Betaderm, ointment 0.05%+0.1%, 15 g

Composition

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of 1 g of ointment for external use contains:

active ingredients:

betamethasone (in the form of dipropionate) 500 mcg,

gentamicin (in the form of sulfate) 1 mg,

excipients:

liquid paraffin,

lanolin alcohol,

cetostearyl alcohol,

butylhydroxytoluene,

butylhydroxyanisole,

white vaseline.

Pharmacological action

Combined preparation for external use. The properties of Betaderm are due to the combined action of betamethasone dipropionate and gentamicin sulfate.

Betamethasone dipropionate is a synthetic fluorinated derivative of hydrocortisone. It has a pronounced anti-inflammatory, antipruritic, anti-allergic and vasoconstrictor effect. Reduces the inflammatory process by reducing the production of prostaglandins and leukotrienes, which leads to inhibition of phospholipase A2 activity and a decrease in the release of arachidonic acid from cell membrane phospholipids. It has an anti-allergic effect by inhibiting local allergic reactions. Due to the local vasoconstrictor effect, it reduces exudative reactions. Reduces protein synthesis, collagen deposition, accelerates protein biotransformation in the skin and inhibits proliferative processes.

Gentamicin sulfate is a broad-spectrum antibiotic from the group of aminoglycosides. The bactericidal effect is caused by a violation of the structure and function of the cytoplasmic membrane, a violation of RNA synthesis at the level of the 30S ribosomal subunit. Active against gram-positive bacteria: Streptococcus spp. (sensitive strains of beta-and alpha-hemolytic streptococcus group A), Staphylococcus spp. (coagulase-positive, coagulase-negative and some penicillinase-producing strains); against gram-negative bacteria: Escherichia coli, Proteus spp., Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Salmonella spp., Shigella spp.

Pharmacokinetics

Suction

Betamethasone dipropionate is a lipophilic substance and is easily absorbed through the stratum corneum of the skin without undergoing biotransformation. Absorption increases when applied to the skin in the area of body folds, on skin with damaged epidermis or on the 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.

Gentamicin sulfate is not absorbed after application to undamaged skin. When used on affected skin, it can be absorbed into the bloodstream.

Metabolism and elimination

Betamethasone dipropionate is biotransformed mainly in the liver. In the form of compounds with glucuronic acid and in a small amount in unchanged form, it is excreted mainly in the urine and in a smaller amount in the bile.

Gentamicin sulfate is not biotransformed in the body and is excreted unchanged in the urine.

Indications

• dry inflammatory skin conditions (dermatoses);
• allergodermatoses complicated by secondary bacterial infection and occurring with severe keratosis, pruritus or severe allergic reactions;
• atopic dermatitis;
• seborrheic dermatitis;
• chronic lichen simplex;
• eczema corneum;
• psoriasis;
• allergic contact dermatitis;
• cutaneous form of lupus erythematosus;
• erythema polymorphic.

Use during pregnancy and lactation

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

Contraindications

• hypersensitivity to the components of the drug;
• viral and fungal infections of the skin;
• skin manifestations of syphilis;
• tuberculosis of the skin;
• pink and juvenile acne;
• phlebitis and trophic ulcers;
• vaccination period and skin post-vaccination reactions;
• children under 2 years of age;
• pregnancy;
• lactation.

With caution: in case of subcutaneous tissue atrophy in the elderly.

Side effects

Local reactions: acne, steroid purpura, inhibition of epidermal growth, atrophy of subcutaneous tissue, dryness, depigmentation or hyperpigmentation of the skin, atrophy of the skin and striae, telangiectasia, folliculitis; when used on the skin of the face, the drug can cause perioral dermatitis.

Allergic reactions: rarely-urticaria, maculopapular rash.

From the endocrine system: after a single application of 7 g of ointment, a reversible decrease in ACTH production in the pituitary gland is possible due to suppression of the pituitary-adrenal system.

From the cardiovascular system: edema, arterial hypertension (with prolonged use).

From the sensory organs: when applied on the skin of the eyelids – glaucoma or acceleration of cataract development; when applying the drug to the mucous membranes or a significant surface of the skin (especially damaged by a pathological process), ototoxicity is possible.

Other: reducing the overall resistance of the body.

Interaction

During treatment, smallpox vaccination should not be carried out, as well as other types of immunization, due to possible violations of the immune response.

Increases the effect of immunosuppressants, reduces the effect of immunostimulating drugs.

How to take, course of administration and dosage

Betaderm ointment is applied, rubbing, on the affected areas of the skin 1-2 times a day. Do not apply the drug under an occlusal dressing, and also carry out treatment without a break for more than 2 weeks.

Overdose

Symptoms: after prolonged use on a large surface of the skin, there may be a decrease in body resistance, arterial hypertension, edema, symptoms of Cushing’s disease.

Symptoms of overdose disappear after discontinuation of the drug.

Special instructions

Given the presence of a strong corticosteroid in the composition of the drug, the drug should be used in the acute period of the disease, for a short time, on a small surface of the skin.

It is necessary to avoid long-term use of the drug, since this increases the frequency of side effects and may lead to the development of bacterial resistance to gentamicin sulfate.

In case of activation of the infection in the area of application of the drug, additional antimicrobial or antifungal treatment should be prescribed. If the symptoms of infection do not go away, it is necessary to stop using the drug for the period of complete cure of the infection.

Do not apply the drug on the skin of the face due to the possibility of telangiectasia, perioral dermatitis. On the skin in the armpit and groin area, the drug should be used only in cases of extreme necessity.

Do not use the drug under an occlusal dressing, because this can lead to atrophy of the epidermis, the appearance of striae, the development of superinfection.

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

Influence on the ability to drive motor vehicles and manage mechanisms

The drug does not limit the psychophysical performance, ability to drive vehicles and maintain moving mechanisms.

Form of production

Ointment for external use

Storage conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 25°C. Do not freeze it.

Shelf

life is 3 years.

Active ingredient

Betamethasone, Gentamicin

Dosage form

ointment

Weight

Weight: 25 gr.