Bedicort G – composition, action, indications, dosage, side effects

Proven content

Bedicort G is an antibiotic ointment drug mainly used in allergology and dermatology. The ointment is used topically in the treatment of inflammatory skin lesions, showing a strong anti-inflammatory, antipruritic and vasoconstrictive effect. The active substances are two substances: betamethasone as betamethasone dipropionate and gentamicin as gentamicin sulfate. It is indicated for use by people over 12 years of age and only by people who have been prescribed this drug. What is the full composition of Bedicort G? How does this preparation work? What are the indications and contraindications to its use and what side effects can it cause? How to use the ointment and what precautions should be taken when using it?

Bedicort G – basic information

Bedicort G is a white to off-white translucent ointment for use on the skin. The preparation can be obtained with a prescription for the local treatment of inflammatory skin lesions complicated by secondary bacterial infection.

The active substances of Bedicort G ointment are betamethasone as betamethasone dipropionate and gentamicin as gentamicin sulphate.

The international name of the ointment comes from its active substances and is: Betamethasonum + Gentamicinum.

Bedicort G is available in 15 g or 30 g ointments packed in an aluminum tube with a protective membrane and HDPE or PP screw cap in a cardboard box.

The ointment should be stored at room temperature, i.e. 15 ° C – 25 ° C (do not freeze), out of the sight and reach of children.

Bedicort G is only sold stationary and its price is not refundable. The price for a 15 g package is around PLN 21, while for a 30 g tube it is around PLN 30.

Before using the ointment, read the package leaflet carefully and if you have any doubts, consult your doctor or pharmacist.

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Bedicort G – composition and mode of operation

Bedicort G is a combined preparation containing 2 active substances: gentamicin with an antibacterial effect and betamethasone with an anti-inflammatory effect.

1 g of ointment contains 0,5 mg of betamethasone (in the form of betamethasone dipropionate) and 1 mg gentamicin (as gentamicin sulfate).

Gentamicin is an antibiotic of the aminoglycoside group. It is active against streptococci (group A: beta-hemolytic and alpha-hemolytic), staphylococci (Staphylococcus aureus-coagulase-positive and coagulase-negative, and some penicillinase-producing strains), as well as gram-negative bacteria, including Escherichia coli, Proteus spp., Pseudomonas aeruginosa and bacteria of the genus Klebsiella, Enterobacter, Serratia, Citrobacter, Salmonella and Shigella. The mechanism of action of this substance is to inhibit the synthesis of bacterial proteins.

On the other hand, betamethasone, which is a powerful drug from the group of corticosteroids, has a quick and long-lasting anti-inflammatory, antipruritic and vasoconstrictive effect. Its local vasoconstrictor action reduces exudative reactions.

The properties of Bedicort G ointment result from the combined action of betamethasone dipropionate and gentamicin sulfate.

After topical administration, gentamicin and betamethasone enter the circulation to a small extent. Betamethasone dipropionate easily penetrates the skin through the stratum corneum. Gentamicin sulfate is not absorbed when applied topically to intact skin, while when applied to damaged skin, it is absorbed into the body and is excreted unchanged in the urine.

In addition to the two active substances, Bedicort G includes excipients such as liquid paraffin, lanolin sterol alcohols, cetostearyl alcohol, butylhydroxytoluene, butylhydroxyanisole and white petroleum jelly.

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Bedicort G – dosage and method of administration

Bedicort G ointment should always be used in accordance with the information contained in this leaflet or as instructed by your doctor and pharmacist.

The drug is an ointment intended for use on the affected skin. Due to the content of a potent corticosteroid, the preparation should be used at the beginning of treatment, for a short time and on small areas of the skin.

It is recommended to dose Bedicort G in a small amount to the affected area of ​​skin once or twice a day for a period not exceeding 2 weeks.

Bedicort G ointment should be applied in a thin layer to a small area of ​​the skin without the use of any occlusive (closed) dressings or compresses that may enhance the absorption of active substances. The preparation should not be used on the skin of the face, on large surfaces, especially damaged skin, e.g. as a result of burns.

Bedicort G ointment should not be used for a long time due to the developing bacterial resistance.

Particular care should be taken with the existing atrophy of subcutaneous tissue, especially in the elderly.

The preparation should not be used in children under 12 years of age. Follow the instructions in the package leaflet and your doctor’s instructions.

If you use more than the recommended dose of the drug, immediately consult your doctor or pharmacist. A single administration of about 7 g of the drug may cause a reversible reduction in the secretion of adrenocorticotropic hormone (ACTH) by the pituitary gland as a result of inhibition of the adrenal-pituitary axis.

Incorrect dosage and application of Bedicort G ointment, may cause the symptoms of Cushing’s syndrome, systemic side effects such as hearing and kidney damage, inhibition of growth and development in children, excessive blood glucose, glucosuria, edema, hypertension.

If you miss a dose, do not take a double dose to make up for the forgotten dose.

Treatment with Bedicort G ointment will be effective and safe as long as the recommendations are followed and any doubts related to its use are discussed with the attending physician.

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Bedicort G – indications for use

Bedicort G ointment is mainly indicated for topical use in the treatment of oozing skin inflammations (dermatoses, especially allergic dermatoses) that are associated with hyperkeratosis, itching or severe allergic reaction, and are complicated by secondary infection with gentamicin-sensitive bacteria.

In addition, the preparation is indicated for use in:

1. seborrheic dermatitis (PsA);
2. atopic dermatitis (AD);
3. keratotic eczema;
4. chronic simple lichen;
5. psoriasis;
6. allergic contact dermatitis;
7. cutaneous lupus erythematosus,
8. erythema multiforme.

Due to its potent corticosteroid content, Bedicort G should only be used for a short time at the start of treatment and on small areas.

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Bedicort G – contraindications to use

Bedicort G ointment, although there are indications for its use, may not always be used in every patient. The main contraindication to the use of this drug is hypersensitivity, i.e. allergy to betamethasone dipropionate, gentamicin or any of the other ingredients of Bedicort G ointment.

Contraindications to the use of Bedicort G ointment also include certain diseases and circumstances that may require the complete abandonment of this drug or a change in the dosage of the preparation.

The use of Bedicort G ointment may also require specific follow-up examinations and a thorough medical history.

Bedicort G ointment should also not be used in the course of:

1. skin cancer;
2. viral skin infections such as chicken pox, cold sores;
3. fungal or bacterial (e.g. tuberculosis) skin infections;
4. rosacea, common acne;
5. inflammation or ulceration of varicose veins;
6. extensive skin lesions that lead to skin loss, e.g. after burns;
7. infections with gentamicin-resistant bacteria;
8. skin inflammation around the mouth, anus and genitals.

In addition, the drug should not be used for a long time and in children up to 12 years of age. The preparation is intended only for external use, topically on the skin after consultation with a doctor who will individually assess the risk of using the ointment by the patient.

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Bedicort G – possible side effects

Bedicort G ointment, like all medicines, may cause side effects that do not have to occur in every person using this medicine. After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The use of Bedicort G ointment may cause skin and subcutaneous tissue disorders such as: acne-like lesions, steroid purpura, inhibition of epidermal growth, subcutaneous tissue atrophy, dry skin, skin discoloration or discoloration, skin atrophy and stretch marks, folliculitis, excessive skin hairiness or allergies contact dermatitis.

Urticaria or maculo-papular rash may also occur after use. On the other hand, after applying the ointment to the skin of the face, inflammation of the skin around the mouth may occur.

The long-term use of the ointment (over 2 weeks), on large skin areas, on damaged skin, in the case of closed compresses and in the case of use in children, may lead to endocrine disorders due to the increased absorption of betamethasone dipropionate into the circulation.

Among these side effects are: systemic side effects characteristic of corticosteroids, e.g. suppression of the hypothalamic-pituitary-adrenal axis, Cushing’s syndrome, inhibition of growth and development in children, hyperglycemia, glucosuria, edema, hypertension or decreased immunity.

Bedicort G can also cause immune disorders, eye disorders (worsening of glaucoma symptoms or accelerated cataract development) and dilation of superficial blood vessels.

The gentamicin in the ointment can cause ototoxicity symptoms, especially when applied to large areas of skin or to damaged skin. In addition, this substance increases the risk of kidney damage, especially in the case of concomitant use of nephrotoxic drugs and in the case of renal dysfunction.

Although Bedicort G ointment may cause side effects in some patients using the drug, it should be remembered that the expected benefits of using the drug are usually greater than the harm resulting from the occurrence of side effects.

If you experience any of the side effects listed above or other, please contact your doctor or pharmacist. You can also report side effects to the Marketing Authorization Holder so that they can provide more information on the safety of this medicine.

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Bedicort G – Warnings and Precautions

The use of Bedicort G ointment should always be discussed with your doctor or pharmacist.

It is very important to take precautions, especially when using the ointment during pregnancy or during lactation and breastfeeding. There are no studies on the safety of the topical administration of betamethasone and gentamicin in pregnant women. However, the use of the ointment in pregnant women is not recommended as the active substances are absorbed through the skin.

It is also unknown to what extent betamethasone may pass into breast milk in nursing mothers, therefore discontinuation of breastfeeding or the use of Bedicort G ointment should be considered taking into account the risk of adverse effects in children and the benefit of treatment to the mother.

The active substances of the ointment can be absorbed through the skin and cause a number of side effects. The skin should be monitored while using the ointment, and if an allergic reaction occurs, the ointment should be discontinued immediately.

The preparation must also not be used on the skin of the face, as it may be associated with the risk of telangiectasia or dermatitis perioralis.

Also, special care should be taken when applying the drug to the skin of the armpits or groin, because the skin is particularly sensitive there and the drug should be used only in cases of absolute necessity.

Treatment should be avoided in people who have been diagnosed with impaired liver or kidney function and in children.

Precautions should also be taken in the elderly, especially if there are atrophies in the subcutaneous tissue.

People with psoriasis should take special precautions as topical application of corticosteroids in psoriasis can be dangerous, including due to the relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis and general toxic effects due to the disruption of the skin.

Bedicort G may increase the effect of immunosuppressants, as well as reduce the effect of immunostimulants. Therefore, you should take precautions and inform your doctor about all the medications you are taking or have recently taken, and about any medications you plan to start taking.

During treatment with glucocorticoids, neither smallpox nor other vaccinations should be given.

In any case, before prescribing Bedicort G ointment, the physician should individually assess the risk of using the drug by the patient and the patient should take all precautions when using the ointment.

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