Betnovate cream (Betamethasone)

What Is Betamethasone Cream (Betnovate)?

Betamethasone is a synthetic glucocorticosteroid for external use. It has high glucocorticosteroid activity and only minimal mineralocorticoid effect.

What does Betnovate cream do? When betamethasone is used topically, the cream may be absorbed to a lesser extent by normal, uninjured skin; systemic absorption of corticosteroids is expected only under unfavourable conditions (e.g., skin inflammation, prolonged treatment, or use under occlusive dressings).

Because of their anti-inflammatory, antipruritic, and vasoconstrictive effects, topical glucocorticosteroids such as betamethasone should preferentially be used to treat corticosteroid-sensitive dermatoses.

Active pharmaceutical ingredients:

• Betamethasone 0.05% is a glucocorticoid. It has anti-inflammatory, anti-allergic, anti-edematous, and antipruritic effects;
• Gentamicin 0.1% is a broad-spectrum aminoglycoside antibiotic. It inhibits bacterial protein synthesis and is highly active against aerobic gram-negative bacteria;
• Ketoconazole 1% is a broad-spectrum antifungal agent that is active against dermatophytes, yeasts, and dimorphic fungi. It is also active against staphylococci and streptococci.

Ingredients: caprylic/capric triglycerides, propylene glycol, Vaseline, emulsifier, purified water.

In Australia, betamethasone creams are available under several brand names, including:

• Betnovate (betamethasone valerate);
• Diprosone (betamethasone dipropionate);
• Eleuphrat (betamethasone dipropionate);
• Cortival (betamethasone valerate).

These products are commonly prescribed for various inflammatory skin conditions.

In Australia, the Therapeutic Goods Administration (TGA) is the national regulatory authority responsible for approving medicines, including betamethasone creams. All the aforementioned brands are listed in the Australian Register of Therapeutic Goods (ARTG), indicating their approval for use in the country. The TGA's assessment process includes reviewing clinical data to ensure the safety and efficacy of medicines before approval.

Indications

For reduction of inflammatory manifestations of dermatoses sensitive to GCS therapy, such as all types of eczema and dermatitis (including atopic eczema and photodermatitis), lichen planus, nodular prurigo, discoid lupus erythematosus, lipoid necrobiosis, pretibial myxedema, and erythroderma. It may also be effective in the treatment of psoriasis of the scalp and plaque psoriasis of the upper and lower extremities, except for widespread plaque psoriasis.

Betamethasone creams are classified as Schedule 4 (Prescription Only Medicine) in Australia. This means they can only be dispensed with a valid prescription from a licensed healthcare professional.

Contraindications

Betamethasone is contraindicated in patients with allergic reactions to any of the drug components.

Betamethasone is contraindicated in the following cases:

• viral infections, including postvaccination reactions and chickenpox;
• viral skin infections (e.g., herpes simplex, shingles, varicella);
• acne rosacea.

The use of betamethasone cream under occlusive dressings (plaster, etc.) is not recommended. Prolonged treatment and/or use over a large area of the skin should be avoided because the active ingredient may be absorbed.

How Betamethasone Works

Betamethasone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins, and fats. It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, skin, and bone tissue. Osteoporosis and Itzenko-Cushing's syndrome are the main factors limiting long-term GCS therapy.

If you use betamethasone regularly and want to stop taking it, you should talk to your doctor before stopping this medicine, as your condition may get much worse if you stop taking it suddenly. If you have any further questions, contact your doctor or pharmacist.

Betnovate Cream Uses

Use Betnovate cream only according to the indication, route of administration, and dose given in the instructions for use.

Betamethasone creams are available in various formulations and strengths in Australia:

• Betnovate: Available as a 0.1% cream and ointment.
• Diprosone: Available as a 0.05% cream, ointment, and lotion.
• Eleuphrat: Available as a 0.05% cream and ointment.
• Cortival: Available as a 0.2mg/g (0.02%) cream.

These formulations cater to different severities and types of skin conditions.

Method of administration

1. Betamethasone is usually applied once or twice a day. The frequency of use may decrease as the skin condition improves.
2. This cream is intended for use on the skin only.
3. Do not exceed the prescribed dose.
4. Do not use betamethasone on a large area of the skin for a prolonged time (every day for weeks or months) unless your doctor has prescribed it.
5. Pathogens can promote infection in warm and humid conditions under occlusive dressings. Always rinse your skin before applying a new dressing to help prevent skin infections.
6. If you apply the cream to someone else, wash your hands thoroughly before application or use disposable gloves.
7. If your skin condition does not improve within 2-4 weeks, see your doctor.

Eczema

Eczema is a skin inflammatory disease with a variety of primary and secondary symptoms, including polymorphic rashes. Treatment of this dermatological pathology is a rather long and laborious process aimed at eliminating all irritating factors. It should be carried out as part of a comprehensive approach, which includes local therapy and desensitisation of the body and, if necessary, the correction of systemic diseases and autonomic disorders.

Betamethasone cream for eczema has an exfoliating, antipruritic, and soothing effect. It contributes to the restoration of damaged skin. It suppresses the action of pathogenic agents that have provoked the development of psoriasis or eczema. A positive effect is also achieved thanks to the soothing, moisturising, and disinfecting properties of these medicines.

What is the difference between eczema and atopic dermatitis? Modern science often groups these two conditions together because they exhibit the same symptoms (redness of the skin, itching, swelling, rash), are triggered by the same allergens (food, household, etc.), and are treated with the same drugs.

The main method of treatment of dermatitis and eczema is topical therapy with glucocorticosteroids. Some people are prejudiced against hormones and are afraid to use them even topically. However, there is no reason for such fears.

If you use GCS externally in the right mode (not more than 2 times a day, gently rubbing in a thin layer in an amount no greater than is necessary to cover the entire affected area, until the effect is achieved, but not more than for 4 weeks), there is no reason to fear adverse reactions. This is because topical agents act at the site of application without having a systemic effect on the entire body, as is the case with oral GCS.

Contact Dermatitis

Allergic contact dermatitis, unlike simple contact dermatitis, does not develop from the first contact with an irritant or the first exposure. It may take up to several weeks after initial contact for the allergic reaction (sensitisation) to develop. Then dermatitis develops on repeated contact. The inflammatory skin reaction is not consistent with the intensity of the irritant, which will not cause any changes in non-allergic people. The area of change on the skin may extend beyond the contact.

Simple dermatitis occurs acutely or chronically. Acute dermatitis is characterised by pronounced inflammation accompanied by itching, burning, pain, and sometimes by the formation of blisters and areas of necrosis that leave scars. If dermatitis occurs, it is better to see a doctor rather than self-treat. In the treatment of simple contact dermatitis, the main thing is to stop the irritant. Often patients, understanding the cause of the disease, cope with it on their own. However, there are cases (for example, severe chemical and thermal burns, frostbite) when a doctor's intervention is necessary.

Betamethasone cream meets the highest requirements for drugs used in dermatological practice for external application. It has minimal resorptive effect and practically no systemic effect. This is a major advantage of modern GCS-containing topical preparations over first-generation steroid ointments.

Psoriasis

Modern pharmacology has made a lot of effort to ensure that the patient has a choice of highly effective psoriasis medicines that help against exacerbations and complications. Since the course of the disease is always individual and manifests itself differently in each patient, the treatment of the disease also depends on the individual case. The therapy of a multifactorial disease is always carried out in a comprehensive manner. The complex pathogenetic mechanism of psoriasis development leads to morphofunctional changes in the whole organism; that is why different pharmacological groups use drugs for the treatment of patients.

Betamethasone is an external form, which is the main one in the treatment of this disease. This is justified by the fact that first of all the skin is affected. When a special therapeutic cream is applied to the surface of the skin, its absorption occurs immediately, which carries the greatest therapeutic benefit. In this case, healthy areas of the skin are practically unaffected, which helps prevent the penetration of active elements into the systemic bloodstream. This is very important since many psoriasis medicines have certain side effects.

If the patient has psoriatic plaques on the elbows or knees, the doctor may recommend applying the cream under sealed occlusive dressings. However, this is usually recommended when applying the cream at night to enhance the effect. You should return to the normal cream application mode after a short period.

Betamethasone Side Effects

The frequency and severity of betamethasone side effects depend on the duration of betamethasone dipropionate use and the size of the dose used. High doses or prolonged use of GCS may cause marked mineralocorticoid and glucocorticoid effects that are considered side effects.

Common side effects reported with the use of betamethasone creams in Australia include skin irritation, such as burning, itching, or redness at the application site. Prolonged use may lead to skin thinning or stretch marks. Some individuals might experience allergic reactions, including rash or swelling. It's essential to use the medicine as directed to minimise potential side effects.

External betamethasone cream use may result in:

• skin itching,
• burning,
• irritation,
• acne-like rashes,
• hypopigmentation,
• perioral dermatitis,
• allergic contact dermatitis.

During long-term treatment it is necessary to carefully monitor growth and development dynamics in children, periodically perform ophthalmologic examination (to detect glaucoma, cataracts, etc.), regularly monitor the hypothalamic-pituitary-adrenal system function, blood and urine glucose content (especially in diabetic patients), serum electrolytes, and hidden blood in faeces. In the case of systemic use, EEG control is recommended.

Common Side Effects

Common side effects: Burning sensation, pain, irritation, or itching in the areas where the ointment is applied.

Serious Side Effects

Serious side effects may occur with prolonged use: skin maceration, secondary infection, skin atrophy, local hirsutism, telangiectasia, sweating, purpura.

Serious Allergic Reaction

Allergies are genetic diseases, i.e., predisposition to develop allergies is inherited. For example, if one parent suffers from allergies, the likelihood of the child developing allergic diseases is 25-40%. If both parents suffer from allergies, the likelihood increases to 50-75%. It also depends on several other factors that contribute to the emergence of allergies in children, which include the level of antigenic load (living conditions, improper diet) and the environment.

When used systemically, the therapeutic activity of betamethasone is due to its anti-inflammatory, anti-allergic, immunosuppressive, and antiproliferative effects. When used topically, the therapeutic activity of betamethasone is due to anti-inflammatory, anti-allergic, and anti-exudative effects (due to the vasoconstrictor effect).

Overdose Symptoms and Treatment

Excessive or prolonged use of topical corticosteroids may cause suppression of pituitary-adrenal function, resulting in secondary adrenal insufficiency.

Symptoms and Signs

Although acute overdose is unlikely, a chronic overdose may occur with excessive or prolonged use and may lead to hypercorticism: hyperglycaemia, glucosuria, reversible depression of adrenal function, Icenko-Cushing's syndrome.

Treatment

Gradual withdrawal of the medicine and, if necessary, symptomatic treatment is recommended.

Special Warnings and Precautions for Use

Prolonged external application on the face is not recommended; rosacea, perioral dermatitis, and acne may develop. The course of treatment should not exceed 5 days.

During prolonged treatment, if the medicine is applied to a large surface of the body, as well as in axillae and groin folds, when using occlusive dressings or nappies, systemic absorption of glucocorticosteroids is possible.

Consult your doctor or pharmacist before using betamethasone:

1. If you have had a previous allergic reaction to other steroids.
2. If you plan to apply the medicine under a tight bandage or nappy on a baby, as absorption of the active ingredient through the skin increases under them. This can lead to the risk of excessive absorption of the medicine.
3. If you have psoriasis, you should consult your doctor more often.
4. When treating chronic leg ulcers, there may be an increased risk of allergic reaction or infection.
5. When applied to large areas of skin.
6. When applying the cream to damaged skin or skin folds.
7. When used near the eyes or on the eyelids, this may cause cataracts or glaucoma if the cream repeatedly gets into the eyes.
8. When applied to thin areas of skin, such as the face, or in children, whose skin is thinner than that of adults, which can lead to increased absorption.
9. When applying the cream to the face or in children, the use of occlusive dressings or bandages is not recommended.
10. The course of treatment with betamethasone in children or for facial lesions should not exceed 5 days.

If in any doubt about your condition, ask your doctor or pharmacist before using betamethasone.

Fertility, Pregnancy, and Lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Cautions With Other Medicines

Due to the presence of white soft paraffin and mineral oil, applying betamethasone cream in the anogenital area may damage the structure of latex condoms and reduce their safety when used during treatment.

Storage and Disposal of Betamethasone Topical

Store in the original container at a temperature not exceeding 25ºC. Do not freeze. Keep out of the reach of children.