Composition, form of production and packaging
Cream for external application of white color, soft consistency, homogeneous, does not contain extraneous inclusions.
1 g
betamethasone valerate (equivalent to 1 mg betamethasone) 1.22 mg
gentamicin (in the form of sulfate) 1 mg (1000 IU)
Auxiliary substances: paraffin white soft, cetostearyl alcohol, paraffin liquid, macrogol cetostearate, phosphoric acid, sodium dihydrogen phosphate dihydrate, chlorocresol, sodium hydroxide or phosphoric acid (to create the necessary pH level), purified water.
15 g - aluminum tubes (1) - cardboard boxes.
30 g - aluminum tubes (1) - cardboard boxes.
Ointment for external application of white color, soft consistency, homogeneous, does not contain extraneous inclusions.
1 g
betamethasone valerate (equivalent to 1 mg betamethasone) 1.22 mg
gentamicin (in the form of sulfate) 1 mg (1000 IU)
Auxiliary substances: paraffin liquid, paraffin white soft.
15 g - aluminum tubes (1) - cardboard boxes.
30 g - aluminum tubes (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Betamethasone valerate - GCS - has anti-inflammatory and anti-allergic effect, inhibits the release of cytokines and inflammatory mediators, reduces the metabolism of arachidonic acid, induces the formation of lipocortins, which have anti-edematous activity, and reduces vascular permeability.
Gentamicin is a broad-spectrum antibiotic - when applied topically, it is effective against most common pathogens. Gentamicin susceptible bacteria include sensitive strains of streptococcus (beta-hemolytic, alpha-hemolytic), staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains), as well as Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
INDICATIONS
Local treatment of skin disease susceptible to GCS therapy in the presence of secondary infection caused by susceptible to gentamicin microorganisms, or when suspected of such infection:
- eczema (atonic, childish, coin-like);
contact dermatitis;
- seborrheic dermatitis;
- Neurodermatitis;
- sunny dermatitis;
- exfoliative dermatitis;
- Radiation dermatitis;
- intertrigo;
- psoriasis;
anogenital and senile itching.
Ointment is used for skin lesions against a background of eczema or psoriasis, and the cream is used for diseases of moist or oily skin.
DOSING MODE
Outwardly. Apply a thin layer on the affected skin 2 times / day - morning and evening.
The frequency of application, other than the recommended, can set the doctor, focusing on the severity of the disease. In mild cases, the application of 1 time / day is usually sufficient, with more severe lesions, more frequent use may be required.
SIDE EFFECT
Local reactions: skin irritation (pruritus, erythema), burning sensation, dry skin, folliculitis, hypertrichosis, acne vulgaris, hypopigmentation, perioral dermatitis, allergic contact dermatitis. When using occlusive dressings: skin maceration, secondary infection, skin atrophy, striae, sweating.
With prolonged treatment or application to a large surface: it is possible to develop systemic side effects characteristic of GCS: weight gain, osteoporosis, increased blood pressure, edema, ulceration of the mucous membrane of the gastrointestinal tract, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, menstrual irregularity .
Children receiving local SCS may experience the following side effects: suppression of the hypothalamic-pituitary-adrenal system, Cushing's syndrome, growth retardation, lag in weight gain, increased intracranial pressure. Symptoms of suppression of adrenal cortex function in children include a decrease in the level of cortisol in the plasma and a lack of response to stimulation of ACTH. Increase in intracranial pressure is manifested by bulging fontanel, headache, bilateral edema of the optic disc.
CONTRAINDICATIONS
- Hypersensitivity to any of the components of the drug;
- Tuberculosis of the skin, cutaneous manifestations of syphilis, chickenpox, herpes simplex, fungal skin diseases;
- the period of vaccination and skin postvaccinal reactions;
- lactation period;
- pregnancy (prolonged treatment of extensive skin areas);
- Children's age - up to 6 months.
With caution: pregnancy (in the absence of criteria for contraindications), especially in the first trimester; long-term treatment of large areas of the skin, especially in children, or in the presence of skin cracks or the use of occlusive dressings;
PREGNANCY AND LACTATION
Due to the fact that the safety of the use of local GCS in pregnant women has not been established, administration of this class of drugs during pregnancy is justified only if the benefit to the mother clearly exceeds the possible harm to the fetus. SCS should not be used during pregnancy for a long time or in high doses.
Since it has not been established to date whether SCS can be absorbed into breast milk by topical application and systemic absorption, a decision should be made whether to stop breastfeeding or to abolish the drug, given the need for its use for the mother.
APPLICATION FOR CHILDREN
Celestoderm-B with Garamycin can be used to treat children between the ages of 6 months. Children may be more susceptible to the action of local GCS. causing oppression of the hypothalamic-pituitary-adrenal system than older patients. This is due to a higher absorption of the drug in children due to a greater ratio of surface area and body weight.
SPECIAL INSTRUCTIONS
In the absence of the effect of treatment for 2 weeks, it is recommended that you consult your doctor to clarify the diagnosis and treatment.
If irritation or hypersensitivity occurs during the use of the drug, treatment should be discontinued and the patient should be treated differently.
Any side effects of systemic SCS, including oppression of the function of the adrenal cortex, can also be noted when using local GCS, especially in children. Systemic absorption of local GCS may increase with prolonged use, treatment of extensive body surfaces or the use of occlusive dressings, especially in children.
Systemic absorption of gentamicin in topical application may increase in case of application to extensive areas of the skin, especially with prolonged treatment or in the presence of skin cracks. In such cases, development of undesirable phenomena characteristic of gentamicin in its systemic application, especially in children, is possible.
With topical application of antibiotics, insensitive microflora, including fungal growth, is occasionally observed. In this case, treatment should be stopped and appropriate therapy prescribed.
Celestoderm-B with Garamycin is indicated for external use only and is not intended for use in ophthalmology.
Pediatric Use
Celestoderm-B with Garamycin can be used to treat children between the ages of 6 months.
Children may be more susceptible to the action of local GCS. causing oppression of the hypothalamic-pituitary-adrenal system than older patients. This is due to a higher absorption of the drug in children due to a greater ratio of surface area and body weight.
OVERDOSE
Symptoms. Excessive or prolonged use of local SCS can cause oppression of the function of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency and the emergence of symptoms of hypercorticism, including Cushing's syndrome.
A single overdose of gemtamycin is not accompanied by the appearance of any symptoms. Long-term use in doses exceeding recommended, can lead to a significant increase in insensitive flora, incl. fungal, in the lesion.
Treatment. The corresponding symptomatic treatment was shown. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correction of electrolyte imbalance is shown. In the case of chronic toxic effects, gradual cancellation of GCS is recommended. With uncontrolled growth of microorganisms, appropriate antibacterial or antifungal treatment should be selected.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a place inaccessible to children, at a temperature not exceeding 25 В° C. Shelf life of the cream is 3 years, ointments - 5 years.
Do not use the drug after the expiration date.
