Betaderm - instructions for use, dose, side effects, contraindications

Excipients: paraffin liquid 250.00 mg, lanolin alcohol 30.00 mg, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] 20.00 mg, butylhydroxytoluene 0.05 mg, butyl hydroxy anisole 0.05 mg, petrolatum up to 1.0 in

Description:White or almost white translucent mass.

Pharmacotherapeutic group:Glucocorticosteroid for topical use + antibiotic aminoglycoside

ATX: & nbsp

D.07.X.C.01 Betamethasone in combination with other drugs

Pharmacodynamics:Properties of the drug Betaderm® are due to the combined effect of betamethasone and gentamicin.

Betamethasone is a synthetic fluorinated derivative of hydrocortisone, has a strong anti-inflammatory, antipruritic, anti-allergic and vasoconstrictive effect.Reduces inflammatory processes by inhibiting the production of prostaglandins and leukotrienes due to oppression of phospholipase activity A₂ and reducing the release of arachidonic acid from the phospholipids of cell membranes, and also has an antiallergic effect. Due to local vasoconstrictive action reduces exudative reactions. Accelerates biotransformation of protein in the skin and weakens proliferative processes.

Gentamicin refers to antibiotics from the aminoglycoside group, is active against Streptococcus spp. (group A - β-hemolytic and α-hemolytic), Staphylococcus spp. (Staphylococcus aureus - coagulase-positive and coagulase-negative and some strains producing penicillinase), gram-negative bacteria: Escherichia coli, Proteus spp., Pseudomonas aeruginosa, as well as bacteria from the group Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Salmonella spp. and Shigella spp.

Pharmacokinetics:

Suction

Betamethasone easily penetrates the skin through the stratum corneum. Do not undergo biotransformation in the skin and penetrate through it into the body. The absorption of betamethasone through the skin increases when applied to the delicate skin in the fold area, when applied to the skin with damaged epidermis or skin damaged by the inflammatory process.In addition, absorption increases with frequent use of the drug or after application on a significant surface of the skin.

Gentamicin after topical application to intact skin is not absorbed, and after application to the skin, damaged by the pathological process, can be absorbed into the bloodstream.

Metabolism

Betamethasone is biotransformed mainly in the liver.

Excretion

Betamethasone in the form of compounds with glucuronic acid and in small amounts in unchanged form is mainly excreted through the kidneys and in a smaller amount - with bile.

Gentamicin is not biotransformed in the body and is excreted through the kidneys unchanged.

Indications:

Dry, inflammatory conditions of the skin (dermatosis), complicated by a secondary bacterial infection and proceeding with hyperkeratosis, itching:

- atopic dermatitis;

- seborrheic dermatitis;

- simple chronic lichen;

- eczema;

- psoriasis;

- allergic contact dermatitis;

- lupus erythematosus (skin manifestations);

- polymorphic erythema.

Contraindications:

- Pincreased sensitivity to the components of the drug;

- viral and fungal skin infections;

- cutaneous manifestations of syphilis;

- lupus;

- pink and youthful acne;

- phlebitis and trophic ulcers;

- the vaccination period and skin post-vaccination reactions;

- children under 2 years;

- pregnancy;

- lactation period.

Carefully:Atrophy of subcutaneous fat in elderly people.

Pregnancy and lactation:Do not use in pregnant women.

It is recommended to stop breastfeeding for the duration of treatment.

Dosing and Administration:

Outwardly. Apply a small amount of the drug to the affected skin 1-2 times a day. Continuous use of the drug within a week should not exceed 45 g. The duration of treatment depends on the effectiveness and tolerability of therapy and is, as a rule, no more than 2-4 weeks.

Side effects:

Very rarely, when using the drug Betaderm®, there are: burning sensation, erythema, exudation, pigmentation disorder and itching.

There may be: acne, steroid purpura, suppression of epidermal growth, subcutaneous fat atrophy, dry skin, depigmentation or hyperpigmentation of the skin, skin and stria atrophy, telangiectasia, folliculitis. Sometimes there may be hives or a spotty-papular rash.

With long-term use or when applied to a large surface, systemic side effects characteristic of glucocorticosteroids (oppression of adrenal cortex function, weight gain, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of hidden foci of infection, hyperkalemia, excitation, insomnia, menstrual disorder).

After application on the skin of the face, the drug can cause perioral dermatitis, and after application to the skin, the eyelids sometimes can cause increased manifestation of glaucoma or accelerate the development of cataracts. In addition, given the presence of gentamicin, symptoms of ototoxicity may appear if the drug is applied to mucous membranes or a significant surface of the skin, in particular damaged by the pathological process.

In children (side effects are additional to side effects in adults) - oppression of the hypothalamic-pituitary-adrenal system, Itenko-Cushing syndrome, growth retardation, lag in weight gain, increased intracranial pressure (betamethasone).

Overdose:

Overdose is very rare. However, with prolonged use and the use of local glucocorticosteroids on a large surface, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Itenko-Cushing syndrome, is possible. An overdose of gentamicin can lead to an increase in insensitive flora.

Treatment: symptomatic. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correct the electrolyte balance.

Interaction:The drug can enhance the action of immunosuppressive drugs and weaken the action of immunostimulating drugs.

Special instructions:

It is necessary to avoid long-term use, as this increases the incidence of side effects and the resistance of bacteria to gentamicin may develop.

Do not use the drug on the skin of the face in connection with the possibility of the appearance of telangiectasias even after a short application.

Do not allow Betaderm® to enter the eyes and periorbital area.

Some areas of the body (inguinal folds, axillary cavities and perianal region) are more susceptible to the risk of striae. Therefore, the duration of application of the drug in these areas should be limited. With long-term use of the drug Betaderm® on large surfaces of the skin with compromised integrity, there is the potential for absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity.

Do not use the drug under an occlusive dressing.

If there is an extreme need for dressing, then a bandage that allows air to be applied and not to use a sealing, glue bandage should be applied.

In cases of fungal superinfection, an additional use of an antifungal drug is necessary.

Children. Children are allowed to prescribe the drug from two years only on strict indications and under the supervision of a doctor.

In connection with the fact that in children the area of the skin with respect to the body weight is greater, as well as the epidermis is not sufficiently developed, with external application of the drug, it is possible to absorb proportionally more active substances and, consequently,there is a greater risk of developing systemic side effects. Use the drug in children should be as short as possible and with all precautions.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of the drug on the ability to control vehicles and mechanisms are not available.

Form release / dosage:

Ointment for external use, 0.05% + 0.1%.

Packaging:

For 15 grams of ointments in aluminum tubes with a varnished inner surface. The tube is placed in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-003630/10

Date of registration:30.04.2010 / 04.10.2013

Expiration Date:Unlimited

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

PHARMACEUTICAL WORKS JELFA, S.A. Poland

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp24.01.2017

Illustrated instructions

Instructions

Betaderm® (Betaderm®)