical safety data
Carcinogenesis / Mutagenesis
Carcinogenesis
Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical betamethasone valerate.
Genotoxicity
No specific studies have been performed to evaluate the genotoxic potential of betamethasone valerate.
Fertility
The effect of topical betamethasone valerate on fertility in animals has not been evaluated.
Pregnancy
Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥ 0.1 mg / kg / day or rabbits at doses ≥ 12 mcg / kg / day during pregnancy resulted in fetal abnormalities including cleft palate.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cream:
chlorocresol, eterepolyoxyethylene ethyl stearyl, cetostearyl alcohol, white petroleum jelly, liquid paraffin, monobasic sodium phosphate, phosphoric acid or sodium hydroxide, purified water.
Skin emulsion:
E218 methylhydroxybenzoate, xanthan gum, cetostearyl alcohol, liquid paraffin, isopropyl alcohol, glycerol, eterepolyoxyethylene ethyl stearyl, citric acid monohydrate, sodium citrate, purified water.
Ointment:
liquid paraffin, white petroleum jelly.
Skin solution:
carbopol 980, isopropyl alcohol, sodium hydroxide, purified water.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
Cream: 2 years.
Ointment - Skin emulsion: 3 years.
Skin solution: 18 months.
06.4 Special precautions for storage
Cream: store below 30 ° C
Ointment: This medicine does not require any special storage conditions
Skin emulsion: store below 25 ° C
Keep container tightly closed when not in use. Flammable content. Keep away from fire, flame or heat. Do not leave the emulsion in direct sunlight.
Skin solution: store below 25 ° C.
Keep container tightly closed when not in use. Flammable content. Keep away from fire, flame or heat. Do not leave the emulsion in direct sunlight.
06.5 Nature of the immediate packaging and contents of the package
ECOVAL 0.1% skin emulsion
Polyethylene bottle with screw cap - 30 g.
ECOVAL - 0.1% cream
ECOVAL - 0.1% ointment
Aluminum tube with screw cap - 30 g.
ECOVAL 0.05% - cutaneous solution
Polyethylene bottle with screw cap - 30 g.
06.6 Instructions for use and handling
No special instructions for disposal.
07.0 MARKETING AUTHORIZATION HOLDER
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona
08.0 MARKETING AUTHORIZATION NUMBER
ECOVAL - 0.1% cream 30 g tube A.I.C .: 020423137
ECOVAL - 0.1% ointment 30 g tube A.I.C .: 020423048
ECOVAL - 0.1% skin emulsion bottle of 30 g A.I.C .: 020423087
ECOVAL - 0.05% cutaneous solution 30 g bottle A.I.C .: 020423265
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
August 1964 / May 2009
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 26 September 2014
