Betaderm, 0.05%+0.1% ointment 15 g

A 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 hydrocortisone derivative containing fluorine. It has a pronounced anti-inflammatory, antipruritic, anti-allergic and vasoconstrictor effect. It reduces inflammation due to lower production of prostaglandins and leukotrienes, which leads to inhibition of phospholipase A2 activity and reduction of arachidonic acid release from phospholipids of cell membranes. It has anti-allergic effect by inhibiting local allergic reactions. Due to the local vasoconstrictor action it reduces the exudative reactions. It reduces protein synthesis, collagen deposition, accelerates biotransformation of proteins in the skin and inhibits proliferative processes.

Gentamicin sulfate is a broad-spectrum antibiotic of the aminoglycoside group. Bactericidal activity is caused by disruption of structure and function of cytoplasmic membrane, disruption of RNA synthesis at 30S ribosomal subunit level. 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

Absorption

Betamethasone dipropionate is a lipophilic substance and is easily absorbed through the stratum corneum without biotransformation. Absorption is increased when applied to the skin in body folds, on skin with damaged epidermis or in areas of inflammation, when using the product frequently or after application over a large area of skin. Absorption of betamethasone dipropionate through the skin in children is faster than in adults.

Gentamicin sulfate is not absorbed after application to intact skin. When used on the affected skin it may be absorbed into the bloodstream.

Metabolism and excretion

Betamethasone dipropionate is biotransformed mainly in the liver. As compounds with glucuronic acid and in small amounts unchanged it is excreted mainly in the urine and in smaller amounts in the bile.

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

Indications

Active ingredient

Composition

1 g ointment for external use contains:

acting substances:

Betamethasone (in the form of dipropionate) 500 µg,

gentamicin (in the form of sulfate) 1 mg,

complementary substances:

liquid paraffin,

lanolinic alcohol,

cetostearyl alcohol,

How to take, the dosage

Betaderm ointment is applied by rubbing on the affected areas of the skin 1-2 times a day. The drug should not be used under an occlusive dressing, and treatment should not be interrupted for more than 2 weeks.

Interaction

Vaccination against smallpox and other types of immunization should not be performed during treatment due to possible immune response disorders.

It enhances the effect of immunosuppressants, reduces the effect of immunostimulant drugs.

Special Instructions

Given the potent GCS in the drug, the drug should be used in the acute period of the disease, for short periods of time, on a small surface area of the skin.

Long-term use of the drug should be avoided because it increases the incidence of side effects and resistance of bacteria to gentamicin sulfate may develop.

If infection is active in the area of application, additional antimicrobial or antifungal treatment should be prescribed. If the symptoms of the infection persist, the drug should be discontinued while the infection is fully cured.

The drug should not be used on the face due to the possibility of telangiectasia, perioral dermatitis. The drug should only be used on the skin in the axillary and inguinal areas if absolutely necessary.

The drug should not be used under an occlusive dressing, as it can cause atrophy of the epidermis, stretch marks and superinfection.

With caution, use with subcutaneous atrophy, especially in the elderly.

Impact on ability to drive and operate machinery

The drug does not limit psychophysical performance, ability to drive vehicles and operate moving machinery.

Contraindications

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

Side effects

Local reactions: acne, steroid purpura, suppression of epidermal growth, subcutaneous atrophy, dryness, skin depigmentation or hyperpigmentation, skin atrophy and stretch marks, telangiectasia, folliculitis; when used on the face the drug may cause perioral dermatitis.

Allergic reactions: rare – urticaria, maculopapular rash.

Endocrine system disorders: already after a single use of 7 g of the ointment a reversible decrease of ACTH production in the pituitary gland due to inhibition of the pituitary-adrenal system is possible.

Cardiovascular system: edema, arterial hypertension (with prolonged use).

Sensory system disorders: glaucoma or cataract acceleration when applied to the eyelids; ototoxicity is possible if the drug is applied to mucous membranes or large skin surface (especially if pathologically damaged).

Others: decrease in general resistance of the body.

Overdose

Symptoms: after prolonged use on a large surface of the skin, decreased body resistance, arterial hypertension, edema, symptoms of Cushing’s disease are possible.

The symptoms of overdose disappear after discontinuation of the drug.

Pregnancy use

The drug is contraindicated in pregnancy and during lactation (breast-feeding).

Similarities