Supirocin-B ointment, 15 g

• It is used to treat atopic dermatitis

• diffuse neurodermatitis

• contact dermatitis (simple and allergic)

• exfoliative dermatitis

• hives

• dermatitis herpetiformis

• seborrheic dermatitis

• eczema

• psoriasis

• complicated by secondary bacterial infections.

Outwardly.

Recommended dosage : Apply a thin layer of ointment to the affected area 2-3 times a day for 5-14 days.

Use only for treatment of affected areas with a length of no more than 10 cm or an area of ??no more than 100 cm2.

If within 3-5 days the patients do not have a clinical reaction, they need to be re-examined.

100 g of ointment contains:

Active ingredients: betamethasone dipropionate, equivalent to betamethasone - 0.05 g, mupirocin - 2.0 g;

Excipients: macrogol 400 (polyethylene glycol 400), macrogol 4000 (polyethylene glycol 4000).

• Hypersensitivity to mupirocin betamethasone dipropionate or any other component of the drug in history;

• cutaneous manifestations of syphilis;

• lupus;

• bacterial viral fungal skin diseases;

• trophic leg ulcers associated with varicose veins;

• skin cancer;

• nevus atheroma melanoma hemangioma xanthoma sarcoma;

• rosacea acne vulgaris post-vaccination skin reactions during pregnancy and breastfeeding children under 12 years of age.

Carefully:

Renal failure of moderate to severe degree.

For patients with diabetes mellitus, glaucoma, tuberculosis, cataract, prolonged use of the ointment on large areas of the skin is not recommended.

It should be used with caution in atrophy of the subcutaneous tissue, especially in the elderly.

Trade name of the drug

Supirocin-B

International non-proprietary name

Betamethasone + Mupirocin

Dosage form

topical ointment

Composition

100 g of ointment contains:

Active ingredients: betamethasone dipropionate, equivalent to betamethasone - 0.05 g, mupirocin - 2.0 g;

Excipients: macrogol 400 (polyethylene glycol 400), macrogol 4000 (polyethylene glycol 4000).

Description

Homogeneous white ointment.

Pharmacotherapeutic group

Glucocorticosteroids in combination with antibiotics

ATX code

D07CC01

Pharmacodynamics:

Pharmacological properties

Combined drug for external use, the effect of which is due to its constituent components.

Pharmacodynamics

Mechanism of action

Mupirocin is a new antibiotic that is produced by fermentation of Pseudomonas fluorescens.

Mupirocin inhibits isoleucyl transfer RNA synthetase by blocking protein synthesis in the bacterial cell.

Due to its specific mechanism of action and unique chemical structure, mupirocin is not cross-resistant with other antibiotics used in clinical practice.

When applied topically in minimal inhibitory concentrations (MIC), mupirocin has bacteriostatic properties, and in higher concentrations, bactericidal properties.

Pharmacodynamic effects

Activity

Mupirocin is a topical antibacterial agent showing in vivo activity against Staphylococcus aureus (including methicillin-resistant strains) S. epidermidis and beta-hemolytic strains of Streptococcus species .

The in vitro spectrum of activity includes the following bacteria:

Sensitive species:

- Staphylococcus aureus 12;

- Staphylococcus epidermidis 12;

- coagulase-negative staphylococci12 ;

- Streptococcus species 1;

- Haemophilus influenzae;

- Neisseria gonorrhoeae;

- Neisseria meningitidis;

- Moraxella catarrhalis;

- Pasteurella multocida.

1 - Clinical efficacy has been demonstrated for isolates of susceptible bacteria for registered clinical indications for use.

2 - Including beta-lactamase-producing strains and methicillin-resistant strains.

Resistant species

- Corynebacterium species;

- Enterobacteriaceae;

- gram-negative non-fermenting sticks;

- Micrococcus species;

- anaerobes.

The cut-off concentrations of mupirocin susceptibility (MIC) for Staphylococcus spp.

Sensitive : less than or equal to 1 ?g / ml.

Intermediate sensitivity : 2 to 256 ?g / ml.

Stable : above 256 ?g / ml.

Betamethasone is a glucocorticosteroid for external use.

It has an anti-inflammatory local anti-allergic anti-edema and anti-proliferative effect.

Has a stronger vasoconstrictor effect than other fluorinated glucocorticosteroids; systemic effects are insignificant due to limited absorption through the skin.

When exposed to the skin, the marginal accumulation of neutrophils is prevented, which leads to a decrease in exudation of cytokine production, inhibition of the migration of macrophages, which ultimately leads to a decrease in the processes of infiltration and granulation.

Pharmacokinetics:

Mupirocin is poorly absorbed through intact human skin.

In the case of absorption through damaged skin, mupirocin is rapidly metabolized to inactive monic acid.

Mupirocin is rapidly excreted from the body by metabolic conversion into an inactive metabolite - monic acid, which is rapidly excreted by the kidneys.

Betamethasone dipropionate is a lipophilic substance and is easily absorbed through the stratum corneum without biotransformation. Absorption increases when applied to the skin in the area of ??the folds of the body, to skin with damaged epidermis or to an area of ??inflammation with frequent use of the drug or after application to a significant surface of the skin. The absorption of betamethasone dipropionate through the skin in children is faster than in adults.

Indications:

• It is used to treat atopic dermatitis

• diffuse neurodermatitis

• contact dermatitis (simple and allergic)

• exfoliative dermatitis

• hives

• dermatitis herpetiformis

• seborrheic dermatitis

• eczema

• psoriasis

• complicated by secondary bacterial infections.

Contraindications:

• Hypersensitivity to mupirocin betamethasone dipropionate or any other component of the drug in history;

• cutaneous manifestations of syphilis;

• lupus;

• bacterial viral fungal skin diseases;

• trophic leg ulcers associated with varicose veins;

• skin cancer;

• nevus atheroma melanoma hemangioma xanthoma sarcoma;

• rosacea acne vulgaris post-vaccination skin reactions during pregnancy and breastfeeding children under 12 years of age.

Carefully:

Renal failure of moderate to severe degree.

For patients with diabetes mellitus, glaucoma, tuberculosis, cataract, prolonged use of the ointment on large areas of the skin is not recommended.

It should be used with caution in atrophy of the subcutaneous tissue, especially in the elderly.

Pregnancy and lactation:

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Method of administration and dosage:

Outwardly.

Recommended dosage : Apply a thin layer of ointment to the affected area 2-3 times a day for 5-14 days.

Use only for treatment of affected areas with a length of no more than 10 cm or an area of ??no more than 100 cm2.

If within 3-5 days the patients do not have a clinical reaction, they need to be re-examined.

Side effects:

Burning itching irritation skin dryness folliculitis hypertrichosis acne-like eruptions hypopigmentation perioral dermatitis allergic contact dermatitis skin maceration secondary infection skin atrophy prickly heat allergic reactions (including anaphylaxis generalized rash urticaria and angioedema.

Overdose:

Symptoms : reversible suppression of the hypothalamic-pituitary-adrenal system; manifestations of Itsenko-Cushing's syndrome; hyperglycemia, glucosuria.

Treatment : symptomatic.

Interaction:

There were no interactions with other drugs.

Special instructions:

Avoid getting the ointment in the eyes, on the mucous membranes, as well as on open wounds and burns.

As with other antibacterial agents, prolonged use of the ointment can lead to overgrowth of insensitive microorganisms, including fungi.

Macrogol (polyethylene glycol) can be absorbed through the wound surface or through other skin lesions and excreted by the kidneys.

Macrogol-based ointments should not be used on large surfaces in conditions accompanied by increased absorption of polyethylene glycol, especially in moderate to severe renal failure.

Given the presence of a potent glucocorticosteroid in the composition of the drug, the drug should be used in the acute period of the disease for a short time on an insignificant surface of the skin.

Do not use the drug on the skin of the face due to the possibility of telangiectasia of perioral dermatitis.

On the skin in the axillary and groin areas, the drug should be used only in cases of extreme necessity.

You should not use the drug under an occlusive dressing, as this can lead to atrophy of the epidermis, the appearance of striae and the development of superinfection.

ѕри применении антибиотиков были описаны случаи развити¤ псевдомембранозного колита степень т¤жести которого может варьировать от легкой до угрожающей жизни. “аким образом важно рассматривать возможность диагноза у пациентов в случае развити¤ диареи на фоне или после применени¤ антибиотиков.

Ќесмотр¤ на то что веро¤тность развити¤ этого ¤влени¤ при наружном применении мупироцина меньше в случае развити¤ продолжительной или выраженной диареи или спазмов в животе лечение следует немедленно прекратить и провести дополнительное обследование пациента.

Ќельз¤ использовать препарат в офтальмологии интраназально в сочетании с использованием катетеров.

¬ли¤ние на способность управл¤ть трансп. ср. и мех.:

Ќе изучалось.

‘орма выпуска/дозировка:

ћазь дл¤ наружного применени¤.

”паковка:

On 5 g and 15 g in aluminum tubes from the inside lacquered with latex having a nozzle with a closed end with a lid having a tip for piercing.

One tube, together with instructions for use, is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ? C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiration date.

Vacation conditions

On prescription.