The instruction for medical use
of Tselestoderm-B® medicine with Garamitsinom®
the Trade name
of Tselestoderm-B® with Garamitsinom®
the International unlicensed name
Is not present
the Dosage form
1 g of cream contains
active agents: betamethasone valerate of 1.22 mg (it is equivalent to 1 mg of betamethasone), gentamycin of 1.00 mg or 1000 ME (in the form of Gentamycini sulfas),
excipients: chlorcresol, sodium dihydrophosphate a dihydrate, phosphoric acid, liquid paraffin, cetostearyl alcohol, a macrogoal cetostearyl ether, paraffin white soft, sodium hydroxide, the phosphoric acid, water purified.
Soft, uniform white cream, without lumps and visible mechanical inclusions
Glucocorticosteroids active in a combination with antibiotics. Betamethasone in a combination with antibiotics.
The ATX D07CC01 code
Tselestoderm-B® properties with Garamitsinom® – the combined drug which effect is caused by the entering components.
Betamethasone valerate renders local anti-inflammatory, antiallergic and vasoconstrictive action. The anti-inflammatory effect is caused by A2 phospholipase inhibition with the subsequent oppression of formation of pro-inflammatory mediators – PG and leukotrienes, stabilizing of cellular membranes, including membranes of lysosomes. Betamethasone valerate prevents an exit of lizosomalny enzymes and reduces their concentration in the inflammation center. Slows down migration of neutrophils and macrophages in the center of inflammation and their phagocytal activity. Improves microcirculation, reduces permeability of vessels, causes vasoconstriction of capillaries, reduces liquid exudation.
Antiallergic action develops as a result of decrease in synthesis and secretion of mediators of an allergy, slowing down of release from sensitized mast cells and basophiles of a histamine and other biologically active agents, reduction of number of the circulating basophiles, suppression of proliferation of adenoid and connective tissue, reduction of number of T – and B-lymphocytes, mast cells, decrease in sensitivity of effector cells to mediators of an allergy, oppression of antibodyformation, change of the immune response of an organism.
Gentamycin – an antibiotic of a broad spectrum of activity from group of aminoglycosides. It is active concerning gram-negative bacteria: pyocyanic stick, enterobakter aerogenesis, colibacillus, vulgar protea and pnevmoniyny klebsiyella, gram-positive bacteria: golden staphylococcus (the koagulazo-positive, koagulazo-negative and some penitsillinazo-producing strains). Slows down release of cytokines and mediators of inflammation, reduces metabolism of arachidonic acid, induces formation of a lipokortin.
– the skin diseases sensitive to corticosteroid therapy and complicated by the consecutive infection caused by the microorganisms sensitive to gentamycin:
– dermatitis (contact – without allergic component, seborrheal, solar, exfoliative)
– neurodermatitis, atopic dermatitis
– an intertrigo
– an anogenitalny and senile itching
the Route of administration and doses
of Tselestoderm-B® with Garamitsinom®, cream it is necessary to apply with a thin layer on affected areas of skin 2 times a day – in the morning and in the evening.
Use frequency, excellent from recommended, and the doctor taking into account disease severity can establish duration of treatment. In mild cases the use usually is once a day sufficient, at more severe defeats also more frequent use can be required.
Duration of therapy depends extents of defeat, localization, and reaction of the patient to the carried-out therapy. At inefficiency of therapy within 3-4 weeks it is necessary to make repeated diagnosis of a disease.
– burning sensation
– irritation of skin
– an itching, xeroderma
– hypersensitivity of skin, rash, decolouration of skin
– a folliculitis
– a hypertrichosis
– acneform rashes
– perioral dermatitis
– allergic contact dermatitis
– maceration of skin
– consecutive infection
– a skin atrophy
– a heat rash
– irritation of skin: an itching, erythematic rashes (gentamycin influence)
Use for children
– oppression of a system hypophyses-hypothalamus-adrenal glands
– Cushing’s syndrome
– a growth inhibition, lag in a body weight increase
– increase in intracranial pressure (betamethasone influence) which is followed by protrusion of a fontanel, a headache, bilateral hypostasis of disks of optic nerves (papillary stasis sign)
of the Contraindication
– hypersensitivity to any component of drug
– children’s age till 1 year
Interaction of Tselestoderm-B® cream with Garamitsinom® with other drugs is not revealed. However it is not recommended to be applied along with other ointments or creams, in particular, containing the anion surfactants inactivating action chloride cetylpyridinium. At its combined use with cardiac glycosides their action amplifies, when sharing with diuretics the potassium removal, with gipoglikemiziruyushchy drugs, oral anticoagulants possibly weakening of their action increases.
At the same time or at once on the termination of a course of treatment of the drug Tselestoderm-B® with Garamitsinom® it is not necessary to appoint the antimicrobial and other drugs having otonefrotoksichesky effect.
instructions Tselestoderm-B® with Garamitsinom® it is not intended for use in ophthalmology.
If at use of drug the irritation or hypersensitivity is noted, treatment the patient should stop and pick up other therapy. At topical administration of antibiotics growth of insensitive microflora, including fungal is sometimes observed. At emergence of irritation, development of hypersensitivity or superinfection, treatment it is necessary to stop and appoint the corresponding treatment.
Appearance of a cross allergy to other aminoglycosides is noted.
System absorption of gentamycin at topical use will be higher at use on an extensive body surface, especially at long-term treatment or at disturbance of integrity of skin. In these cases the emergence of the undesirable phenomena connected with system absorption of gentamycin is possible. It is necessary to adhere to the appropriate measures of precaution in such cases, especially at treatment of children.
Any side effects of system glucocorticosteroids, including oppression of function of bark of adrenal glands, can be noted also when using local glucocorticosteroids, in particular at children.
System absorption of local glucocorticosteroids is increased at their prolonged use, at their use on an extensive body surface or when using occlusive bandages. It is necessary to adhere to the appropriate measures of precaution, especially at treatment of children.
Treatment by gentamycin can be followed by tranzitorny irritation of skin (itching, an erythema) that in most cases does not demand the therapy termination.
Use in pediatrics
Children can be more susceptible to action of the local glucocorticosteroids causing oppression gipotalamo – a hypophysial and adrenal system, than patients of advanced age. It is connected with higher absorption of drug at children owing to the bigger size of a ratio of surface area and body weight.
Pregnancy and the period of a lactation
Safety of use of local glucocorticosteroids for pregnant women is not established. Use of this group of drugs during pregnancy is carried out only if the potential advantage for the woman exceeds potential risk for a fruit. During pregnancy, drugs of this group should not be used often, in high doses or it is long.
There are no data whether can lead topical administration of corticosteroids through system absorption to emergence them in breast milk. The decision on the termination of breastfeeding or drug withdrawal should be accepted taking into account need of use of drug for mother.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Symptoms: excessive or prolonged use of local glucocorticosteroids can cause oppression of function of a hypophysial and adrenal system that there can be the reason of development of secondary insufficiency of bark of adrenal glands and emergence of symptoms of a hypercorticoidism, including Cushing’s syndrome. The single overdose of gentamycin is not followed by emergence of any symptoms. Prolonged use in the doses exceeding recommended can lead to significant growth in insensitive flora, including fungal.
Treatment: symptomatic treatment. Acute giperkortikoidny symptoms are usually reversible. If necessary it is necessary to carry out treatment of an electrolytic imbalance. In case of development of chronic toxic action, gradual cancellation of glucocorticosteroids is recommended.
In case of significant growth in insensitive flora, including fungal, it is necessary to carry out the corresponding antibacterial or antifungal treatment.
The form of release and packing
On 30 g of cream place in tubas aluminum with a membrane, with internal varnish coating, the membranes which are screwing up a plastic cap with a pin for piercing.
1 tuba together with the instruction for medical use in the state and Russian languages is placed in a box of cardboard
to Store at a temperature not above 25 °C.
To store out of children’s reach.
not to apply a period of storage after an expiration date.
According to the prescription
Shering-Plau Labo Producer H. B., Belgium
the Owner of the registration certificate
Shering-Plau Sentral East AG, Switzerland
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Representative office of Shering-Plau Sentral East AG in
Kazakhstan, Almaty, Dostyk Ave., 38, business center “Ken Dala”, the 5th floor
Ph. +7 (727) 330-42-66
Fax +7 (727) 321-60-47
To Develop email@example.com