Название документа

Pharmacological properties

Pharmacodynamics. betamethasone Dipropionas belongs to strong corticosteroids. at topical administration renders fast and long anti-inflammatory, antiallergic and also vasoconstrictive action.

Topical treatment of a kortikoidama is not etiotropic; in case of the termination of therapy the disease recurrence is possible.

Salicylic acid thanks to the keratolytic and peeling properties makes skin sublayers available to effect of betamethasone of Dipropionas and improves its absorption.

Pharmacokinetics. Absorption of betamethasone of Dipropionas is possible, mainly, after long-term treatment with drawing on the extensive surface of skin.

Indication

Local treatments of a dermatosis sensitive to corticosteroids, such, as: chronic, erythematic or giperkeratozny psoriasis and other dermatosis erythematic skvamatoznogo character, such as seborrheal dermatitis (eczema), dry eczema in a desquamative phase, lichenification.

Use

Ointment is applied a thin layer on all affected area of skin by 2 times a day, in the morning and in the evening, and allow to get into skin which is at the same time easily massed. for some patients for achievement of satisfactory result can be rather single daily drawing.

Maximum daily dose should be reduced to lower which would allow to control symptoms gradually.

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Contraindication

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Drug is contraindicated to patients with hypersensitivity to active agents or any other component of medicine.

Also medicine is contraindicated to

at bacterial and viral infections, such as syphilitic and tubercular damages of skin; vaccine-challenged reactions, smallpox, chicken pox, herpes simplex, shingles, perioral dermatitis, perianal itching and itching of genitals, widespread blyashechny psoriasis, varicosity, diaper dermatitis, contagious mollusk, dermatomycoses, rozatsea, acne, fungal infections.

Side effects

At application of local corticosteroids can arise such side reactions: burning sensation, itch, irritation, xeroderma, skin pricking, skin consolidation, skin cracking, caumesthesia, lamellar peeling of skin, focal peeling of skin, erythema, teleangiectasias, folliculitis, hypertrichosis, aknepodobny rash, hypopigmentation, perioral dermatitis and allergic contact dermatitis.

At use of medicine in the big square or under an occlusive bandage, especially during the long period, it must be kept in mind a possibility of development of systemic action of medicine.

At persons with individual intolerance to components of medicine reactions of hypersensitivity are possible

.

Any by-effects noted at system application of glucocorticoids, including suppression of bark of adrenal glands, can arise also at topical administration of GKS.

side Below-mentioned reactions can arise more often at application of occlusive bandages: skin maceration, consecutive infection, atrophy of skin, striya and heat rash.

Striya's

and vasodilatation, generally on a face, can be result of long continuous putting medicine.

Special instructions Drug is not intended to

by

for application in ophthalmology. it is necessary to avoid hit of medicine in eyes, on mucous membranes, wound surfaces and ulcers.

At emergence of irritation of skin or signs of hypersensitivity treatment the patient should stop and pick up adequate therapy.

Any side effects which are found at application of system corticosteroids, including oppression of function of bark of adrenal glands, can be noted by

also at topical administration of GKS, especially at children.

System absorption of local corticosteroids increases with increase in the area of the processed body surface or when using occlusive bandages. In such cases or at prolonged use it is necessary to take the appropriate measures.

Corticosteroids with high activity on big sites of skin should be applied under careful and periodic monitoring as they can cause oppression gipotalamo - a hypophysial and adrenal system. In case of oppression development, medicine should be cancelled, the frequency of drawing to lower or transfer the patient to corticosteroid medicine of weaker action.

Function gipotalamo - a hypophysial and adrenal system, as a rule, is restored by

at medicament withdrawal. In some cases cancellation symptoms which demand addition of a system corticosteroid can develop.

At disappearance of dandruff or an orogovelost treatment is continued only by corticosteroids.

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does not recommend use of medicine under occlusive bandages.

At emergence of excessive dryness or in case of increase in irritation of skin use of medicine should be stopped.

Corticosteroids for external use for a number of reasons can cause psoriasis, including resumption of symptoms with the subsequent development of tolerance, risk of developing of pustulous psoriasis and local system toxicity owing to decrease in protective function of skin. Patients with abnormal liver functions are more sensitive to system influence. Careful observation of the patient is necessary.

should appoint by

in the presence of an infection antifungal or antibacterial agents respectively. If at the same time the desirable effect does not occur quickly, application of corticosteroids needs to be stopped before elimination of symptoms of an infection.

Should observe the appropriate measures for prevention of increase in the area of absorption at use of medicine on the damaged sites, atrophied skin, big sites of a body surface, under occlusive bandages or at children (because of increase in a ratio "the surface area of a body/body weight"). At application on extensive sites of a body surface it is necessary to consider absorption of salicylic acid also.

Local corticosteroids can distort a clinical picture.

Are possible

a recurrence at treatment interruption and also exacerbation of an infection and delay of healing.

should not apply Drug to

on mucous membranes or sites around eyes because of keratolytic effect of salicylic acid.

putting medicine on sites with atrophied skin Is contraindicated to

.

Use during pregnancy and feeding by a breast. It is not necessary to apply in the I trimester of pregnancy.

For the reason that safety of application of local corticosteroids for pregnant women is not established, prescribing of these medicines is possible only if the expected advantage for future mother obviously exceeds potential threat for a fruit. It is contraindicated to use medicaments of this group at pregnant women in high doses and for a long time.

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it is not established For today whether corticosteroids at topical administration as a result of system absorption can get into breast milk therefore when prescribing medicine it is necessary to make the decision on the breastfeeding termination.

Children. There are no clinical data on use of medicine for children therefore it is undesirable to apply it at patients of this age category.

As children have a ratio of surface area and body weight it is more, than at adults, they note more active absorption of medicine. Therefore children are more inclined to function oppression development gipotalamo - a hypophysial and adrenal system because of application of corticosteroids and development of exogenous effects of corticosteroids.

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At the children receiving corticosteroids for topical administration noted oppression of function of adrenal glands, Cushing's syndrome, a growth inhibition, insufficient gain of body weight, increase in intracranial pressure.

Manifestation of oppression of function of bark of adrenal glands: low level of cortisol in blood plasma and lack of reaction to test with stimulation of adrenal glands using medicines AKTG. Increase in intracranial pressure is shown by protrusion of a fontanel, a headache, a bilateral papilledema.

As corticosteroids can influence products of growth hormones at children, it is necessary to watch the body weight and growth of patients of pediatric population.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Usually medicine does not influence speed of response at control of vehicles or work with other mechanisms.

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Interaction

with other medicines does not know to

interaction cases.

should not combine Topical administration of salicylic acid with oral administration of the medicines containing acetylsalicylic acid and other NPVP. Not to apply together with benzoilperoksidy and local retinoids. Salicylic acid can increase permeability of skin for other medicines of topical administration and by that to increase their hit in an organism. Besides, salicylic acid can strengthen undesirable action of a methotrexate and hypoglycemic effect of oral antidiabetic medicines — sulphonylurea derivatives. If the patient accepts any other medicines, it is necessary to report about it to the doctor surely.

Overdose

At prolonged or excessive use local gks oppression of hypophysial and adrenal function with development of secondary adrenal insufficiency and emergence of symptoms of a hypercorticoidism, including Cushing's disease is possible

. excessive or prolonged use of topical medicines with salicylic acid can lead to emergence of symptoms of a salitsizm.

Treatment. Appoint the corresponding symptomatic therapy. Symptoms of a sharp hypercorticoidism are usually reversible. If it is necessary, carry out correction of electrolytic balance. In case of chronic toxic action it is recommended gradual it is cancelled corticosteroids.

Treatment of a salitsizm symptomatic. Take measures for faster removal of salicylates from an organism. In case of the excess growth of resistant microorganisms recommend to stop medicament treatment and to appoint necessary therapy. Orally apply Natrii hydrocarbonas to alkalization of urine and strengthening of a diuresis.

Storage conditions

In original packing at a temperature not above 25 °C.

Characteristics
Active ingredients Betamethasone, salicylic acid
Applicant Arterium
Code of automatic telephone exchange D07XC01 Betamethasone
Interaction with food It doesn't matter
Light sensitivity Sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing tuba
Producer KIYEVMEDPREPARAT OF JOINT STOCK COMPANY
Quantity in packing 15 g
Release form ointment for external use
Route of administration External
Sign Domestic
Storage temperature from 5 °C to 25 °C
Trade name Betasalik

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Betasalik ointment of a tube of 15 g

  • Product Code: 177004
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