Betamethasone Dipropionate Cream - Indication, Dosage, Precautions, Side Effects, and Pharmacological Aspects

Drug Overview:

Betamethasone topical, a corticosteroid medication, is employed to alleviate symptoms such as itching, redness, dryness, scaling, crusting, inflammation, and discomfort in various skin conditions, including psoriasis (characterized by red, scaly patches on the skin) and eczema (causing dry, itchy skin and occasionally red, scaly rashes). The FDA (Food and Drug Administration) approved the drug on March 10, 2001.

For Patient:

What Are the Clinical Indications for Betamethasone Dipropionate Cream?

Betamethasone dipropionate cream is a topical corticosteroid that may be prescribed by a healthcare professional for the treatment of eczema (atopic dermatitis), itching, and rashes.

What Is the Dosage of Betamethasone Dipropionate Cream?

Betamethasone dipropionate cream, 0.05 percent, has 0.643 milligrams (mg) of Betamethasone dipropionate per gram, equivalent to 0.5 mg of Betamethasone. It comes in a white to off-white ointment base. To treat affected skin areas, apply a thin layer of the cream once or twice a day.

What Are the Things to Inform the Doctor Before Taking Betamethasone Dipropionate Cream?

The patient must inform the doctor if they are on other medications before starting this drug. They should also inform them about the below-mentioned conditions:

• Breastfeeding.

• Diabetes.

• Pregnancy.

• Dental surgery.

• Liver disease.

• Cushing syndrome (a disorder characterized by the prolonged production of excessive cortisol hormone in the body).

How Is Betamethasone Dipropionate Administered?

Apply this drug as an ointment. Treatment should be stopped once the condition is under control, and if there is no noticeable improvement within two weeks, it may be necessary to reevaluate the diagnosis. Betamethasone dipropionate cream, classified as a super-high-potency topical corticosteroid, should not be used in amounts exceeding 50 grams per week due to the risk of suppressing the hypothalamic-pituitary-adrenal (HPA) axis.

What Are the Side Effects of Betamethasone Dipropionate?

Below are some side effects:

• Skin discomfort, including burning, itching, irritation, stinging, redness, or dryness.

• Acne breakouts.

• Undesired hair growth.

• Alterations in skin pigmentation.

• Appearance of bruises or shininess on the skin.

• Development of small red bumps or a rash around the mouth.

• Occurrence of small white or red skin bumps.

Missed Dose:

If an individual misses a dose, they should apply it as soon as they recall. Nevertheless, if it is close to the time for the subsequent dose, they should omit the missed dose and adhere to their usual dosing routine. Doubling the dose to compensate for a missed one should be avoided.

Overdose:

Overdose can lead to an increased risk of side effects, including skin thinning, excessive absorption of the medication into the bloodstream, and potential systemic effects like adrenal gland suppression. Medical professionals will provide appropriate treatment and guidance to manage the situation effectively.

Storage:

Store Betamethasone dipropionate cream in its original container, tightly sealed, and in a location inaccessible to children. Store it at room temperature, keeping it away from excessive heat and moisture (avoid storing it in the bathroom), and make sure not to freeze it.

It is essential to protect all medications from being accessible to children because some containers, like those for eye drops, creams, patches, and inhalers, may not have child-resistant features and can be easily opened by small children. To avoid unintentional poisoning in young children, consistently ensure that safety caps are tightly closed and promptly store the medications in a secure location, placed out of their line of sight and out of their reach.

For Doctors:

Indication:

Betamethasone dipropionate cream is a corticosteroid prescribed to alleviate the inflammatory and itchy symptoms of corticosteroid-responsive dermatoses in patients aged 13 years and older.

Dose:

• Apply a thin layer of Betamethasone dipropionate cream once or twice daily.

• Discontinue treatment upon achieving control.

• Limit use to a maximum of two consecutive weeks.

• Do not exceed 50 grams per week.

• Avoid applying on the face, groin, or axillae or on skin with atrophy at the treatment site.

• This medication is not intended for oral, ophthalmic, or intravaginal use.

Dosing Considerations:

• Apply the cream thinly to the affected skin areas once or twice daily, following the instructions provided by a healthcare provider.

• Do not use the cream with occlusive dressings (bandages or wraps) unless directed by a physician.

• It is important to monitor the skin's response to treatment and report any adverse effects or lack of improvement to a healthcare provider.

• Individuals who are pregnant or breastfeeding should consult their healthcare provider before using this medication, as there may be specific considerations during these periods.

• Although the risk of systemic absorption is lower with topical corticosteroids compared to oral forms, it is still important to be aware of potential side effects and follow the prescribed treatment plan.

• If a woman is using Betamethasone dipropionate cream and experiences a delay in contraceptive pill intake by three hours or more, or if she has vomiting or diarrhea within four hours of taking the pill, she should use a non-hormonal backup form of contraception (for example, condoms or spermicides) for the next 48 hours to reduce the risk of unintended pregnancy.

What Are the Pharmacological Aspects of Betamethasone Dipropionate Cream?

Mechanism of Action:

Betamethasone dipropionate is a synthetic corticosteroid that, when applied topically, binds to skin cell corticosteroid receptors. This binding regulates gene expression, suppressing inflammation by reducing the production of inflammatory molecules and modulating immune cell activity. The cream also causes vasoconstriction, reducing redness and swelling. It inhibits an overactive immune response common in conditions like eczema, providing relief from itching and discomfort. However, prolonged or excessive use may lead to skin thinning, emphasizing the importance of following healthcare provider guidance. Topical corticosteroids like Betamethasone primarily act locally, minimizing systemic effects and immune suppression compared to oral corticosteroids.

Pharmacodynamics:

Betamethasone dipropionate cream delivers potent anti-inflammatory and immunosuppressive effects, reducing the production of inflammatory mediators and immune cell activity while inducing vasoconstriction to minimize redness and swelling. It alleviates itching, acts locally, and provides rapid relief. Prolonged use may lead to skin thinning and other local side effects, requiring careful adherence to prescribed usage. Tolerance may develop, necessitating breaks or alternate treatments. Topical corticosteroids like Betamethasone are designed for minimal systemic effects, but proper dosing is crucial to minimize absorption.

Pharmacokinetics:

The pharmacokinetics of Betamethasone dipropionate cream, when applied topically to the skin, involve the following key aspects:

• Topical Absorption: When Betamethasone dipropionate cream is administered topically, the medication permeates the outermost skin layer known as the stratum corneum.

• Limited Systemic Absorption: The majority of the medication remains in the skin, and only a small amount is absorbed into the bloodstream. This limited systemic absorption is a key feature of topical corticosteroids and helps minimize the risk of systemic side effects.

• Skin Barrier: The stratum corneum acts as a protective barrier that restricts the medication's penetration into deeper layers of the skin and prevents it from entering the bloodstream in significant amounts.

• Metabolism: Once absorbed into the skin, Betamethasone dipropionate undergoes metabolism, or chemical changes, within the skin cells and is converted into its active form.

• Excretion: Any absorbed Betamethasone is eventually metabolized in the liver and then excreted from the body through various mechanisms.

• Duration of Action: The cream's effects are primarily localized to the skin where it is applied. These effects are relatively short-lived, so regular application is necessary to maintain therapeutic levels in the skin.

• Individual Variability: The extent of absorption can vary from person to person and depends on factors such as the thickness and condition of the skin, as well as whether occlusive dressings (bandages or wraps) are used over the cream.

• Potency and Formulation: The cream's potency (how strong it is) and its specific formulation can influence the rate of absorption. More potent formulations may have a greater effect but also carry a higher risk of side effects.

• Duration of Use: Extended or excessive use of the cream can elevate the chances of systemic absorption and potential side effects. Following the prescribed dosing and duration instructions is crucial.

• Systemic Side Effects: While topical corticosteroids are designed to minimize systemic effects, long-term or high-dose use can still lead to systemic side effects, particularly in certain populations or with certain formulations.

• Monitoring: Healthcare providers may monitor patients using Betamethasone Dipropionate cream for signs of systemic effects, especially if the cream is used for an extended period.

Clinical Studies And Efficacy:

• Safety and efficacy assessment of Betamethasone dipropionate cream has been done for the treatment of corticosteroid-responsive dermatoses, including psoriasis (a chronic skin condition characterized by the rapid buildup of skin cells) and atopic dermatitis (skin inflammation and irritation).

• Conducted in three randomized active-controlled trials.

• Two of these trials focused on psoriasis, and one targeted atopic dermatitis.

• A total of 378 subjects participated in these trials.

• Of these, 152 individuals received Betamethasone dipropionate cream.

• Apply the cream twice daily for 14 days.

• Betamethasone dipropionate cream demonstrated effectiveness in relieving signs and symptoms of both psoriasis and atopic dermatitis.

What Are the Contraindications of Betamethasone Dipropionate Cream?

The contraindications are given below:

• Hypersensitivity: Individuals who have a known hypersensitivity or allergy to Betamethasone dipropionate or any of the cream's components should not use this medication. Allergic reactions can range from skin irritation to severe systemic reactions and should be avoided.

• Perioral Dermatitis: Betamethasone dipropionate cream is generally contraindicated for use on or near the face, including the perioral area. Perioral dermatitis is a specific skin condition characterized by a rash around the mouth, and the use of topical steroids in this area can exacerbate the condition.

• Skin Infections: The cream should not be applied to areas of the skin affected by active infections, including bacterial, fungal, or viral infections. Using a corticosteroid in the presence of infection can potentially worsen the infection or mask its symptoms.

• Open Wounds: It is contraindicated to apply Betamethasone dipropionate cream to open wounds, cuts, or ulcerated skin areas. The medication is intended for intact skin and can be harmful if applied to damaged skin.

• Rosacea: In individuals with rosacea, a skin condition characterized by facial redness and flushing, the use of topical steroids like Betamethasone dipropionate cream can exacerbate the condition. Hence, it is typically contraindicated for use on the face.

• Skin Atrophy: If there is evidence of skin atrophy (thinning) at the intended treatment site, it's generally contraindicated to use the cream in that area. Prolonged use of topical corticosteroids can lead to skin thinning, and caution is necessary.

• Vaccinations: Applying Betamethasone dipropionate cream to the skin area where vaccination was recently administered should be avoided. It can potentially interfere with the immune response to the vaccine.

• Pregnancy and Breastfeeding: Though it is not an absolute contraindication, it is advisable to discuss with a healthcare provider about using this medication during pregnancy and breastfeeding. It may be necessary to weigh the potential benefits against the risks in these situations.

What Are the Warnings and Precautions Associated With Betamethasone Dipropionate?

• Betamethasone dipropionate cream can potentially lead to reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which may result in glucocorticosteroid insufficiency. This effect can occur during treatment or after discontinuation.

• Factors that increase the risk of HPA axis suppression include the use of high-potency steroids, application over large skin areas, prolonged use, use of occlusive dressings, compromised skin barrier, liver dysfunction, and young age.

• The evaluation of HPA axis suppression can be done using the adrenocorticotropic hormone (ACTH) stimulation test.

• In a trial assessing the impact of Betamethasone dipropionate cream on the HPA axis, it was found that when applied at a dose of 14 grams per day, the cream suppressed adrenal cortical hormone levels in relation to psoriasis. These effects could be reversed when the treatment was stopped.

• When applied at a dose of 7 grams per day, Betamethasone dipropionate cream caused minimal HPA axis inhibition when used twice daily for two to three weeks in both healthy subjects and those with psoriasis and eczematous disorders.

• Using 6 to 7 grams of Betamethasone dipropionate cream once daily for three weeks did not significantly inhibit the HPA axis in subjects with psoriasis and atopic dermatitis, as assessed by cortisol and urinary 17-hydroxy-corticosteroid levels.

• If HPA axis suppression is confirmed, the medication should be gradually discontinued, the frequency of application reduced, or a less potent corticosteroid considered. In rare cases, signs and symptoms of steroid withdrawal may necessitate systemic corticosteroid supplementation.

• Cushing's syndrome and hyperglycemia (increased blood sugar) are rare events associated with topical corticosteroids and typically occur after prolonged exposure to high-potency formulations.

• Pediatric patients may be more vulnerable to systemic effects due to their larger skin surface relative to body mass.

• There is a potential risk of developing posterior subcapsular cataracts and glaucoma with the use of Betamethasone dipropionate cream. Such effects have been reported in postmarketing data. Patients should be cautioned against getting the cream in their eyes, and any visual symptoms should be reported promptly for evaluation by an ophthalmologist.

• Allergic contact dermatitis may occur with corticosteroid use and is often diagnosed by observing a lack of healing rather than clinical exacerbation. If irritation or allergic reactions develop, discontinuation of topical corticosteroids and appropriate therapy is recommended.

Use in Specific Population:

• Pregnancy: There have not been enough studies on pregnant women to know if using Betamethasone dipropionate cream during pregnancy is safe. It should only be used if the benefits outweigh the potential risks to the baby. In studies with rabbits, a similar substance, Betamethasone dipropionate, caused birth defects like umbilical hernias, cephalocele, and cleft palate when given in high doses through a needle into the muscles.

• Nursing Mothers: Corticosteroids taken by mouth can get into breast milk and affect the baby's growth or natural corticosteroid production. It is not clear if applying corticosteroids on the skin can lead to enough absorption into breast milk to be detected. Since many drugs can end up in breast milk, it is important to be cautious when using Betamethasone dipropionate cream if you are nursing.

• Pediatric Use: Using Betamethasone dipropionate cream in children under 13 years old is not recommended because it can affect their adrenal gland function. In a study with children aged three months to 12 years who had skin problems, applying Betamethasone dipropionate cream led to adrenal suppression in some of them. The younger the child, the more likely it is bound to happen. Kids have a higher risk of experiencing side effects like Cushing's syndrome, slow growth, delayed weight gain, and intracranial hypertension, especially if they use strong corticosteroid creams for a long time. There have also been reports of skin thinning in kids who use these creams. It is best not to use Betamethasone dipropionate cream to treat diaper rash.